Tesamorelin Side Effects: 17 % Injection Site Reaction, 6 % on Placebo

The headline is the highest tesamorelin rate in the pooled adverse-reaction table: 543 EGRIFTA patients versus 263 placebo patients during the first 26 weeks across all studies (EGRIFTA WR label section 6.1 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)).

The label describes EGRIFTA WR as a growth hormone-releasing hormone (GHRH) that stimulates growth hormone production (EGRIFTA WR label section 5.7 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)). As a US approved-indication fact, the label states: “EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.” (EGRIFTA WR label section 1 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)).

This report uses DailyMed labels, posted registry tables, primary publications and a Reddit question corpus. Forum posts are not adverse-effect evidence. Labels describe approved medicines; their clinical findings do not establish the characteristics of research-grade material.

PeptidesDirect does not sell Egrifta. PeptidesDirect does not sell Egrifta SV. PeptidesDirect does not sell Egrifta WR.

Tesamorelin is listed at PeptidesDirect as a research-grade peptide.

Tesamorelingrowth

Tesamorelin is a stabilised GHRH(1-44) analogue with a trans-3-hexenoyl N-terminal modification, an agonist at the pituitary GHRH receptor. Lyophilized powder, specified purity at or above 98% (HPLC), batch CoA.

What research communities ask about

The Reddit corpus labeled “12 months” spans 2025-08-01 to 2026-09-04: 777 compound-matching question posts among 92,763 question posts (corpus 12 months). The separate delta spans 2026-09-04 to 2026-09-12: 31 among 2,321 (corpus delta). These windows represent different populations and are never added.

Method: title plus body is matched case-insensitively against \btesamorelin\b|\begrifta\b. Post IDs are deduplicated in file order; the delta excludes previously seen IDs. Category-match starts must fall within 250 characters of a compound-match start (corpus method). The shorthand includes the brand token. Matches can be questions, reports or denials; the script does not interpret causality. Longer-window dates are corpus labels; delta dates use UTC timestamps. The subreddit sets differ between windows.

Each cell means “N of M question posts mention tesamorelin and the category term within 250 characters” under that regex definition (corpus method). Column sources: corpus 12 months; corpus delta.

Column sources: corpus 12 months; corpus delta. The leading categories in the longer window are redness/welt/hive/itch, sting/burn and water retention (corpus counts). A zero is a missing text match, not an observed clinical absence.

Injection-site reactions

The label table reports injection site reaction at 17 % versus placebo 6 %, with 543 EGRIFTA and 263 placebo patients during the first 26 weeks across all studies (EGRIFTA WR label section 6.1 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)). Its narrative names erythema, pruritus, pain, irritation, hemorrhage, urticaria and swelling without separate injection-site rates. Rash is a separate preferred term, not a site-specific row.

The warning section instead reports injection-site reactions at 25 % versus placebo 14 % during the first 26 weeks of treatment, without denominators (EGRIFTA WR label section 5.6 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)). These label figures remain separate. The label also describes hypersensitivity reactions, discussed below (EGRIFTA WR label section 5.5 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)).

The pivotal records have no posted results (NCT00123253; NCT00435136). The extension uses T-T for continued tesamorelin over 52 weeks and P-T for placebo for 26 weeks followed by tesamorelin for 26 weeks; T-P is the record's third group (NCT00608023 posted results). Its adverse-event timeframe field is empty; rows refer to the extension period (NCT00608023 posted results).

Other-event reporting thresholds are 5 % for NCT00608023, NCT01263717 and NCT00675506, and 0 % for the double-blind phase of NCT03375788 (respective posted results). Rows count affected participants, not repeated events.

The meta-analysis extracts injection-site bruising for Falutz 2007 over 26 weeks as 25 of 273 tesamorelin versus 13 of 137 placebo participants; for Falutz 2010, whose duration the review’s own table gives as 26 weeks, 15 of 270 versus 13 of 126 (PMID 42538058). These counts are the reviewers’ extraction. The Falutz abstract describes withdrawals for adverse events without counts (PMID 18057338).

Arthralgia, myalgia, extremity pain and sensory events

The following label rows share 543 EGRIFTA versus 263 placebo patients and the first 26 weeks across all studies (EGRIFTA WR label section 6.1 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)).

Table source: EGRIFTA WR label section 6.1 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75). These are distinct coded terms; adding them would not yield a participant-level combined rate.

During the extension period, paresthesia affected 2 of 92 T-T versus 5 of 86 P-T participants (NCT00608023 posted results). During the 6-month randomized portion, paresthesia affected 6 of 28 tesamorelin versus 1 of 22 placebo participants; arthralgia, 4 of 28 versus 4 of 22; myalgia, 3 of 28 versus 0 of 22 (NCT01263717 posted results).

Over 12 months, arthralgia affected 2 of 31 tesamorelin versus 0 of 29 placebo participants and myalgia 2 of 31 versus 3 of 29 (NCT00675506 posted results). Double-blind months 0-12 recorded arthralgia in 6 of 26 tesamorelin versus 1 of 25 placebo participants (NCT03375788 posted results). Another meta-analysis names arthralgia, myalgia, paresthesia and injection-site reactions without rates or windows in its abstract (PMID 41545261).

Peripheral edema and fluid retention

Peripheral edema was 6 % versus placebo 2 %, and joint swelling 1 % versus 0 %, among 543 EGRIFTA and 263 placebo patients during the first 26 weeks across all studies (EGRIFTA WR label section 6.1 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)). The label states that fluid retention may occur and associates it with induced GH secretion, tissue turgor, edema, arthralgia and carpal tunnel syndrome (EGRIFTA WR label section 5.3 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)). This warning is not a separate incidence estimate.

Edema affected 2 of 28 tesamorelin versus 1 of 22 placebo participants during the 6-month randomized portion (NCT01263717 posted results). Peripheral edema affected 3 of 31 versus 1 of 29 over 12 months (NCT00675506 posted results). Edema affected 6 of 26 versus 1 of 25 during double-blind months 0-12 (NCT03375788 posted results).

Glucose, HbA1c and IGF-1

The label states that treatment can result in glucose intolerance. Elevated HbA1c, at least 6.5 %, occurred in 5 % of EGRIFTA versus 1 % of placebo patients from baseline to week 26; this warning prints no arm denominators (EGRIFTA SV label section 5.4 (DailyMed setid 3d783378-b02d-4f19-99dd-0fc91a042224)). This threshold outcome differs from a mean change.

At 26 weeks, 47 % of EGRIFTA recipients had IGF-1 standard deviation scores above 2 and 36 % above 3; the label describes the effect as early as 13 weeks (EGRIFTA WR label section 5.2 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)). Among those remaining on EGRIFTA for 52 weeks, the respective proportions were 34 % and 23 % at treatment end (EGRIFTA WR label section 5.2 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)). Neither comparison supplies a placebo rate or a denominator. The continuing subset is not the initial pooled population.

The pooled Falutz publication reports IGF-I change of +108 +/- 112 ng/ml in 543 tesamorelin versus -7 +/- 64 ng/ml in 263 placebo patients at week 26; its abstract does not identify the dispersion measure (PMID 20554713).

Stanley’s study reports fasting glucose change at week 2 of +9 mg/dL versus placebo +2 mg/dL, and at month 6 of +4 mg/dL versus +2 mg/dL, in tesamorelin (28) and placebo (22) participants (PMID 25038357). HbA1c change over 6 months was +0.20 versus +0.02 percentage points in those arms (PMID 25038357). These laboratory changes are not percentages of participants with events.

In the NAFLD publication, investigator discontinuation under predefined criteria involved 4 tesamorelin participants, including 2 for hyperglycemia, versus 1 placebo participant during the 12-month double-blind phase; that paragraph supplies no arm denominators (PMID 31611038).

Hypersensitivity, rash, urticaria and antibodies

Hypersensitivity occurred in 4 % of EGRIFTA-treated patients in clinical trials, without a printed denominator, placebo rate or observation window; the label lists pruritus, erythema, flushing, urticaria and rash (EGRIFTA WR label section 5.5 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)). It is not interchangeable with the rash row.

Rash was 4 % versus placebo 2 %, and pruritus 2 % versus 1 %, among 543 EGRIFTA and 263 placebo patients during the first 26 weeks across all studies (EGRIFTA SV label section 6.1 (DailyMed setid 3d783378-b02d-4f19-99dd-0fc91a042224)).

Detectable anti-tesamorelin IgG was reported in 50 % at 26 weeks and 47 % at 52 weeks among EGRIFTA-treated patients, and in 85 % of the hypersensitivity subset, whose window is unstated (EGRIFTA WR label section 12.6 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)). These denominators are not printed and differ by assessment. Antibody detection and clinical hypersensitivity are separate measurements.

Malignancy and the class warning

The EGRIFTA WR label lists active malignancy as a contraindication (EGRIFTA WR label section 5.1 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)). This warning supplies neither a malignancy rate nor an observation window.

The acute-critical-illness warning describes increased mortality reported after pharmacologic amounts of growth hormone in critically ill patients, and identifies tesamorelin as a GHRH that stimulates GH production (EGRIFTA WR label section 5.7 (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75)). That class observation is not a numerical tesamorelin trial result.

Discontinuation and serious adverse events

Neither supplied label prints a pooled discontinuation percentage. Across trial durations of 12, 26, 26 and 52 weeks, the meta-analysis reports a discontinuation risk ratio of 2.25, with 95 % CI 0.98 to 5.17, for pooled tesamorelin 595 versus placebo 314 participants (PMID 42538058). A risk ratio is not an absolute rate.

Extension non-completion for “Adverse Event” was 1 of 92 T-T, 4 of 85 T-P and 5 of 86 P-T participants over the overall study period (NCT00608023 posted results). In the abdominal-obesity study, non-completion for elevated fasting glucose was 2 of 31 tesamorelin versus 1 of 29 placebo participants, and for hypersensitivity 1 of 31 versus 0 of 29 over the overall study period (NCT00675506 posted results).

Mortality fields are empty in the extension, Stanley’s shorter randomized study and the abdominal-obesity record, rather than recorded zeros (NCT00608023, NCT01263717 and NCT00675506 posted results). Double-blind months 0-12 recorded deaths in 0 of 26 tesamorelin versus 0 of 25 placebo participants (NCT03375788 posted results). The separate uncontrolled NAFLD open-label phase recorded 1 of 43 participants with a death over 6 months (NCT02196831 posted results). These counts do not assign causality.

Who the trials enrolled

The doses named here are the arms of the cited studies, not an application protocol for research vials.

Falutz 2007 enrolled HIV-infected adults receiving antiretroviral therapy with abdominal fat accumulation: tesamorelin 273 and placebo 137, with the tesamorelin arm described as 2 mg subcutaneously daily for 26 weeks (PMID 18057338). Falutz 2010 studied the same broad population, tesamorelin 270 versus placebo 126, across 52 weeks including an extension (PMID 20101189). The pooled publication describes 543 versus 263 participants and follow-up through 52 weeks (PMID 20554713).

Stanley 2014 studied antiretroviral-treated adults with HIV and abdominal fat accumulation for 26 weeks; the publication reports 50 randomized and 48 treated, while the registry’s adverse-event denominators are 28 and 22 (PMID 25038357; NCT01263717 posted results). Those different analysis populations remain labeled separately.

Stanley 2019 enrolled people with HIV and NAFLD for 52 weeks (PMID 31611038). Its registry flow shows 30 participants per arm, but the adverse-event denominator conflicts with flow; the double-blind registry event rows are excluded here (NCT02196831 posted results).

Makimura 2012 enrolled abdominally obese adults without HIV who had reduced GH secretion, tesamorelin 31 versus placebo 29 over 52 weeks (PMID 23015655; NCT00675506 posted results). Another trial enrolled adults without HIV with hepatic steatosis and obesity, tesamorelin 26 versus placebo 25 over 52 weeks (NCT03375788 posted results).

The immediate-versus-deferred study enrolled aging adults with HIV and abdominal obesity, 43 versus 30 over 48 weeks (NCT02572323 posted results). Adverse-event observation covered immediate baseline to week 24 and deferred week 24 to 48; the deferred group was not assessed at baseline to week 24 (NCT02572323 posted results). Its zeros cannot serve as concurrent placebo rates.

Healthy men also appear in a single-group study: 15 started, 13 in the adverse-event table, with a 4-week observation period (NCT00850564 posted results). These distinct eligibility criteria and observation periods limit transfer between populations.

What the documented searches returned

As of 2026-09-09, no completed study has reported alopecia or hair loss for tesamorelin (PubMed search: 'tesamorelin AND (alopecia OR "hair loss")', 0 hits; ClinicalTrials.gov search: 'tesamorelin AND (alopecia OR "hair loss")', 0 records); neither DailyMed label has an alopecia or hair-loss row in section 6.1 Table 1.

As of 2026-09-09, no completed study has reported pancreatitis or gallbladder events for tesamorelin (PubMed search: 'tesamorelin AND (pancreatitis OR cholelithiasis OR gallbladder)', 0 hits; ClinicalTrials.gov search: 'tesamorelin AND (pancreatitis OR cholelithiasis OR gallbladder)', 0 records); neither DailyMed label carries a pancreatitis or gallbladder warning.

These documented searches were reverified on 2026-09-13. They delimit what the searches returned; they do not measure the probability of an event.

Conclusions for research

The pooled label, registry rows and publication narratives describe different evidence units. Each comparison retains its population, denominator and observation window. Warning sections without denominators cannot inherit the pooled table’s population. Corpus mentions describe questions, while the clinical sources describe recorded events and laboratory findings.

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Sources and further reading:

- EGRIFTA WR, US prescribing information, label version Aug 03, 2026. DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75

- EGRIFTA SV, US prescribing information, label version Jul 31, 2026. DailyMed setid 3d783378-b02d-4f19-99dd-0fc91a042224: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224

- Falutz pivotal trial. PMID 18057338: https://pubmed.ncbi.nlm.nih.gov/18057338/

- Falutz trial and extension. PMID 20101189: https://pubmed.ncbi.nlm.nih.gov/20101189/

- Falutz pooled analysis. PMID 20554713: https://pubmed.ncbi.nlm.nih.gov/20554713/

- Stanley glucose and adverse-event findings. PMID 25038357: https://pubmed.ncbi.nlm.nih.gov/25038357/

- Stanley HIV and NAFLD trial. PMID 31611038: https://pubmed.ncbi.nlm.nih.gov/31611038/

- Makimura abdominal-obesity trial. PMID 23015655: https://pubmed.ncbi.nlm.nih.gov/23015655/

- Meta-analysis and per-trial extraction. PMID 42538058: https://pubmed.ncbi.nlm.nih.gov/42538058/

- Meta-analysis abstract. PMID 41545261: https://pubmed.ncbi.nlm.nih.gov/41545261/

- ClinicalTrials.gov, NCT00123253: https://clinicaltrials.gov/study/NCT00123253

- ClinicalTrials.gov, NCT00435136: https://clinicaltrials.gov/study/NCT00435136

- ClinicalTrials.gov, NCT00608023: https://clinicaltrials.gov/study/NCT00608023

- ClinicalTrials.gov, NCT01263717: https://clinicaltrials.gov/study/NCT01263717

- ClinicalTrials.gov, NCT00675506: https://clinicaltrials.gov/study/NCT00675506

- ClinicalTrials.gov, NCT03375788: https://clinicaltrials.gov/study/NCT03375788

- ClinicalTrials.gov, NCT02196831: https://clinicaltrials.gov/study/NCT02196831

- ClinicalTrials.gov, NCT02572323: https://clinicaltrials.gov/study/NCT02572323

- ClinicalTrials.gov, NCT00850564: https://clinicaltrials.gov/study/NCT00850564

- Search logs: absence searches dated 2026-09-09 and reverified 2026-09-13; strings and hit counts printed above.

- Reddit corpus: .scratch/reddit-corpus/question-posts.jsonl and .scratch/reddit-corpus/delta-question-posts.jsonl, 12 months, 2025-08-01 to 2026-09-04; .scratch/reddit-corpus/delta2/questions.json, delta, 2026-09-04 to 2026-09-12. Counts: .scratch/paketA/tesamorelin/reddit-counts.json. Compound regex: \btesamorelin\b|\begrifta\b; category regexes and 250-character rule: .scratch/paketA/count-reactions.py.

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Tesamorelingrowth

Tesamorelin is a stabilised GHRH(1-44) analogue with a trans-3-hexenoyl N-terminal modification, an agonist at the pituitary GHRH receptor. Lyophilized powder, specified purity at or above 98% (HPLC), batch CoA.

This article is for informational purposes only for scientific research.