What it is
Tesamorelin is a synthetic analog of growth hormone-releasing hormone (GHRH) that prompts the pituitary to release growth hormone.
What the research says
- An approved tesamorelin product has labeling describing its approved use and risks [1].
- The approved product's label states it is not indicated for weight loss management as it has a weight neutral effect [1].
Regulatory status
An approved tesamorelin product exists for a specific use in adults with HIV and lipodystrophy [1]. Compounded tesamorelin is not that product and is not FDA approved. Where prescribed, compounded versions are prepared by state-licensed 503A compounding pharmacies.
Safety and side effects
The approved tesamorelin label warns of an increased risk of neoplasms (any prior cancer must be inactive and its treatment complete before starting), elevated IGF-1 levels with unknown long-term effects, fluid retention (including edema, arthralgia and carpal tunnel syndrome), glucose intolerance or diabetes, hypersensitivity reactions, and increased mortality in patients with acute critical illness. It is contraindicated in pregnancy, in active cancer, and in people with disruption of the hypothalamic-pituitary axis [1]. A licensed healthcare provider should review your history, medications and labs, including blood glucose.
Is it right for you?
Only a licensed healthcare provider can decide whether any treatment is appropriate for you.
Frequently asked questions
Is compounded tesamorelin approved by FDA?
No. Compounded tesamorelin is not FDA approved. A separate approved tesamorelin product exists for a specific use in adults with HIV and lipodystrophy [1].
Is tesamorelin indicated for weight loss?
No. The approved product's label states it is not indicated for weight loss management as it has a weight neutral effect [1].
Do I need a prescription for Tesamorelin?
Yes. Prescription only, requires evaluation by a licensed provider. A provider decides whether it is appropriate for you.
Sources
- FDA prescribing information, EGRIFTA WR (tesamorelin), revised 3/2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf
Tesamorelin content on this page is for education. Compounded medications are not FDA approved. Prescription only, requires evaluation by a licensed provider. Educational content only, not medical advice.