Tesamorelin Safety Profile
Label-based safety information for tesamorelin, including contraindications, glucose and IGF-1 risks, formulation differences and evidence limits.
Last updated: September 28, 2026
For Educational Purposes Only
This safety information is compiled from clinical trial data and regulatory documents for educational purposes. It is not a substitute for professional medical advice. Always consult your healthcare provider about medication safety, especially regarding your individual circumstances, medical history, and other medications.
Safety is specific to population and formulation
The pivotal safety evidence concerns people with HIV and excess abdominal fat. The pooled report followed a placebo-controlled phase with an extension, not an indefinite comparison. Evidence grade: moderate for the observed trial safety profile. Approval does not establish safety for unrelated uses. (Pooled trial report)
Contraindications in the label
The Egrifta WR label lists active malignancy, specified hypothalamic-pituitary disruption, pregnancy and hypersensitivity to tesamorelin or its formulation ingredients. These are formal contraindications, distinct from precautions requiring clinical judgment. (FDA label, section 4)
Risks and unanswered questions
| Label topic | What the evidence summary should convey |
|---|---|
| IGF-1 | Levels rise; consequences of prolonged elevation remain uncertain. |
| Glucose | Glucose intolerance or diabetes may develop. |
| Fluid retention | Swelling and musculoskeletal symptoms can occur. |
| Hypersensitivity and injection reactions | Both appear in the label; they are different event categories. |
| Cardiovascular outcomes | Long-term cardiovascular safety is not established. |
These statements summarize the current prescribing information; they are not a complete list or individual risk estimate.
Formulations and interpretation
WR and SV are not substitutable. Their instructions and ingredients must not be conflated. Clinical trial adverse-event percentages also cannot be transferred directly to another population or compared casually with another drug’s studies. (FDA label)
See the tesamorelin dossier for efficacy and ongoing research, and the introductory guide for terminology.
Educational information only. It does not recommend starting, stopping or combining medications.
Sources & Citations
- 1
- 2regulatoryEGRIFTA WR - tesamorelin kit; DailyMed label updated July 29, 2026
dailymed-egrifta-wr-2026
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Important: Safety information evolves as post-marketing data accumulates. This page reflects data available as of the last update date. Check official FDA and EMA resources for the most current safety information. This content is not intended to diagnose, treat, cure, or prevent any disease.