Is Tesamorelin (compounded) safe?
Phase 3 safety data; IGF-1 monitoring advised
In the HIV trials, the common effects were injection-site reactions, joint pain, swollen limbs, muscle aches and tingling. These fit with raised growth hormone. In the NEJM trial, more patients on tesamorelin than placebo quit because of adverse events. Overall event rates did not differ. The label warns about fluid retention, glucose intolerance and raised IGF-1. It advises considering stopping the drug if IGF-1 stays well above the normal range. It is contraindicated with active malignancy and in pregnancy. 81
The label says long-term heart safety has not been established. For off-label use the gap is wider. The whole controlled record is 60 people studied for one year. Compounded product adds doubt about potency and sterility, which the trials did not test. 56
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Citations
- DailyMed: Egrifta SV (tesamorelin) prescribing information dailymed.nlm.nih.gov
- Falutz 2010, J Acquir Immune Defic Syndr: tesamorelin in HIV abdominal fat accumulation, RCT with extension pubmed.ncbi.nlm.nih.gov
- DailyMed: Egrifta WR (tesamorelin) prescribing information dailymed.nlm.nih.gov
- Falutz 2008, AIDS: long-term safety and effects of tesamorelin, extension study doi.org
- FDA label, 2025: Egrifta WR accessdata.fda.gov
- Makimura 2012, J Clin Endocrinol Metab: tesamorelin in obese subjects with reduced GH secretion, RCT pubmed.ncbi.nlm.nih.gov
- Stanley 2019, Lancet HIV: tesamorelin for NAFLD in HIV, RCT pubmed.ncbi.nlm.nih.gov
- Falutz 2007, NEJM: metabolic effects of a GHRH analog in patients with HIV pubmed.ncbi.nlm.nih.gov
- Falutz 2010, J Clin Endocrinol Metab: pooled analysis of two phase 3 tesamorelin trials pubmed.ncbi.nlm.nih.gov
- Clemmons 2017, PLoS One: tesamorelin in type 2 diabetes, RCT pubmed.ncbi.nlm.nih.gov
- 2007, Basic Clin Pharmacol Toxicol: non-clinical pharmacology of TH9507 pubmed.ncbi.nlm.nih.gov
Reference information only, not medical advice. Drawn from the Tesamorelin (compounded) article, fact-checked against the cited sources. No dosing anywhere on this site.