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Important Safety Information for GLP-1s

This page contains important safety information for FDA-approved GLP-1 medications including Zepbound®, Wegovy®, Mounjaro®, and Ozempic®. Please read it carefully and discuss with your healthcare provider before starting treatment.

If at any point during treatment you experience any of the serious side effects described below, contact your healthcare provider immediately or call 911.

Information on this page is summarized from the manufacturers' FDA-approved Prescribing Information and Medication Guides. pepti is not affiliated with, endorsed by, or sponsored by Eli Lilly and Company or Novo Nordisk. Zepbound®, Mounjaro®, Wegovy®, and Ozempic® are registered trademarks of their respective owners.

tirzepatide · Eli Lilly and Company

Zepbound®

Boxed Warning

WARNING: RISK OF THYROID C-CELL TUMORS — In male and female rats, tirzepatide causes a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors after lifetime exposure. It is unknown whether Zepbound causes such tumors in humans, including medullary thyroid carcinoma (MTC). Zepbound is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

FDA-Approved Use

Zepbound is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity or overweight in the presence of at least one weight-related comorbidity.

Limitations of Use:

  • •Coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended.
  • •The safety and effectiveness of Zepbound in combination with other products for weight management have not been established.
  • •Zepbound has not been studied in patients with a history of pancreatitis.

Contraindications

Do not use Zepbound® if you have:

  • •Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • •Known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound.

Administration

Administer subcutaneously in the abdomen, thigh, or upper arm once weekly, on the same day each week, with or without meals. Rotate injection sites with each dose.

Before starting treatment

  • •Disclose all current medications including insulin and insulin secretagogues (sulfonylureas), oral medications, and oral hormonal contraceptives.
  • •Disclose history of pancreatitis, gallbladder disease, severe gastrointestinal disease (including gastroparesis), diabetic retinopathy, suicidal behavior or ideation, and kidney problems.
  • •Notify your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding. Tirzepatide may cause fetal harm. There is a pregnancy registry for women exposed to Zepbound during pregnancy.

Serious side effects to monitor

Zepbound® may cause serious side effects, including:

Thyroid tumors, including thyroid cancer

Watch for a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

Inflammation of the pancreas (pancreatitis)

Stop using Zepbound and call a healthcare provider right away if you have severe pain in the stomach area that will not go away, with or without vomiting. The pain may radiate to the back.

Severe stomach problems

Stomach problems, sometimes severe, have been reported. Tell your provider if you have stomach problems that are severe or will not go away.

Kidney problems (kidney failure)

Severe diarrhea, nausea, and vomiting can cause loss of fluids (dehydration) and may cause kidney problems.

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; very rapid heartbeat.

Gallbladder problems

Tell your provider right away if you have symptoms of gallbladder problems including pain in the upper stomach, fever, yellowing of skin or eyes, or clay-colored stools.

Low blood sugar (hypoglycemia)

Risk is higher when used with insulin or sulfonylureas. Watch for dizziness, blurred vision, confusion, sweating, and fast heartbeat.

Changes in vision in patients with type 2 diabetes

Tell your provider if you have changes in vision during treatment.

Depression or thoughts of suicide

Pay attention to changes in mood, behavior, feelings, or thoughts. Call a healthcare provider right away if you have any mental changes that are new, worse, or worry you.

If you experience any of these symptoms, contact your healthcare provider or call 911.

Common side effects

The most common side effects of Zepbound® include:

NauseaDiarrheaVomitingConstipationStomach (abdominal) painIndigestionInjection site reactionsFatigueHypersensitivity reactionsBurpingHair lossHeartburn

Reporting and full prescribing information

For complete prescribing information, please refer to the manufacturer's full label:

To report negative side effects, contact Eli Lilly and Company or call FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

semaglutide · Novo Nordisk

Wegovy®

Boxed Warning

WARNING: RISK OF THYROID C-CELL TUMORS — In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether Wegovy causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined. Wegovy is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC and symptoms of thyroid tumors.

FDA-Approved Use

Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults and pediatric patients aged 12 years and older with obesity, and to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight.

Limitations of Use:

  • •Coadministration with other semaglutide-containing products or with any GLP-1 receptor agonist is not recommended.
  • •The safety and effectiveness of Wegovy in combination with other products for weight management have not been established.
  • •Wegovy has not been studied in patients with a history of pancreatitis.

Contraindications

Do not use Wegovy® if you have:

  • •Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • •Known hypersensitivity to semaglutide or to any of the excipients in Wegovy.

Administration

Administer subcutaneously in the abdomen, thigh, or upper arm once weekly on the same day each week, at any time of day, with or without meals. Rotate injection sites with each dose.

Before starting treatment

  • •Disclose all current medications including insulin and insulin secretagogues, oral medications, and oral hormonal contraceptives.
  • •Disclose history of pancreatitis, gallbladder disease, severe gastrointestinal disease (including gastroparesis), diabetic retinopathy, suicidal behavior or ideation, and kidney problems.
  • •Notify your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding. There is a pregnancy registry for women exposed to Wegovy during pregnancy.

Serious side effects to monitor

Wegovy® may cause serious side effects, including:

Thyroid tumors, including thyroid cancer

Watch for a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath.

Inflammation of the pancreas (pancreatitis)

Severe pain in the stomach area that will not go away, with or without vomiting.

Gallbladder problems

Pain in the upper stomach, fever, yellowing of skin or eyes, or clay-colored stools.

Low blood sugar (hypoglycemia)

Especially when used with insulin or sulfonylureas.

Kidney problems (kidney failure)

Severe nausea, vomiting, and diarrhea can lead to dehydration and kidney problems.

Serious allergic reactions

Swelling of face/lips/tongue/throat, breathing problems, severe rash, fainting.

Diabetic retinopathy in patients with type 2 diabetes

Changes in vision during treatment should be reported.

Suicidal behavior or ideation

Monitor for depression or suicidal thoughts.

Increased heart rate

Tell your provider if you have a racing heartbeat at rest.

If you experience any of these symptoms, contact your healthcare provider or call 911.

Common side effects

The most common side effects of Wegovy® include:

NauseaDiarrheaVomitingConstipationStomach painHeadacheTirednessIndigestionDizzinessBloatingBurpingGasStomach fluHeartburnRunny nose or sore throat

Reporting and full prescribing information

For complete prescribing information, please refer to the manufacturer's full label:

To report negative side effects, contact Novo Nordisk or call FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

tirzepatide · Eli Lilly and Company

Mounjaro®

Boxed Warning

WARNING: RISK OF THYROID C-CELL TUMORS — In male and female rats, tirzepatide causes a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors. It is unknown whether Mounjaro causes such tumors, including medullary thyroid carcinoma (MTC), in humans. Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors.

FDA-Approved Use

Mounjaro is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

  • •Mounjaro has not been studied in patients with a history of pancreatitis.
  • •Mounjaro is not indicated for use in patients with type 1 diabetes mellitus.

Contraindications

Do not use Mounjaro® if you have:

  • •Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • •Known serious hypersensitivity to tirzepatide or any of the excipients in Mounjaro.

Administration

Administer subcutaneously in the abdomen, thigh, or upper arm once weekly, with or without meals.

Before starting treatment

  • •Disclose all current medications including insulin and insulin secretagogues, and oral medications.
  • •Disclose history of pancreatitis, gallbladder disease, severe gastrointestinal disease, diabetic retinopathy, suicidal behavior or ideation, and kidney problems.
  • •Notify your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding.

Serious side effects to monitor

Mounjaro® may cause serious side effects, including:

Thyroid tumors, including thyroid cancer

Watch for a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath.

Inflammation of the pancreas (pancreatitis)

Severe abdominal pain, with or without vomiting, that may radiate to the back.

Severe stomach problems

Including delayed gastric emptying. Tell your provider if you have severe stomach problems.

Hypoglycemia

Risk is higher when used with insulin or sulfonylureas.

Serious allergic reactions

Swelling of face/lips/tongue, breathing or swallowing trouble, severe rash, fainting.

Acute kidney injury

From dehydration due to nausea, vomiting, or diarrhea.

Severe gastrointestinal disease

Reports of severe gastrointestinal disease, including delayed gastric emptying.

Acute gallbladder disease

Including cholelithiasis and cholecystitis.

Diabetic retinopathy complications

Patients with a history of diabetic retinopathy should be monitored.

If you experience any of these symptoms, contact your healthcare provider or call 911.

Common side effects

The most common side effects of Mounjaro® include:

NauseaDiarrheaDecreased appetiteVomitingConstipationIndigestionStomach pain

Reporting and full prescribing information

For complete prescribing information, please refer to the manufacturer's full label:

To report negative side effects, contact Eli Lilly and Company or call FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

semaglutide · Novo Nordisk

Ozempic®

Boxed Warning

WARNING: RISK OF THYROID C-CELL TUMORS — In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether Ozempic causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Ozempic is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC and symptoms of thyroid tumors.

FDA-Approved Use

Ozempic is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease, and to reduce the risk of sustained eGFR decline, end stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.

Limitations of Use:

  • •Has not been studied in patients with a history of pancreatitis.
  • •Not indicated for use in patients with type 1 diabetes mellitus.

Contraindications

Do not use Ozempic® if you have:

  • •Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • •Known hypersensitivity to semaglutide or to any of the excipients in Ozempic.

Administration

Administer subcutaneously in the abdomen, thigh, or upper arm once weekly, at any time of day, with or without meals.

Before starting treatment

  • •Disclose all current medications including insulin and insulin secretagogues, and oral medications.
  • •Disclose history of pancreatitis, gallbladder disease, severe gastrointestinal disease (including gastroparesis), diabetic retinopathy, suicidal behavior or ideation, and kidney problems.
  • •Notify your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding.

Serious side effects to monitor

Ozempic® may cause serious side effects, including:

Thyroid tumors, including thyroid cancer

Watch for neck mass, dysphagia, dyspnea, or persistent hoarseness.

Inflammation of the pancreas (pancreatitis)

Severe abdominal pain that may radiate to the back, with or without vomiting.

Diabetic retinopathy complications

Patients with a history of diabetic retinopathy should be monitored.

Hypoglycemia

Especially when used with insulin or sulfonylureas.

Acute kidney injury

From dehydration due to nausea, vomiting, or diarrhea.

Hypersensitivity reactions

Including anaphylaxis and angioedema.

Acute gallbladder disease

Including cholelithiasis and cholecystitis.

If you experience any of these symptoms, contact your healthcare provider or call 911.

Common side effects

The most common side effects of Ozempic® include:

NauseaVomitingDiarrheaStomach painConstipation

Reporting and full prescribing information

For complete prescribing information, please refer to the manufacturer's full label:

To report negative side effects, contact Novo Nordisk or call FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Questions about your treatment?

Talk to your healthcare provider, or check whether your insurance covers brand-name GLP-1s through pepti.

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