Tesamorelin Side Effects: What the Egrifta Label Lists

By DoseGauge Editorial · Updated 2026-06-13 · 7 min read

The side effects below come from the FDA prescribing information for Egrifta (tesamorelin). Tesamorelin is FDA-approved, as Egrifta, only for the reduction of excess abdominal fat in HIV-infected adults with lipodystrophy, so the label's safety data describe that population and that use. Off-label use is not covered by the label. According to the Egrifta SV and Egrifta WR labels, the most commonly reported reactions are injection-site reactions, joint pain (arthralgia), pain in an extremity, peripheral edema, and muscle pain (myalgia). The labels also raise IGF-1 and call for glucose and IGF-1 monitoring, and they list several contraindications. Everything here is taken from those labels. It is information, not medical advice, and it is not a complete list of every reaction in the label.

The most common adverse reactions

The Egrifta labels report adverse reactions from the 26-week controlled phase of the clinical trials, comparing tesamorelin against placebo. The reactions reported in more than 5% of treated patients are arthralgia, injection-site reactions (including erythema, pruritus, pain, and irritation), pain in extremity, peripheral edema, and myalgia. The table below lists the rates the labels report for the tesamorelin and placebo groups during that period. For more background on the compound itself, see what tesamorelin is.

The labels also report that, counting injection-site reactions more broadly, the incidence of injection-site reactions was 25% in the tesamorelin group versus 14% in the placebo group during the first 26 weeks.

Two things are worth stating plainly about this list. First, it is the common-frequency tier, the reactions reported above the labels' reporting threshold, not the full catalog. The labels' adverse-reaction tables contain additional, less frequent reactions. Second, the list is descriptive: it records what was reported, at what rate, in the studied population (HIV-infected adults with lipodystrophy). It does not predict whether a given person will have any of these reactions or how severe they would be.

Effects on blood sugar and IGF-1

Tesamorelin works by stimulating the body's own growth hormone (GH) production, which in turn raises serum IGF-1, a growth factor. The label addresses both effects directly.

On IGF-1, the label instructs clinicians to monitor IGF-1 levels during therapy and to consider discontinuing in patients with persistent IGF-1 elevations. That instruction follows from the mechanism: because the drug increases IGF-1, the label treats sustained elevation as a reason to reassess.

On blood sugar, the label directs clinicians to evaluate glucose status before starting tesamorelin and to monitor patients periodically to identify those who develop impaired glucose tolerance or diabetes. In the 26-week trial data, the label notes a higher rate of elevated HbA1c in the tesamorelin group (5%) than in the placebo group (1%). The label frames this as a reason for glucose monitoring, not as a contraindication for everyone. These are the label's monitoring instructions to prescribers; they are not advice about what any individual should do.

Who should not use it (contraindications and warnings)

The Egrifta labels list four contraindications, meaning situations in which the labels state the drug should not be used:

• Disruption of the hypothalamic-pituitary axis (for example, due to hypophysectomy, hypopituitarism, pituitary tumor or surgery, head irradiation, or head trauma).
• Active malignancy.
• Known hypersensitivity to tesamorelin or to the excipients in the product.
• Pregnancy.

Beyond the contraindications, the labels' Warnings and Precautions section covers several distinct risks. Each is attributed to the label, not to any judgment on this page:

• Increased risk of neoplasms. The label addresses the possibility of malignancy and calls for careful evaluation, with discontinuation if a recurrence is detected.
• Elevated IGF-1 levels. The drug increases IGF-1; the label directs IGF-1 monitoring and reassessment if elevations persist.
• Fluid retention. The label notes that tesamorelin may cause fluid retention, which can present as edema, arthralgia, or carpal tunnel syndrome, and that these often resolve on continued treatment or after stopping.
• Glucose intolerance or diabetes mellitus. The label directs evaluation of glucose status before starting and periodic monitoring during use.
• Hypersensitivity reactions. The label reports that hypersensitivity reactions occurred in about 4% of patients, including pruritus, erythema, flushing, urticaria, and rash.
• Injection-site reactions. The label reports a higher incidence of injection-site reactions in treated patients than in placebo patients.
• Increased mortality in patients with acute critical illness. The label recommends discontinuation in patients who become acutely critically ill.

This list reflects the section headings in the labels. The labels themselves contain the full detail and the complete adverse-reaction tables.

A note on off-label use

Everything above is drawn from the Egrifta label, and the label's safety data describe one specific situation: the approved population (HIV-infected adults with lipodystrophy) at the approved daily subcutaneous dose (1.4 mg/day for Egrifta SV, 1.28 mg/day for Egrifta WR). The trials that generated these frequencies studied that population at that dose.

That matters for any other use. When tesamorelin is used off-label, in a different population, for a different purpose, or at a different dose, the documented adverse-reaction rates, the monitoring guidance, and the contraindications were not studied in that context, so the label's profile may not apply in the same way. The label does not characterize off-label use, and this page cannot either. Anyone considering tesamorelin should talk to a licensed clinician who can weigh their individual situation.

Frequently asked questions

What are the most common tesamorelin side effects?

Per the Egrifta labels, the most common adverse reactions (reported in more than 5% of treated patients) are arthralgia (joint pain), injection-site reactions such as erythema, pruritus, pain, and irritation, pain in an extremity, peripheral edema, and myalgia (muscle pain). These rates come from the 26-week controlled phase of the clinical trials in HIV-infected adults with lipodystrophy.

Does tesamorelin affect blood sugar?

The label directs clinicians to evaluate glucose status before starting tesamorelin and to monitor patients periodically, because some patients developed impaired glucose tolerance or diabetes during treatment. In the trial data, the label notes a higher rate of elevated HbA1c in the tesamorelin group than in placebo. This is the label's monitoring guidance, not advice for any individual.

Who should not take tesamorelin?

The Egrifta labels contraindicate it in people with disruption of the hypothalamic-pituitary axis, an active malignancy, a known hypersensitivity to tesamorelin or its excipients, and in pregnant women. Eligibility beyond those contraindications is determined by a licensed clinician.

Are the side effects different for off-label use?

The label's documented side effects, frequencies, and monitoring guidance come from trials in the approved population (HIV-associated lipodystrophy) at the approved daily dose. The label does not characterize off-label use, so for a different population, purpose, or dose, the documented profile may not apply in the same way. A licensed clinician is the right person to weigh that.

Informational and educational only. Not medical advice. DoseGauge computes from the values you enter and does not recommend a dose. Talk to a licensed clinician before using any peptide or GLP-1 medication.