Tirzepatide Safety Information
Warning: Risk of Thyroid C-Cell Tumors
In studies with rats, tirzepatide led to thyroid tumors, including thyroid cancer. It’s unknown whether this risk applies to humans, but watch for symptoms like neck lumps, hoarseness, trouble swallowing, or shortness of breath, and notify your healthcare provider if they occur.
Do not use tirzepatide if you or your family members have a history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Approved Uses
Used with a reduced-calorie diet and increased physical activity for chronic weight management in adults who:
Have a BMI of 30 kg/m² or greater (obesity), or
Have a BMI of 27 kg/m² or greater (overweight) with at least one weight-related medical condition (such as high blood pressure, abnormal cholesterol, type 2 diabetes, sleep apnea, or heart disease).
Limitations
Avoid use with other tirzepatide-containing products or other GLP-1 receptor agonists.
Safety when combined with other weight management products has not been established.
Not studied in patients with a history of pancreatitis.
Who Should Not Use
Those with a history of thyroid cancer (MTC), MEN 2, or known allergies to tirzepatide.
Administration
Taken with or without food as a weekly subcutaneous injection (stomach, thigh, or upper arm), using a pre-filled pen. Dose increases may be recommended every four weeks.
Do not alter dosing without first consulting a healthcare provider.
Important Precautions
Inform your healthcare provider of all medications and supplements you use, especially diabetes medicines, oral drugs, birth control, or other GLP-1 medications and weight loss products.
Disclose your entire medical history, including diabetes, thyroid cancer, gastrointestinal disease, pancreatitis, kidney disease, diabetic retinopathy, depression, and any mental health history.
Not recommended during pregnancy or if breastfeeding; consult your provider about risks.
There’s a pregnancy registry to monitor outcomes for use during pregnancy.
Serious Side Effects
Thyroid cancer risk.
Severe gastrointestinal issues.
Acute kidney or gallbladder disease.
Inflammation of the pancreas.
Severe allergic reactions.
Low blood sugar for those on diabetes medications.
Diabetic retinopathy changes.
Suicidal thoughts or behaviors.
Never share injection pens to avoid infection risk.
Common Side Effects
Nausea
Diarrhea
Vomiting
Constipation
Stomach pain
Indigestion
Tiredness
Injection site reactions
Belching
Hair loss
Heartburn
More information is available in the full Prescribing Information. Report adverse reactions to the FDA via www.fda.gov/medwatch or 1-800-FDA-1088.
Semaglutide Safety Information
Warning: Risk of Thyroid C-Cell Tumors
May increase risk for thyroid cancer; do not use with family history of MTC or MEN 2.
FDA-Approved Use
Improve blood sugar in adults with type 2 diabetes and reduce major cardiovascular events for those with heart disease.
Limitations
Not for people with pancreatitis or type 1 diabetes, or for children under 18.
Who Should Not Use
People with a history of MTC, MEN 2, or allergies to semaglutide.
Administration
Weekly subcutaneous injection; follow provider’s instructions.
Important Precautions
Share complete medication and medical history, including diabetes, thyroid cancer, GI disease, kidney disease, retinopathy, depressive disorders, and if pregnant or breastfeeding.
Serious Side Effects
Thyroid cancer
Pancreatitis
Gallbladder and kidney issues
Hypoglycemia
Severe allergic reactions
Stomach issues
Vision changes
Mental health changes
Infection risk from pen-sharing
Common Side Effects
Nausea
Diarrhea
Constipation
Stomach pain
Fatigue
Indigestion
Injection site reactions
Hair loss
Heartburn
Report negative reactions to FDA MedWatch at www.fda.gov/medwatch or 1-800-FDA-1088.