Important Safety Information (ISI) - Wegovy®

Prescription only. For use under the supervision of a qualified healthcare provider.

BLACK BOX WARNING – Risk of Thyroid C-Cell Tumors

  • Do not use Wegovy® if you:
    • Have a personal or family history of medullary thyroid carcinoma (MTC).
    • Have multiple endocrine neoplasia syndrome type 2 (MEN 2).
    • Have ever had thyroid cancer.
  • In animal studies, GLP-1 receptor agonists caused thyroid tumors, including cancer. It is not known if this occurs in humans.
  • Call your healthcare provider immediately if you notice a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.

Before Using Wegovy®

Tell your healthcare provider about your full medical history, including if you have:

  • Kidney, liver, or pancreas problems
  • Severe gastrointestinal disease
  • A history of diabetic retinopathy
  • Depression, suicidal thoughts, or behavior changes

Discuss all prescription and non-prescription medications, vitamins, and herbal supplements you take, especially:

  • Insulin or insulin secretagogues (e.g., sulfonylureas)
  • Thyroid hormone medication
  • Medications with a narrow therapeutic range (e.g., warfarin)

Pregnancy, Breastfeeding & Contraception

  • Do not use if you are pregnant, planning to become pregnant, or breastfeeding.
  • Stop Wegovy® at least 2 months before trying to conceive.
  • Use effective contraception while on treatment.
  • Wegovy® may cause fetal harm.

Alcohol

Avoid alcohol while taking Wegovy®.

Serious Warnings – Call Your Doctor Immediately If You Experience:

  • Thyroid C-cell tumor symptoms (see Black Box Warning)
  • Pancreatitis: severe abdominal or back pain that does not go away, with or without vomiting
  • Gallbladder disease: pain in the upper right stomach, fever, yellowing skin/eyes, nausea/vomiting
  • Kidney problems/failure: reduced urination, swelling, fatigue (especially if dehydrated from nausea, vomiting, or diarrhea)
  • Hepatitis or elevated liver enzymes: yellowing skin/eyes, dark urine
  • Diabetic retinopathy changes: sudden vision changes
  • Serious allergic reaction: swelling of face/lips/tongue/throat, difficulty breathing or swallowing, rash, itching, fainting, dizziness, or rapid heartbeat
  • Severe gastrointestinal issues
  • Hypoglycemia (especially if also taking insulin/sulfonylureas): dizziness, confusion, sweating, rapid heartbeat, shakiness, headache
  • Increased heart rate
  • Worsening depression or suicidal thoughts

If any of these occur, stop Wegovy® and seek immediate medical attention.

Common Side Effects

Some people experience no side effects. The most common include:

  • Nausea, vomiting, diarrhea, constipation, abdominal pain, bloating, belching, flatulence
  • Headache, dizziness, fatigue
  • Indigestion, upset stomach, acid reflux
  • Nasopharyngitis (common cold)
  • Back pain
  • Altered taste
  • Decreased appetite
  • Injection site reactions
  • Gastroenteritis
  • Increased lipase or amylase

Most side effects improve as your body adjusts. Contact your provider if symptoms persist.

Drug Interactions

  • Wegovy® may delay stomach emptying, which can affect absorption of oral medications.
  • Dose adjustments may be required for insulin, sulfonylureas, thyroid hormone, and medications with a narrow therapeutic index.
  • Monitor closely if on warfarin or other blood thinners.

Other Safety Notes

  • Stay hydrated to reduce risk of dehydration-related kidney issues.
  • Never share your Wegovy® pen with anyone, even if the needle is changed.

Emergency Information

  • In case of a medical emergency, call 911 or go to the nearest emergency room.
  • To report side effects, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.