Tesamorelin: Side Effects & Safety

As an FDA-approved drug, tesamorelin has the most thoroughly documented safety profile among GHRH analogs. Side effects reported in pivotal trials:

Side Effect	Incidence	Severity
Injection site reactions	25–36%	Mild to moderate
Arthralgia (joint pain)	13%	Mild to moderate
Peripheral edema	6%	Mild
Myalgia (muscle pain)	5%	Mild
Paresthesias	5%	Mild to moderate

Injection site reactions — erythema, pruritus, pain, or irritation — are the most frequently reported adverse event. These are consistent with daily subcutaneous injection of any peptide and typically diminish with continued use and proper site rotation.

Tesamorelin increases growth hormone levels, which has metabolic implications:

• Glucose tolerance: GH is a counter-regulatory hormone to insulin. Tesamorelin may impair glucose tolerance and increase fasting blood glucose. Patients with diabetes or pre-diabetes should be monitored closely.
• IGF-1 elevation: Treatment increases IGF-1 levels. If IGF-1 rises persistently above the age-adjusted normal range, treatment should be discontinued per FDA labeling.
• Fluid retention: GH promotes sodium and water retention, contributing to peripheral edema, arthralgias, and carpal tunnel-like symptoms in some patients.

• Active malignancy: GH stimulation could theoretically promote tumor growth. Tesamorelin is contraindicated in patients with active cancer.
• Disrupted HPA axis: Head irradiation, head surgery, or pituitary trauma — tesamorelin requires a functional pituitary to work.
• Pregnancy: Contraindicated based on animal data showing adverse developmental effects.
• Hypersensitivity: To tesamorelin or mannitol (excipient).

For the complete tesamorelin overview, see the tesamorelin complete guide.