Tesamorelin Side Effects: What the Egrifta Label Says

Written by Dr. Andrii Kaleniuk. Updated November 13, 2026.

The most common side effects of tesamorelin, according to the FDA label for Egrifta, are injection-site reactions, joint pain (arthralgia), pain in the arms or legs, muscle pain (myalgia), swelling of the hands or feet (peripheral edema) and tingling or numbness (paresthesia). The label also warns about more serious risks: higher levels of the growth factor IGF-1, raised blood sugar, fluid retention including carpal tunnel syndrome, allergic reactions, and a possible effect on cancer growth. Tesamorelin is a lab-made version of growth hormone-releasing hormone (GHRH), a brain signal that tells the pituitary gland to release growth hormone. It is FDA-approved for one use only: reducing excess belly fat in adults with HIV who have lipodystrophy, an abnormal shift in body fat. This guide goes through the label's side-effect table, each warning, who should not use it, and the difference between Egrifta SV and Egrifta WR. All figures come from the FDA labels as of November 2026.

The FDA label approves tesamorelin for the "reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy." The label adds three limitations: long-term heart safety has not been established, it is "not indicated for weight loss management as it has a weight neutral effect," and there is no evidence it improves adherence to HIV medicines. The original Egrifta was approved in November 2010, Egrifta SV followed in 2019, and Egrifta WR was approved on March 25, 2025. Per the labels, Egrifta WR is 1.28 mg injected under the skin of the abdomen once daily, and Egrifta SV is 1.4 mg once daily; the two products are not interchangeable. In the two phase 3 trials, visceral (deep belly) fat fell by 18% versus a 2% rise on placebo, and by 14% versus 2%, over 26 weeks.

The Egrifta WR label pools data from the first 26 weeks of the phase 3 trials, comparing 543 people on tesamorelin with 263 on placebo. The table lists adverse reactions reported more often with tesamorelin. Many of them, such as joint pain, swelling and tingling, reflect the effects of extra growth hormone.

The label also lists indigestion, musculoskeletal pain, general pain, itching and musculoskeletal stiffness at 2% each, and joint swelling and raised creatine phosphokinase (CPK, a muscle enzyme) at 1%. In an older version of the label, 9.6% of people on tesamorelin stopped because of side effects in the first 26 weeks, versus 6.8% on placebo, mainly because of growth hormone-related effects or injection-site reactions. The current labels do not restate that figure.

The label gives two numbers, which can be confusing. The side-effect table reports 17% versus 6%, while the warnings section reports 25% versus 14% in the first 26 weeks. The difference comes from how broadly reactions were grouped: the warnings figure counts a wider set of injection-site events. Reactions include redness, itching, rash, hives, pain, swelling, irritation and bleeding at the site. The label advises rotating injection sites on the abdomen to reduce them. A reaction that spreads, blisters or comes with fever should be checked by a clinician.

Yes. Growth hormone works against insulin, so tesamorelin can make blood sugar harder to control. At week 26, HbA1c (a measure of average blood sugar over about three months) reached 6.5% or higher, the threshold used to diagnose diabetes, in 5% of people on tesamorelin versus 1% on placebo. The label reports a hazard ratio of 3.3 for developing diabetes, meaning roughly three times the risk, although the confidence interval was wide (1.4 to 9.6). The label advises checking blood sugar before starting and during treatment, and regular eye checks for diabetic retinopathy in people who already have diabetes.

Growth hormone causes the body to hold on to salt and water. That fluid retention shows up as swollen ankles or hands, stiff and painful joints, and sometimes carpal tunnel syndrome, where swelling in the wrist presses on a nerve and causes tingling or numbness in the fingers. The Egrifta label says these effects are "either transient or resolve with discontinuation of treatment." Side-effect reports for unapproved compounds that also raise growth hormone are discussed in ipamorelin side effects and CJC-1295 and ipamorelin side effects; those products have no FDA label.

IGF-1 (insulin-like growth factor 1) is made mainly in the liver in response to growth hormone, and doctors use it as a marker of how much growth hormone activity is going on. In the trials, IGF-1 rose more than 2 standard deviations above normal for age (SDS) in 47% of people and more than 3 SDS in 36% at 26 weeks; at 52 weeks the figures were 34% and 23%. Because long-term high IGF-1 is a concern, the label advises regular IGF-1 testing and considering stopping tesamorelin if levels stay above 3 SDS, especially if the belly-fat response is weak.

Yes. Hypersensitivity reactions occurred in 4% of people in the trials, with symptoms such as itching, redness, flushing, hives and rash. About half of people (50%) developed antibodies against tesamorelin by 26 weeks, and 85% of those who had an allergic reaction were antibody-positive. Neutralizing antibodies appeared in 10% by week 52, but antibodies did not clearly reduce the drug's effect. Swelling of the face or throat, trouble breathing or a racing heart after an injection needs emergency care.

The label does not say tesamorelin causes cancer, but it warns that people with HIV already have a higher background risk of some cancers, and that increased growth hormone and IGF-1 could in theory encourage existing tumors to grow. Active cancer is a contraindication, and the label says to stop tesamorelin if a previously treated cancer returns. Separately, the label warns that growth hormone given to people with acute critical illness, such as after major surgery or trauma, has been linked to higher death rates, so stopping should be considered in that situation. Long-term safety beyond 52 weeks has not been established.

No. Tesamorelin has no FDA approval for bodybuilding, muscle gain, general fat loss or anti-aging, and the label specifically says it is not for weight loss. It is also banned in sport: the World Anti-Doping Agency (WADA) 2026 Prohibited List names tesamorelin under section S2.4 as a GHRH analogue, alongside sermorelin and CJC-1295. More on that list is in peptides banned by WADA. Products sold online as "research peptides" are not the FDA-approved drug; their purity, strength and sterility are unknown, as explained in research-use-only peptides and FDA peptide rules in 2026.

Both contain tesamorelin and share the same warnings. Egrifta SV uses a 2 mg vial that is mixed fresh each day. Egrifta WR, approved in 2025, uses an 11.6 mg vial that is mixed once a week and provides seven daily doses, with less than half the injection volume and room-temperature storage. The manufacturer, Theratechnologies, said WR is "set to replace" SV. The labels state that the two are not substitutable, so switching should only be done with a prescriber. How tesamorelin compares with unapproved growth hormone secretagogues is covered in tesamorelin vs ipamorelin, tesamorelin vs CJC-1295 vs ipamorelin and sermorelin vs ipamorelin.

Tesamorelin is FDA-approved only to reduce abdominal fat in adults with HIV-associated lipodystrophy. Its common side effects, including injection-site reactions, joint and muscle pain, swelling and tingling, are mostly mild and linked to raised growth hormone. The bigger concerns are high IGF-1, higher blood sugar and allergic reactions, which is why the label calls for regular monitoring. It is not approved for bodybuilding or weight loss, and it is prohibited in sport by WADA as of November 2026.

This article summarizes FDA labeling for general information and is not medical advice. Tesamorelin should be used only as prescribed for its approved indication. The clinical trials cited were funded by the manufacturer.