Peptide Graded

Tesamorelin

Is Tesamorelin safe?

Phase 3 safety data; IGF-1 monitoring advised

BSome human evidenceFDA approvedas of 2026-10-26

The most common side effects in the phase 3 trials were injection-site reactions (redness, itching, pain), joint pain, swollen limbs, muscle aches and tingling. More patients on tesamorelin than on placebo quit because of adverse events. IGF-1 rises substantially. The label advises monitoring it, because long-lasting high IGF-1 is linked to cancer risk in other settings. 1910

The label lists contraindications for pregnancy, active cancer, and damage to the pituitary-hypothalamic axis from surgery, tumor or radiation. Glucose was unchanged in the trials. Still, the label flags that tesamorelin can raise blood sugar and advises checking it. The trial that included people with diabetes excluded those with poorly controlled disease. No one has studied long-term heart outcomes. No trial has tested tesamorelin in healthy people who want cosmetic fat loss. 11213

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More on Tesamorelin

Citations

  1. DailyMed: Egrifta (tesamorelin) prescribing information dailymed.nlm.nih.gov
  2. Falutz 2010, JAIDS: Tesamorelin in HIV-infected patients with abdominal fat accumulation, randomized trial with safety extension doi.org
  3. DailyMed: Egrifta WR (tesamorelin) prescribing information dailymed.nlm.nih.gov
  4. Falutz 2008, AIDS: Long-term safety and effects of tesamorelin, 52-week extension doi.org
  5. Falutz 2010, JAIDS: Effects on visceral adipose tissue doi.org
  6. FDA 2025: Egrifta prescribing information (NDA 022505) accessdata.fda.gov
  7. Stanley 2012, J Clin Endocrinol Metab: Metabolic effects of a GHRH analog in obese subjects with reduced GH secretion, randomized controlled trial pubmed.ncbi.nlm.nih.gov
  8. Stanley 2019, Lancet HIV: Effects of tesamorelin on non-alcoholic fatty liver disease in HIV, randomized trial pubmed.ncbi.nlm.nih.gov
  9. Falutz 2007, NEJM: Metabolic effects of a growth hormone-releasing factor in patients with HIV pubmed.ncbi.nlm.nih.gov
  10. Falutz 2010, J Clin Endocrinol Metab: Pooled analysis of two phase 3 tesamorelin trials pubmed.ncbi.nlm.nih.gov
  11. Falutz 2010, JAIDS: Tesamorelin in HIV with abdominal fat, randomized trial with safety extension pubmed.ncbi.nlm.nih.gov
  12. Clemmons 2017, PLoS One: Safety and metabolic effects of tesamorelin in type 2 diabetes, randomized trial pubmed.ncbi.nlm.nih.gov
  13. DailyMed: Egrifta label, warnings on glucose dailymed.nlm.nih.gov
  14. Ferdinandi 2007, Basic Clin Pharmacol Toxicol: Non-clinical pharmacology and safety of TH9507 pubmed.ncbi.nlm.nih.gov

Reference information only, not medical advice. Drawn from the Tesamorelin article, fact-checked against the cited sources. No dosing anywhere on this site.