Tesamorelin side effects: what the FDA label and trials report

What are the side effects of tesamorelin?

The Egrifta SV label lists joint pain (arthralgia), redness and itching at the site where the study drug was given, pain in an arm or leg, swelling (peripheral edema) and muscle pain (myalgia) as its most commonly reported adverse reactions, each above 5% among 543 tesamorelin participants in pooled 26-week trials, in these selected adults with HIV only; the pooled table does not report events by sex (Egrifta SV label, section 6.1 and highlights). In those trials, joint pain was reported by 13% of 543 tesamorelin participants and 11% of 263 placebo participants, and swelling by 6% and 2%, in adults with HIV only (Egrifta SV label, Table 1).

Numbness or tingling (paresthesia) was reported by 5% of 543 tesamorelin participants and 2% of 263 placebo participants, reduced sensation by 4% and 2%, rash by 4% and 2%, and vomiting by 3% and 0%, among adults with HIV in the pooled 26-week trials only (Egrifta SV label, Table 1). Carpal tunnel syndrome, a pinched nerve at the wrist, was reported by 1% of 543 tesamorelin participants and 0% of 263 placebo participants, among adults with HIV in the pooled 26-week trials only (Egrifta SV label, Table 1). The full list sits in the table below.

The label links fluid retention to growth hormone. It says fluid retention may occur during treatment, is thought to be related to the induction of growth hormone secretion, and shows up as reactions such as edema, joint pain and carpal tunnel syndrome that are either transient or resolve with discontinuation of treatment, a statement the section gives without a participant number (Egrifta SV label, section 5.3). A 2026 meta-analysis of five randomised trials in adults with HIV, whose abstract gives no participant total, listed joint pain, muscle pain, tingling and site reactions such as redness among the adverse events associated with tesamorelin, and covers only those trials (Badran et al., Obesity Research & Clinical Practice, 2026).

Evidence limits

What do tesamorelin safety records not show?

The trial record has edges too. The two pivotal trials enrolled adults aged 18 to 65 with HIV and excess abdominal fat, 86% of the 412 adults in the first trial and 84% of the 404 adults in the second being men, with a 26-week phase plus a 26-week extension, so their results say little about women, older adults or people without HIV (Egrifta SV label, section 14). Data in healthy adults are thin: a 2-week study of 13 healthy men measured hormone levels and glucose uptake, and its abstract reports no adverse-event counts (Stanley et al., Journal of Clinical Endocrinology and Metabolism, 2011). A 12-month randomised trial of 61 adults with HIV and fatty liver disease states that it 'was not powered to detect differences in adverse events' (Stanley et al., The Lancet HIV, 2019).

None of this describes research-use material. The TGA says unapproved peptide products have not been assessed for safety, quality or effectiveness, and lists what side effects they may cause among the unknowns (TGA peptide products page, updated 23 September 2026; TGA advisory, 13 April 2026).

Is tesamorelin safe, and what are its dangers?

The Egrifta SV label lists seven warnings: new or returning cancers (neoplasms), raised IGF-1, fluid retention, glucose intolerance or diabetes, hypersensitivity reactions, reactions at the site where the study drug was given, and higher mortality in acute critical illness (Egrifta SV label, section 5). The label also lists contraindications in people with active malignancy, pituitary-axis disruption, known hypersensitivity and pregnancy (section 4). A trial result is a measured risk in a defined group of adults with HIV, not a verdict on safety for any one person.

Three of those warnings carry numbers from the label's trials, and all three come from adults with HIV only. Hypersensitivity reactions, such as itching, flushing, hives and rash, were reported in 4% of adults with HIV treated with tesamorelin in the Egrifta SV label's clinical trials, with no participant number given (Egrifta SV label, section 5.5). Diabetes, defined as an HbA1c (a three-month blood-sugar marker) of 6.5% or more, appeared in 5% of adults with HIV on tesamorelin and 1% on placebo by week 26 in the Egrifta SV label's trials, with an intent-to-treat 'hazard odds ratio' of 3.3 (CI 1.4 to 9.6) in the label's words and no participant number in that section (Egrifta SV label, section 5.4). IGF-1 rose above 2 standard deviation scores (a measure of distance from the age-matched average) in 47% of adults with HIV treated for 26 weeks, and in 34% of those who remained on treatment for 52 weeks, in the Egrifta SV label's trials, with no participant numbers given in that section (Egrifta SV label, section 5.2).

A 2026 meta-analysis of four randomised trials in 909 adults with HIV reported growth-hormone-related adverse effects and a higher rate of stopping tesamorelin that did not reach statistical significance (risk ratio 2.25, 95% confidence interval 0.98 to 5.17, p = 0.06), and its findings apply only to those trials (Ditta et al., Journal of the International Association of Providers of AIDS Care, 2026).

Who does the FDA label list as contraindicated for tesamorelin?

The Egrifta SV label lists four contraindications: a disrupted hypothalamic-pituitary axis (from pituitary removal, underactive pituitary, pituitary tumour or surgery, head irradiation or head trauma), active malignancy, known hypersensitivity to tesamorelin or its ingredients, and pregnancy (Egrifta SV label, section 4). Its indication is limited to adults with HIV and lipodystrophy, and it says safety and effectiveness in children have not been established (sections 1 and 8.4). It has no information for people over 65 (section 8.5).

The pivotal trials applied further limits. They enrolled adults aged 18 to 65 and excluded people with a body-mass index of 20 or below, type 1 or type 2 diabetes, previous treatment with insulin or oral blood-sugar agents, a history of malignancy, or hypopituitarism (Egrifta SV label, section 14). The trial results therefore describe a narrower group than 'anyone'.

Whether any person in Australia may lawfully supply or obtain tesamorelin is a separate question, answered on the legal status page.

What do tesamorelin records say about women and men?

The Egrifta SV label describes two pivotal trials of 412 and 404 adults with HIV and excess abdominal fat, in which 86% and 84% were male, with no sex-specific adverse-event rates supplied in the label's pooled table, so these records say little about women (Egrifta SV label, sections 6.1 and 14). The label lists pregnancy as a contraindication, saying modifying visceral fat offers no benefit in pregnancy and could result in fetal harm, and it records hydrocephaly in rat offspring after tesamorelin acetate exposure during pregnancy and lactation, a rat result that does not establish the same in people (Egrifta SV label, sections 4 and 8.1).

Women appear in other trials in smaller numbers. Seven of the 31 adults assigned to tesamorelin (22.6%) and 6 of the 30 assigned to placebo (20.0%) in the 12-month trial in adults with HIV and fatty liver disease were women, and the adverse-event table in that paper is by treatment group, not by sex (Stanley et al., The Lancet HIV, 2019). A 12-month trial of 60 abdominally obese adults with reduced growth hormone secretion enrolled 21 women and 39 men, and its abstract reports adverse events for all participants together (Makimura et al., Journal of Clinical Endocrinology and Metabolism, 2012).

The label also records that there are no data on the presence of tesamorelin in human milk (Egrifta SV label, section 8.2). In rats, the Egrifta SV label records no effect on fertility in male or female animals, a rat result that does not establish the same in people (Egrifta SV label, section 13.1). The label's indication is the same for both sexes, and the sources read for this page did not report a sex-specific effect or a testosterone result.

Is tesamorelin bad for your heart?

The Egrifta SV label states that the long-term cardiovascular safety of tesamorelin has not been established (Egrifta SV label, section 1). In a 12-month randomised trial of 60 obese adults with low growth hormone, the thickness of the carotid artery wall (the artery in the neck) changed by -0.03 mm with tesamorelin and +0.01 mm with placebo, a treatment effect of -0.04 mm (95% confidence interval -0.07 to -0.01), a marker measure and not a count of heart attacks or strokes (Makimura et al., Journal of Clinical Endocrinology and Metabolism, 2012). In the pooled phase 3 trials of 806 adults with HIV, palpitations were reported by 1% of 543 tesamorelin participants and 0% of 263 placebo participants, for that group only (Egrifta SV label, Table 1).

Small trials cannot settle heart safety. In a randomised trial of 50 adults with HIV that its authors call preliminary, each arm had three serious adverse events, including one hospitalisation for worsening of existing congestive heart failure in the tesamorelin arm and one for acute stroke in the placebo arm, counts too small to estimate rates (Stanley et al., JAMA, 2014). A 2026 review of peptides in urology and sexual medicine, a review and not a trial, says safety data for the peptide classes it covers are limited by short follow-up, small samples and incomplete assessment of cardiovascular, metabolic and oncologic outcomes (Vasylieva et al., Sexual Medicine Reviews, 2026).

The label adds a related warning. It records that increased mortality in patients with acute critical illness, due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or in those with acute respiratory failure, has been reported after treatment with pharmacologic amounts of growth hormone (Egrifta SV label, section 5.7). That warning rests on growth hormone reports and not on a tesamorelin trial.

Does tesamorelin affect the liver?

In a 6-month randomised trial of 50 adults with HIV that its authors call preliminary, median liver fat changed by -2.0% (lipid-to-water percentage) with tesamorelin and +0.9% with placebo, a net effect of -2.9%, for that group only (Stanley et al., JAMA, 2014). In a 12-month randomised trial of 61 adults with HIV and fatty liver disease, hepatic fat fraction fell by an absolute 4.1 percentage points more with tesamorelin than with placebo (95% confidence interval -7.6 to -0.7), also for that group only (Stanley et al., The Lancet HIV, 2019). The Egrifta SV label lists no liver warning among its section 5 warnings and says tesamorelin's pharmacokinetics in people with hepatic impairment have not been established (Egrifta SV label, sections 5 and 12.3).

In the 2019 trial, 2 of 19 people on tesamorelin (10.5%) and 9 of 24 on placebo (37.5%) showed fibrosis (scarring) progression (p = 0.04), and tesamorelin did not improve scarring that was already present, in that small trial of 61 adults with HIV and fatty liver disease only (Stanley et al., The Lancet HIV, 2019; ClinicalTrials.gov NCT02196831). In a responder analysis of two phase 3 trials with 806 adults with HIV, those with high starting liver enzymes whose visceral fat fell by at least 8% had a mean ALT change of -8.9 U/l against +1.4 U/l in those whose fat did not, an association within the tesamorelin arm, with no subgroup size in the abstract, that does not show tesamorelin caused it (Fourman et al., AIDS, 2017).

The liver also processes other medicines. The label notes that published data suggest growth hormone may alter the clearance of compounds metabolised by liver CYP450 enzymes, such as corticosteroids, sex steroids, anticonvulsants and cyclosporine (Egrifta SV label, section 7.1). All of the trial data in this section come from adults with HIV.

Can tesamorelin change hormones, including testosterone?

In the first pivotal trial of 412 adults with HIV, IGF-1 (insulin-like growth factor 1, a growth signal made mainly in the liver) rose by 81.0% with tesamorelin and fell by 5.0% with placebo, a result for that group only (Falutz et al., New England Journal of Medicine, 2007). The Egrifta SV label's clinical-trial summary reports no clinically significant changes in thyroid-stimulating hormone, luteinizing hormone, ACTH or prolactin, and this passage does not specify the patient population or a participant number (Egrifta SV label, section 12.2). A PubMed search run for this page on 14 October 2026 returned no trial that reports a testosterone result in its title or abstract.

That search paired tesamorelin with testosterone, androgen, sex steroids, estradiol, luteinizing hormone, gonadal or sex hormone in titles and abstracts. It returned three records, all of them reviews, and no trial. The silence is a gap in the records the search reached, not a finding that testosterone is unaffected. The World Anti-Doping Agency files tesamorelin under growth hormone releasing factors (S2.2.4), not under its separate group for testosterone-stimulating peptides in males (S2.2.1) (WADA 2026 Prohibited List, effective 1 January 2026).

Two other records bear on hormones. The label's interaction section records that growth hormone inhibits an enzyme (11β-HSD1) required to convert cortisone to active cortisol (Egrifta SV label, section 7.2). And in the Egrifta SV label's trials in adults with HIV, 5% of tesamorelin participants reached the diabetes marker (HbA1c of 6.5% or more) against 1% on placebo, with no participant number in that section (Egrifta SV label, section 5.4).

How long was tesamorelin studied, and what do records say about long-term safety?

The sources read for this page do not define a safe length of time for tesamorelin. The Egrifta SV label lists long-term cardiovascular safety among the unknowns (Egrifta SV label, section 1). Each of the two pivotal trials in adults with HIV (412 and 404 adults) had a 26-week placebo-controlled phase plus a 26-week extension, 52 weeks in total, so the label's trial data cover 52 weeks at most (Egrifta SV label, section 14). A trial of 61 adults with HIV and fatty liver disease ran 12 months double-blind and then 6 months open-label, up to 18 months in total (Stanley et al., The Lancet HIV, 2019). A trial period shows what was measured, not what is safe.

The extension of the first pivotal trial (154 participants continuing tesamorelin and 50 switched to placebo) was reported separately (Falutz et al., AIDS, 2008). The label records two gaps that bear on length of study: the effects of prolonged IGF-1 elevation are unknown, and long-term cardiovascular safety has not been established (Egrifta SV label, sections 1 and 5.2). Those are statements about gaps in the evidence for a medicine under medical care, and they do not describe research material.

How long does tesamorelin stay in your system?

The Egrifta SV label reports a mean elimination half-life (the time for the blood level to fall by half) of 8 minutes in healthy subjects, and the Egrifta WR label (a different formulation, revised March 2025) reports 11 minutes in healthy subjects, with no participant number stated in either passage (labels, section 12.3). A half-life describes the blood level and does not describe how long any effect lasts.

In the 26-week extension of the two pivotal trials, in these re-randomised adults with HIV only, mean IGF-1 fell by 137 ng/mL in the first trial (50 people) and 135 ng/mL in the second (85 people) among those re-randomised to placebo, against falls of 59 ng/mL (154 people) and 25 ng/mL (92 people) among those who stayed on tesamorelin (Egrifta SV label, Table 5). In a group of trial participants who had antibodies to tesamorelin after 26 weeks and were re-assessed 6 months after stopping, 18% were still antibody-positive, in adults with HIV only and with no participant number given in that section (Egrifta SV label, section 12.6).

Whether a lab test can find tesamorelin is a separate question. The page on peptides and drug tests covers how laboratories look for peptides.

What happens after tesamorelin is stopped?

In the 26-week extension of the two pivotal trials in adults with HIV, participants re-randomised to placebo regained visceral fat (the fat packed around the organs inside the abdomen) by 22% in the first trial (50 people) and 16% in the second (85 people), while those who stayed on tesamorelin changed by 0% (154 people) and -5% (92 people), in these selected extension participants only (Egrifta SV label, Table 4).

Among adults with HIV in two phase 3 trials (806 adults) who had high liver enzymes at the start and whose visceral fat had fallen, the enzyme improvement persisted over 52 weeks even in those switched to placebo, despite a partial return of visceral fat, in an association that does not show tesamorelin caused it and with no subgroup size in the abstract (Fourman et al., AIDS, 2017).

The label sections read for this page do not describe a withdrawal syndrome. Egrifta SV label section 5.3 lists fluid retention and describes its possible resolution, without supplying a participant number or quantified resolution rate. The study findings page sets the visceral-fat numbers beside the rest of the trial record.

What do studies and sport rules say about tesamorelin in bodybuilding?

The sources read for this page did not include a randomised trial of tesamorelin in bodybuilders or healthy athletes. A 2026 narrative review of growth-hormone-axis peptides says off-label claims about body composition and recovery extend beyond the endpoints of the randomised trials and should be presented cautiously as marketing narratives rather than established clinical effects (Dominikowski et al., Frontiers in Endocrinology, 2026). The World Anti-Doping Agency's 2026 Prohibited List, effective 1 January 2026, names tesamorelin in class S2.2.4, prohibited at all times, in and out of competition (WADA, 2026 Prohibited List, read 14 October 2026).

The healthy-adult record is small. In a 2-week study of only 13 healthy men, overnight growth hormone and IGF-1 rose, while fasting glucose and insulin-stimulated glucose uptake did not change significantly, in that small group only (Stanley et al., Journal of Clinical Endocrinology and Metabolism, 2011). A 2026 sports-medicine review, a review and not a trial, says growth-hormone-axis secretagogues including tesamorelin remain investigational, with uncertain safety profiles, product-quality concerns and widespread antidoping restrictions (Villegas Meza et al., JBJS Reviews, 2026).

Sport Integrity Australia says a Therapeutic Use Exemption is unlikely to be granted for an unregistered medicine, and that the athlete may then face an anti-doping rule violation (Sport Integrity Australia, Peptides explained, read 14 October 2026). That page does not name tesamorelin; the WADA list does.

What did trials record for visceral fat and for adverse events together?

In the first pivotal trial of 412 adults with HIV (86% men), visceral fat fell 15.2% with tesamorelin and rose 5.0% with placebo over 26 weeks, adverse events overall did not differ significantly between the two groups, and more tesamorelin participants than placebo participants withdrew because of an adverse event, in that trial population only (Falutz et al., New England Journal of Medicine, 2007). A trial result describes a defined group of adults with HIV and does not weigh risks for any one person.

The trials also recorded other measured changes. In the second pivotal trial of 404 adults with HIV, trunk fat, waist circumference and waist-hip ratio improved with tesamorelin against placebo over 26 weeks, in that trial only (Falutz et al., Journal of Acquired Immune Deficiency Syndromes, 2010). In the pooled analysis of 806 adults with HIV, triglycerides changed by a treatment effect of -12.3% against placebo, in those pooled trials only (Falutz et al., Journal of Clinical Endocrinology and Metabolism, 2010). The adverse events recorded in the label's pooled trials are in the table below.

The comparison is only as wide as the people studied. These were adults with HIV and excess abdominal fat, and the trials do not say how the record would read for anyone else.

Do these side-effect records apply to research-use tesamorelin?

No. Every figure on this page describes tesamorelin received by enrolled adults under medical care in clinical trials, or the FDA label that summarises such trials. Research-use tesamorelin reference material is a laboratory compound, is not a medicine, is not a substitute for one, and is not for human or animal use. The sources read for this page contain no adverse-event record for that material, and the TGA says it has not assessed unapproved peptide products for safety, quality or effectiveness (TGA peptide products page, updated 23 September 2026).

This site's catalogue lists tesamorelin reference material as freeze-dried laboratory stock, with a historical sample report that covers only the sample it names. Reading that paperwork is a skill of its own, and the trial and label figures above are not a description of any vial.