▶ TESAMORELIN · SUBTOPIC · SAFETY PROFILE
TESAMORELIN Safety Profile
For Laboratory Research Use Only. This page summarises observed adverse events and regulatory status reported in the peer- reviewed literature. It is not medical advice and does not recommend any human use of TESAMORELIN.
OBSERVED ADVERSE EVENTS IN LITERATURE
The following adverse events have been observed in trials or animal studies of TESAMORELIN. Severity, frequency, and attribution depend on the source publication.
- Injection-site reactions
- Arthralgia
- Peripheral edema
- Carpal tunnel symptoms (transient)
- Hyperglycemia (mild, in some)
DRUG INTERACTIONS
The following interactions are reported in or theorised from the published mechanism for TESAMORELIN.
- Corticosteroids may blunt GH response
- Concurrent rhGH not recommended
CONTRAINDICATIONS REPORTED IN LITERATURE
Contraindications recorded for TESAMORELIN in the published record:
- Active malignancy
- Pituitary tumor
- Pregnancy/lactation
- Hypersensitivity to mannitol
FDA REGULATORY STATUS
FDA-approved as Egrifta® (2010) and Egrifta SV® (reformulated 2019) for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
WADA REGULATORY STATUS
Prohibited at all times under Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics) in the GHRH-analog sub-category.
SAFETY Q+A FROM LITERATURE
▶ What is tesamorelin?
Tesamorelin is a stabilized 44-amino-acid analog of human growth-hormone-releasing hormone GHRH(1-44). It is the only GHRH analog currently FDA-approved for a chronic indication (HIV-associated lipodystrophy, marketed as Egrifta® and Egrifta SV®).
▶ What is tesamorelin approved for?
Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. The branded human-prescription products (Egrifta, Egrifta SV) are FDA-approved under separate clinical pathways. Marketing rights are held by Theratechnologies Inc. (Montreal).
▶ Tesamorelin vs CJC-1295 · what's different?
Both are GHRH analogs. Tesamorelin is a stabilized GHRH(1-44) · preserves the full natural 44-aa hormone sequence. CJC-1295 is a GHRH(1-29) analog with stabilizing substitutions; the With-DAC variant adds an albumin-tethering linker that extends half-life to a week. Tesamorelin is FDA-approved; CJC-1295 is research-use only.
▶ Is tesamorelin banned in sports?
Yes. Tesamorelin is prohibited at all times under WADA Section S2 in the GHRH-analog sub-category. Detectable on standard anti-doping screens.
▶ Side effects of tesamorelin?
Most common per Phase 3 data: injection-site reactions, arthralgia, peripheral edema, transient carpal-tunnel-type symptoms, and mild hyperglycemia in a minority. The trials reported no clinically meaningful changes in fasting glucose at the approved 2 mg dose.
▶ How is research-grade tesamorelin different from Egrifta?
The active molecule is the same. Branded Egrifta is formulated, labeled, and quality-controlled to FDA pharmaceutical standards. Research-grade tesamorelin sold as a chemical reference compound is for laboratory use only and is not interchangeable with the approved product.
CITED LITERATURE
The safety statements above are drawn from the following peer-reviewed sources. Refer to the originals for adverse- event tables, attribution, and full context.
- Falutz J, Mamputu JC, Potvin D, et al.. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in HIV patients with excess abdominal fat: pooled analysis of two phase 3 trials. J Clin Endocrinol Metab 2010. PMID 20554713. link
- Falutz J, Potvin D, Mamputu JC, et al.. Effects of tesamorelin in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with safety extension. J Acquir Immune Defic Syndr 2010. PMID 20101189. link
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▶ LAST UPDATED · 2026-05-19