Drug · FAERS side-effect profile with label screen
Ezetimibe and Simvastatin side effects: what 15,109 FDA adverse event reports show
Drug class
Dietary Cholesterol Absorption Inhibitor
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Ezetimibe (Ezetimibe)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
15,109 reports · 63% serious · 856 with death outcome · 54% 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 1Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 35
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.
- 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. 1,075 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 |
|---|---|---|---|---|---|---|
| Aortic calcification | 12 | 28.8 16.2–50.9ROR 28.8 · χ² 288 / p 6e-65 | 27.1 EB05 16.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 21 | 27.6 17.9–42.5ROR 27.6 · χ² 502 / p 2e-111 | 26.5 EB05 18.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Ischaemic cardiomyopathy | 54 | 24.6 18.8–32.2ROR 24.7 · χ² 1,178 / p 2e-258 | 24.0 EB05 19.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=54 | NCT00202878: 2/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Hyperparathyroidism secondary | 43 | 24.0 17.7–32.4ROR 24.0 · χ² 907 / p 1e-199 | 23.4 EB05 18.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=43 | NCT00202878: 2/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Colonic polyp | 25 | 21.0 14.2–31.2ROR 21.0 · χ² 450 / p 5e-100 | 20.4 EB05 14.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=25 | not reported in cached trials |
| Dyspnoea paroxysmal nocturnal | 11 | 21.0 11.6–38.1ROR 21.0 · χ² 187 / p 7e-43 | 19.7 EB05 11.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=11 | NCT00202878: 1/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Nephrogenic anaemia | 69 | 20.8 16.4–26.3ROR 20.9 · χ² 1,260 / p 3e-276 | 20.4 EB05 16.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=69 | not reported in cached trials |
| Vertebral foraminal stenosis | 11 | 18.7 10.3–33.9ROR 18.7 · χ² 165 / p 5e-38 | 17.4 EB05 9.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 | NCT00202878: 3/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Pleural fibrosis | 13 | 17.7 10.3–30.6ROR 17.7 · χ² 186 / p 1e-42 | 16.6 EB05 9.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=13 | NCT00202878: 1/9,077 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Angioplasty | 18 | 16.9 10.6–26.9ROR 16.9 · χ² 250 / p 1e-56 | 16.1 EB05 10.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Cardiac stress test abnormal | 10 | 16.8 9.0–31.3ROR 16.8 · χ² 131 / p 1e-30 | 15.1 EB05 7.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=10 | not reported in cached trials |
| Adenocarcinoma pancreas | 15 | 16.3 9.8–27.2ROR 16.4 · χ² 199 / p 2e-45 | 15.4 EB05 9.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=15 | NCT00202878: 1/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Vascular calcification | 12 | 15.7 8.9–27.7ROR 15.7 · χ² 149 / p 2e-34 | 14.3 EB05 7.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Sick sinus syndrome | 13 | 15.6 9.1–27.0ROR 15.7 · χ² 162 / p 2e-37 | 14.4 EB05 8.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=13 | NCT00202878: 17/9,067 (0.2%) on Ezetimibe and Simvastatin (serious AE) |
| Anaemia of chronic disease | 10 | 15.5 8.3–28.9ROR 15.5 · χ² 120 / p 3e-28 | 13.7 EB05 6.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=10 | NCT00202878: 1/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Rhabdomyolysis (muscle breakdown) | 445 | 15.0 13.7–16.4ROR 15.4 · χ² 5,743 / p <1e-300 | 14.8 EB05 13.7 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.6 · 94% clinician | NCT00202878: 12/9,067 (0.1%) on Ezetimibe and Simvastatin (serious AE) |
| Aortic arteriosclerosis | 27 | 14.7 10.0–21.4ROR 14.7 · χ² 327 / p 3e-73 | 14.1 EB05 9.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=27 | not reported in cached trials |
| Arteriosclerosis | 97 | 14.4 11.8–17.6ROR 14.5 · χ² 1,186 / p 4e-260 | 14.2 EB05 11.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 | NCT00202878: 1/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Hyperlipidaemia | 117 | 13.7 11.4–16.4ROR 13.8 · χ² 1,349 / p 2e-295 | 13.5 EB05 11.5 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.6 | not reported in cached trials |
| Diabetic neuropathy | 48 | 13.5 10.2–17.9ROR 13.5 · χ² 538 / p 3e-119 | 13.2 EB05 10.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=46 | NCT00202878: 4/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Arterial occlusive disease | 76 | 13.5 10.8–16.9ROR 13.5 · χ² 857 / p 1e-188 | 13.2 EB05 10.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 | NCT00202878: 1/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Carotid artery disease | 12 | 13.2 7.5–23.2ROR 13.2 · χ² 122 / p 1e-28 | 11.5 EB05 6.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Intermittent claudication | 15 | 13.2 7.9–21.9ROR 13.2 · χ² 155 / p 6e-36 | 11.9 EB05 7.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=14 | NCT00202878: 6/9,067 (0.1%) on Ezetimibe and Simvastatin (serious AE) |
| Implantable defibrillator insertion | 12 | 12.8 7.2–22.5ROR 12.8 · χ² 118 / p 1e-27 | 11.1 EB05 6.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=12 | NCT00202878: 3/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Renal artery stenosis | 12 | 12.1 6.9–21.4ROR 12.1 · χ² 110 / p 4e-26 | 10.4 EB05 5.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=12 | NCT00202878: 2/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Spondylolisthesis | 15 | 12.0 7.2–20.0ROR 12.0 · χ² 140 / p 2e-32 | 10.7 EB05 6.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=15 | NCT00202878: 2/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Left atrial dilatation | 11 | 12.0 6.6–21.7ROR 12.0 · χ² 99 / p 1e-23 | 10.0 EB05 5.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Meniscus lesion | 12 | 11.9 6.7–21.0ROR 11.9 · χ² 108 / p 1e-25 | 10.1 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Dilatation atrial | 10 | 11.8 6.4–22.1ROR 11.9 · χ² 88 / p 3e-21 | 9.7 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Coronary artery disease | 256 | 11.7 10.4–13.3ROR 11.9 · χ² 2,485 / p <1e-300 | 11.6 EB05 10.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | not reported in cached trials |
| Renal failure chronic | 65 | 11.7 9.1–14.9ROR 11.7 · χ² 618 / p 1e-136 | 11.3 EB05 9.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | NCT00202878: 38/9,067 (0.4%) on Ezetimibe and Simvastatin (serious AE) |
| Amyotrophic lateral sclerosis | 17 | 11.2 6.9–18.0ROR 11.2 · χ² 146 / p 6e-34 | 9.9 EB05 6.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=16 | NCT00202878: 2/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Early satiety | 15 | 11.0 6.6–18.3ROR 11.0 · χ² 125 / p 2e-29 | 9.6 EB05 5.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=8 | not reported in cached trials |
| Rebound acid hypersecretion | 24 | 10.9 7.3–16.3ROR 11.0 · χ² 205 / p 8e-47 | 10.1 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Pathological gambling | 13 | 10.8 6.3–18.6ROR 10.8 · χ² 105 / p 6e-25 | 9.1 EB05 5.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=8 | not reported in cached trials |
| Stomach discomfort | 39 | 10.4 7.6–14.2ROR 10.4 · χ² 320 / p 8e-72 | 9.8 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=14 · 71% consumer | not reported in cached trials |
| Multiple injuries | 47 | 10.3 7.7–13.7ROR 10.3 · χ² 383 / p 2e-85 | 9.8 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=47 | NCT00202878: 2/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Diverticulum | 53 | 10.3 7.8–13.5ROR 10.3 · χ² 432 / p 4e-96 | 9.9 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=50 | NCT00202878: 11/9,067 (0.1%) on Ezetimibe and Simvastatin (serious AE) |
| Echocardiogram abnormal | 10 | 10.0 5.4–18.6ROR 10.0 · χ² 72 / p 1e-17 | 7.9 EB05 4.2 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious n=9 | not reported in cached trials |
| Blood cholesterol decreased | 13 | 9.7 5.7–16.8ROR 9.8 · χ² 93 / p 3e-22 | 8.1 EB05 4.7 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications | – | 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 Ezetimibe and Simvastatin 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 (20 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 |
|---|---|---|---|---|---|---|
| Nausea | 1,011 | 1.8 1.7–1.9ROR 1.8 · χ² 357 / p 6e-80 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | NCT00202878: 8/9,067 (0.1%) on Ezetimibe and Simvastatin (serious AE) |
| Drug ineffective (drug did not work) | 821 | 0.9 0.8–0.9ROR 0.9 · χ² 18 / p 1e-5 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 · 72% consumer | not reported in cached trials |
| Fatigue (tiredness) | 776 | 1.4 1.3–1.5ROR 1.4 · χ² 86 / p 7e-21 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.5 | NCT00202878: 9/9,067 (0.1%) on Ezetimibe and Simvastatin (serious AE) |
| Dizziness | 734 | 2.0 1.9–2.2ROR 2.1 · χ² 401 / p 1e-89 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.9 | NCT00202878: 30/9,067 (0.3%) on Ezetimibe and Simvastatin (serious AE) |
| Pain | 705 | 1.6 1.5–1.7ROR 1.6 · χ² 159 / p 1e-36 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.9 | NCT00202878: 41/9,067 (0.5%) on Ezetimibe and Simvastatin (serious AE) |
| Myalgia (muscle pain) | 675 | 5.5 5.1–6.0ROR 5.7 · χ² 2,510 / p <1e-300 | 5.5 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | NCT00202878: 1/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Dyspnoea (shortness of breath) | 645 | 1.6 1.5–1.7ROR 1.6 · χ² 142 / p 6e-33 | 1.6 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.6 | NCT00202878: 47/9,067 (0.5%) on Ezetimibe and Simvastatin (serious AE) |
| Diarrhoea (diarrhea) | 604 | 1.3 1.2–1.4ROR 1.3 · χ² 44 / p 2e-11 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT00202878: 23/9,067 (0.3%) on Ezetimibe and Simvastatin (serious AE) |
| Asthenia (weakness) | 604 | 2.2 2.1–2.4ROR 2.3 · χ² 416 / p 1e-92 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | NCT00202878: 14/9,067 (0.2%) on Ezetimibe and Simvastatin (serious AE) |
| Headache | 564 | 1.3 1.2–1.4ROR 1.3 · χ² 29 / p 4e-8 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT00202878: 11/9,067 (0.1%) on Ezetimibe and Simvastatin (serious AE) |
| Pain in extremity | 549 | 2.6 2.4–2.8ROR 2.6 · χ² 538 / p 2e-119 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | NCT00202878: 10/9,067 (0.1%) on Ezetimibe and Simvastatin (serious AE) |
| Arthralgia (joint pain) | 532 | 1.8 1.6–1.9ROR 1.8 · χ² 185 / p 2e-42 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.1 | NCT00202878: 25/9,067 (0.3%) on Ezetimibe and Simvastatin (serious AE) |
| Myocardial infarction (heart attack) | 518 | 4.1 3.8–4.5ROR 4.2 · χ² 1,216 / p 9e-267 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | not reported in cached trials |
| Weight decreased (weight loss) | 502 | 2.5 2.3–2.7ROR 2.6 · χ² 455 / p 3e-101 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 · 70% consumer | NCT00202878: 3/9,067 (0.0%) on Ezetimibe and Simvastatin (serious AE) |
| Blood glucose increased | 477 | 3.5 3.2–3.8ROR 3.6 · χ² 857 / p 1e-188 | 3.5 EB05 3.2 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 4.0 · 75% consumer | NCT00202878: 2/9,077 (0.0%) on Ezetimibe and Simvastatin (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.
- Chronic kidney disease-mineral and bone disorder — n=21, PRR 27.6
- Ischaemic cardiomyopathy — n=54, PRR 24.6 (also seen in trial arm)
- Hyperparathyroidism secondary — n=43, PRR 24.0 (also seen in trial arm)
- Colonic polyp — n=25, PRR 21.0
- Nephrogenic anaemia — n=69, PRR 20.8
- Aortic arteriosclerosis — n=27, PRR 14.7
- Arteriosclerosis — n=97, PRR 14.4 (also seen in trial arm)
- Diabetic neuropathy — n=48, PRR 13.5 (also seen in trial arm)
- Arterial occlusive disease — n=76, PRR 13.5 (also seen in trial arm)
- Coronary artery disease — n=256, PRR 11.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Simvastatin (statins) ↔ Rhabdomyolysis.
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 and Simvastatin?
In FDA FAERS, the most frequently co-reported reaction terms for Ezetimibe and Simvastatin are nausea, fatigue, dizziness, pain, myalgia, 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 and Simvastatin have an FDA boxed warning?
No. The FDA label retrieved for Ezetimibe and Simvastatin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ezetimibe and Simvastatin 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, fieldpatient.drug.openfda.generic_name.exact, 1,115 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 2026-10-08. 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.