Important safety information
Important Safety Information for Tirzepatide
Warning: Risk of Thyroid C-Cell Tumors
Studies in rodents have shown that tirzepatide, a dual GIP and GLP-1 receptor agonist, may increase the risk of thyroid tumors, including medullary thyroid carcinoma (MTC). It is currently unknown whether tirzepatide causes thyroid tumors or MTC in humans. Seek medical attention if you develop symptoms such as a lump or swelling in the neck, hoarseness, difficulty swallowing, or shortness of breath.
Who Should Avoid Using Tirzepatide
Do not use tirzepatide if:
You or a family member has a history of medullary thyroid carcinoma (MTC).
You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
You have experienced a serious allergic reaction to tirzepatide or any of its ingredients.
Tirzepatide should not be used in combination with other GLP-1 receptor agonists or drugs containing tirzepatide. It has not been studied in people with a history of pancreatitis and is not recommended during pregnancy or breastfeeding, as effects on the fetus or infant are unknown.
FDA-Approved Uses of Tirzepatide
Tirzepatide is FDA-approved under different brand names for:
Improving blood sugar control in adults with type 2 diabetes (as an adjunct to diet and exercise).
Chronic weight management in adults with obesity or who are overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or obstructive sleep apnea), when combined with a reduced-calorie diet and increased physical activity.
Before Using Tirzepatide, Tell Your Healthcare Provider If You:
Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.
Have or have had thyroid cancer, pancreatitis, kidney disease, gallbladder disease, gastroparesis, diabetic eye disease, or depression or suicidal thoughts.
Are undergoing any surgery or procedures.
Are taking any medications, especially for diabetes (e.g., insulin or sulfonylureas), or oral contraceptives (as tirzepatide may reduce their effectiveness due to delayed stomach emptying).
Possible Serious Side Effects of Tirzepatide Include:
Thyroid tumors, including possible thyroid cancer.
Severe gastrointestinal issues, such as nausea, vomiting, and gastroparesis.
Kidney problems, potentially worsened by dehydration from vomiting or diarrhea.
Gallbladder issues, including gallstones and gallbladder inflammation.
Pancreatitis (inflammation of the pancreas).
Severe allergic reactions, including anaphylaxis.
Hypoglycemia (low blood sugar), particularly when used with insulin or insulin secretagogues.
Vision changes, especially in individuals with diabetic retinopathy.
Suicidal thoughts or behaviors.
Risk of aspiration (inhalation of food or fluid into the lungs) during surgery—notify your provider if undergoing a procedure.
Common Side Effects of Tirzepatide Include:
Nausea, vomiting, diarrhea, constipation, and abdominal discomfort
Indigestion, gas, bloating, and belching
Injection site reactions
Fatigue or tiredness
Hair loss
Mild allergic reactions
Low blood sugar, particularly in individuals with type 2 diabetes using other glucose-lowering medications
Reporting Side Effects
Report any side effects to the FDA MedWatch program at 1-800-FDA-1088 or www.fda.gov/medwatch. If you are pregnant and were exposed to tirzepatide, contact the manufacturer to report the exposure and obtain more information.
Additional Notes
Tirzepatide is marketed under different brand names, including:
Zepbound® for weight management
Mounjaro® for type 2 diabetes
Both are manufactured by Eli Lilly and Company.
Important Safety Information for Zepbound® (tirzepatide) Injection
Warning: Risk of Thyroid C-Cell Tumors
Studies in rodents have shown that tirzepatide, the active ingredient in Zepbound® , can lead to thyroid tumors, including thyroid cancer. It is unknown if Zepbound® can cause thyroid tumors or medullary thyroid carcinoma (MTC) in humans. Notify your healthcare provider if you experience symptoms such as a new lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath, as these could indicate thyroid cancer.
Who Should Avoid Using Zepbound®
Do not use Zepbound® if you or your family members have a history of medullary thyroid carcinoma (MTC) or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Additionally, avoid Zepbound® if you are allergic to tirzepatide.
Zepbound® should not be used with other products containing tirzepatide or any other GLP-1 receptor agonists, and it has not been studied in patients with a history of pancreatitis.
Avoid using Zepbound® during pregnancy or breastfeeding. It is unclear whether Zepbound® could harm an unborn baby or pass into breast milk.
FDA-Approved Use of Zepbound®
Zepbound® is FDA-approved for weight management (in conjunction with a reduced calorie diet and exercise) in adults with obesity or who are overweight with at least one weight-related medical condition (such as high blood pressure, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease).
Before using Zepbound®, tell your healthcare provider about
All of your medical conditions. Provide your complete medical history, particularly if you are pregnant or planning to become pregnant, are breastfeeding or planning to breastfeed, have any planned surgeries or procedures, or if you have a history of diabetes, thyroid cancer, pancreatitis, ileus, severe gastroparesis, kidney disease, gallstones, diabetic eye disease, depression, or suicidal thoughts.
All medications you are taking. Zepbound® causes a delay in stomach emptying, which can impact the absorption of some medications in the stomach. Inform your healthcare provider about all prescriptions, over-the-counter medications, vitamins, and herbal supplements you take, especially any diabetes treatments such as insulin or sulfonylureas and hormonal birth control. Zepbound® may reduce the efficacy of oral hormonal contraceptives.
Zepbound® may cause serious side effects, including:
Potential thyroid tumors, including cancer. Notify your healthcare provider if you notice a new lump or swelling in your neck, experience hoarseness, difficulty swallowing, or shortness of breath. These symptoms may indicate thyroid cancer.
Severe gastrointestinal adverse reactions, including severe gastroparesis. Notify your healthcare provider if you experience severe nausea and vomiting, inability to tolerate fluids or liquids, or severe, persistent abdominal pain or bloating.
Kidney problems (kidney failure). In individuals with existing kidney issues, dehydration from diarrhea, nausea, or vomiting may worsen kidney function. It is extremely important to maintain adequate fluid intake to reduce dehydration risk.
Gallbladder problems. Some individuals using Zepbound® have reported gallbladder issues, including gallstones, which may require surgery. Notify your healthcare provider right away if you experience symptoms such as upper abdominal pain, fever, yellowing of the skin or eyes, or pale-colored stools.
Inflammation of the pancreas (acute pancreatitis). Stop using Zepbound® and contact your healthcare provider immediately if you experience severe, persistent abdominal pain with or without vomiting, often radiating to the back.
Serious allergic reactions. Stop Zepbound® use immediately and seek medical assistance if you experience symptoms like swelling of the face, lips, tongue, or throat; shortness of breath, wheezing or swallowing difficulties; severe rash or itching; fainting or dizziness; or rapid resting heartbeat.
Low blood sugar (hypoglycemia). Your risk of hypoglycemia may increase if you use Zepbound® with other medications that lower blood sugar, such as sulfonylureas or insulin. Symptoms may include dizziness, blurred vision, anxiety, sweating, confusion, shakiness, weakness, headache, rapid resting heartbeat, and jitteriness.
Vision changes. Notify your healthcare provider if you notice changes in your vision while using Zepbound®, particularly if you have type 2 diabetes or a history of diabetic retinopathy.
Suicidal thoughts or behavior. Notify your healthcare provider if you experience sudden changes in your mental health or suicidal thoughts.
Food or liquid getting to the lungs during surgery. Notify your healthcare provider that you are taking Zepbound® before you are scheduled to have surgery or other procedures.
Common side effects of Zepbound® include nausea, diarrhea, vomiting, constipation, abdominal pain, upset stomach, heartburn, bloating, gas, belching, injection site reactions, fatigue, allergic reactions, hair loss, and low blood sugar (specifically in people with type 2 diabetes).
Consult the complete prescribing information for more details about the safety of Zepbound®. If you experience side effects from prescription medications, please report them to FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch. Pregnant patients exposed to Zepbound® during pregnancy are encouraged to contact Eli Lilly and Company at 1-800-545-5979.
Important Safety Information for Semaglutide
Warning: Risk of Thyroid C-Cell Tumors
Animal studies have shown that semaglutide, a GLP-1 receptor agonist, may increase the risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether semaglutide causes thyroid tumors or MTC in humans. Notify your healthcare provider right away if you experience symptoms such as a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
Who Should Avoid Using Semaglutide
Do not use semaglutide if:
You or a family member has a history of medullary thyroid carcinoma (MTC).
You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
You are allergic to semaglutide or any ingredients in the formulation.
Semaglutide has not been studied in people with a history of pancreatitis and is not recommended during pregnancy or breastfeeding due to potential risk to the unborn baby or infant. Avoid use in combination with other GLP-1 receptor agonists.
FDA-Approved Uses of Semaglutide
Ozempic® (semaglutide) is FDA-approved to improve blood sugar in adults with type 2 diabetes, along with diet and exercise.
Wegovy® (semaglutide) is FDA-approved for chronic weight management in adults and adolescents aged 12 and older with obesity or who are overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol).
Before Using Semaglutide, Tell Your Healthcare Provider If You:
Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.
Have or have had pancreatitis, gallbladder disease, kidney problems, eye problems related to diabetes, thyroid cancer, depression, or suicidal thoughts or behaviors.
Are scheduled for surgery or any procedure requiring fasting.
Take any medications, especially insulin, sulfonylureas, or oral contraceptives (as semaglutide may reduce their effectiveness by slowing stomach emptying).
Serious Potential Side Effects of Semaglutide Include:
Thyroid tumors, including possible thyroid cancer. Seek immediate evaluation for neck lumps, hoarseness, or swallowing difficulties.
Pancreatitis (inflammation of the pancreas), which can present as severe stomach pain that may radiate to the back, with or without vomiting.
Gallbladder problems, including gallstones or inflammation. Symptoms may include abdominal pain, fever, yellowing of the skin or eyes, or light-colored stools.
Kidney injury, often from dehydration caused by vomiting or diarrhea. Drink plenty of fluids to help prevent dehydration.
Low blood sugar (hypoglycemia), especially when combined with other diabetes medications. Symptoms may include dizziness, confusion, sweating, and blurred vision.
Severe allergic reactions, such as swelling of the face, lips, tongue, or throat; rash; difficulty breathing or swallowing; or fainting.
Diabetic retinopathy complications in individuals with existing eye disease. Notify your provider if you notice changes in vision.
Suicidal thoughts or behavior. Report any changes in mood or mental health to your healthcare provider.
Risk of aspiration during surgery, due to delayed gastric emptying. Tell your surgical team you are using semaglutide.
Common Side Effects of Semaglutide Include:
Nausea, vomiting, diarrhea, constipation, and stomach pain
Indigestion, heartburn, gas, and bloating
Fatigue or tiredness
Injection site reactions
Headache
Dizziness or lightheadedness
Low blood sugar, especially in those with type 2 diabetes using insulin or sulfonylureas
Pregnancy and Breastfeeding
Semaglutide should be discontinued at least 2 months before a planned pregnancy due to its long half-life. The safety of semaglutide during pregnancy and lactation is not established. Inform your healthcare provider if you are pregnant or plan to become pregnant while on semaglutide.
Reporting Adverse Effects
If you experience any side effects, report them to the FDA MedWatch at 1-800-FDA-1088 or online at www.fda.gov/medwatch. Pregnant individuals exposed to semaglutide are encouraged to contact the manufacturer for additional support and safety information.
Brand Names and Manufacturer
Semaglutide is the active ingredient in:
Ozempic® (for type 2 diabetes)
Wegovy® (for chronic weight management)
Rybelsus® (oral form for type 2 diabetes)
These products are manufactured by Novo Nordisk A/S, a global healthcare company specializing in diabetes care and chronic disease treatment.
Important Safety Information for Ozempic® (semaglutide) Injection
Warning: Risk of Thyroid C-Cell Tumors
Studies in rodents have shown that semaglutide, the active ingredient in Ozempic®, can lead to thyroid tumors, including thyroid cancer. It is unknown if Ozempic® can cause thyroid tumors or medullary thyroid carcinoma (MTC) in humans. Notify your healthcare provider if you experience symptoms such as a lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath, as these could indicate thyroid cancer.
Who Should Avoid Using Ozempic®
Do not use Ozempic® if you or your family members have a history of medullary thyroid carcinoma (MTC) or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Additionally, avoid Ozempic® if you are allergic to semaglutide.
Avoid using Ozempic® during pregnancy or breastfeeding. It is unclear whether Ozempic® could harm an unborn baby or pass into breast milk. Discontinue Ozempic® at least two months before planning to conceive.
Ozempic® has not been studied in patients with a history of pancreatitis or children under the age of 18 and is not intended for treating type 1 diabetes mellitus.
FDA-Approved Use of Ozempic®
Ozempic® is FDA-approved as a glucagon-like peptide-1 (GLP-1) receptor agonist used:
- Alongside diet and exercise to improve blood sugar (glucose) levels in adults with type 2 diabetes
- To lower the risk of major cardiovascular events like heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.
Before using Ozempic®, tell your healthcare provider about
All of your medical conditions. Provide your complete medical history, particularly if you are pregnant or planning to become pregnant, are breastfeeding or planning to breastfeed, have any planned surgeries or procedures, or if you have a history of diabetes, thyroid cancer, pancreatitis, ileus, kidney disease, gallstones, diabetic eye disease, depression, or suicidal thoughts.
All medications you are taking. Inform your healthcare provider about all prescriptions, over-the-counter medications, vitamins, and herbal supplements you take, especially any diabetes treatments such as insulin or sulfonylureas.
Ozempic® may cause serious side effects, including:
- Potential thyroid tumors, including cancer. Notify your healthcare provider if you notice a new lump or swelling in your neck, experience hoarseness, difficulty swallowing, or shortness of breath. These symptoms may indicate thyroid cancer.
- Inflammation of the pancreas (acute pancreatitis). Stop using Ozempic® and contact your healthcare provider immediately if you experience severe, persistent abdominal pain with or without vomiting, often radiating to the back.
- Serious allergic reactions. Stop Ozempic® use immediately and seek medical assistance if you experience symptoms like swelling of the face, lips, tongue, or throat; shortness of breath, wheezing or swallowing difficulties; severe rash or itching; fainting or dizziness; or rapid resting heartbeat.
- Kidney problems (kidney failure). In individuals with existing kidney issues, dehydration from diarrhea, nausea, or vomiting may worsen kidney function. It is extremely important to maintain adequate fluid intake to reduce dehydration risk.
- Gallbladder problems. Some individuals using Ozempic® have reported gallbladder issues. Notify your healthcare provider right away if you experience symptoms such as upper abdominal pain, fever, yellowing of the skin or eyes, or pale-colored stools.
- Vision changes. Notify your healthcare provider if you notice changes in your vision while using Ozempic®.
- Low blood sugar (hypoglycemia). Your risk of hypoglycemia may increase if you use Ozempic® with other medications that lower blood sugar, such as sulfonylureas or insulin. Symptoms may include dizziness, blurred vision, anxiety, sweating, confusion, shakiness, weakness, headache, rapid heartbeat, and jitteriness.
- Suicidal thoughts or behavior. Notify your healthcare provider if you experience sudden changes in your mental health or suicidal thoughts.
- Infection. Do not share your Ozempic® pen with others, even if the needle has been changed. Doing so could lead to serious infections.
- Food or liquid getting to the lungs during surgery. Notify your healthcare provider that you are taking Ozempic® before you are scheduled to have surgery or other procedures.
Common side effects of Ozempic® may include nausea, vomiting, diarrhea, stomach pain, and constipation.
Consult the complete prescribing information for more details about the safety of Ozempic®. If you experience side effects from prescription medications, please report them to FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Important Safety Information for Wegovy® (semaglutide) Injection
Warning: Risk of Thyroid C-Cell Tumors
Studies in rodents have shown that semaglutide, the active ingredient in Wegovy®, can lead to thyroid tumors, including thyroid cancer. It is unknown if Wegovy® can cause thyroid tumors or medullary thyroid carcinoma (MTC) in humans. Notify your healthcare provider if you experience symptoms such as a new lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath, as these could indicate thyroid cancer.
Who Should Avoid Using Wegovy®
Do not use Wegovy® if you or your family members have a history of medullary thyroid carcinoma (MTC) or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Additionally, avoid Wegovy® if you are allergic to semaglutide.
Wegovy® should not be used with other products containing semaglutide or any other GLP-1 receptor agonists and has not been studied for safety and effectiveness in children under the age of 12.
Avoid using Wegovy® during pregnancy or breastfeeding. It is unclear whether Wegovy® could harm an unborn baby or pass into breast milk. Discontinue Wegovy® at least two months before planning to conceive.
FDA-Approved Use of Wegovy®
Weight management (in conjunction with a reduced calorie diet and exercise) in adults with a body mass index (BMI) of
- 30 kg/m2 or more (obesity)
- 27 kg/m2 or more (overweight) with at least one weight-related medical condition (such as high blood pressure, type 2 diabetes, or high cholesterol)
Reducing the risk of major cardiovascular events like heart attack, stroke, or death in adults with known heart disease who are obese or overweight.
Before using Wegovy®, tell your healthcare provider about
All of your medical conditions. Provide your complete medical history, particularly if you are pregnant or planning to become pregnant, are breastfeeding or planning to breastfeed, have any planned surgeries or procedures, or if you have a history of diabetes, thyroid cancer, pancreatitis, ileus, kidney disease, gallstones, diabetic eye disease, depression, or suicidal thoughts.
All medications you are taking. Wegovy® causes a delay in stomach emptying, which can impact the absorption of some medications in the stomach. Inform your healthcare provider about all prescriptions, over-the-counter medications, vitamins, and herbal supplements you take, especially any diabetes treatments such as insulin or sulfonylureas.
Wegovy® may cause serious side effects, including:
- Potential thyroid tumors, including cancer. Notify your healthcare provider if you notice a new lump or swelling in your neck, experience hoarseness, difficulty swallowing, or shortness of breath. These symptoms may indicate thyroid cancer.
- Inflammation of the pancreas (acute pancreatitis). Stop using Wegovy® and contact your healthcare provider immediately if you experience severe, persistent abdominal pain with or without vomiting, often radiating to the back.
- Serious allergic reactions. Stop Wegovy® use immediately and seek medical assistance if you experience symptoms like swelling of the face, lips, tongue, or throat; shortness of breath, wheezing or swallowing difficulties; severe rash or itching; fainting or dizziness; or rapid resting heartbeat.
- Kidney problems (kidney failure). In individuals with existing kidney issues, dehydration from diarrhea, nausea, or vomiting may worsen kidney function. It is extremely important to maintain adequate fluid intake to reduce dehydration risk.
- Gallbladder problems. Some individuals using Wegovy® have reported gallbladder issues, including gallstones, which may require surgery. Notify your healthcare provider right away if you experience symptoms such as upper abdominal pain, fever, yellowing of the skin or eyes, or pale-colored stools.
- Vision changes. Notify your healthcare provider if you notice changes in your vision while using Wegovy®, particularly if you have type 2 diabetes.
- Low blood sugar (hypoglycemia). Your risk of hypoglycemia may increase if you use Wegovy® with other medications that lower blood sugar, such as sulfonylureas or insulin. Symptoms may include dizziness, blurred vision, anxiety, sweating, confusion, shakiness, weakness, headache, rapid resting heartbeat, and jitteriness.
- Suicidal thoughts or behavior. Notify your healthcare provider if you experience sudden changes in your mental health or suicidal thoughts.
- Food or liquid getting to the lungs during surgery. Notify your healthcare provider that you are taking Wegovy® before you are scheduled to have surgery or other procedures.
Common side effects of Wegovy® include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, upset stomach, heartburn, bloating, gas, belching, dizziness, low blood sugar (specifically in people with type 2 diabetes), and runny nose or sore throat.
Consult the complete prescribing information for more details about the safety of Wegovy®. If you experience side effects from prescription medications, please report them to FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.