Tesamorelin side effects: what 1,586 FDA adverse event reports show

Tesamorelin · Egrifta Wr · 42 reaction terms · 1,563 drug–reaction co-reports · data 2026-09-14

Drug class

Growth hormone-releasing factor (ghrf) analog

FDA label, Indications wording

Brand names

Egrifta Wr

openFDA label

Who reports

1,586 reports · 20% serious · 31 with death outcome · 16% female

openFDA FAERS counts, all years, deduplication not applied

Used for

EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: Long-term cardiovascular safety of EGRIFTA WR has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect.

FDA label, Indications and Usage

What it is

Tesamorelin is a human growth hormone-releasing factor (GRF) analog produced synthetically. It is comprised of the 44 amino acid sequence of human GRF and a hexenoyl moiety, a C6 chain with a double bond at position 3, attached to the tyrosine residue at the N-terminal part of the molecule.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 29 strongest signals

Labeled adverse reaction 8Labeled (related wording) 6Likely indication confounding 1Reporting / coding artifact 12Lab value / disease marker 1Not in label — unassessed 1

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 13 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Product dose omission in error	51	25.2 19.2–33.0ROR 26.0 · χ² 1,158 / p 4e-254	24.9 EB05 19.7 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 32.8 · 94% consumer	no trial data cached
Drug effect less than expected	25	23.5 15.9–34.7ROR 23.8 · χ² 515 / p 2e-114	23.1 EB05 16.4 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious n=2 · 92% consumer	no trial data cached
Product administration error	31	20.6 14.5–29.1ROR 21.0 · χ² 557 / p 2e-123	20.3 EB05 14.9 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 22.8	no trial data cached
Injection site nodule	16	19.3 11.8–31.4ROR 19.5 · χ² 259 / p 1e-58	18.7 EB05 11.9 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Intentional dose omission	39	18.9 13.8–25.7ROR 19.3 · χ² 643 / p 5e-142	18.7 EB05 14.2 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 2.8 · 87% consumer	no trial data cached
Therapeutic product effect incomplete	86	16.1 13.1–19.8ROR 17.0 · χ² 1,205 / p 2e-264	16.0 EB05 13.3 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 9.9 · 91% consumer	no trial data cached
Injection site mass	43	15.4 11.5–20.7ROR 15.8 · χ² 567 / p 2e-125	15.2 EB05 11.7 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.5 · 86% consumer	no trial data cached
Injection site pruritus	77	15.3 12.3–19.0ROR 16.0 · χ² 1,018 / p 1e-223	15.2 EB05 12.5 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 43.4 · 88% consumer	no trial data cached
Carpal tunnel syndrome	16	15.1 9.3–24.6ROR 15.2 · χ² 196 / p 6e-45	14.3 EB05 8.7 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.1	no trial data cached
Injection site bruising	89	14.9 12.2–18.3ROR 15.8 · χ² 1,147 / p 1e-251	14.8 EB05 12.4 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 37.2 · 87% consumer	no trial data cached
Accidental underdose	16	14.5 8.9–23.7ROR 14.7 · χ² 188 / p 4e-43	13.7 EB05 8.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Injection site discomfort	11	14.1 7.8–25.4ROR 14.2 · χ² 121 / p 2e-28	12.5 EB05 6.5 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Product dose omission issue	285	13.2 11.9–14.7ROR 15.9 · χ² 3,256 / p <1e-300	13.2 EB05 12.0 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 13.8 · 75% consumer	no trial data cached
Product preparation error	19	12.1 7.8–19.0ROR 12.3 · χ² 183 / p 5e-42	11.2 EB05 7.1 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Spinal operation	10	10.9 5.9–20.3ROR 11.0 · χ² 81 / p 1e-19	8.8 EB05 4.6 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 33.5	no trial data cached
Injection site discolouration	10	10.7 5.8–19.8ROR 10.7 · χ² 78 / p 5e-19	8.6 EB05 4.5 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious n=1	no trial data cached
Incorrect dose administered	164	9.6 8.3–11.2ROR 10.6 · χ² 1,275 / p 1e-279	9.5 EB05 8.3 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 6.2 · 92% consumer	no trial data cached
Injection site urticaria	16	8.7 5.4–14.2ROR 8.8 · χ² 102 / p 3e-24	7.5 EB05 4.7 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=2	no trial data cached
Treatment noncompliance	33	8.0 5.7–11.3ROR 8.2 · χ² 197 / p 6e-45	7.4 EB05 5.5 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 5.3 · 82% consumer	no trial data cached
Injection site pain (pain where injected)	141	6.1 5.2–7.2ROR 6.6 · χ² 611 / p 4e-135	6.0 EB05 5.2 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.1 · 88% consumer	no trial data cached
Weight increased (weight gain)	97	5.8 4.7–7.0ROR 6.1 · χ² 381 / p 5e-85	5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree	Likely indication confounding term in indications	serious PRR 3.4 · 81% consumer	no trial data cached
Injection site rash	13	5.7 3.3–9.7ROR 5.7 · χ² 45 / p 8e-12	4.8 EB05 3.0 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Joint stiffness	11	5.5 3.1–10.0ROR 5.6 · χ² 37 / p 7e-10	4.6 EB05 2.7 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.6	no trial data cached
Glycosylated haemoglobin increased	10	5.2 2.8–9.7ROR 5.3 · χ² 30 / p 2e-8	4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree	Lab value / disease marker	serious PRR 3.4	no trial data cached
Wrong technique in product usage process	78	5.1 4.1–6.3ROR 5.3 · χ² 256 / p 7e-58	5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5 · 92% consumer	no trial data cached
Injection site haemorrhage	27	4.5 3.1–6.5ROR 4.6 · χ² 70 / p 3e-17	4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.5 · 85% consumer	no trial data cached
Product storage error	27	4.1 2.8–6.0ROR 4.2 · χ² 61 / p 3e-15	3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.6	no trial data cached
Injection site erythema (redness where injected)	29	3.1 2.2–4.5ROR 3.1 · χ² 40 / p 2e-10	3.0 EB05 2.2 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.2 · 83% consumer	no trial data cached
Injection site reaction	16	3.1 1.9–5.0ROR 3.1 · χ² 21 / p 3e-6	2.9 EB05 1.9 · IC025 +0.7	Labeled adverse reaction exact term	serious PRR 11.2	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Product dose omission issue	285	13.2 11.9–14.7ROR 15.9 · χ² 3,256 / p <1e-300	13.2 EB05 12.0 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 13.8 · 75% consumer	no trial data cached
Incorrect dose administered	164	9.6 8.3–11.2ROR 10.6 · χ² 1,275 / p 1e-279	9.5 EB05 8.3 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 6.2 · 92% consumer	no trial data cached
Injection site pain (pain where injected)	141	6.1 5.2–7.2ROR 6.6 · χ² 611 / p 4e-135	6.0 EB05 5.2 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.1 · 88% consumer	no trial data cached
Weight increased (weight gain)	97	5.8 4.7–7.0ROR 6.1 · χ² 381 / p 5e-85	5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree	Likely indication confounding term in indications	serious PRR 3.4 · 81% consumer	no trial data cached
Injection site bruising	89	14.9 12.2–18.3ROR 15.8 · χ² 1,147 / p 1e-251	14.8 EB05 12.4 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 37.2 · 87% consumer	no trial data cached
Therapeutic product effect incomplete	86	16.1 13.1–19.8ROR 17.0 · χ² 1,205 / p 2e-264	16.0 EB05 13.3 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 9.9 · 91% consumer	no trial data cached
Wrong technique in product usage process	78	5.1 4.1–6.3ROR 5.3 · χ² 256 / p 7e-58	5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5 · 92% consumer	no trial data cached
Injection site pruritus	77	15.3 12.3–19.0ROR 16.0 · χ² 1,018 / p 1e-223	15.2 EB05 12.5 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 43.4 · 88% consumer	no trial data cached
Product dose omission in error	51	25.2 19.2–33.0ROR 26.0 · χ² 1,158 / p 4e-254	24.9 EB05 19.7 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 32.8 · 94% consumer	no trial data cached
Injection site mass	43	15.4 11.5–20.7ROR 15.8 · χ² 567 / p 2e-125	15.2 EB05 11.7 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.5 · 86% consumer	no trial data cached
Intentional dose omission	39	18.9 13.8–25.7ROR 19.3 · χ² 643 / p 5e-142	18.7 EB05 14.2 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 2.8 · 87% consumer	no trial data cached
Treatment noncompliance	33	8.0 5.7–11.3ROR 8.2 · χ² 197 / p 6e-45	7.4 EB05 5.5 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 5.3 · 82% consumer	no trial data cached
Product administration error	31	20.6 14.5–29.1ROR 21.0 · χ² 557 / p 2e-123	20.3 EB05 14.9 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 22.8	no trial data cached
Injection site erythema (redness where injected)	29	3.1 2.2–4.5ROR 3.1 · χ² 40 / p 2e-10	3.0 EB05 2.2 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.2 · 83% consumer	no trial data cached
Product storage error	27	4.1 2.8–6.0ROR 4.2 · χ² 61 / p 3e-15	3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.6	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Tesamorelin?

In FDA FAERS, the most frequently co-reported reaction terms for Tesamorelin are injection site pain, weight increased, injection site bruising, injection site pruritus, injection site mass, injection site erythema. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Tesamorelin have an FDA boxed warning?

No. The FDA label retrieved for Tesamorelin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Tesamorelin causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 839334d3-8c1d-4c26-9036-2ab524a6ea75, effective 20260729; matched on openfda.generic_name.exact:"TESAMORELIN")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 42 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.