Drug · FAERS side-effect profile with label screen
Fenofibrate side effects: what 35,231 FDA adverse event reports show
Drug class
Peroxisome Proliferator Receptor alpha Agonist
FDA label (Established Pharmacologic Class) · compare the class
Who reports
35,231 reports · 68% serious · 2,766 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Fenofibrate tablets are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: • To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). • For treatment of adult patients with severe hypertriglyceridemia (1.2).
FDA label, Indications and Usage
What it is
Fenofibrate, USP is a lipid regulating agent 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 (related wording) 3Likely indication confounding 12Lab value / disease marker 5Not in label — unassessed 20
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.
- 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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,114 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 |
|---|---|---|---|---|---|---|
| Amaurosis fugax | 228 | 161.4 139.4–186.8ROR 162.4 · calibrated p 3e-9 ✓ | 125.4 EB05 112.4 · IC025 +6.4 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 27.3 (15.3–48.8) | Not in label — unassessed | serious n=228 · 94% clinician | no trial arm names this drug |
| Pancreatitis haemorrhagic | 32 | 43.7 30.5–62.6ROR 43.8 · calibrated p 5e-5 ✓ | 39.9 EB05 29.6 · IC025 +4.1 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=32 · ♀ 100% (drug 48%) · 100% clinician | no trial arm names this drug |
| High density lipoprotein decreased | 160 | 29.9 25.5–35.0ROR 30.0 · calibrated p 3e-4 ✓ | 28.4 EB05 24.9 · IC025 +4.5 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 6.6 (4.6–9.5) | Likely indication confounding term in indications | serious n=134 | no trial arm names this drug |
| Urinary tract disorder | 205 | 28.4 24.7–32.6ROR 28.5 · calibrated p 4e-4 ✓ | 27.0 EB05 24.1 · IC025 +4.4 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 21.0 (12.2–36.1) | Not in label — unassessed | serious n=205 · 93% clinician | no trial arm names this drug |
| Chronic kidney disease-mineral and bone disorder | 44 | 25.3 18.7–34.2ROR 25.4 · calibrated p 8e-4 ✓ | 24.1 EB05 18.7 · IC025 +3.8 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 2.5 (1.5–4.1) | Not in label — unassessed | serious n=44 | no trial arm names this drug |
| Hypertriglyceridaemia | 222 | 23.5 20.6–26.9ROR 23.6 · calibrated p 9e-4 ✓ | 22.6 EB05 20.2 · IC025 +4.2 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.0 (2.4–3.8) | Likely indication confounding shares a disease stem with the indications wording | serious n=217 | no trial arm names this drug |
| Blood triglycerides abnormal | 31 | 21.8 15.2–31.1ROR 21.8 · calibrated p 0.002 ✓ | 20.8 EB05 15.3 · IC025 +3.4 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.2 (1.7–6.0) | Likely indication confounding term in indications | serious n=19 | no trial arm names this drug |
| Haemorrhagic stroke | 266 | 20.8 18.4–23.5ROR 21.0 · calibrated p 0.002 ✓ | 20.1 EB05 18.2 · IC025 +4.1 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 19.1 (12.1–30.1) | Not in label — unassessed | serious PRR 16.9 | no trial arm names this drug |
| Pancreatitis relapsing | 25 | 18.9 12.7–28.1ROR 18.9 · calibrated p 0.004 ✓ | 18.0 EB05 12.7 · IC025 +3.1 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.0 (1.5–6.0) | Likely indication confounding shares a disease stem with the indications wording | serious n=25 | no trial arm names this drug |
| Nephrogenic anaemia | 143 | 18.7 15.9–22.1ROR 18.8 · calibrated p 0.003 ✓ | 18.2 EB05 15.8 · IC025 +3.8 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 2.3 (1.7–2.9) | Not in label — unassessed | serious n=143 | no trial arm names this drug |
| Glomerular filtration rate increased | 24 | 18.1 12.0–27.1ROR 18.1 · calibrated p 0.004 ✓ | 17.2 EB05 12.0 · IC025 +3.0 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Lab value / disease marker | serious n=21 · 100% clinician | no trial arm names this drug |
| Hyperparathyroidism secondary | 69 | 16.6 13.1–21.1ROR 16.7 · calibrated p 0.005 ✓ | 16.1 EB05 13.1 · IC025 +3.5 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 2.5 (1.7–3.7) | Not in label — unassessed | serious n=69 | no trial arm names this drug |
| Diabetic metabolic decompensation | 34 | 14.9 10.6–21.0ROR 15.0 · calibrated p 0.009 ✓ | 14.3 EB05 10.5 · IC025 +3.0 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Labeled (related wording) related wording | serious n=34 · 100% clinician | no trial arm names this drug |
| Blood alkaline phosphatase abnormal | 22 | 14.9 9.8–22.8ROR 14.9 · calibrated p 0.010 ✓ | 14.1 EB05 9.4 · IC025 +2.8 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Lab value / disease marker | serious n=21 · 100% clinician | no trial arm names this drug |
| Rebound acid hypersecretion | 70 | 13.9 10.9–17.6ROR 13.9 · calibrated p 0.010 ✓ | 13.4 EB05 10.9 · IC025 +3.2 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.5 (2.3–5.3) | Not in label — unassessed | serious n=70 | no trial arm names this drug |
| Ocular discomfort | 241 | 13.5 11.9–15.3ROR 13.6 · calibrated p 0.011 ✓ | 13.2 EB05 11.8 · IC025 +3.5 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 26.6 (15.2–46.5) | Not in label — unassessed | serious n=230 | no trial arm names this drug |
| Pancreatitis necrotising | 47 | 12.5 9.4–16.7ROR 12.6 · calibrated p 0.016 ✓ | 12.0 EB05 9.3 · IC025 +3.0 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=47 · 100% clinician | no trial arm names this drug |
| Blood triglycerides increased | 353 | 12.1 10.9–13.4ROR 12.2 · calibrated p 0.016 ✓ | 11.8 EB05 10.8 · IC025 +3.4 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 1.9 (1.6–2.3) | Likely indication confounding term in indications | serious PRR 10.5 | no trial arm names this drug |
| Generalised oedema | 242 | 11.9 10.5–13.5ROR 12.0 · calibrated p 0.017 ✓ | 11.6 EB05 10.4 · IC025 +3.3 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 23.2 (13.8–39.0) | Not in label — unassessed | serious PRR 10.8 · 90% clinician | no trial arm names this drug |
| Stenosis | 34 | 11.1 7.9–15.6ROR 11.1 · calibrated p 0.026 ✓ | 10.4 EB05 7.5 · IC025 +2.7 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Not in label — unassessed | serious n=34 · ♀ 0% (drug 48%) · 100% clinician | no trial arm names this drug |
| Blood bilirubin abnormal | 23 | 11.0 7.3–16.6ROR 11.0 · calibrated p 0.029 ✓ | 9.9 EB05 6.7 · IC025 +2.5 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Lab value / disease marker | serious n=23 · 100% clinician | no trial arm names this drug |
| Pancreatitis acute | 402 | 10.9 9.9–12.0ROR 11.0 · calibrated p 0.023 ✓ | 10.7 EB05 9.8 · IC025 +3.2 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 5.7 (4.6–7.1) | Likely indication confounding term in indications; also in warnings | serious PRR 9.0 | no trial arm names this drug |
| Myoglobin blood increased | 26 | 10.2 6.9–15.1ROR 10.2 · calibrated p 0.036 ✓ | 9.3 EB05 6.4 · IC025 +2.4 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.4 (1.7–6.9) | Lab value / disease marker | serious n=26 · 100% clinician | no trial arm names this drug |
| Dyslipidaemia | 86 | 10.2 8.3–12.6ROR 10.2 · calibrated p 0.031 ✓ | 9.8 EB05 8.2 · IC025 +2.9 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 4.3 (2.8–6.5) | Likely indication confounding term in indications | serious n=86 | no trial arm names this drug |
| Metabolic syndrome | 27 | 9.9 6.8–14.5ROR 9.9 · calibrated p 0.039 ✓ | 9.0 EB05 6.3 · IC025 +2.4 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 2.8 (1.5–5.3) | Labeled (related wording) related wording | serious n=26 · ♀ 0% (drug 48%) · 100% clinician | no trial arm names this drug |
| Mitral valve disease | 29 | 9.8 6.8–14.2ROR 9.9 · calibrated p 0.040 ✓ | 9.0 EB05 6.4 · IC025 +2.5 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Not in label — unassessed | serious n=29 · 100% clinician | no trial arm names this drug |
| Head discomfort | 257 | 8.8 7.8–9.9ROR 8.9 · calibrated p 0.049 ✓ | 8.6 EB05 7.7 · IC025 +2.9 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 18.5 (11.7–29.1) | Not in label — unassessed | serious PRR 12.2 | no trial arm names this drug |
| Dilatation ventricular | 30 | 8.5 5.9–12.2ROR 8.5 · calibrated p 0.063 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.3 (1.7–6.4) | Not in label — unassessed | serious n=30 · ♀ 100% (drug 48%) · 100% clinician | no trial arm names this drug |
| Kidney fibrosis | 24 | 8.4 5.6–12.5ROR 8.4 · calibrated p 0.068 | 7.4 EB05 5.1 · IC025 +2.2 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Not in label — unassessed | serious n=24 · 100% clinician | no trial arm names this drug |
| Aortic arteriosclerosis | 35 | 8.2 5.9–11.4ROR 8.2 · calibrated p 0.069 | 7.5 EB05 5.6 · IC025 +2.3 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.0 (1.7–5.3) | Not in label — unassessed | serious n=35 · ♀ 100% (drug 48%) · 100% clinician | no trial arm names this drug |
| Chronic kidney disease | 1,039 | 8.2 7.7–8.7ROR 8.4 · calibrated p 0.058 | 8.0 EB05 7.6 · IC025 +2.9 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.1 (2.8–3.4) | Not in label — unassessed | serious PRR 6.9 | no trial arm names this drug |
| Blood calcium abnormal | 22 | 8.0 5.3–12.2ROR 8.0 · calibrated p 0.078 | 7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Lab value / disease marker | serious n=22 · 100% clinician | no trial arm names this drug |
| End stage renal disease | 240 | 7.8 6.9–8.9ROR 7.9 · calibrated p 0.070 | 7.7 EB05 6.9 · IC025 +2.7 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 2.2 (1.8–2.7) | Not in label — unassessed | serious PRR 6.5 | no trial arm names this drug |
| Pancreatitis chronic | 30 | 7.7 5.4–11.0ROR 7.7 · calibrated p 0.085 | 6.9 EB05 5.0 · IC025 +2.2 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 1.8 (1.1–3.1) | Likely indication confounding term in indications; also in warnings | serious n=30 | no trial arm names this drug |
| Altered state of consciousness | 270 | 7.5 6.7–8.5ROR 7.6 · calibrated p 0.079 | 7.4 EB05 6.7 · IC025 +2.7 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 21.6 (13.4–34.7) | Not in label — unassessed | serious PRR 6.3 · ♀ 72% (drug 48%) · 92% clinician | no trial arm names this drug |
| Mucosal dryness | 25 | 7.5 5.1–11.2ROR 7.5 · calibrated p 0.091 | 6.7 EB05 4.7 · IC025 +2.1 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Not in label — unassessed | serious n=25 · 100% clinician | no trial arm names this drug |
| Euglycaemic diabetic ketoacidosis | 49 | 7.4 5.6–9.8ROR 7.4 · calibrated p 0.090 | 6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=49 · 100% clinician | no trial arm names this drug |
| Hypertonic bladder | 35 | 7.3 5.2–10.2ROR 7.3 · calibrated p 0.095 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=31 · ♀ 100% (drug 48%) | no trial arm names this drug |
| Cholestatic liver injury | 26 | 7.3 5.0–10.7ROR 7.3 · calibrated p 0.099 | 6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Labeled (related wording) related wording | serious n=26 · 100% clinician | no trial arm names this drug |
| Distributive shock | 26 | 7.1 4.8–10.4ROR 7.1 · calibrated p 0.108 | 6.3 EB05 4.5 · IC025 +2.0 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: only this drug | Not in label — unassessed | serious n=26 · ♀ 100% (drug 48%) · 100% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Fenofibrate only as a background or rescue medication (NCT00000620, NCT01492361); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 2,173 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.775 | 1.7 EB05 1.6 · IC025 +0.7 vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.8 (3.5–4.1) | Labeled (related wording) related wording | serious PRR 1.7 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 2,103 | 1.9 1.9–2.0ROR 2.0 · calibrated p 0.949 | 1.9 EB05 1.9 · IC025 +0.9 vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 4.1 (3.8–4.5) | Not in label — unassessed | serious PRR 1.8 | no trial arm names this drug |
| Nausea | 2,045 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.692 | 1.5 EB05 1.5 · IC025 +0.6 vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.3 (3.1–3.6) | Labeled adverse reaction exact term | serious PRR 1.6 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 1,790 | 0.8 0.8–0.8ROR 0.8 · calibrated p 0.183 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.3 (3.1–3.6) | Reporting / coding artifact | serious PRR 1.0 | no trial arm names this drug |
| Headache | 1,571 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.653 | 1.5 EB05 1.4 · IC025 +0.5 vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 4.0 (3.6–4.4) | Labeled adverse reaction exact term | serious PRR 1.7 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 1,527 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.729 | 1.6 EB05 1.5 · IC025 +0.6 vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.6 (3.3–4.0) | Not in label — unassessed | serious PRR 1.5 | no trial arm names this drug |
| Off label use (used outside approved label) | 1,386 | 1.0 0.9–1.0ROR 0.9 · calibrated p 0.273 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 5.7 (5.1–6.4) | Reporting / coding artifact | serious PRR 1.0 | no trial arm names this drug |
| Dizziness | 1,383 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.758 | 1.7 EB05 1.6 · IC025 +0.6 vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.2 (2.9–3.5) | Not in label — unassessed | serious PRR 1.7 | no trial arm names this drug |
| Pain | 1,380 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.541 | 1.3 EB05 1.3 · IC025 +0.3 vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 2.9 (2.6–3.1) | Labeled adverse reaction exact term | serious PRR 1.3 | no trial arm names this drug |
| Fall | 1,370 | 2.5 2.3–2.6ROR 2.5 · calibrated p 0.806 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 4.3 (3.9–4.8) | Not in label — unassessed | serious PRR 2.2 | no trial arm names this drug |
| Asthenia (weakness) | 1,313 | 2.1 2.0–2.2ROR 2.1 · calibrated p 0.991 | 2.1 EB05 2.0 · IC025 +1.0 vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.2 (2.9–3.5) | Labeled adverse reaction exact term | serious PRR 2.0 | no trial arm names this drug |
| Acute kidney injury (sudden kidney damage) | 1,243 | 4.9 4.6–5.2ROR 5.0 · calibrated p 0.232 | 4.8 EB05 4.6 · IC025 +2.2 3/3 methods agree vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 4.0 (3.6–4.5) | Labeled (related wording) related wording | serious PRR 4.1 | no trial arm names this drug |
| Vomiting | 1,229 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.694 | 1.6 EB05 1.5 · IC025 +0.5 vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.4 (3.1–3.8) | Not in label — unassessed | serious PRR 1.5 | no trial arm names this drug |
| Arthralgia (joint pain) | 1,176 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.778 | 1.7 EB05 1.6 · IC025 +0.7 vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 3.9 (3.5–4.3) | Labeled adverse reaction exact term | serious PRR 1.8 | no trial arm names this drug |
| Pruritus (itching) | 1,155 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.858 | 1.8 EB05 1.7 · IC025 +0.8 vs other Peroxisome Proliferator Receptor alpha Agonists: PRR 5.2 (4.6–5.8) | Labeled adverse reaction exact term | serious PRR 2.1 | no trial arm names this drug |
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.
- Amaurosis fugax — n=228, PRR 161.4
- Urinary tract disorder — n=205, PRR 28.4
- Chronic kidney disease-mineral and bone disorder — n=44, PRR 25.3
- Haemorrhagic stroke — n=266, PRR 20.8
- Nephrogenic anaemia — n=143, PRR 18.7
- Hyperparathyroidism secondary — n=69, PRR 16.6
- Rebound acid hypersecretion — n=70, PRR 13.9
- Ocular discomfort — n=241, PRR 13.5
- Generalised oedema — n=242, PRR 11.9
- Stenosis — n=34, PRR 11.1
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 Fenofibrate?
In FDA FAERS, the most frequently co-reported reaction terms for Fenofibrate are fatigue, diarrhoea, nausea, headache, dyspnoea, dizziness. 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 Fenofibrate have an FDA boxed warning?
No. The FDA label retrieved for Fenofibrate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Fenofibrate 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 06870192-c92a-40c7-a619-efda0c006301, effective 20230419; matched on
openfda.generic_name.exact:"FENOFIBRATE") - 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, 1,154 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
FENOFIBRATE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.