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Evidence-led guide

GLP-1 Medicines: Labels, Evidence, and Safer Questions

A GLP-1 discussion starts with the exact medicine, approved indication, current label and supply route. Approved products, compounded products and research-market products are not interchangeable.

Product status comes first

FDA-approved prescription products have product-specific labeling. FDA separately warns that unapproved GLP-1 products do not undergo its premarket review for safety, effectiveness and quality.1

Three records answer three different questions

Current Zepbound record

Use the exact tirzepatide label for its approved uses, warnings and instructions.2

Current Wegovy record

Use the exact semaglutide label; do not transfer a claim from a different drug or formulation.3

Unapproved-product warning

Use FDA’s regulatory page for compounded, counterfeit, salt-form and illegal-sale concerns.1

Questions for an appointment

  • What exact product and labeled indication are being considered?
  • Which medical history, medicines, pregnancy plans, symptoms or procedures change suitability?
  • Which adverse effects require routine contact, prompt care or emergency care under the current label?
  • How will nutrition, hydration, symptoms, strength, function and follow-up be monitored?

What this hub will not do

It will not select a drug, compounder, telehealth provider, pharmacy, dose or titration schedule, and it will not advise starting, stopping or changing treatment.

Claim-level evidence

Sources and exact limits

  1. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. FDA regulatory source. Design/population: Current regulatory safety page; U.S. patients, prescribers and compounders. Limit: Supports unapproved/compounded-product risks and regulatory distinctions only; it does not replace an approved product label. Disclosure: Not reported or not applicable. Checked 2026-09-02.
  2. Zepbound (tirzepatide) current label record. FDA label repository record. Design/population: Product-specific prescribing information; People within the exact labeled indications. Limit: Product-specific and date-sensitive; current prescribing information controls. Disclosure: Manufacturer-authored labeling reviewed through the FDA approval process. Checked 2026-09-02.
  3. Wegovy (semaglutide) prescribing information. FDA-approved product labeling. Design/population: Product-specific prescribing information; People within the exact labeled indications. Limit: Product-specific and date-sensitive; readers must use the latest approved label. Disclosure: Manufacturer-authored labeling reviewed through the FDA approval process. Checked 2026-09-02.