Drug · FAERS side-effect profile with label screen
Isosorbide Dinitrate side effects: what 19,411 FDA adverse event reports show
Who reports
19,411 reports · 75% serious · 2,553 with death outcome · 47% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
FDA label, Indications and Usage
What it is
DESCRIPTION Isosorbide dinitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins.
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) 2Likely indication confounding 2Lab value / disease marker 1Not in label — unassessed 35
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). 1,142 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 |
|---|---|---|---|---|---|---|
| Cardiospasm | 375 | 2,269.2 1,898.2–2,712.8ROR 2,313.9 · calibrated p 1e-21 ✓ | 699.4 EB05 642.0 · IC025 +8.4 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.7 (1.5–2.0) | Not in label — unassessed | serious n=375 | no trial data cached |
| Immunisation | 245 | 1,425.9 1,178.0–1,725.9ROR 1,444.1 · calibrated p 6e-19 ✓ | 582.3 EB05 523.6 · IC025 +7.9 3/3 methods agree vs other Nitrate Vasodilators: PRR 2.0 (1.7–2.4) | Not in label — unassessed | serious n=245 | no trial data cached |
| Palmoplantar keratoderma | 366 | 1,129.9 976.0–1,308.0ROR 1,151.6 · calibrated p 7e-18 ✓ | 533.4 EB05 489.1 · IC025 +8.1 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.7 (1.5–2.0) | Not in label — unassessed | serious n=366 | no trial data cached |
| Atrial tachycardia | 382 | 239.3 214.4–267.2ROR 244.1 · calibrated p 7e-11 ✓ | 193.7 EB05 177.9 · IC025 +7.1 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.7 (1.5–1.9) | Not in label — unassessed | serious n=382 | no trial data cached |
| Pruritus genital | 370 | 204.3 182.9–228.1ROR 208.2 · calibrated p 3e-10 ✓ | 170.1 EB05 156.0 · IC025 +7.0 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.7 (1.5–1.9) | Not in label — unassessed | serious n=369 | no trial data cached |
| Carotid artery occlusion | 388 | 128.2 115.5–142.3ROR 130.8 · calibrated p 2e-8 ✓ | 113.9 EB05 104.7 · IC025 +6.5 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.6 (1.4–1.9) | Not in label — unassessed | serious n=387 | no trial data cached |
| Sleep terror | 368 | 103.6 93.1–115.2ROR 105.6 · calibrated p 8e-8 ✓ | 94.0 EB05 86.2 · IC025 +6.2 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.7 (1.5–2.0) | Not in label — unassessed | serious n=368 | no trial data cached |
| Tension headache | 368 | 101.2 91.0–112.5ROR 103.1 · calibrated p 1e-7 ✓ | 92.1 EB05 84.4 · IC025 +6.2 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.7 (1.5–1.9) | Labeled (related wording) related wording | serious n=367 | no trial data cached |
| Facial pain | 378 | 47.8 43.1–52.9ROR 48.7 · calibrated p 2e-5 ✓ | 45.7 EB05 41.9 · IC025 +5.3 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.7 (1.5–1.9) | Not in label — unassessed | serious n=374 | no trial data cached |
| Subarachnoid haemorrhage | 420 | 46.3 42.0–51.0ROR 47.3 · calibrated p 2e-5 ✓ | 44.3 EB05 40.9 · IC025 +5.2 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.6 (1.4–1.8) | Not in label — unassessed | serious PRR 34.3 | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 44 | 46.0 34.1–62.2ROR 46.1 · calibrated p 3e-5 ✓ | 43.4 EB05 33.7 · IC025 +4.4 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.6 (0.4–0.8) | Not in label — unassessed | serious n=44 | no trial data cached |
| Nephrogenic anaemia | 177 | 42.5 36.6–49.3ROR 42.9 · calibrated p 4e-5 ✓ | 40.7 EB05 35.9 · IC025 +5.0 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.7 (0.6–0.8) | Not in label — unassessed | serious n=177 | no trial data cached |
| Jugular vein distension | 21 | 41.0 26.5–63.4ROR 41.1 · calibrated p 9e-5 ✓ | 38.3 EB05 26.4 · IC025 +3.7 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=21 | no trial data cached |
| Vascular stent stenosis | 15 | 40.3 24.1–67.5ROR 40.4 · calibrated p 1e-4 ✓ | 37.2 EB05 23.9 · IC025 +3.3 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=15 | no trial data cached |
| Mediastinal disorder | 13 | 39.2 22.6–68.2ROR 39.2 · calibrated p 2e-4 ✓ | 36.0 EB05 22.4 · IC025 +3.1 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=13 | no trial data cached |
| Vasculitis | 382 | 36.6 33.1–40.5ROR 37.3 · calibrated p 8e-5 ✓ | 35.3 EB05 32.5 · IC025 +4.9 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.6 (1.4–1.9) | Not in label — unassessed | serious PRR 29.4 | no trial data cached |
| Hyperparathyroidism secondary | 77 | 33.9 27.0–42.5ROR 34.0 · calibrated p 2e-4 ✓ | 32.6 EB05 26.9 · IC025 +4.4 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.5 (0.4–0.6) | Not in label — unassessed | serious n=77 | no trial data cached |
| Silent myocardial infarction | 20 | 33.3 21.3–51.9ROR 33.3 · calibrated p 3e-4 ✓ | 31.4 EB05 21.5 · IC025 +3.4 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Labeled (related wording) related wording | serious n=18 | no trial data cached |
| Ventricular tachycardia | 470 | 31.5 28.8–34.5ROR 32.3 · calibrated p 2e-4 ✓ | 30.6 EB05 28.3 · IC025 +4.7 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.2 (1.0–1.3) | Not in label — unassessed | serious PRR 23.8 | no trial data cached |
| Prinzmetal angina | 26 | 29.0 19.6–42.8ROR 29.0 · calibrated p 5e-4 ✓ | 27.7 EB05 19.9 · IC025 +3.6 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.7 (0.4–1.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=26 · 100% clinician | no trial data cached |
| Anosmia (loss of smell) | 375 | 28.7 25.9–31.7ROR 29.2 · calibrated p 3e-4 ✓ | 27.9 EB05 25.6 · IC025 +4.6 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.7 (1.5–2.0) | Not in label — unassessed | serious n=370 | no trial data cached |
| Pericarditis | 388 | 25.7 23.3–28.4ROR 26.2 · calibrated p 5e-4 ✓ | 25.1 EB05 23.1 · IC025 +4.4 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.6 (1.4–1.8) | Not in label — unassessed | serious PRR 19.6 | no trial data cached |
| Lip erosion | 15 | 22.4 13.5–37.4ROR 22.5 · calibrated p 0.002 ✓ | 21.4 EB05 13.5 · IC025 +2.8 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=15 | no trial data cached |
| Ischaemic cardiomyopathy | 63 | 22.4 17.5–28.8ROR 22.5 · calibrated p 0.001 ✓ | 21.8 EB05 17.7 · IC025 +3.8 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.5 (0.4–0.7) | Not in label — unassessed | serious n=63 | no trial data cached |
| Rebound acid hypersecretion | 61 | 21.9 17.0–28.2ROR 22.0 · calibrated p 0.002 ✓ | 21.4 EB05 17.2 · IC025 +3.8 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.6 (0.4–0.8) | Not in label — unassessed | serious n=61 | no trial data cached |
| Angina unstable | 114 | 19.1 15.9–23.0ROR 19.2 · calibrated p 0.003 ✓ | 18.7 EB05 16.0 · IC025 +3.8 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.4 (0.4–0.5) | Likely indication confounding shares a disease stem with the indications wording | serious n=113 | no trial data cached |
| Left atrial dilatation | 22 | 18.8 12.3–28.7ROR 18.8 · calibrated p 0.004 ✓ | 18.1 EB05 12.5 · IC025 +3.0 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.4 (0.3–0.7) | Not in label — unassessed | serious n=22 | no trial data cached |
| Muscle twitching | 395 | 18.8 17.0–20.7ROR 19.1 · calibrated p 0.002 ✓ | 18.4 EB05 17.0 · IC025 +4.0 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.5 (1.3–1.8) | Not in label — unassessed | serious PRR 22.0 | no trial data cached |
| Renal atrophy | 21 | 18.4 12.0–28.4ROR 18.4 · calibrated p 0.004 ✓ | 17.7 EB05 12.0 · IC025 +3.0 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=21 | no trial data cached |
| Mucosal erosion | 15 | 18.2 10.9–30.2ROR 18.2 · calibrated p 0.005 ✓ | 17.2 EB05 10.6 · IC025 +2.7 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.9 (0.5–1.7) | Not in label — unassessed | serious n=15 | no trial data cached |
| Orthopnoea | 51 | 17.5 13.3–23.1ROR 17.6 · calibrated p 0.004 ✓ | 17.1 EB05 13.5 · IC025 +3.4 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.7 (0.5–1.0) | Not in label — unassessed | serious n=51 | no trial data cached |
| End stage renal disease | 289 | 17.2 15.3–19.3ROR 17.5 · calibrated p 0.004 ✓ | 16.9 EB05 15.4 · IC025 +3.8 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.7 (0.6–0.8) | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Sick sinus syndrome | 18 | 16.9 10.6–27.0ROR 16.9 · calibrated p 0.006 ✓ | 16.1 EB05 10.4 · IC025 +2.8 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.7 (0.4–1.3) | Not in label — unassessed | serious n=18 | no trial data cached |
| Therapeutic agent toxicity | 51 | 16.5 12.5–21.8ROR 16.6 · calibrated p 0.005 ✓ | 16.2 EB05 12.7 · IC025 +3.4 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.1 (0.8–1.5) | Not in label — unassessed | serious n=51 | no trial data cached |
| Diplopia (double vision) | 388 | 16.4 14.8–18.1ROR 16.7 · calibrated p 0.005 ✓ | 16.1 EB05 14.8 · IC025 +3.8 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.0 (0.9–1.2) | Not in label — unassessed | serious PRR 16.9 | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 487 | 15.7 14.4–17.2ROR 16.1 · calibrated p 0.005 ✓ | 15.5 EB05 14.4 · IC025 +3.8 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.0 (0.9–1.2) | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Atrioventricular block first degree | 62 | 15.6 12.1–20.0ROR 15.6 · calibrated p 0.007 ✓ | 15.2 EB05 12.3 · IC025 +3.4 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.7 (0.5–0.9) | Not in label — unassessed | serious n=62 | no trial data cached |
| Pain of skin | 380 | 15.4 13.9–17.0ROR 15.7 · calibrated p 0.006 ✓ | 15.2 EB05 13.9 · IC025 +3.7 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.7 (1.5–1.9) | Not in label — unassessed | serious PRR 43.8 | no trial data cached |
| Left ventricular hypertrophy | 59 | 15.1 11.7–19.5ROR 15.1 · calibrated p 0.008 ✓ | 14.7 EB05 11.8 · IC025 +3.3 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.9 (0.6–1.2) | Not in label — unassessed | serious n=58 | no trial data cached |
| Echocardiogram abnormal | 19 | 14.9 9.5–23.4ROR 14.9 · calibrated p 0.010 ✓ | 14.1 EB05 9.0 · IC025 +2.7 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.8 (0.5–1.4) | Lab value / disease marker | serious n=19 | 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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 1,664 | 3.2 3.0–3.3ROR 3.4 · calibrated p 0.513 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.6 (0.5–0.6) | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Nausea | 1,376 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.918 | 1.9 EB05 1.8 · IC025 +0.8 vs other Nitrate Vasodilators: PRR 0.6 (0.6–0.6) | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Fatigue (tiredness) | 1,352 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.915 | 1.9 EB05 1.8 · IC025 +0.8 vs other Nitrate Vasodilators: PRR 0.5 (0.5–0.6) | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Dizziness | 1,311 | 2.8 2.7–3.0ROR 3.0 · calibrated p 0.632 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.6 (0.6–0.6) | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Diarrhoea (diarrhea) | 1,305 | 2.2 2.1–2.3ROR 2.3 · calibrated p 0.912 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.6 (0.6–0.7) | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Myocardial infarction (heart attack) | 1,212 | 7.5 7.1–7.9ROR 7.9 · calibrated p 0.069 | 7.4 EB05 7.1 · IC025 +2.8 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.5 (0.5–0.6) | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Chest pain | 1,159 | 6.8 6.4–7.2ROR 7.2 · calibrated p 0.093 | 6.7 EB05 6.4 · IC025 +2.7 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.5 (0.5–0.6) | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Pain | 1,065 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.901 | 1.9 EB05 1.8 · IC025 +0.8 vs other Nitrate Vasodilators: PRR 0.5 (0.4–0.5) | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Headache | 1,024 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.836 | 1.8 EB05 1.7 · IC025 +0.7 vs other Nitrate Vasodilators: PRR 0.5 (0.5–0.6) | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Vomiting | 1,006 | 2.3 2.2–2.5ROR 2.4 · calibrated p 0.860 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.7 (0.6–0.7) | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Malaise (feeling unwell) | 901 | 2.2 2.1–2.4ROR 2.3 · calibrated p 0.914 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.6 (0.6–0.6) | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Off label use (used outside approved label) | 862 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.357 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Nitrate Vasodilators: PRR 0.6 (0.5–0.6) | Reporting / coding artifact | serious PRR 1.2 | no trial data cached |
| Asthenia (weakness) | 809 | 2.3 2.2–2.5ROR 2.4 · calibrated p 0.864 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.5 (0.5–0.6) | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Arthralgia (joint pain) | 806 | 2.1 2.0–2.3ROR 2.2 · calibrated p 0.976 | 2.1 EB05 2.0 · IC025 +1.0 vs other Nitrate Vasodilators: PRR 0.6 (0.6–0.7) | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Death | 803 | 1.0 0.9–1.1ROR 1.0 · calibrated p 0.312 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Nitrate Vasodilators: PRR 0.5 (0.5–0.6) | Outcome field, not a reaction | serious PRR 0.8 | no trial data cached |
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.
- Cardiospasm — n=375, PRR 2,269.2
- Immunisation — n=245, PRR 1,425.9
- Palmoplantar keratoderma — n=366, PRR 1,129.9
- Atrial tachycardia — n=382, PRR 239.3
- Pruritus genital — n=370, PRR 204.3
- Carotid artery occlusion — n=388, PRR 128.2
- Sleep terror — n=368, PRR 103.6
- Facial pain — n=378, PRR 47.8
- Subarachnoid haemorrhage — n=420, PRR 46.3
- Chronic kidney disease-mineral and bone disorder — n=44, PRR 46.0
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 Isosorbide Dinitrate?
In FDA FAERS, the most frequently co-reported reaction terms for Isosorbide Dinitrate are dyspnoea, nausea, fatigue, dizziness, diarrhoea, myocardial infarction. 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 Isosorbide Dinitrate have an FDA boxed warning?
No. The FDA label retrieved for Isosorbide Dinitrate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Isosorbide Dinitrate 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 0e5842f2-74f6-1f02-01bc-07578bd3b393, effective 20260210; matched on
openfda.generic_name.exact:"ISOSORBIDE DINITRATE") - 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, 1,182 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 2026-10-14. 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.