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Safety

Important Safety Information

This page summarizes key safety information for GLP-1 receptor agonist medications that clinicians on the Journey platform may prescribe. It is a summary, not a substitute for the full FDA-approved Prescribing Information and Medication Guide for your specific medication.

Boxed Warning — Risk of Thyroid C-Cell Tumors

GLP-1 receptor agonists (including semaglutide and tirzepatide products) caused thyroid C-cell tumors in rodent studies. It is unknown whether these medications cause such tumors, including medullary thyroid carcinoma (MTC), in humans. Do not use if you or any member of your family has a history of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your clinician right away if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.

Do not use if you

  • Have a personal or family history of medullary thyroid carcinoma (MTC).
  • Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Have had a serious allergic reaction to the medication or any of its ingredients.
  • Are pregnant, trying to become pregnant, or breastfeeding.
  • Are under 18 years of age (use in pediatric patients is not established for all products).

Warnings and precautions

  • Pancreatitis: Inflammation of the pancreas has been reported. Stop the medication and contact a clinician if you have severe abdominal pain that does not go away, with or without vomiting.
  • Gallbladder problems: Including gallstones and cholecystitis. Contact a clinician for pain in the upper-right stomach area, fever, yellowing of skin or eyes, or clay-colored stools.
  • Low blood sugar (hypoglycemia): Risk is higher if you also take insulin or a sulfonylurea.
  • Kidney problems (including kidney failure): Can be caused by dehydration from nausea, vomiting, or diarrhea. Drink fluids to reduce risk.
  • Serious allergic reactions: Stop using and seek emergency care for swelling of face/lips/tongue/throat, trouble breathing, severe rash or itching, or fainting.
  • Changes in vision: Especially in patients with type 2 diabetes; report vision changes to your clinician.
  • Increased heart rate and depression or thoughts of suicide have been reported; report mood changes immediately.

Common side effects

The most common side effects of GLP-1 receptor agonists include nausea, vomiting, diarrhea, constipation, stomach (abdominal) pain, headache, fatigue, indigestion, dizziness, gas, and acid reflux. Tell your care team about any side effect that bothers you or does not go away.

Pregnancy and breastfeeding

GLP-1 medications may harm an unborn baby. Stop the medication at least two months before a planned pregnancy. It is not known if these medications pass into breast milk. Do not use while breastfeeding without clinician guidance.

Use with other medications

Tell your clinician about all medicines you take, including prescription, over-the-counter, vitamins, and herbal supplements. GLP-1 medications slow stomach emptying and can affect how other oral medications are absorbed.

Medication Guides and full Prescribing Information

This is a summary. For each medication, please review the full Medication Guide and Prescribing Information from the FDA:

Reporting side effects

Message your Journey care team immediately about any side effects. You are also encouraged to report negative side effects of prescription drugs to the FDA at fda.gov/medwatch or by calling 1-800-FDA-1088.

Emergencies

If you are experiencing a medical emergency, call 911 or go to the nearest emergency room. Journey is not designed for urgent or emergency care.