Fenofibric Acid side effects: what 775 FDA adverse event reports show

Fenofibric Acid · 15 reaction terms · 106 drug–reaction co-reports · data 2026-09-14

Drug class

Peroxisome Proliferator Receptor alpha Agonist

FDA label (Established Pharmacologic Class) · compare the class

Who reports

775 reports · 58% serious · 76 with death outcome · 45% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.

FDA label, Indications and Usage

What it is

Fenofibric acid is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid.

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 8 strongest signals

Labeled (related wording) 1Reporting / coding artifact 1Lab value / disease marker 2Outcome field, not a reaction 1Not in label — unassessed 3

What the badges mean

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.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
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. 7 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
Blood triglycerides increased	19	29.0 18.6–45.2ROR 29.7 · χ² 486 / p 6e-108	28.2 EB05 19.1 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 35.9	no trial data cached
Nephropathy	5	14.4 6.0–34.5ROR 14.5 · χ² 50 / p 9e-13	9.9 EB05 3.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 12.2	no trial data cached
Tendonitis	8	13.9 7.0–27.7ROR 14.0 · χ² 83 / p 3e-20	11.4 EB05 5.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.6	no trial data cached
Upper gastrointestinal haemorrhage	7	11.2 5.4–23.4ROR 11.3 · χ² 55 / p 5e-14	8.2 EB05 3.7 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.2	no trial data cached
Prostatic specific antigen increased	5	9.8 4.1–23.4ROR 9.8 · χ² 31 / p 1e-8	6.2 EB05 2.6 · IC025 +0.9 3/3 methods agree	Lab value / disease marker	serious PRR 12.8	no trial data cached
Product physical issue	6	8.1 3.7–18.1ROR 8.2 · χ² 31 / p 1e-8	5.5 EB05 2.6 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Blood glucose decreased	13	7.3 4.3–12.5ROR 7.4 · χ² 65 / p 5e-16	6.0 EB05 3.7 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 11.5	no trial data cached
Completed suicide (death by suicide)	19	6.1 3.9–9.5ROR 6.2 · χ² 76 / p 1e-18	5.4 EB05 3.6 · IC025 +1.7 3/3 methods agree	Outcome field, not a reaction	serious PRR 6.1	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
Completed suicide (death by suicide)	19	6.1 3.9–9.5ROR 6.2 · χ² 76 / p 1e-18	5.4 EB05 3.6 · IC025 +1.7 3/3 methods agree	Outcome field, not a reaction	serious PRR 6.1	no trial data cached
Blood triglycerides increased	19	29.0 18.6–45.2ROR 29.7 · χ² 486 / p 6e-108	28.2 EB05 19.1 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 35.9	no trial data cached
Blood glucose decreased	13	7.3 4.3–12.5ROR 7.4 · χ² 65 / p 5e-16	6.0 EB05 3.7 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 11.5	no trial data cached
Tendonitis	8	13.9 7.0–27.7ROR 14.0 · χ² 83 / p 3e-20	11.4 EB05 5.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.6	no trial data cached
Upper gastrointestinal haemorrhage	7	11.2 5.4–23.4ROR 11.3 · χ² 55 / p 5e-14	8.2 EB05 3.7 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.2	no trial data cached
Product physical issue	6	8.1 3.7–18.1ROR 8.2 · χ² 31 / p 1e-8	5.5 EB05 2.6 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Prostatic specific antigen increased	5	9.8 4.1–23.4ROR 9.8 · χ² 31 / p 1e-8	6.2 EB05 2.6 · IC025 +0.9 3/3 methods agree	Lab value / disease marker	serious PRR 12.8	no trial data cached
Nephropathy	5	14.4 6.0–34.5ROR 14.5 · χ² 50 / p 9e-13	9.9 EB05 3.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 12.2	no trial data cached
Wrong technique in drug usage process	4	2.9 1.1–7.8ROR 2.9 · χ² 3 / p 0.034	2.4 EB05 1.1 · IC025 -0.5 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 2.4	no trial data cached
Blindness unilateral	4	7.7 2.9–20.4ROR 7.7 · χ² 17 / p 2e-5	4.6 EB05 1.9 · IC025 +0.4	Not in label — unassessed	serious PRR 7.9	no trial data cached
Impaired driving ability	4	9.5 3.6–25.2ROR 9.5 · χ² 23 / p 1e-6	5.5 EB05 2.2 · IC025 +0.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Product taste abnormal	3	6.0 1.9–18.7ROR 6.0 · χ² 8 / p 0.002	3.6 EB05 1.4 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached
Sexual dysfunction	3	6.9 2.2–21.5ROR 7.0 · χ² 10 / p 8e-4	3.9 EB05 1.5 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 6.9	no trial data cached
Internal haemorrhage	3	7.1 2.3–21.9ROR 7.1 · χ² 10 / p 7e-4	3.9 EB05 1.5 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 7.2	no trial data cached
Bipolar disorder	3	7.4 2.4–22.9ROR 7.4 · χ² 11 / p 5e-4	4.1 EB05 1.5 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 8.4	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.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Zoledronic acid (bisphosphonates) ↔ Osteonecrosis of the jaw.

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 Fenofibric Acid?

In FDA FAERS, the most frequently co-reported reaction terms for Fenofibric Acid are blood triglycerides increased, blood glucose decreased, tendonitis, upper gastrointestinal haemorrhage, prostatic specific antigen increased, nephropathy. 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 Fenofibric Acid have an FDA boxed warning?

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

Do FAERS signals prove that Fenofibric Acid 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 9ad201de-fa62-4c49-bc61-ee09b9ba434c, effective 20250802; matched on openfda.generic_name.exact:"FENOFIBRIC ACID")
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, 15 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.