Drug · FAERS side-effect profile with label screen
Gemfibrozil side effects: what 15,087 FDA adverse event reports show
Drug class
Peroxisome Proliferator Receptor alpha Agonist
FDA label (Established Pharmacologic Class) · compare the class
Who reports
15,087 reports · 67% serious · 1,220 with death outcome · 44% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.
FDA label, Indications and Usage
What it is
DESCRIPTION Gemfibrozil is a lipid regulating agent. It is available as tablets for oral administration.
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 2Labeled (related wording) 2Likely indication confounding 11Reporting / coding artifact 1Not in label — unassessed 24
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.
- 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. 1,101 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 |
|---|---|---|---|---|---|---|
| Chronic kidney disease-mineral and bone disorder | 25 | 33.0 22.2–49.1ROR 33.1 · χ² 728 / p 2e-160 | 31.6 EB05 22.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=25 | not reported in cached trials |
| Diabetes mellitus non-insulin-dependent | 33 | 31.8 22.5–44.9ROR 31.9 · χ² 933 / p 3e-205 | 30.6 EB05 22.8 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=31 | not reported in cached trials |
| Erosive duodenitis | 16 | 28.4 17.3–46.6ROR 28.4 · χ² 388 / p 1e-86 | 27.0 EB05 17.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Nephrogenic anaemia | 91 | 27.6 22.4–33.9ROR 27.7 · χ² 2,259 / p <1e-300 | 26.9 EB05 22.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=91 | not reported in cached trials |
| Hypertriglyceridaemia | 107 | 26.0 21.4–31.4ROR 26.1 · χ² 2,495 / p <1e-300 | 25.4 EB05 21.6 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=103 | not reported in cached trials |
| Bronchitis viral | 12 | 25.0 14.1–44.2ROR 25.0 · χ² 248 / p 3e-56 | 23.6 EB05 14.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Venous insufficiency | 12 | 23.2 13.1–41.0ROR 23.2 · χ² 229 / p 5e-52 | 21.9 EB05 13.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Blood triglycerides abnormal | 14 | 22.5 13.3–38.2ROR 22.5 · χ² 262 / p 2e-59 | 21.5 EB05 13.4 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications | serious n=9 | not reported in cached trials |
| Hyperparathyroidism secondary | 40 | 22.3 16.3–30.5ROR 22.4 · χ² 780 / p 7e-172 | 21.8 EB05 16.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=40 | not reported in cached trials |
| Polymyositis | 27 | 21.6 14.7–31.5ROR 21.6 · χ² 501 / p 3e-111 | 20.9 EB05 15.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 44%) · 100% clinician | not reported in cached trials |
| Aortic valve sclerosis | 11 | 21.1 11.6–38.3ROR 21.1 · χ² 188 / p 4e-43 | 19.8 EB05 11.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Pancreatitis relapsing | 12 | 20.8 11.8–36.9ROR 20.9 · χ² 204 / p 1e-46 | 19.7 EB05 11.5 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | not reported in cached trials |
| Rhabdomyolysis (muscle breakdown) | 605 | 20.5 18.9–22.2ROR 21.3 · χ² 11,052 / p <1e-300 | 20.2 EB05 18.9 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.2 · 95% clinician | not reported in cached trials |
| Diabetic neuropathy | 69 | 19.5 15.4–24.7ROR 19.6 · χ² 1,177 / p 3e-258 | 19.2 EB05 15.7 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=64 | not reported in cached trials |
| Blood triglycerides increased | 245 | 19.5 17.2–22.1ROR 19.8 · χ² 4,217 / p <1e-300 | 19.2 EB05 17.2 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 20.8 | not reported in cached trials |
| Amaurosis fugax | 12 | 15.8 8.9–27.8ROR 15.8 · χ² 150 / p 1e-34 | 14.4 EB05 7.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| High density lipoprotein decreased | 35 | 14.7 10.5–20.5ROR 14.7 · χ² 429 / p 1e-95 | 14.3 EB05 10.6 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications | serious n=26 | not reported in cached trials |
| Joint sprain | 11 | 14.6 8.0–26.4ROR 14.6 · χ² 124 / p 3e-29 | 12.9 EB05 6.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Hyperlipidaemia | 123 | 14.4 12.1–17.2ROR 14.5 · χ² 1,506 / p <1e-300 | 14.2 EB05 12.2 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 12.6 | not reported in cached trials |
| Acute prerenal failure | 12 | 14.4 8.1–25.4ROR 14.4 · χ² 135 / p 2e-31 | 12.9 EB05 6.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Pancreatitis chronic | 24 | 14.3 9.6–21.4ROR 14.3 · χ² 281 / p 2e-63 | 13.7 EB05 9.3 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=24 | not reported in cached trials |
| Colonic polyp | 17 | 14.2 8.8–22.9ROR 14.2 · χ² 194 / p 2e-44 | 13.3 EB05 8.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Lipids increased | 20 | 14.0 9.0–21.7ROR 14.0 · χ² 226 / p 2e-51 | 13.2 EB05 8.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Angioneurotic oedema | 26 | 13.5 9.2–19.8ROR 13.5 · χ² 286 / p 2e-64 | 12.9 EB05 8.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | not reported in cached trials |
| Renal failure chronic | 75 | 13.5 10.8–16.9ROR 13.6 · χ² 847 / p 2e-186 | 13.2 EB05 10.8 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.7 | not reported in cached trials |
| Rebound acid hypersecretion | 29 | 13.3 9.2–19.1ROR 13.3 · χ² 314 / p 2e-70 | 12.7 EB05 9.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=29 | not reported in cached trials |
| Otitis externa | 11 | 12.6 7.0–22.8ROR 12.6 · χ² 105 / p 6e-25 | 10.7 EB05 5.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Granulocytopenia | 50 | 12.2 9.2–16.1ROR 12.2 · χ² 499 / p 1e-110 | 11.8 EB05 9.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=32 · 100% clinician | not reported in cached trials |
| Carotid artery disease | 11 | 12.1 6.7–21.9ROR 12.1 · χ² 100 / p 7e-24 | 10.1 EB05 5.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Renal failure acute | 371 | 12.1 10.9–13.4ROR 12.4 · χ² 3,733 / p <1e-300 | 11.9 EB05 11.0 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.2 · ♀ 23% (drug 44%) · 92% clinician | not reported in cached trials |
| End stage renal disease | 158 | 12.0 10.3–14.0ROR 12.1 · χ² 1,572 / p <1e-300 | 11.8 EB05 10.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | not reported in cached trials |
| Left atrial dilatation | 11 | 12.0 6.6–21.7ROR 12.0 · χ² 99 / p 1e-23 | 10.1 EB05 5.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Carotid artery stenosis | 30 | 12.0 8.4–17.1ROR 12.0 · χ² 288 / p 6e-65 | 11.3 EB05 8.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=30 | not reported in cached trials |
| Fanconi syndrome | 12 | 12.0 6.8–21.1ROR 12.0 · χ² 109 / p 9e-26 | 10.2 EB05 5.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Metabolic syndrome | 14 | 11.9 7.1–20.2ROR 11.9 · χ² 128 / p 5e-30 | 10.5 EB05 6.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Ischaemic cardiomyopathy | 26 | 11.8 8.0–17.3ROR 11.8 · χ² 243 / p 4e-55 | 11.0 EB05 7.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 44%) | not reported in cached trials |
| Diabetic retinopathy | 27 | 11.1 7.6–16.2ROR 11.1 · χ² 237 / p 1e-53 | 10.4 EB05 7.2 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=27 | not reported in cached trials |
| Ventricular hypertrophy | 20 | 11.1 7.1–17.2ROR 11.1 · χ² 172 / p 2e-39 | 10.0 EB05 6.5 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=19 | not reported in cached trials |
| Myopathy | 68 | 11.0 8.7–13.9ROR 11.0 · χ² 603 / p 2e-133 | 10.7 EB05 8.6 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 | not reported in cached trials |
| Diabetic complication | 20 | 10.9 7.0–16.9ROR 10.9 · χ² 169 / p 6e-39 | 9.9 EB05 6.4 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=18 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Gemfibrozil as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT05959447 — Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant (N=45, PHASE1; 32 AE terms posted; arms: Part 1: Camlipixant 50 mg; Part 1: Gemfibrozil 600 mg; Part 1: Camlipixant 50 mg+ Gemfibrozil 6; Part 2: Dabigatran Etexilate 150 mg)
- NCT01836198 — The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream (N=30, PHASE1; 29 AE terms posted; arms: LY2409021 Only (Part A, Cohort 1); Gemfibrozil Only (Part A, Cohort 1); LY2409021+Gemfibrozil (Part A, Cohort 1); LY2409021 Only (Part A, Cohort 2))
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Nausea | 886 | 1.6 1.5–1.7ROR 1.6 · χ² 185 / p 2e-42 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT05959447: 1/16 (6.2%) on Gemfibrozil |
| Fatigue (tiredness) | 831 | 1.5 1.4–1.6ROR 1.5 · χ² 137 / p 6e-32 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.6 | NCT01836198: 2/15 (13.3%) on Gemfibrozil |
| Drug ineffective (drug did not work) | 772 | 0.8 0.8–0.9ROR 0.8 · χ² 34 / p 2e-9 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Diarrhoea (diarrhea) | 731 | 1.6 1.5–1.7ROR 1.6 · χ² 160 / p 6e-37 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 | NCT05959447: 1/15 (6.7%) on Gemfibrozil |
| Pain | 695 | 1.6 1.5–1.7ROR 1.6 · χ² 148 / p 3e-34 | 1.6 EB05 1.5 · IC025 +0.5 | Likely indication confounding term in indications; also in warnings | serious PRR 1.6 | NCT05959447: 1/16 (6.2%) on Gemfibrozil |
| Dizziness | 618 | 1.7 1.6–1.9ROR 1.8 · χ² 192 / p 5e-44 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.9 | NCT05959447: 1/15 (6.7%) on Gemfibrozil |
| Rhabdomyolysis (muscle breakdown) | 605 | 20.5 18.9–22.2ROR 21.3 · χ² 11,052 / p <1e-300 | 20.2 EB05 18.9 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.2 · 95% clinician | not reported in cached trials |
| Dyspnoea (shortness of breath) | 602 | 1.5 1.4–1.6ROR 1.5 · χ² 96 / p 7e-23 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.4 | not reported in cached trials |
| Asthenia (weakness) | 596 | 2.2 2.0–2.4ROR 2.3 · χ² 398 / p 9e-89 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | not reported in cached trials |
| Headache | 564 | 1.3 1.2–1.4ROR 1.3 · χ² 29 / p 3e-8 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.4 | NCT05959447: 1/16 (6.2%) on Gemfibrozil |
| Renal failure (kidney failure) | 559 | 5.8 5.4–6.3ROR 6.0 · χ² 2,236 / p <1e-300 | 5.8 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | not reported in cached trials |
| Vomiting | 514 | 1.5 1.4–1.7ROR 1.5 · χ² 94 / p 1e-22 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 | not reported in cached trials |
| Chronic kidney disease | 484 | 8.8 8.1–9.6ROR 9.1 · χ² 3,342 / p <1e-300 | 8.7 EB05 8.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | not reported in cached trials |
| Drug interaction | 470 | 4.1 3.8–4.5ROR 4.2 · χ² 1,115 / p 8e-245 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 | not reported in cached trials |
| Pain in extremity | 458 | 2.2 2.0–2.4ROR 2.2 · χ² 287 / p 1e-64 | 2.2 EB05 2.0 · IC025 +1.0 | Not in label — unassessed | serious PRR 2.4 | not reported in cached trials |
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.
- Chronic kidney disease-mineral and bone disorder — n=25, PRR 33.0
- Nephrogenic anaemia — n=91, PRR 27.6
- Hyperparathyroidism secondary — n=40, PRR 22.3
- Polymyositis — n=27, PRR 21.6
- Lipids increased — n=20, PRR 14.0
- Angioneurotic oedema — n=26, PRR 13.5
- Rebound acid hypersecretion — n=29, PRR 13.3
- Granulocytopenia — n=50, PRR 12.2
- End stage renal disease — n=158, PRR 12.0
- Carotid artery stenosis — n=30, PRR 12.0
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 Gemfibrozil?
In FDA FAERS, the most frequently co-reported reaction terms for Gemfibrozil are nausea, fatigue, diarrhoea, pain, dizziness, rhabdomyolysis. 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 Gemfibrozil have an FDA boxed warning?
No. The FDA label retrieved for Gemfibrozil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Gemfibrozil 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 17529d33-f24a-1f3f-e063-6394a90ae374, effective 20240430; matched on
openfda.generic_name.exact:"GEMFIBROZIL") - 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, 1,141 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 - ClinicalTrials.gov API v2 (query
GEMFIBROZIL, results-bearing studies sorted by enrollment)
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.