Drug · FAERS side-effect profile with label screen
Isosorbide Mononitrate side effects: what 20,611 FDA adverse event reports show
Who reports
20,611 reports · 84% serious · 2,596 with death outcome · 46% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Isosorbide mononitrate extended-release tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate 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 mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), 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 adverse reaction 1Labeled (related wording) 3Likely indication confounding 3Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 31
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.
- 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.
- 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, 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). 1,153 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 | 385 | 2,325.5 1,939.5–2,788.2ROR 2,369.7 · calibrated p 1e-21 ✓ | 677.5 EB05 622.6 · IC025 +8.4 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.8 (1.6–2.1) | Not in label — unassessed | serious n=385 | no trial data cached |
| Immunisation | 243 | 1,317.0 1,088.3–1,593.8ROR 1,332.7 · calibrated p 2e-18 ✓ | 545.2 EB05 490.1 · IC025 +7.8 3/3 methods agree vs other Nitrate Vasodilators: PRR 2.0 (1.7–2.4) | Not in label — unassessed | serious n=243 | no trial data cached |
| Palmoplantar keratoderma | 374 | 1,112.8 961.0–1,288.4ROR 1,133.3 · calibrated p 8e-18 ✓ | 514.0 EB05 471.7 · IC025 +8.1 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.8 (1.6–2.1) | Not in label — unassessed | serious n=374 | no trial data cached |
| Neuroglycopenia | 31 | 409.0 269.4–620.9ROR 409.6 · calibrated p 4e-12 ✓ | 246.6 EB05 182.0 · IC025 +5.1 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=31 · ♀ 100% (drug 46%) · 100% clinician | no trial data cached |
| Agitation postoperative | 14 | 286.5 158.2–518.8ROR 286.7 · calibrated p 5e-10 ✓ | 171.3 EB05 108.5 · IC025 +3.8 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=14 | no trial data cached |
| Atrial tachycardia | 389 | 230.4 206.5–257.0ROR 234.8 · calibrated p 1e-10 ✓ | 185.8 EB05 170.8 · IC025 +7.1 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.7 (1.5–2.0) | Labeled (related wording) related wording | serious n=389 | no trial data cached |
| Pruritus genital | 382 | 199.8 179.2–222.8ROR 203.6 · calibrated p 4e-10 ✓ | 165.4 EB05 151.9 · IC025 +6.9 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.8 (1.6–2.1) | Not in label — unassessed | serious n=380 | no trial data cached |
| Confusion postoperative | 14 | 121.0 69.5–210.7ROR 121.1 · calibrated p 2e-7 ✓ | 94.5 EB05 59.8 · IC025 +3.6 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=14 | no trial data cached |
| Carotid artery occlusion | 387 | 120.3 108.4–133.6ROR 122.6 · calibrated p 3e-8 ✓ | 107.0 EB05 98.3 · IC025 +6.4 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.6 (1.4–1.8) | Not in label — unassessed | serious n=387 | no trial data cached |
| Sleep terror | 378 | 100.4 90.4–111.5ROR 102.3 · calibrated p 1e-7 ✓ | 91.0 EB05 83.5 · IC025 +6.2 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.8 (1.6–2.1) | Not in label — unassessed | serious n=374 | no trial data cached |
| Peripheral circulatory failure | 36 | 98.1 69.7–138.1ROR 98.3 · calibrated p 3e-7 ✓ | 85.5 EB05 64.5 · IC025 +4.8 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Labeled (related wording) related wording | serious n=36 · ♀ 100% (drug 46%) · 100% clinician | no trial data cached |
| Tension headache | 375 | 97.3 87.6–108.0ROR 99.0 · calibrated p 1e-7 ✓ | 88.4 EB05 81.1 · IC025 +6.1 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.7 (1.5–2.0) | Labeled (related wording) related wording | serious n=374 | no trial data cached |
| Multiple drug therapy | 48 | 75.1 56.0–100.6ROR 75.3 · calibrated p 1e-6 ✓ | 68.1 EB05 53.4 · IC025 +4.9 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.1 (0.7–1.5) | Reporting / coding artifact | serious n=47 · ♀ 100% (drug 46%) · 100% clinician | no trial data cached |
| Genital erosion | 19 | 70.8 44.5–112.8ROR 70.9 · calibrated p 4e-6 ✓ | 62.3 EB05 42.1 · IC025 +3.9 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=19 | no trial data cached |
| Fear of eating | 19 | 67.3 42.3–107.1ROR 67.4 · calibrated p 6e-6 ✓ | 59.6 EB05 40.3 · IC025 +3.8 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=19 | no trial data cached |
| Gastrointestinal tract mucosal pigmentation | 14 | 56.1 32.8–96.2ROR 56.2 · calibrated p 2e-5 ✓ | 49.8 EB05 31.6 · IC025 +3.3 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=13 | no trial data cached |
| Venous pressure jugular increased | 18 | 52.3 32.6–84.0ROR 52.4 · calibrated p 3e-5 ✓ | 47.4 EB05 31.7 · IC025 +3.6 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=18 | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 48 | 47.5 35.5–63.4ROR 47.6 · calibrated p 3e-5 ✓ | 44.6 EB05 35.0 · IC025 +4.5 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.7 (0.5–0.9) | Not in label — unassessed | serious n=48 | no trial data cached |
| Facial pain | 380 | 45.2 40.8–50.1ROR 46.1 · calibrated p 2e-5 ✓ | 43.2 EB05 39.7 · IC025 +5.2 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.7 (1.5–1.9) | Not in label — unassessed | serious n=379 | no trial data cached |
| Subarachnoid haemorrhage | 430 | 44.7 40.6–49.2ROR 45.6 · calibrated p 2e-5 ✓ | 42.7 EB05 39.4 · IC025 +5.2 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 |
| Cardiorenal syndrome | 23 | 42.7 28.1–64.8ROR 42.8 · calibrated p 7e-5 ✓ | 39.8 EB05 27.9 · IC025 +3.8 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=23 · ♀ 100% (drug 46%) · 100% clinician | no trial data cached |
| Glasgow coma scale abnormal | 14 | 39.8 23.3–67.8ROR 39.8 · calibrated p 2e-4 ✓ | 36.6 EB05 23.1 · IC025 +3.2 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=14 | no trial data cached |
| Mucosal erosion | 32 | 37.2 26.1–52.9ROR 37.2 · calibrated p 1e-4 ✓ | 35.2 EB05 26.1 · IC025 +4.0 3/3 methods agree vs other Nitrate Vasodilators: PRR 4.3 (2.3–7.9) | Not in label — unassessed | serious n=31 · ♀ 100% (drug 46%) | no trial data cached |
| Vasculitis | 400 | 36.1 32.7–39.9ROR 36.8 · calibrated p 9e-5 ✓ | 34.8 EB05 32.1 · IC025 +4.9 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.8 (1.6–2.0) | Not in label — unassessed | serious PRR 25.8 | no trial data cached |
| Hyperparathyroidism secondary | 84 | 34.9 28.1–43.3ROR 35.0 · calibrated p 1e-4 ✓ | 33.5 EB05 27.9 · IC025 +4.5 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.6 (0.4–0.7) | Not in label — unassessed | serious n=84 | no trial data cached |
| Autoimmune myositis | 15 | 34.4 20.6–57.6ROR 34.4 · calibrated p 3e-4 ✓ | 32.1 EB05 20.6 · IC025 +3.2 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=15 | no trial data cached |
| Nephrogenic anaemia | 143 | 32.1 27.2–37.9ROR 32.3 · calibrated p 2e-4 ✓ | 31.0 EB05 27.0 · IC025 +4.5 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.5 (0.4–0.6) | Not in label — unassessed | serious n=143 | no trial data cached |
| Left atrial dilatation | 39 | 31.8 23.1–43.8ROR 31.9 · calibrated p 3e-4 ✓ | 30.5 EB05 23.2 · IC025 +4.0 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.9 (0.6–1.4) | Not in label — unassessed | serious n=39 · ♀ 0% (drug 46%) · 100% clinician | no trial data cached |
| Ventricular tachycardia | 470 | 29.7 27.1–32.5ROR 30.3 · calibrated p 3e-4 ✓ | 28.8 EB05 26.7 · IC025 +4.7 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.2 (1.0–1.3) | Labeled adverse reaction exact term | serious PRR 20.0 | no trial data cached |
| Anosmia (loss of smell) | 376 | 27.1 24.4–29.9ROR 27.5 · calibrated p 4e-4 ✓ | 26.3 EB05 24.2 · IC025 +4.5 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.7 (1.5–2.0) | Not in label — unassessed | serious n=374 | no trial data cached |
| Pericarditis | 396 | 24.7 22.4–27.3ROR 25.2 · calibrated p 7e-4 ✓ | 24.1 EB05 22.2 · IC025 +4.4 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.7 (1.4–1.9) | Not in label — unassessed | serious PRR 16.7 | no trial data cached |
| Prinzmetal angina | 23 | 24.0 15.9–36.4ROR 24.1 · calibrated p 0.001 ✓ | 23.1 EB05 16.2 · IC025 +3.3 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.6 (0.4–0.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=23 | no trial data cached |
| Ventricular dysfunction | 60 | 24.0 18.6–31.0ROR 24.1 · calibrated p 1e-3 ✓ | 23.3 EB05 18.8 · IC025 +3.9 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.2 (0.9–1.7) | Not in label — unassessed | serious n=60 · ♀ 0% (drug 46%) | no trial data cached |
| Blood cholesterol decreased | 41 | 22.9 16.8–31.2ROR 22.9 · calibrated p 0.001 ✓ | 22.2 EB05 17.0 · IC025 +3.6 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Lab value / disease marker | serious n=41 · ♀ 100% (drug 46%) · 100% clinician | no trial data cached |
| Gastric polyps | 48 | 22.0 16.5–29.3ROR 22.1 · calibrated p 0.002 ✓ | 21.4 EB05 16.8 · IC025 +3.7 3/3 methods agree vs other Nitrate Vasodilators: PRR 4.8 (2.8–8.1) | Not in label — unassessed | serious n=48 · ♀ 87% (drug 46%) · 100% clinician | no trial data cached |
| Anti-neutrophil cytoplasmic antibody positive vasculitis | 50 | 21.3 16.1–28.1ROR 21.3 · calibrated p 0.002 ✓ | 20.7 EB05 16.3 · IC025 +3.7 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=50 · 100% clinician | no trial data cached |
| Arteriospasm coronary | 70 | 18.3 14.5–23.2ROR 18.4 · calibrated p 0.003 ✓ | 18.0 EB05 14.7 · IC025 +3.6 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.8 (0.6–1.0) | Likely indication confounding shares a disease stem with the indications wording | serious n=70 · 91% clinician | no trial data cached |
| Atrioventricular block first degree | 77 | 18.3 14.6–22.9ROR 18.3 · calibrated p 0.003 ✓ | 17.9 EB05 14.8 · IC025 +3.6 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.0 (0.7–1.3) | Not in label — unassessed | serious n=77 · ♀ 75% (drug 46%) · 92% clinician | no trial data cached |
| Muscle twitching | 408 | 18.3 16.6–20.1ROR 18.6 · calibrated p 0.003 ✓ | 17.9 EB05 16.5 · IC025 +4.0 3/3 methods agree vs other Nitrate Vasodilators: PRR 1.6 (1.4–1.9) | Not in label — unassessed | serious PRR 19.0 | no trial data cached |
| Angina pectoris | 486 | 17.4 15.9–19.0ROR 17.8 · calibrated p 0.003 ✓ | 17.1 EB05 15.9 · IC025 +3.9 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.6 (0.6–0.7) | Likely indication confounding term in indications; also in warnings | serious PRR 11.7 | 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) | 1,566 | 2.8 2.7–3.0ROR 3.0 · calibrated p 0.636 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.5 (0.5–0.6) | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Dizziness | 1,464 | 3.0 2.9–3.1ROR 3.1 · calibrated p 0.580 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.7 (0.6–0.7) | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Fatigue (tiredness) | 1,313 | 1.7 1.6–1.8ROR 1.8 · calibrated p 0.812 | 1.7 EB05 1.6 · IC025 +0.7 vs other Nitrate Vasodilators: PRR 0.5 (0.5–0.6) | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Diarrhoea (diarrhea) | 1,311 | 2.1 2.0–2.2ROR 2.1 · calibrated p 0.978 | 2.1 EB05 2.0 · IC025 +1.0 vs other Nitrate Vasodilators: PRR 0.6 (0.6–0.7) | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Nausea | 1,283 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.768 | 1.7 EB05 1.6 · IC025 +0.6 vs other Nitrate Vasodilators: PRR 0.5 (0.5–0.6) | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Chest pain | 1,226 | 6.8 6.4–7.1ROR 7.1 · calibrated p 0.094 | 6.7 EB05 6.4 · IC025 +2.7 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.6 (0.6–0.6) | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Headache | 1,077 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.825 | 1.7 EB05 1.7 · IC025 +0.7 vs other Nitrate Vasodilators: PRR 0.6 (0.5–0.6) | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Myocardial infarction (heart attack) | 1,065 | 6.2 5.8–6.6ROR 6.5 · calibrated p 0.123 | 6.1 EB05 5.8 · IC025 +2.5 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.5 (0.4–0.5) | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Vomiting | 990 | 2.2 2.0–2.3ROR 2.2 · calibrated p 0.947 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.6 (0.6–0.7) | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Malaise (feeling unwell) | 938 | 2.2 2.0–2.3ROR 2.2 · calibrated p 0.937 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.6 (0.6–0.7) | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Hypotension (low blood pressure) | 934 | 4.8 4.5–5.1ROR 4.9 · calibrated p 0.241 | 4.7 EB05 4.5 · IC025 +2.1 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.6 (0.6–0.7) | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Off label use (used outside approved label) | 922 | 1.1 1.0–1.2ROR 1.1 · calibrated p 0.363 | 1.1 EB05 1.0 · IC025 +0.0 vs other Nitrate Vasodilators: PRR 0.6 (0.6–0.7) | Reporting / coding artifact | serious PRR 1.1 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 917 | 6.2 5.8–6.6ROR 6.4 · calibrated p 0.127 | 6.1 EB05 5.8 · IC025 +2.5 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.8 (0.7–0.9) | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Pain | 895 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.643 | 1.5 EB05 1.4 · IC025 +0.5 vs other Nitrate Vasodilators: PRR 0.4 (0.4–0.4) | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Fall | 847 | 2.6 2.4–2.8ROR 2.7 · calibrated p 0.746 | 2.6 EB05 2.4 · IC025 +1.3 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.5 (0.4–0.5) | Not in label — unassessed | serious PRR 2.0 | 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=385, PRR 2,325.5
- Immunisation — n=243, PRR 1,317.0
- Palmoplantar keratoderma — n=374, PRR 1,112.8
- Neuroglycopenia — n=31, PRR 409.0
- Pruritus genital — n=382, PRR 199.8
- Carotid artery occlusion — n=387, PRR 120.3
- Sleep terror — n=378, PRR 100.4
- Chronic kidney disease-mineral and bone disorder — n=48, PRR 47.5
- Facial pain — n=380, PRR 45.2
- Subarachnoid haemorrhage — n=430, PRR 44.7
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 Mononitrate?
In FDA FAERS, the most frequently co-reported reaction terms for Isosorbide Mononitrate are dyspnoea, dizziness, fatigue, diarrhoea, nausea, chest pain. 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 Mononitrate have an FDA boxed warning?
No. The FDA label retrieved for Isosorbide Mononitrate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Isosorbide Mononitrate 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 0e3c4461-2e04-481f-a9e5-29f21cc71ec5, effective 20250606; matched on
openfda.generic_name.exact:"ISOSORBIDE MONONITRATE") - 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, 1,193 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.