Important Safety Information

Table of Contents

Wegovy®

What is the most important information I should know about Wegovy®?

Wegovy® may cause serious side effects, including:

  • Possible thyroidtumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid In studies with rodents, Wegovy® and medicines that work like Wegovy® caused thyroid tumors, including thyroid cancer. It is not known if Wegovy® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people
  • Do not use Wegovy® if you or any of your family have ever had a type of thyroidcancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Do not use Wegovy® if:

  • you or any of your family have ever had a type of thyroidcancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy®

Before using Wegovy®, tell your healthcare provider if you have any other medical conditions, including if you:

  • have or have had problems with your pancreas or kidneys
  • have type 2 diabetes and a history of diabetic retinopathy
  • have or have had depression, suicidal thoughts, or mental health issues
  • are pregnant or plan to become pregnant. Wegovy® may harm your unborn baby. You should stop using Wegovy® 2 months before you plan to become pregnant
  • are breastfeeding or plan to breastfeed. It is not known if Wegovy® passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy® may affect the way some medicines work and some medicines may affect the way Wegovy® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy® slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

What are the possible side effects of Wegovy®?

Wegovy® may cause serious side effects, including:

  • inflammation of your pancreas (pancreatitis). Stop using Wegovy® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
  • gallbladder problems. Wegovy® may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools
  • increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines for type 2 diabetes such as sulfonylureas or insulin. This can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy®. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery
  • kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration
  • serious allergic reactions. Stop using Wegovy® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat
  • change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy®
  • increased heart rate. Wegovy® can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes
  • depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you

The most common side effects of Wegovy® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, gas, stomach flu, heartburn, and runny nose or sore throat.

Please click here for Prescribing Information and Medication Guide for Wegovy®.

Wegovy® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

What is RYBELSUS®?

RYBELSUS® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.

  • It is not known if RYBELSUS® can be used in people who have had pancreatitis
  • RYBELSUS® is not for use in people with type 1 diabetes
  • It is not known if RYBELSUS® is safe and effective for use in children under 18 years of age

What is the most important information I should know about RYBELSUS®?

RYBELSUS® may cause serious side effects, including:

  • Possible thyroidtumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid In studies with rodents, RYBELSUS® and medicines that work like RYBELSUS® caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

Do not use RYBELSUS® if:

  • you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • you have had a serious allergic reaction to semaglutide or any of the ingredients in RYBELSUS®. See symptoms of serious allergic reaction in “What are the possible side effects of RYBELSUS®?”

Before using RYBELSUS®, tell your healthcare provider if you have any other medical conditions, including if you:

  • have or have had problems with your pancreas or kidneys
  • have a history of vision problems related to your diabetes
  • are pregnant or plan to become pregnant. It is not known if RYBELSUS® will harm your unborn baby. You should stop using RYBELSUS® 2 months before you plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant
  • are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with RYBELSUS®

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RYBELSUS® may affect the way some medicines work and some medicines may affect the way RYBELSUS® works.

How should I take RYBELSUS®?

  • Take RYBELSUS® exactly as your healthcare provider tells you to
  • Take RYBELSUS® by mouth on an empty stomach when you first wake up with a sip of plain water (no more than 4 ounces)
  • Do not split, crush, or chew. Swallow RYBELSUS® whole
  • After 30 minutes, you can eat, drink, or take other oral medicines
  • If you miss a dose of RYBELSUS®, skip the missed dose and go back to your regular schedule

What are the possible side effects of RYBELSUS®?

RYBELSUS® may cause serious side effects, including:

  • inflammation of your pancreas (pancreatitis).Stop using RYBELSUS® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
  • changes in vision.Tell your healthcare provider if you have changes in vision during treatment with RYBELSUS®
  • low blood sugar (hypoglycemia).Your risk for getting low blood sugar may be higher if you use RYBELSUS® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery
  • kidney problems (kidney failure).In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration
  • serious allergic reactions.Stop using RYBELSUS® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat
  • gallbladder problems.Gallbladder problems have happened in some people who take RYBELSUS®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include: pain in your upper stomach (abdomen), yellowing of skin or eyes (jaundice), fever, and clay-colored stools

The most common side effects of RYBELSUS® may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting, and constipation. Nausea, vomiting, and diarrhea are most common when you first start RYBELSUS®.

Please see Prescribing Information and Medication Guide for RYBELSUS®.

RYBELSUS® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is Saxenda®?

Saxenda® (liraglutide) injection 3 mg is an injectable prescription medicine used for adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30), and children aged 12-17 years with a body weight above 132 pounds (60 kg) and obesity to help them lose weight and keep the weight off. Saxenda® should be used with a reduced calorie diet and increased physical activity.

  • Saxenda® and Victoza® have the same active ingredient, liraglutide, and should not be used together or with other GLP-1 receptor agonist medicines
  • It is not known if Saxenda® is safe and effective when taken with other prescription, over-the-counter medicines, or herbal weight-loss products
  • It is not known if Saxenda® is safe and effective in children under 12 years of age
  • It is not known if Saxenda® is safe and effective in children aged 12 to 17 years with type 2 diabetes

Do not share your Saxenda® pen with others even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

What is the most important information I should know about Saxenda®?

Serious side effects may happen in people who take Saxenda®, including:

Possible thyroid tumors, including cancer. Tell your health care professional if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Saxenda® and medicines that work like Saxenda® caused thyroid tumors, including thyroid cancer. It is not known if Saxenda® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Do not use Saxenda® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Who should not use Saxenda®?

Do not use Saxenda® if:

  • you or any of your family have ever had MTC or if you have MEN 2
  • you have had a serious allergic reaction to liraglutide or any of the ingredients in Saxenda®. See symptoms of serious allergic reactions in “What are the possible side effects of Saxenda®?”
  • you are pregnant or plan to become pregnant. Saxenda® may harm your unborn baby

Before taking Saxenda®, tell your health care provider about all of your medical conditions, including if you:

  • are taking certain medicines called GLP-1 receptor agonists
  • have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food
  • have or have had problems with your pancreas, kidneys or liver
  • have or have had depression or suicidal thoughts, or mental health issues
  • are breastfeeding or plan to breastfeed. It is not known if Saxenda® passes into your breast milk. You and your health care provider should decide if you will use Saxenda® or breastfeed

Tell your health care provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements. Saxenda® slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Saxenda® may affect the way some medicines work and some other medicines may affect the way Saxenda® works. Tell your health care provider if you take diabetes medicines, especially insulin and sulfonylurea medicines.

How should I use Saxenda®?

  • Read the Instructions for Use that comes with Saxenda®
  • Inject your dose of Saxenda® under the skin (subcutaneously) in your stomach area (abdomen), upper leg (thigh), or upper arm, as instructed by your health care provider. Do not inject into a vein or muscle
  • Change (rotate) your injection site within the area you choose with each injection to reduce your risk of getting lumps under the skin (cutaneous amyloidosis). Do not use the same site for each injection

What are the possible side effects of Saxenda®?

Saxenda® may cause serious side effects, including:

  • inflammation of the pancreas (pancreatitis). Stop using Saxenda® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your stomach area (abdomen) to your back
  • gallbladder problems. Saxenda® may cause gallbladder problems, including gallstones. Some gallbladder problems need surgery. Call your health care provider if you have any of the following symptoms: pain in your upper stomach (abdomen), fever, yellowing of your skin or eyes (jaundice), or clay-colored stools
  • increased risk of low blood sugar (hypoglycemia) in adults with type 2 diabetes who also take medicines to treat type 2 diabetes such as sulfonylureas or insulin
  • risk of low blood sugar (hypoglycemia) in children who are 12 years of age and older without type 2 diabetes
  • Signs and symptoms of low blood sugar may include: shakiness, sweating, headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, and feeling jittery. You should check your blood sugar before you start taking Saxenda® and while you take Saxenda®
  • increased heart rate. Saxenda® can increase your heart rate while you are at rest. Your health care provider should check your heart rate while you take Saxenda®. Tell your health care professional if you feel your heart racing or pounding in your chest and it lasts for several minutes
  • kidney problems (kidney failure). Saxenda® may cause nausea, vomiting, or diarrhea leading to loss of fluids (dehydration). Dehydration may cause kidney failure, which can lead to the need for dialysis. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration. Call your health care provider right away if you have nausea, vomiting, or diarrhea that does not go away, or if you cannot drink liquids by mouth
  • serious allergic reactions. Stop using Saxenda® and get medical help right away if you have any symptoms of a serious allergic reaction including swelling of your face, lips, tongue, or throat, fainting or feeling dizzy, very rapid heartbeat, problems breathing or swallowing, or severe rash or itching
  • depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your health care provider right away if you have any mental changes that are new, worse, or worry you

The most common side effects of Saxenda® in adults include nausea, diarrhea, constipation, vomiting, injection site reaction, low blood sugar (hypoglycemia), headache, tiredness (fatigue), dizziness, stomach pain, and change in enzyme (lipase) levels in your blood. Additional common side effects in children are fever and gastroenteritis.

Please click here for Prescribing Information and Medication Guide for Saxenda®.

Saxenda® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

What is the most important information I should know about Ozempic®?

Ozempic® may cause serious side effects, including:

  • Possible thyroidtumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid In studies with rodents, Ozempic® and medicines that work like Ozempic® caused thyroid tumors, including thyroid cancer. It is not known if Ozempic® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
  • Do not use Ozempic® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do not use Ozempic® if:

  • you or any of your family have ever had MTC or if you have MEN 2.
  • you are allergic to semaglutide or any of the ingredients in Ozempic®. See symptoms of serious allergic reaction in “What are the possible side effects of Ozempic®?”.

Before using Ozempic®, tell your health care provider if you have any other medical conditions, including if you:

  • have or have had problems with your pancreas or kidneys.
  • have a history of diabetic retinopathy.
  • are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Ozempic® will harm your unborn baby or passes into your breast milk. You should stop using Ozempic® 2 months before you plan to become pregnant.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

What are the possible side effects of Ozempic®?

Ozempic® may cause serious side effects, including:

  • inflammation of your pancreas (pancreatitis). Stop using Ozempic® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
  • changes in vision. Tell your health care provider if you have changes in vision during treatment with Ozempic®.
  • low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Ozempic® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
  • kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
  • serious allergic reactions. Stop using Ozempic® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
  • gallbladder problems. Gallbladder problems have happened in some people who take Ozempic®. Tell your healthcare provider right away if you get symptoms which may include: pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.

The most common side effects of Ozempic® may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.

Please click here for Prescribing Information and Medication Guide.

Ozempic® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is the most important information I should know about Victoza®?

Victoza® may cause serious side effects, including:

  • Possible thyroidtumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid In studies with rats and mice, Victoza® and medicines that work like Victoza® caused thyroid tumors, including thyroid cancer. It is not known if Victoza® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Who should not use Victoza®?

Do not use Victoza® if:

  • you or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • you are allergic to liraglutide or any of the ingredients in Victoza®. See symptoms of serious allergic reaction in “What are the possible side effects of Victoza®?”.

What is Victoza®?

Victoza® (liraglutide) injection 1.2 mg or 1.8 mg is an injectable prescription medicine used:

  • along with diet and exercise to lower blood sugar (glucose) in adults and children who are 10 years of age and older with type 2 diabetes mellitus.
  • to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes mellitus with known heart disease.

Victoza® is not for use in people with type 1 diabetes. It should not be used with other medicines that contain liraglutide. It is not known if Victoza® is safe and effective to lower blood sugar in children under 10 years of age.

What should I tell my healthcare provider before using Victoza®?

Before using Victoza®, tell your health care provider if you:

  • have or have had problems with your pancreas, kidneys, or liver.
  • have any other medical conditions or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
  • are pregnant or breastfeeding or plan to become pregnant or breastfeed.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

How should I use Victoza®?

  • Inject under the skin of your stomach (abdomen), thigh, or upper arm. Do notinject Victoza® into a muscle or vein.
  • Change (rotate) your injection site within the area you choose with each injection to reduce your risk of getting lumps under the skin (cutaneous amyloidosis). Do notuse the same site for each injection.
  • Do notmix insulin and Victoza® together in the same injection.
  • You may give an injection of Victoza® and insulin in the same body area (such as your stomach area), but not right next to each other.
  • Do not share your Victoza® pen with other people, even if the needle has been changed.You may give other people a serious infection, or get a serious infection from them.

What are the possible side effects of Victoza®?
Victoza® may cause serious side effects, including:

  • inflammation of your pancreas (pancreatitis).Stop using Victoza® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
  • low blood sugar (hypoglycemia).Your risk for getting low blood sugar may be higher if you use Victoza® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. In children who are 10 years of age and older, the risk for low blood sugar may be higher with Victoza® regardless of use with another medicine that can also lower blood sugar. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
  • kidney problems (kidney failure).In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse.
  • serious allergic reactions.Stop using Victoza® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or a very rapid heartbeat.
  • gallbladder problems.Gallbladder problems have happened in some people who take Victoza®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in the upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

The most common side effects of Victoza® may include nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.

Please click here for Prescribing Information and Medication Guide.

Victoza® is a prescription medication.

Trulicity®

Trulicity®  is for adults and children 10 years of age and older with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose). Trulicity® is also used in adults with type 2 diabetes to reduce the risk of major cardiovascular events (problems having to do with the heart and blood vessels) such as death, heart attack, or stroke in people who have heart disease or multiple cardiovascular risk factors.

  • It is not known if TRULICITY® can be used in people who have had inflammation of the pancreas (pancreatitis). TRULICITY® is not for use in people with type 1 diabetes and is not recommended for use in people with severe stomach or intestinal problems. It is not known if TRULICITY® is safe and effective in children under 10 years of age.
  • Trulicity® is given through an injection (needle). You take it once a week by injecting it under the skin of your stomach, thigh, or upper arm.

Warnings: Trulicity® may cause tumors in the thyroid , including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, trouble swallowing, hoarseness, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

  • Do not use Trulicity® if you or any of your family have ever had a type of thyroidcancer called medullary thyroid carcinoma (MTC).
  • Do not use Trulicity® if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Do not use Trulicity® if you are allergic to dulaglutide or other ingredients in Trulicity®.

Ask your healthcare provider how to recognize possible serious side effects and what to do :

Inflamed pancreas (pancreatitis). Stop using Trulicity® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen), with or without vomiting, that will not go away. You may feel the pain from your abdomen to your back.
Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use TRULICITY® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin.
Signs and symptoms of low blood sugar may include dizziness or light-headedness, confusion or drowsiness, headache, blurred vision, slurred speech, fast heartbeat, sweating, hunger, shakiness, feeling jittery, weakness, anxiety, irritability, or mood changes.
Serious allergic reactions. Stop using Trulicity® and get medical help right away if you have any symptoms of a serious allergic reaction which may include swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting, or feeling dizzy, or very rapid heartbeat.
Acute kidney injury. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration). This may cause kidney problems to get worse.
Severe stomach problems. Trulicity® may cause stomach problems, which could be severe.
Changes in vision. Tell your healthcare provider if you have changes in your eyesight (vision) during treatment with Trulicity®.
Gallbladder problems. Gallbladder problems have happened in some people who take Trulicity®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), clay-colored stools.

Common side effects

The most common side effects of Trulicity® include nausea, diarrhea, vomiting, abdominal pain and decreased appetite, indigestion, and fatigue.

These are not all the possible side effects of Trulicity®.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

  • Your healthcare provider should show you how to use Trulicity® before you use it for the first time.
  • Before you use Trulicity®, talk to your healthcare provider about low blood sugar and how to manage it.

Review these questions with your healthcare provider:

  • Do you have other medical conditions, including problems with your pancreas, kidneys, liver, or stomach, or have a history of diabetic retinopathy (vision problems related to diabetes)?
  • Do you take other diabetes medicines, such as insulin or sulfonylureas?
  • Are you pregnant or plan to become pregnant or breastfeeding or plan to breastfeed?
  • Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?

How to take

  • Read the Instructions for Use that come with Trulicity®.
  • Use Trulicity® exactly as your healthcare provider says.
  • Do not share your Trulicity® pen, syringe, or needles with another person.
  • Do not give Trulicity® to other people.
  • If you take too much Trulicity®, call your healthcare provider or seek medical advice promptly.

Trulicity® is a prescription medicine. For more information, call 1-844-TRU-INFO (1-844-878-4636) or go to www.TRULICITY®.com.

This summary provides basic information about Trulicity® but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Trulicity® and how to take it. Your healthcare provider is the best person to help you decide if Trulicity® is right for you.

Zepbound

Warnings:  Zepbound may cause tumors in the thyroid , including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

  • Do not use Zepbound if you or any of your family have ever had a type of thyroidcancer called medullary thyroid carcinoma (MTC).
  • Do not use Zepbound Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.

Zepbound may cause serious side effects, including:

Severe stomach problems.  Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Kidney problems (kidney failure). Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration.

Gallbladder problems.  Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Inflammation of the pancreas (pancreatitis).  Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Serious allergic reactions.  Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Low blood sugar (hypoglycemia).  Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin.

Signs and symptoms of low blood sugar may include  dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.

Changes in vision in patients with type 2 diabetes.  Tell your healthcare provider if you have changes in vision during treatment with Zepbound.

Depression or thoughts of suicide.  You should pay attention to changes in your mood, behaviors, feelings or thoughts. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

Common side effects

The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using Zepbound

  • Your healthcare provider should show you how to use Zepbound before you use it for the first time.
  • Tell your healthcare provider if you are taking medicines to treat diabetes including insulin or sulfonylureas which could increase your risk of low blood sugar. Talk to your healthcare provider about low blood sugar levels and how to manage them.
  • If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound.

Review these questions with your healthcare provider:

  • Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
  • Do you take other diabetes medicines, such as insulin or sulfonylureas?
  • Do you have a history of diabetic retinopathy?
  • Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
  • Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. It is not known if Zepbound passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.

How to take

  • Read the Instructions for Usethat come with Zepbound.
  • Use Zepbound exactly as your healthcare provider says.
  • Zepbound is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
  • Use Zepbound 1 time each week, at any time of the day.
  • Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
  • If you take too much Zepbound, call your healthcare provider, seek medical advice promptly, or contact a Poison Center expert right away at 1-800-222-1222.

Learn more

Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to  www.zepbound.lilly.com.

Mounjaro

Warnings: Mounjaro® may cause tumors in the thyroid , including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

  • Do not use Mounjaro if you or any of your family have ever had a type of thyroidcancer called medullary thyroid carcinoma (MTC).
  • Do not use Mounjaro if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Do not use Mounjaro if you are allergic to it or any of the ingredients in Mounjaro.

Mounjaro may cause serious side effects, including:

Inflammation of the pancreas (pancreatitis). Stop using Mounjaro and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Mounjaro with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may includedizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery.

Serious allergic reactions. Stop using Mounjaro and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.

Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Mounjaro. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Mounjaro.

Gallbladder problems. Gallbladder problems have happened in some people who use Mounjaro. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools.

Common side effects
The most common side effects of Mounjaro include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Mounjaro. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using Mounjaro

  • Your healthcare provider should show you how to use Mounjaro before you use it for the first time.
  • Talk to your healthcare provider about low blood sugar and how to manage it.
  • If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro. Birth control pills may not work as well while using Mounjaro. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro and for 4 weeks after each increase in your dose of Mounjaro.

Review these questions with your healthcare provider:

  • Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
  • Do you take other diabetes medicines, such as insulin or sulfonylureas?
  • Do you have a history of diabetic retinopathy?
  • Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? It is not known if Mounjaro will harm your unborn baby or pass into your breast milk.
  • Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?

How to take

  • Read the Instructions for Usethat come with Mounjaro.
  • Use Mounjaro exactly as your healthcare provider says.
  • Mounjaro is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
  • Use Mounjaro 1 time each week, at any time of the day.
  • Do notmix insulin and Mounjaro together in the same injection.
  • You may give an injection of Mounjaro and insulin in the same body area (such as your stomach area), but not right next to each other.
  • Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
  • If you take too much Mounjaro, call your healthcare provider or seek medical advice promptly.

Learn more
Mounjaro is a prescription medicine. For more information, call 1-833-807-MJRO (833-807-6576) or go to www.mounjaro.com.

Semaglutide

What is the most important information I should know about Semaglutide?

Semaglutide may cause serious side effects, including:

  • Possible thyroidtumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid In studies with rodents, Semaglutide and medicines that work like Semaglutide caused thyroid tumors, including thyroid cancer. It is not known if Semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people
  • Do not use Semaglutide if you or any of your family have ever had a type of thyroidcancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Do not use Semaglutide if:

  • you or any of your family have ever had a type of thyroidcancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • you have had a serious allergic reaction to semaglutide or any of the ingredients in Semaglutide

Before using Semaglutide, tell your healthcare provider if you have any other medical conditions, including if you:

  • have or have had problems with your pancreas or kidneys
  • have type 2 diabetes and a history of diabetic retinopathy
  • have or have had depression, suicidal thoughts, or mental health issues
  • are pregnant or plan to become pregnant. Semaglutide may harm your unborn baby. You should stop using Semaglutide 2 months before you plan to become pregnant
  • are breastfeeding or plan to breastfeed. It is not known if Semaglutide passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Semaglutide may affect the way some medicines work and some medicines may affect the way Semaglutide works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Semaglutide slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

What are the possible side effects of Semaglutide?

Semaglutide may cause serious side effects, including:

  • inflammation of your pancreas (pancreatitis). Stop using Semaglutide and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
  • gallbladder problems. Semaglutide may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools
  • increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines for type 2 diabetes such as sulfonylureas or insulin. This can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Semaglutide. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery
  • kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration
  • serious allergic reactions. Stop using Semaglutide and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat
  • change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Semaglutide
  • increased heart rate. Semaglutide can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes
  • depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you

The most common side effects of Semaglutide may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, gas, stomach flu, heartburn, and runny nose or sore throat.

Semaglutide is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Tirzepatide

What is the most important information I should know about Tirzepatide? Tirzepatide may cause serious side effects, including:

Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats, Tirzepatide and medicines that work like Tirzepatide caused thyroid tumors, including thyroid cancer. It is not known if Tirzepatide will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Do not use Tirzepatide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Tirzepatide may cause serious side effects, including:

Inflammation of the pancreas (pancreatitis). Stop using Tirzepatide and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Tirzepatide with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery.

Serious allergic reactions. Stop using Tirzepatide and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.

Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Tirzepatide. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Tirzepatide.

Gallbladder problems. Gallbladder problems have happened in some people who use Tirzepatide. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools.

Common side effects
The most common side effects of Tirzepatide include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Tirzepatide. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

This summary provides basic information about Tirzepatide but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Tirzepatide and how to take it. Your healthcare provider is the best person to help you decide if Tirzepatide is right for you.

Orlistat

Important Safety Information

Orlistat is contraindicated in patients:

  • who are pregnant. Weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy
  • with chronic malabsorption syndrome
  • with cholestasis
  • with known hypersensitivity to Orlistat or to any component of this product

Warnings and Precautions:

  • Orlistat may interact with concomitant drugs including cyclosporine, levothyroxine, warfarin, amiodarone, antiepileptic drugs, and antiretroviral drugs
  • Orlistat can decrease cyclosporine exposure. Orlistat and cyclosporine should not be simultaneously co-administered
  • Patients should be strongly encouraged to take a multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition because Orlistat has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene
  • Rare cases of severe liver injury with hepatocellular necrosis or acute hepatic failure have been reported, with some of these cases resulting in liver transplant or death
  • Patients may develop increased levels of urinary oxalate following treatment with Orlistat. Monitor renal function in patients at risk for renal insufficiency.
  • Substantial weight loss can increase the risk of cholelithiasis
  • Exclude organic causes of obesity (e.g., hypothyroidism) before prescribing Orlistat
  • Patients should be advised to adhere to dietary guidelines. Gastrointestinal events may increase when Orlistat is taken with a diet high in fat (>30% total daily calories from fat)

It is not known if Orlistat is present in human milk. Caution should be exercised when Orlistat is administered to a nursing woman.

The most commonly observed adverse events (incidence of ≥5% and twice that of placebo) were oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation and fecal incontinence. In general, the first occurrence of these events was within 3 months of starting therapy.

Overall, approximately 50% of all episodes of GI adverse events associated with Orlistat treatment lasted for less than 1 week, and a majority lasted for no more than 4 weeks. However, GI adverse events may occur in some individuals over a period of 6 months or longer.

Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

Contrave

IMPORTANT SAFETY INFORMATION

CONTRAVE can cause serious side effects including:
Suicidal thoughts or actions: One of the ingredients in CONTRAVE is bupropion. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase the risk of suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment.
While taking CONTRAVE, you or your family members should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when you start taking CONTRAVE or when your dose changes.

Stop taking CONTRAVE and call a healthcare provider right away if you or your family members notice any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; depression; anxiety; feeling agitated or restless; panic attacks; irritability; aggression, anger, or violence; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood; trouble sleeping.

CONTRAVE is not approved for use in children under the age of 18.

Do not take CONTRAVE if you have uncontrolled high blood pressure; have or have had seizures; use other medicines that contain bupropion such as WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, APLENZIN and ZYBAN; have or have had an eating disorder called anorexia or bulimia; are dependent on opioid pain medicines or use medicines to help stop taking opioids, or are in opiate withdrawal; drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti‐seizure medicines and stop using them all of a sudden; are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs) in the past 14 days; or are allergic to any of the ingredients in CONTRAVE.

Tell your healthcare provider about all of your medical conditions including if you have: depression or other mental illnesses; attempted suicide; seizures; head injury; tumor or infection of brain or spine; low blood sugar or low sodium; liver or kidney problems; high blood pressure; heart attack, heart problems, or stroke; eating disorder; drinking a lot of alcohol; prescription medicine or street drug abuse; are 65 or older; diabetes; pregnant or planning to become pregnant; or breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

CONTRAVE may cause serious side effects, including:

  • There is a risk of having a seizure when you take CONTRAVE. The risk of seizure is higher in people who take higher doses of CONTRAVE, have certain medical conditions, or take CONTRAVE with certain other medicines. Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider has said it is okay to take them. If you have a seizure while taking CONTRAVE, stop taking CONTRAVE and call your healthcare provider right away.
  • Risk of opioid overdose. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of naltrexone. This can lead to serious injury, coma, or death.
    Get emergency medical help right away if you take opioids and you:

    • have trouble breathing
    • become very drowsy with slowed breathing
    • have slow, shallow breathing
    • feel faint, very dizzy, confused, or have unusual symptoms
  • Sudden opioid withdrawal. People who take CONTRAVE must not use any type of opioid including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, for at least 7 to 10 days before starting CONTRAVE. Using opioids in the 7 to 10 days before you start taking CONTRAVE may cause you to suddenly have symptoms of opioid withdrawal when you take it. Sudden opioid withdrawal can be severe, and you may need to go to the hospital. Tell your healthcare provider you are taking CONTRAVE before a medical procedure or surgery.
  • Severe allergic reactions. Stop taking CONTRAVE and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of an allergic reaction: rash, itching, hives, fever, swollen lymph glands, painful sores in your mouth or around your eyes, swelling of your lips or tongue, chest pain, or trouble breathing.
  • Increases in blood pressure or heart rate. Some people may get high blood pressure or have a higher heart rate when taking CONTRAVE. Your healthcare provider should check your blood pressure and heart rate before you start taking, and while you take CONTRAVE.
  • Liver damage or hepatitis. Stop taking CONTRAVE and tell your healthcare provider if you have any of the following symptoms of liver problems: stomach area pain lasting more than a few days, dark urine, yellowing of the whites of your eyes, or tiredness. Your healthcare provider may need to stop treating you with CONTRAVE if you get signs or symptoms of a serious liver problem.
  • Manic episodes. Bupropion can cause some people who were manic or depressed in the past to become manic or depressed again.
  • Visual problems (angle-closure glaucoma). Signs and symptoms may include: eye pain, changes in vision, swelling or redness in or around the eye. Talk with your healthcare provider to find out if you are at risk for angle-closure glaucoma and to get treatment to prevent it if you are at risk.
  • Increased risk of low blood sugar in people with type 2 diabetes mellitus who also take medicines to treat their diabetes (such as insulin or sulfonylureas). You should check your blood sugar before you start taking CONTRAVE and while you take CONTRAVE.

The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea. These are not all of the possible side effects of CONTRAVE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Metformin

Important Safety Information

Postmarketing cases of Metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of Metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms suchas malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (> 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and Metformin plasma levels generally > 5 mcg/mL .

Risk factors for Metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g. carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

Steps to reduce the risk of and manage Metformin-associated lactic acidosis in these high risk groups are provided.

If Metformin-associated lactic acidosis is suspected, immediately discontinue Metformin hydrochloride tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended .

Contraindications
Metformin hydrochloride tablets are contraindicated in patients with:

Severe renal impairment (eGFR below 30 mL/min/1.73 m 2)
Hypersensitivity to Metformin.
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

SGLT-2 Inhibitors

Sodium-Glucose cotransporter type 2 (SGLT2) inhibitors are a class of prescription medicines approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.  Medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. They are available as single-ingredient products and also in combination with other diabetes medicines such as metformin (see FDA-approved SGLT2 Inhibitors).

SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. Common side effects of SGLT2 inhibitors include yeast infections, urinary tract infections, and low blood sugar when combined with other prescription diabetes medicines.  In 2017, an estimated 1.7 million patients received a dispensed prescription for an SGLT2 inhibitor from U.S. outpatient retail pharmacies.

SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. First approved in 2013, medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin (see FDA-Approved SGLT2 Inhibitors). In addition, empagliflozin is approved to lower the risk of death from heart attack and stroke in adults with type 2 diabetes and heart disease.

The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. Patients should seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.

DPP4 Inhibitors

Dipeptidyl peptidase type 4 inhibitors (DPP-4 inhibitors) are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. These medicines are available as single-ingredient products and in combination with other diabetes medicines such as metformin.

The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. The FDA has added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP4) inhibitors. Severe and disabling joint pain has been reported with the use of dipeptidyl peptidase-4 (DPP-4 inhibitors). The time to onset of symptoms following initiation of drug therapy varied from 1 day to years. Patients experienced relief of symptoms upon discontinuation of the medication. Some patients had a recurrence of severe joint pain when restarted on either their original DPP-4 inhibitor medication or another DPP-4 inhibitor.

Patients should not stop taking their DPP-4 inhibitor medicine, but should contact their health care professional right away if they experience severe and persistent joint pain. Health care professionals should consider DPP-4 inhibitors as a possible cause of severe joint pain and discontinue the drug if appropriate.  Contact your health care professional right away if you develop severe and persistent joint pain while taking one of these medicines. Do not stop taking your DPP-4 inhibitor medicine without first talking to your health care professional.

DPP-4 inhibitors are a class of prescription medicines that are used with diet and exercise to control high blood sugar in adults with type 2 diabetes.  Medicines in the DPP-4 inhibitor class include sitagliptin, saxagliptin, linagliptin, and alogliptin. They are available as single-ingredient products and in combination with other diabetes medicines such as metformin (see Table 1 in the Safety Announcement section for a complete list of FDA-approved DPP-4 inhibitors).  DPP-4 inhibitors lower blood sugar by helping the body increase the level of the hormone insulin after meals. Insulin helps move sugar from the blood into the tissues so the body can use the sugar to produce energy and keep blood sugar levels stable.  In addition to severe joint pain, other possible side effects of DPP-4 inhibitors include inflammation of the pancreas, low blood sugar when this class of medicines is combined with other prescription medicines used to treat diabetes, and allergic reactions.