Drug · FAERS side-effect profile with label screen
Pegvisomant side effects: what 4,093 FDA adverse event reports show
Drug class
Growth hormone receptor antagonist
FDA label, Indications wording
Brand names
Somavert
openFDA label
Who reports
4,093 reports · 56% serious · 318 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-1 (IGF-1) levels.
FDA label, Indications and Usage
What it is
Pegvisomant is an analog of human growth hormone (GH) of recombinant DNA origin that acts as a GH receptor antagonist. It contains 191 amino acid residues.
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 40 strongest signals
Labeled adverse reaction 3Labeled (related wording) 5Reporting / coding artifact 3Lab value / disease marker 6Not in label — unassessed 23
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.
- 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. 197 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Needle issue | 201 | 36.3 31.7–41.5ROR 38.1 · χ² 6,815 / p <1e-300 | 35.9 EB05 31.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=121 | no trial data cached |
| Helicobacter infection | 57 | 28.8 22.2–37.3ROR 29.2 · χ² 1,494 / p <1e-300 | 28.4 EB05 22.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 31.2 | no trial data cached |
| Injection site discomfort | 54 | 26.9 20.6–35.1ROR 27.3 · χ² 1,316 / p 2e-288 | 26.6 EB05 21.1 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=50 · ♀ 86% (drug 58%) | no trial data cached |
| Neoplasm | 54 | 24.1 18.5–31.5ROR 24.4 · χ² 1,169 / p 2e-256 | 23.8 EB05 19.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 24.6 | no trial data cached |
| Bladder disorder | 42 | 21.7 16.1–29.4ROR 21.9 · χ² 806 / p 1e-177 | 21.4 EB05 16.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 100% (drug 58%) | no trial data cached |
| Brain neoplasm | 36 | 20.1 14.5–27.9ROR 20.3 · χ² 634 / p 4e-140 | 19.9 EB05 15.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.1 | no trial data cached |
| Thyroid disorder | 53 | 17.7 13.5–23.1ROR 17.9 · χ² 815 / p 2e-179 | 17.5 EB05 13.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 25.2 · ♀ 94% (drug 58%) | no trial data cached |
| Peripheral coldness | 47 | 17.5 13.2–23.3ROR 17.7 · χ² 714 / p 1e-157 | 17.3 EB05 13.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 27.4 · ♀ 95% (drug 58%) | no trial data cached |
| Poor quality product administered | 34 | 17.1 12.2–23.9ROR 17.2 · χ² 498 / p 2e-110 | 16.8 EB05 12.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Mass | 46 | 16.9 12.6–22.5ROR 17.0 · χ² 669 / p 8e-148 | 16.7 EB05 12.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 24.6 · ♀ 95% (drug 58%) | no trial data cached |
| Gallbladder disorder | 58 | 16.6 12.9–21.5ROR 16.9 · χ² 835 / p 6e-184 | 16.5 EB05 13.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.5 · ♀ 91% (drug 58%) | no trial data cached |
| Blood pressure systolic increased | 62 | 16.3 12.7–20.8ROR 16.5 · χ² 871 / p 1e-191 | 16.1 EB05 13.0 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 18.3 · ♀ 90% (drug 58%) | no trial data cached |
| Blood glucose fluctuation | 33 | 15.4 11.0–21.7ROR 15.5 · χ² 430 / p 1e-95 | 15.1 EB05 11.1 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=4 | no trial data cached |
| Heart rate decreased | 103 | 15.0 12.4–18.1ROR 15.4 · χ² 1,330 / p 2e-291 | 14.9 EB05 12.6 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 19.1 | no trial data cached |
| Musculoskeletal discomfort | 47 | 14.0 10.6–18.7ROR 14.2 · χ² 555 / p 6e-123 | 13.8 EB05 10.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 24.7 · ♀ 100% (drug 58%) | no trial data cached |
| Neoplasm progression | 95 | 13.9 11.4–17.0ROR 14.2 · χ² 1,123 / p 2e-246 | 13.8 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.7 | no trial data cached |
| Bone disorder | 49 | 13.7 10.4–18.1ROR 13.8 · χ² 563 / p 1e-124 | 13.5 EB05 10.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 · ♀ 93% (drug 58%) | no trial data cached |
| Cholelithiasis | 87 | 13.6 11.1–16.8ROR 13.9 · χ² 1,004 / p 1e-220 | 13.5 EB05 11.2 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.3 | no trial data cached |
| Injection site mass | 91 | 12.7 10.3–15.5ROR 12.9 · χ² 966 / p 2e-212 | 12.5 EB05 10.5 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 54.9 · ♀ 84% (drug 58%) | no trial data cached |
| Syringe issue | 42 | 12.3 9.1–16.6ROR 12.4 · χ² 424 / p 1e-94 | 12.0 EB05 9.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Nocturia (night-time urination) | 28 | 11.9 8.2–17.2ROR 11.9 · χ² 267 / p 2e-60 | 11.3 EB05 7.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 18.8 · ♀ 85% (drug 58%) | no trial data cached |
| Sleep apnoea syndrome | 42 | 11.3 8.3–15.2ROR 11.4 · χ² 382 / p 2e-85 | 10.9 EB05 8.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Wound infection | 23 | 10.9 7.2–16.3ROR 10.9 · χ² 196 / p 8e-45 | 10.0 EB05 6.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · ♀ 13% (drug 58%) | no trial data cached |
| Glycosylated haemoglobin increased | 53 | 10.8 8.3–14.1ROR 10.9 · χ² 461 / p 1e-102 | 10.4 EB05 8.2 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 13.8 · 92% clinician | no trial data cached |
| Full blood count decreased | 42 | 10.7 7.9–14.4ROR 10.8 · χ² 359 / p 2e-80 | 10.2 EB05 7.7 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 15.9 · ♀ 100% (drug 58%) | no trial data cached |
| Incorrect route of product administration | 35 | 10.7 7.7–14.9ROR 10.8 · χ² 297 / p 6e-67 | 10.1 EB05 7.4 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 15.1 · ♀ 23% (drug 58%) | no trial data cached |
| Faeces discoloured | 45 | 10.7 8.0–14.3ROR 10.8 · χ² 384 / p 1e-85 | 10.2 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 | no trial data cached |
| Diabetes mellitus | 147 | 9.9 8.4–11.5ROR 10.2 · χ² 1,162 / p 5e-255 | 9.7 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.0 | no trial data cached |
| Body temperature decreased | 19 | 9.8 6.3–15.4ROR 9.9 · χ² 142 / p 6e-33 | 8.7 EB05 5.6 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 11.2 | no trial data cached |
| Brain injury | 18 | 9.2 5.8–14.6ROR 9.2 · χ² 123 / p 6e-29 | 8.0 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 48 | 9.1 6.9–12.1ROR 9.2 · χ² 339 / p 5e-76 | 8.7 EB05 6.7 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 · ♀ 98% (drug 58%) | no trial data cached |
| Limb discomfort | 55 | 9.1 7.0–11.9ROR 9.2 · χ² 389 / p 6e-87 | 8.7 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · ♀ 96% (drug 58%) | no trial data cached |
| Injection site bruising | 139 | 9.0 7.7–10.7ROR 9.3 · χ² 989 / p 3e-217 | 8.9 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 35.7 | no trial data cached |
| Product dose omission in error | 47 | 9.0 6.8–11.9ROR 9.1 · χ² 325 / p 5e-73 | 8.5 EB05 6.6 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 12.4 | no trial data cached |
| Device leakage | 72 | 8.7 6.9–11.0ROR 8.9 · χ² 485 / p 9e-108 | 8.4 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Tooth abscess | 17 | 8.5 5.3–13.7ROR 8.6 · χ² 106 / p 5e-25 | 7.3 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Foot deformity | 18 | 8.3 5.2–13.2ROR 8.4 · χ² 109 / p 1e-25 | 7.2 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Injection site induration | 21 | 8.3 5.4–12.7ROR 8.3 · χ² 128 / p 6e-30 | 7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious n=11 · ♀ 81% (drug 58%) | no trial data cached |
| Hepatic enzyme increased | 110 | 8.3 6.9–10.0ROR 8.5 · χ² 701 / p 1e-154 | 8.1 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Urinary incontinence | 42 | 7.3 5.4–9.8ROR 7.3 · χ² 221 / p 3e-50 | 6.8 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · ♀ 100% (drug 58%) | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 489 | 2.9 2.7–3.1ROR 3.1 · χ² 627 / p 1e-138 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Headache | 402 | 3.3 3.0–3.6ROR 3.5 · χ² 658 / p 2e-145 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Fatigue (tiredness) | 385 | 2.5 2.3–2.8ROR 2.7 · χ² 371 / p 4e-83 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Arthralgia (joint pain) | 300 | 3.7 3.3–4.1ROR 3.9 · χ² 603 / p 2e-133 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Product dose omission issue | 268 | 4.8 4.3–5.4ROR 5.1 · χ² 819 / p 2e-180 | 4.8 EB05 4.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 | no trial data cached |
| Injection site pain (pain where injected) | 261 | 4.4 3.9–5.0ROR 4.6 · χ² 694 / p 3e-153 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.1 | no trial data cached |
| Blood pressure increased | 205 | 6.9 6.0–7.8ROR 7.2 · χ² 1,027 / p 1e-225 | 6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.0 | no trial data cached |
| Product use issue | 203 | 5.6 4.9–6.4ROR 5.8 · χ² 762 / p 5e-168 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 | no trial data cached |
| Needle issue | 201 | 36.3 31.7–41.5ROR 38.1 · χ² 6,815 / p <1e-300 | 35.9 EB05 31.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=121 | no trial data cached |
| Malaise (feeling unwell) | 200 | 2.3 2.0–2.7ROR 2.4 · χ² 154 / p 1e-35 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 · ♀ 79% (drug 58%) | no trial data cached |
| Diabetes mellitus | 147 | 9.9 8.4–11.5ROR 10.2 · χ² 1,162 / p 5e-255 | 9.7 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.0 | no trial data cached |
| Injection site bruising | 139 | 9.0 7.7–10.7ROR 9.3 · χ² 989 / p 3e-217 | 8.9 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 35.7 | no trial data cached |
| Back pain | 137 | 3.0 2.6–3.6ROR 3.1 · χ² 185 / p 2e-42 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Peripheral swelling | 128 | 4.3 3.6–5.1ROR 4.4 · χ² 320 / p 7e-72 | 4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Gait disturbance | 123 | 3.3 2.8–3.9ROR 3.4 · χ² 195 / p 1e-44 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Needle issue — n=201, PRR 36.3
- Helicobacter infection — n=57, PRR 28.8
- Neoplasm — n=54, PRR 24.1
- Bladder disorder — n=42, PRR 21.7
- Brain neoplasm — n=36, PRR 20.1
- Thyroid disorder — n=53, PRR 17.7
- Peripheral coldness — n=47, PRR 17.5
- Poor quality product administered — n=34, PRR 17.1
- Mass — n=46, PRR 16.9
- Gallbladder disorder — n=58, PRR 16.6
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 Pegvisomant?
In FDA FAERS, the most frequently co-reported reaction terms for Pegvisomant are headache, fatigue, arthralgia, injection site pain, blood pressure increased, needle issue. 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 Pegvisomant have an FDA boxed warning?
No. The FDA label retrieved for Pegvisomant has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pegvisomant 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 3cbb485b-6df1-49ce-8747-592b395b1988, effective 20251218; matched on
openfda.generic_name.exact:"PEGVISOMANT") - 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, fieldpatient.drug.openfda.generic_name.exact, 237 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.