Ezetimibe side effects: what 74,507 FDA adverse event reports show

Ezetimibe · 1,179 reaction terms · 280,456 drug–reaction co-reports · data 2026-09-14

Drug class

Dietary Cholesterol Absorption Inhibitor

FDA label (Established Pharmacologic Class)

Who reports

74,507 reports · 65% serious · 4,305 with death outcome · 53% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Ezetimibe Tablets is indicated: In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).

FDA label, Indications and Usage

What it is

Ezetimibe, USP is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols.

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 2Likely indication confounding 7Lab value / disease marker 4Not in label — unassessed 27

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.
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). 1,139 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
Amyloid arthropathy	57	2,252.3 1,027.4–4,937.7ROR 2,254.0 · calibrated p 4e-17 ✓	228.4 EB05 182.8 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=57 · ♀ 100% (drug 53%) · 100% clinician	not reported in cached trials
Hyper ige syndrome	55	262.3 181.4–379.3ROR 262.5 · calibrated p 1e-10 ✓	129.1 EB05 103.0 · IC025 +5.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=55 · ♀ 100% (drug 53%)	not reported in cached trials
Truncus arteriosus persistent	71	153.4 114.8–205.0ROR 153.6 · calibrated p 8e-9 ✓	96.5 EB05 79.1 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=71 · 100% clinician	not reported in cached trials
Neurologic neglect syndrome	171	123.8 103.4–148.3ROR 124.1 · calibrated p 3e-8 ✓	85.0 EB05 74.9 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=171 · ♀ 100% (drug 53%) · 100% clinician	not reported in cached trials
Type iia hyperlipidaemia	65	113.1 84.7–150.9ROR 113.2 · calibrated p 8e-8 ✓	78.8 EB05 64.0 · IC025 +5.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=63 · ♀ 0% (drug 53%) · 100% clinician	not reported in cached trials
Amaurosis fugax	239	80.9 70.1–93.4ROR 81.2 · calibrated p 6e-7 ✓	62.5 EB05 56.2 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=239 · 93% clinician	not reported in cached trials
Lipoprotein (a) increased	63	75.8 57.3–100.1ROR 75.8 · calibrated p 1e-6 ✓	58.7 EB05 47.5 · IC025 +4.9 3/3 methods agree	Likely indication confounding term in indications	serious n=51 · ♀ 0% (drug 53%)	not reported in cached trials
Carotid artery thrombosis	172	70.9 60.0–83.8ROR 71.1 · calibrated p 2e-6 ✓	56.3 EB05 49.6 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious n=172 · ♀ 100% (drug 53%) · 100% clinician	not reported in cached trials
Low density lipoprotein abnormal	79	41.4 32.7–52.4ROR 41.4 · calibrated p 5e-5 ✓	35.8 EB05 29.7 · IC025 +4.5 3/3 methods agree	Likely indication confounding term in indications	serious n=44	not reported in cached trials
Adjustment disorder	166	40.9 34.8–48.2ROR 41.0 · calibrated p 5e-5 ✓	35.6 EB05 31.3 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=166 · ♀ 100% (drug 53%) · 100% clinician	not reported in cached trials
Vascular stent stenosis	46	34.9 25.7–47.4ROR 34.9 · calibrated p 2e-4 ✓	30.7 EB05 24.0 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=46 · ♀ 0% (drug 53%) · 100% clinician	not reported in cached trials
Cardiac septal defect	59	24.9 19.1–32.5ROR 24.9 · calibrated p 8e-4 ✓	22.8 EB05 18.3 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=59 · 100% clinician	not reported in cached trials
Low density lipoprotein decreased	110	23.6 19.4–28.7ROR 23.6 · calibrated p 1e-3 ✓	21.7 EB05 18.5 · IC025 +4.0 3/3 methods agree	Likely indication confounding term in indications	serious n=62 · ♀ 27% (drug 53%)	not reported in cached trials
Congenital cardiovascular anomaly	63	22.5 17.4–29.0ROR 22.5 · calibrated p 0.001 ✓	20.7 EB05 16.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=63 · 100% clinician	not reported in cached trials
Low density lipoprotein increased	569	22.4 20.6–24.4ROR 22.6 · calibrated p 0.001 ✓	20.8 EB05 19.4 · IC025 +4.2 3/3 methods agree	Likely indication confounding term in indications	serious n=351	not reported in cached trials
Restrictive pulmonary disease	82	21.2 16.9–26.5ROR 21.2 · calibrated p 0.002 ✓	19.7 EB05 16.3 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=81	NCT00202878: 1/9,067 (0.0%) on Ezetimibe (serious AE)
Muscle discomfort	54	21.1 16.0–27.8ROR 21.1 · calibrated p 0.002 ✓	19.5 EB05 15.5 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	100% clinician	not reported in cached trials
Personality disorder	177	20.2 17.3–23.5ROR 20.2 · calibrated p 0.002 ✓	18.8 EB05 16.6 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=174 · ♀ 100% (drug 53%) · 100% clinician	not reported in cached trials
Diaphragmatic disorder	50	19.5 14.6–25.9ROR 19.5 · calibrated p 0.003 ✓	18.1 EB05 14.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=50 · ♀ 0% (drug 53%)	NCT00202878: 1/9,077 (0.0%) on Ezetimibe (serious AE)
Necrotising myositis	52	17.9 13.5–23.7ROR 17.9 · calibrated p 0.004 ✓	16.8 EB05 13.2 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=52 · ♀ 0% (drug 53%) · 100% clinician	not reported in cached trials
High density lipoprotein decreased	177	15.7 13.5–18.3ROR 15.7 · calibrated p 0.006 ✓	14.9 EB05 13.1 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious n=100	not reported in cached trials
Urinary tract disorder	225	14.8 12.9–16.9ROR 14.8 · calibrated p 0.008 ✓	14.0 EB05 12.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=222 · 92% clinician	NCT00202878: 77/9,067 (0.8%) on Ezetimibe (serious AE)
Myopathy	431	14.7 13.3–16.2ROR 14.8 · calibrated p 0.008 ✓	14.0 EB05 12.9 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.5	NCT00202878: 2/9,067 (0.0%) on Ezetimibe (serious AE)
Carotid arteriosclerosis	49	14.1 10.6–18.8ROR 14.1 · calibrated p 0.010 ✓	13.2 EB05 10.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=49 · ♀ 0% (drug 53%)	not reported in cached trials
Hyperparathyroidism secondary	119	13.8 11.5–16.6ROR 13.9 · calibrated p 0.010 ✓	13.1 EB05 11.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=119	NCT00202878: 2/9,067 (0.0%) on Ezetimibe (serious AE)
Pulmonary pain	132	13.5 11.3–16.1ROR 13.5 · calibrated p 0.011 ✓	12.9 EB05 11.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=129	not reported in cached trials
Muscle cramp	79	12.9 10.3–16.1ROR 12.9 · calibrated p 0.014 ✓	12.2 EB05 10.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	100% clinician	not reported in cached trials
Dyslipidaemia	221	12.7 11.1–14.6ROR 12.8 · calibrated p 0.014 ✓	12.2 EB05 10.9 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious n=215	not reported in cached trials
Haemorrhagic stroke	335	12.5 11.2–13.9ROR 12.5 · calibrated p 0.014 ✓	12.0 EB05 10.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	not reported in cached trials
Blood cholesterol decreased	76	11.9 9.5–15.0ROR 11.9 · calibrated p 0.018 ✓	11.3 EB05 9.2 · IC025 +3.0 3/3 methods agree	Likely indication confounding term in indications	serious n=40 · ♀ 33% (drug 53%)	not reported in cached trials
Blood pressure systolic abnormal	97	11.4 9.3–13.9ROR 11.4 · calibrated p 0.022 ✓	10.8 EB05 9.1 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious n=94 · ♀ 100% (drug 53%) · 100% clinician	not reported in cached trials
Polycystic ovaries	60	11.1 8.6–14.4ROR 11.1 · calibrated p 0.024 ✓	10.5 EB05 8.3 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=60 · ♀ 100% (drug 53%)	not reported in cached trials
Angina unstable	247	11.0 9.7–12.5ROR 11.0 · calibrated p 0.024 ✓	10.5 EB05 9.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=246 · ♀ 27% (drug 53%)	not reported in cached trials
Nephrogenic anaemia	175	10.9 9.4–12.7ROR 10.9 · calibrated p 0.024 ✓	10.4 EB05 9.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=175	not reported in cached trials
Immune-mediated myositis	95	10.5 8.5–12.9ROR 10.5 · calibrated p 0.029 ✓	9.9 EB05 8.3 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=94 · 100% clinician	not reported in cached trials
Left atrial dilatation	45	10.2 7.6–13.7ROR 10.2 · calibrated p 0.034 ✓	9.4 EB05 7.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=45 · ♀ 0% (drug 53%) · 100% clinician	not reported in cached trials
Blood creatine phosphokinase increased	1,001	9.9 9.3–10.6ROR 10.1 · calibrated p 0.032 ✓	9.6 EB05 9.1 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	age-adj. PRR 8.3 · serious PRR 7.1	NCT00202878: 4/9,067 (0.0%) on Ezetimibe (serious AE)
Arterial occlusive disease	265	9.7 8.6–11.0ROR 9.8 · calibrated p 0.036 ✓	9.4 EB05 8.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.5 · ♀ 76% (drug 53%)	NCT00202878: 1/9,067 (0.0%) on Ezetimibe (serious AE)
Gangrene	195	9.3 8.1–10.7ROR 9.3 · calibrated p 0.042 ✓	8.9 EB05 7.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=195 · ♀ 100% (drug 53%)	NCT00202878: 1/9,077 (0.0%) on Ezetimibe (serious AE)
Myoglobin blood increased	47	8.9 6.6–11.8ROR 8.9 · calibrated p 0.053	8.2 EB05 6.3 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious n=44 · ♀ 0% (drug 53%) · 100% clinician	not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Rhabdomyolysis / myopathy	2,429	8.78.3–9.0	signal
Pancreatitis	850	3.02.8–3.2	signal
Myocardial infarction	2,045	2.82.7–3.0	signal
Kidney injury	3,919	2.42.4–2.5	signal
Gi bleeding	1,496	2.32.2–2.4	signal
Liver injury	2,222	2.12.0–2.2	raised
Arrhythmia / qt	1,363	2.01.9–2.1	raised
Stroke	1,751	2.01.9–2.1	raised
Tendon disorder	263	1.91.7–2.2	raised
Fall / fracture	2,588	1.91.8–2.0	raised
Hypoglycaemia	644	1.91.8–2.0	raised
Heart failure	1,172	1.81.7–2.0	raised
Hyperglycaemia / diabetes	2,264	1.81.8–1.9	raised
Hyponatraemia	450	1.61.4–1.7	raised
Anaemia	1,610	1.51.4–1.6	raised
Interstitial lung disease	489	1.41.3–1.6	raised

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Ezetimibe 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 (8 of 40 signal terms matched).

NCT00202878 — IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Si (N=18144, PHASE3; 1831 AE terms posted; arms: Ezetimide/Simvastatin; Simvastatin)

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
Fatigue (tiredness)	4,981	1.8 1.8–1.9ROR 1.9 · calibrated p 0.869	1.8 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	age-adj. PRR 1.6 · serious PRR 2.0	NCT00202878: 9/9,067 (0.1%) on Ezetimibe (serious AE)
Myalgia (muscle pain)	4,492	7.6 7.4–7.8ROR 8.0 · calibrated p 0.066	7.4 EB05 7.2 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 6.2 · serious PRR 6.9	NCT00202878: 1/9,067 (0.0%) on Ezetimibe (serious AE)
Nausea	4,450	1.6 1.5–1.6ROR 1.6 · calibrated p 0.724	1.6 EB05 1.5 · IC025 +0.6	Labeled adverse reaction exact term	age-adj. PRR 1.5 · serious PRR 1.8	NCT00202878: 8/9,067 (0.1%) on Ezetimibe (serious AE)
Diarrhoea (diarrhea)	3,954	1.7 1.7–1.8ROR 1.8 · calibrated p 0.815	1.7 EB05 1.7 · IC025 +0.7	Labeled adverse reaction exact term	age-adj. PRR 1.4 · serious PRR 1.7	NCT00202878: 23/9,067 (0.3%) on Ezetimibe (serious AE)
Drug ineffective (drug did not work)	3,710	0.8 0.8–0.8ROR 0.8 · calibrated p 0.173	0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 0.9 · serious PRR 1.1	not reported in cached trials
Dizziness	3,585	2.0 2.0–2.1ROR 2.1 · calibrated p 0.990	2.0 EB05 2.0 · IC025 +1.0	Labeled adverse reaction exact term	age-adj. PRR 1.7 · serious PRR 2.2	NCT00202878: 30/9,067 (0.3%) on Ezetimibe (serious AE)
Dyspnoea (shortness of breath)	3,469	1.7 1.7–1.8ROR 1.8 · calibrated p 0.809	1.7 EB05 1.7 · IC025 +0.7	Not in label — unassessed	age-adj. PRR 1.4 · serious PRR 1.7	NCT00202878: 47/9,067 (0.5%) on Ezetimibe (serious AE)
Headache	3,385	1.5 1.5–1.6ROR 1.5 · calibrated p 0.673	1.5 EB05 1.5 · IC025 +0.5	Labeled adverse reaction exact term	age-adj. PRR 1.5 · serious PRR 1.8	NCT00202878: 11/9,067 (0.1%) on Ezetimibe (serious AE)
Arthralgia (joint pain)	3,053	2.1 2.0–2.2ROR 2.1 · calibrated p 0.988	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 1.7 · serious PRR 2.1	NCT00202878: 25/9,067 (0.3%) on Ezetimibe (serious AE)
Asthenia (weakness)	2,937	2.2 2.1–2.3ROR 2.3 · calibrated p 0.924	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	age-adj. PRR 1.7 · serious PRR 2.1	NCT00202878: 14/9,067 (0.2%) on Ezetimibe (serious AE)
Pain	2,904	1.3 1.3–1.4ROR 1.3 · calibrated p 0.537	1.3 EB05 1.3 · IC025 +0.3	Labeled adverse reaction exact term	age-adj. PRR 1.5 · serious PRR 1.3	NCT00202878: 41/9,067 (0.5%) on Ezetimibe (serious AE)
Fall	2,451	2.1 2.0–2.2ROR 2.1 · calibrated p 0.993	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	age-adj. PRR 1.4 · serious PRR 2.0	NCT00202878: 11/9,067 (0.1%) on Ezetimibe (serious AE)
Pain in extremity	2,448	2.3 2.3–2.4ROR 2.4 · calibrated p 0.861	2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.0 · serious PRR 2.4	NCT00202878: 10/9,067 (0.1%) on Ezetimibe (serious AE)
Off label use (used outside approved label)	2,402	0.8 0.7–0.8ROR 0.8 · calibrated p 0.167	0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 0.7 · serious PRR 0.9	not reported in cached trials
Vomiting	2,395	1.4 1.4–1.5ROR 1.5 · calibrated p 0.611	1.4 EB05 1.4 · IC025 +0.5	Not in label — unassessed	age-adj. PRR 1.4 · serious PRR 1.5	NCT00202878: 1/9,067 (0.0%) on Ezetimibe (serious AE)

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.

Amyloid arthropathy — n=57, PRR 2,252.3
Truncus arteriosus persistent — n=71, PRR 153.4
Neurologic neglect syndrome — n=171, PRR 123.8
Amaurosis fugax — n=239, PRR 80.9
Carotid artery thrombosis — n=172, PRR 70.9
Adjustment disorder — n=166, PRR 40.9
Vascular stent stenosis — n=46, PRR 34.9
Cardiac septal defect — n=59, PRR 24.9
Congenital cardiovascular anomaly — n=63, PRR 22.5
Restrictive pulmonary disease — n=82, PRR 21.2 (also seen in trial arm)

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 Ezetimibe?

In FDA FAERS, the most frequently co-reported reaction terms for Ezetimibe are fatigue, myalgia, nausea, diarrhoea, dizziness, dyspnoea. 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 Ezetimibe have an FDA boxed warning?

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

Do FAERS signals prove that Ezetimibe 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 0e9a9eda-1b2a-4475-8483-0f410a17c524, effective 20251014; matched on openfda.generic_name.exact:"EZETIMIBE")
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, 1,179 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 EZETIMIBE, 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.