Peptide Medicine
Tesamorelin: FDA-Approved Uses, Benefits, and Safety
Medically reviewed by HealthRX.com Medical Team · Last reviewed
What is tesamorelin?
Tesamorelin is a stabilized analog of growth-hormone-releasing hormone (GHRH). It is the active ingredient in Egrifta, which is FDA approved to reduce excess belly fat in people with HIV who have lipodystrophy.
How does tesamorelin work?
Like sermorelin, tesamorelin stimulates the pituitary to release the body's own growth hormone, which in turn promotes the breakdown of fat. It has a particular effect on visceral fat, the deep fat stored around the organs. [1]
What does the research show?
In the trials that led to approval, tesamorelin meaningfully reduced visceral abdominal fat in people with HIV-associated lipodystrophy, on the order of 15 to 18 percent, with improvements in some metabolic markers. Outside that approved use, evidence is more limited and off-label. [1]
- FDA approval was based on randomized trials in HIV-associated lipodystrophy showing reduced visceral fat. [1]
- Off-label use for general visceral-fat reduction or growth-hormone support is less studied.
- Honest framing: the strong evidence is specific to the HIV lipodystrophy population.
How is tesamorelin dosed?
The approved dose of Egrifta is 2 mg by subcutaneous injection once daily. Compounded or off-label regimens vary and should be directed by a licensed provider.
Is tesamorelin safe, and what are the side effects?
Common side effects include injection-site reactions, joint pain, swelling from fluid retention, and changes in blood sugar. It is not recommended in pregnancy or in people with active cancer, and it should be used under medical supervision.
Is tesamorelin legal and FDA approved?
Yes, for a specific use. Tesamorelin (Egrifta) is FDA approved to reduce excess abdominal fat in HIV-associated lipodystrophy. Other uses, including general fat loss, are off-label and prescription only.
How does Tesamorelin compare with other peptides?
| Tesamorelin | Sermorelin | |
|---|---|---|
| Approach | Stimulates your own GH | Stimulates your own GH |
| Best evidence | Visceral fat in HIV lipodystrophy | GH-deficiency testing |
| FDA approved | Yes (Egrifta) | Former (Geref) |
Frequently asked questions
Is tesamorelin FDA approved?
Yes. Tesamorelin (Egrifta) is FDA approved to reduce excess abdominal fat in people with HIV-associated lipodystrophy. Other uses are off-label.
Does tesamorelin reduce belly fat?
In its approved use it reduced visceral abdominal fat by roughly 15 to 18 percent in trials. Evidence outside the HIV lipodystrophy population is more limited.
How is tesamorelin dosed?
The approved dose is 2 mg by subcutaneous injection once daily; off-label regimens vary and need provider oversight.
What are the side effects of tesamorelin?
Injection-site reactions, joint pain, fluid retention and changes in blood sugar. It is avoided in pregnancy and active cancer.
Citations
This guide is educational and is not a substitute for individualized medical advice. Tesamorelin is prescription-only and requires evaluation by a licensed provider.