Drug · FAERS side-effect profile with label screen
Nitroglycerin side effects: what 53,297 FDA adverse event reports show
Who reports
53,297 reports · 79% serious · 7,013 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Nitroglycerin sublingual tablets are nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. ( 1 )
FDA label, Indications and Usage
What it is
Nitroglycerin Sublingual Tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, croscarmellose sodium, silica dimethyl silylate and lactose monohydrate. Nitroglycerin, an organic nitrate, is a vasodilating agent.
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
Likely indication confounding 2Reporting / coding artifact 8Lab value / disease marker 3Not in label — unassessed 27
What the badges mean
- 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). 1,187 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 |
|---|---|---|---|---|---|---|
| Heart sounds | 54 | 497.8 332.6–745.0ROR 498.3 · calibrated p 5e-13 ✓ | 202.8 EB05 161.3 · IC025 +5.7 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=54 · ♀ 100% (drug 48%) | not reported in cached trials |
| Vaginal flatulence | 162 | 448.0 357.4–561.6ROR 449.4 · calibrated p 3e-13 ✓ | 203.3 EB05 178.3 · IC025 +6.7 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=162 · ♀ 100% (drug 48%) · 90% clinician | not reported in cached trials |
| Antacid therapy | 42 | 211.2 145.0–307.5ROR 211.3 · calibrated p 9e-10 ✓ | 129.1 EB05 99.5 · IC025 +5.2 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Reporting / coding artifact | serious n=42 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Sleep disorder therapy | 48 | 136.6 98.3–189.9ROR 136.8 · calibrated p 2e-8 ✓ | 97.4 EB05 76.4 · IC025 +5.2 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Reporting / coding artifact | serious n=48 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Congenital hiatus hernia | 52 | 120.6 88.3–164.6ROR 120.7 · calibrated p 5e-8 ✓ | 89.2 EB05 70.7 · IC025 +5.2 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=52 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Amaurosis fugax | 246 | 117.6 102.0–135.6ROR 118.1 · calibrated p 4e-8 ✓ | 89.8 EB05 80.8 · IC025 +6.0 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=245 · 93% clinician | not reported in cached trials |
| Prolonged expiration | 58 | 110.6 82.6–148.1ROR 110.7 · calibrated p 9e-8 ✓ | 83.9 EB05 67.3 · IC025 +5.2 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=58 · ♀ 100% (drug 48%) | not reported in cached trials |
| Sedation complication | 465 | 89.9 81.3–99.4ROR 90.7 · calibrated p 2e-7 ✓ | 72.9 EB05 67.5 · IC025 +5.9 3/3 methods agree vs other Nitrate Vasodilators: PRR 62.0 (37.1–103.7) | Reporting / coding artifact | serious n=465 · ♀ 100% (drug 48%) | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 161 | 83.8 70.7–99.3ROR 84.0 · calibrated p 5e-7 ✓ | 68.5 EB05 60.1 · IC025 +5.6 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=161 · ♀ 70% (drug 48%) | not reported in cached trials |
| Anticoagulant therapy | 46 | 78.1 56.9–107.2ROR 78.2 · calibrated p 1e-6 ✓ | 63.5 EB05 49.6 · IC025 +4.8 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Reporting / coding artifact | serious n=46 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Analgesic therapy | 48 | 72.9 53.5–99.2ROR 72.9 · calibrated p 2e-6 ✓ | 60.1 EB05 47.1 · IC025 +4.8 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Reporting / coding artifact | serious n=47 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Drug therapy | 44 | 62.6 45.6–86.1ROR 62.7 · calibrated p 5e-6 ✓ | 52.9 EB05 41.0 · IC025 +4.6 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Reporting / coding artifact | serious n=44 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Multiple drug therapy | 91 | 58.9 47.3–73.4ROR 59.0 · calibrated p 6e-6 ✓ | 50.8 EB05 42.6 · IC025 +5.0 3/3 methods agree vs other Nitrate Vasodilators: PRR 3.8 (2.7–5.4) | Reporting / coding artifact | serious n=89 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Creatinine renal clearance decreased | 496 | 55.2 50.2–60.6ROR 55.7 · calibrated p 7e-6 ✓ | 48.3 EB05 44.9 · IC025 +5.4 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Lab value / disease marker | serious n=492 · ♀ 100% (drug 48%) | not reported in cached trials |
| Reversible airways obstruction | 52 | 44.2 33.1–58.8ROR 44.2 · calibrated p 4e-5 ✓ | 39.2 EB05 31.1 · IC025 +4.4 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=52 · ♀ 0% (drug 48%) | not reported in cached trials |
| Female genital tract fistula | 173 | 43.9 37.5–51.4ROR 44.0 · calibrated p 3e-5 ✓ | 39.4 EB05 34.7 · IC025 +4.9 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=173 · ♀ 100% (drug 48%) | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 101 | 40.7 33.2–49.9ROR 40.8 · calibrated p 6e-5 ✓ | 36.7 EB05 31.1 · IC025 +4.6 3/3 methods agree vs other Nitrate Vasodilators: PRR 2.2 (1.7–2.9) | Not in label — unassessed | serious n=101 | not reported in cached trials |
| Hyperparathyroidism secondary | 227 | 38.7 33.8–44.3ROR 38.8 · calibrated p 7e-5 ✓ | 35.2 EB05 31.5 · IC025 +4.8 3/3 methods agree vs other Nitrate Vasodilators: PRR 2.8 (2.3–3.4) | Not in label — unassessed | serious n=227 | not reported in cached trials |
| Cardiospasm | 50 | 38.6 28.9–51.7ROR 38.7 · calibrated p 9e-5 ✓ | 34.8 EB05 27.4 · IC025 +4.2 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.1 (0.1–0.2) | Not in label — unassessed | serious n=50 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Brain scan abnormal | 48 | 36.8 27.4–49.5ROR 36.8 · calibrated p 1e-4 ✓ | 33.3 EB05 26.1 · IC025 +4.2 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Reporting / coding artifact | serious n=48 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Nephrogenic anaemia | 400 | 36.8 33.2–40.7ROR 37.0 · calibrated p 8e-5 ✓ | 33.6 EB05 30.9 · IC025 +4.8 3/3 methods agree vs other Nitrate Vasodilators: PRR 2.5 (2.2–2.9) | Not in label — unassessed | serious n=400 | not reported in cached trials |
| Creatinine renal clearance increased | 64 | 36.5 28.3–47.2ROR 36.6 · calibrated p 1e-4 ✓ | 33.2 EB05 26.9 · IC025 +4.3 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Lab value / disease marker | serious n=59 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Radiculopathy | 209 | 33.8 29.4–38.9ROR 33.9 · calibrated p 1e-4 ✓ | 31.1 EB05 27.7 · IC025 +4.6 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=209 · ♀ 87% (drug 48%) | not reported in cached trials |
| Total lung capacity decreased | 124 | 33.0 27.4–39.6ROR 33.0 · calibrated p 2e-4 ✓ | 30.3 EB05 26.1 · IC025 +4.5 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=121 · ♀ 83% (drug 48%) | not reported in cached trials |
| Oesophageal spasm | 134 | 30.8 25.8–36.7ROR 30.9 · calibrated p 2e-4 ✓ | 28.5 EB05 24.7 · IC025 +4.4 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=125 · ♀ 100% (drug 48%) | not reported in cached trials |
| Ischaemic cardiomyopathy | 205 | 27.8 24.2–32.1ROR 27.9 · calibrated p 4e-4 ✓ | 26.0 EB05 23.1 · IC025 +4.4 3/3 methods agree vs other Nitrate Vasodilators: PRR 4.5 (3.5–5.7) | Not in label — unassessed | serious n=203 | not reported in cached trials |
| Palmoplantar keratoderma | 47 | 27.4 20.4–36.8ROR 27.4 · calibrated p 5e-4 ✓ | 25.4 EB05 19.9 · IC025 +3.9 3/3 methods agree vs other Nitrate Vasodilators: PRR 0.1 (0.1–0.2) | Not in label — unassessed | serious n=47 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Angina unstable | 417 | 26.7 24.1–29.4ROR 26.9 · calibrated p 5e-4 ✓ | 25.0 EB05 23.0 · IC025 +4.4 3/3 methods agree vs other Nitrate Vasodilators: PRR 3.8 (3.2–4.4) | Not in label — unassessed | serious n=416 | not reported in cached trials |
| Proctitis | 172 | 25.7 22.0–29.9ROR 25.7 · calibrated p 6e-4 ✓ | 24.1 EB05 21.2 · IC025 +4.2 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=172 · ♀ 100% (drug 48%) | not reported in cached trials |
| Chronic sinusitis | 227 | 25.3 22.1–29.0ROR 25.4 · calibrated p 7e-4 ✓ | 23.8 EB05 21.3 · IC025 +4.3 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=226 · ♀ 100% (drug 48%) | not reported in cached trials |
| Dyspnoea paroxysmal nocturnal | 44 | 24.9 18.4–33.8ROR 24.9 · calibrated p 9e-4 ✓ | 23.3 EB05 18.0 · IC025 +3.7 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=41 · ♀ 0% (drug 48%) | not reported in cached trials |
| Rebound acid hypersecretion | 161 | 21.7 18.6–25.5ROR 21.8 · calibrated p 0.001 ✓ | 20.6 EB05 18.1 · IC025 +4.0 3/3 methods agree vs other Nitrate Vasodilators: PRR 3.0 (2.4–3.8) | Not in label — unassessed | serious n=161 | not reported in cached trials |
| Prinzmetal angina | 52 | 21.6 16.4–28.6ROR 21.7 · calibrated p 0.002 ✓ | 20.4 EB05 16.2 · IC025 +3.7 3/3 methods agree vs other Nitrate Vasodilators: PRR 2.1 (1.4–3.1) | Not in label — unassessed | serious n=52 · 100% clinician | not reported in cached trials |
| Rales | 301 | 21.5 19.1–24.1ROR 21.6 · calibrated p 0.001 ✓ | 20.4 EB05 18.5 · IC025 +4.1 3/3 methods agree vs other Nitrate Vasodilators: PRR 8.4 (6.5–10.8) | Not in label — unassessed | serious n=298 · ♀ 69% (drug 48%) | not reported in cached trials |
| Urinary tract disorder | 226 | 20.8 18.2–23.7ROR 20.8 · calibrated p 0.002 ✓ | 19.7 EB05 17.7 · IC025 +4.0 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=222 · 92% clinician | not reported in cached trials |
| Lung opacity | 129 | 20.7 17.3–24.7ROR 20.8 · calibrated p 0.002 ✓ | 19.7 EB05 17.0 · IC025 +3.9 3/3 methods agree vs other Nitrate Vasodilators: only this drug | Not in label — unassessed | serious n=129 · ♀ 100% (drug 48%) | not reported in cached trials |
| Left atrial dilatation | 62 | 19.9 15.4–25.7ROR 19.9 · calibrated p 0.002 ✓ | 18.9 EB05 15.2 · IC025 +3.6 3/3 methods agree vs other Nitrate Vasodilators: PRR 2.0 (1.4–2.9) | Not in label — unassessed | serious n=62 | not reported in cached trials |
| Blood calcium decreased | 535 | 19.5 17.9–21.3ROR 19.7 · calibrated p 0.002 ✓ | 18.6 EB05 17.4 · IC025 +4.1 3/3 methods agree vs other Nitrate Vasodilators: PRR 26.8 (19.4–36.9) | Lab value / disease marker | serious PRR 16.9 · ♀ 92% (drug 48%) | not reported in cached trials |
| Coronary arterial stent insertion | 236 | 19.2 16.9–21.9ROR 19.3 · calibrated p 0.002 ✓ | 18.3 EB05 16.4 · IC025 +3.9 3/3 methods agree vs other Nitrate Vasodilators: PRR 6.1 (4.7–7.8) | Likely indication confounding shares a disease stem with the indications wording | serious n=233 | not reported in cached trials |
| Coronary artery disease | 1,403 | 18.9 17.9–19.9ROR 19.4 · calibrated p 0.002 ✓ | 18.1 EB05 17.3 · IC025 +4.1 3/3 methods agree vs other Nitrate Vasodilators: PRR 4.7 (4.2–5.1) | Likely indication confounding term in indications | serious PRR 13.2 | 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 |
|---|---|---|---|
| Myocardial infarction | 4,370 | 8.68.3–8.8 | signal |
| Heart failure | 2,727 | 6.15.9–6.3 | signal |
| Gi bleeding | 2,306 | 5.04.8–5.2 | signal |
| Kidney injury | 4,904 | 4.34.1–4.4 | signal |
| Arrhythmia / qt | 1,879 | 3.83.7–4.0 | signal |
| Fall / fracture | 3,078 | 3.23.1–3.3 | signal |
| Rhabdomyolysis / myopathy | 626 | 3.12.8–3.3 | signal |
| Anaemia | 2,264 | 3.02.9–3.1 | signal |
| Stroke | 1,838 | 2.92.8–3.0 | signal |
| Hyponatraemia | 518 | 2.52.3–2.8 | signal |
| Hypoglycaemia | 569 | 2.32.2–2.5 | signal |
| Depression | 1,642 | 2.32.2–2.4 | signal |
| Hyperglycaemia / diabetes | 1,850 | 2.12.0–2.2 | signal |
| Serious infection | 4,125 | 2.12.0–2.2 | signal |
| Interstitial lung disease | 432 | 1.81.6–2.0 | raised |
| Venous thromboembolism | 952 | 1.71.6–1.8 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Nitroglycerin 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 (0 of 40 signal terms matched).
- NCT03158532 — Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin (N=2040, PHASE3; 1 AE terms posted; arms: Placebo I/Placebo II; Nitroglycerin I/Placebo II; Placebo I /Nitroglycerin II; Nitroglycerin I /Nitroglycerin II)
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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 4,297 | 3.0 2.9–3.1ROR 3.2 · calibrated p 0.571 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Nitrate Vasodilators: PRR 2.7 (2.5–2.8) | Not in label — unassessed | age-adj. PRR 2.3 · serious PRR 2.6 | not reported in cached trials |
| Pain | 3,694 | 2.4 2.3–2.4ROR 2.5 · calibrated p 0.825 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Nitrate Vasodilators: PRR 3.8 (3.6–4.0) | Not in label — unassessed | age-adj. PRR 2.8 · serious PRR 2.4 | not reported in cached trials |
| Fatigue (tiredness) | 3,623 | 1.8 1.8–1.9ROR 1.9 · calibrated p 0.888 | 1.8 EB05 1.8 · IC025 +0.8 vs other Nitrate Vasodilators: PRR 2.7 (2.6–2.9) | Not in label — unassessed | age-adj. PRR 1.5 · serious PRR 2.0 | not reported in cached trials |
| Myocardial infarction (heart attack) | 3,415 | 7.8 7.5–8.0ROR 8.2 · calibrated p 0.061 | 7.6 EB05 7.4 · IC025 +2.9 3/3 methods agree vs other Nitrate Vasodilators: PRR 3.0 (2.9–3.2) | Not in label — unassessed | age-adj. PRR 7.5 · serious PRR 5.6 | not reported in cached trials |
| Nausea | 3,369 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.787 | 1.7 EB05 1.6 · IC025 +0.7 vs other Nitrate Vasodilators: PRR 2.5 (2.4–2.7) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.9 | not reported in cached trials |
| Drug ineffective (drug did not work) | 3,026 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.242 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Nitrate Vasodilators: PRR 4.2 (3.9–4.5) | Reporting / coding artifact | age-adj. PRR 1.2 · serious PRR 1.3 | not reported in cached trials |
| Dizziness | 3,017 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.823 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Nitrate Vasodilators: PRR 2.2 (2.1–2.3) | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 2.5 | not reported in cached trials |
| Chest pain | 3,000 | 6.4 6.2–6.7ROR 6.8 · calibrated p 0.108 | 6.4 EB05 6.2 · IC025 +2.6 3/3 methods agree vs other Nitrate Vasodilators: PRR 2.5 (2.4–2.6) | Not in label — unassessed | age-adj. PRR 5.6 · serious PRR 5.4 | not reported in cached trials |
| Fall | 2,973 | 3.5 3.4–3.7ROR 3.7 · calibrated p 0.440 | 3.5 EB05 3.4 · IC025 +1.8 3/3 methods agree vs other Nitrate Vasodilators: PRR 3.9 (3.7–4.2) | Not in label — unassessed | age-adj. PRR 2.3 · serious PRR 2.9 | not reported in cached trials |
| Diarrhoea (diarrhea) | 2,760 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.787 | 1.7 EB05 1.6 · IC025 +0.7 vs other Nitrate Vasodilators: PRR 2.1 (2.0–2.2) | Not in label — unassessed | age-adj. PRR 1.2 · serious PRR 1.7 | not reported in cached trials |
| Headache | 2,681 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.784 | 1.7 EB05 1.6 · IC025 +0.7 vs other Nitrate Vasodilators: PRR 2.6 (2.4–2.7) | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 2.0 | not reported in cached trials |
| Renal failure (kidney failure) | 2,528 | 7.6 7.3–7.9ROR 7.9 · calibrated p 0.070 | 7.4 EB05 7.2 · IC025 +2.8 3/3 methods agree vs other Nitrate Vasodilators: PRR 3.6 (3.3–3.8) | Not in label — unassessed | age-adj. PRR 5.6 · serious PRR 5.4 | not reported in cached trials |
| Death | 2,458 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.392 | 1.1 EB05 1.1 · IC025 +0.1 vs other Nitrate Vasodilators: PRR 3.3 (3.1–3.5) | Outcome field, not a reaction | age-adj. PRR 1.0 · serious PRR 0.8 | not reported in cached trials |
| Asthenia (weakness) | 2,458 | 2.6 2.5–2.7ROR 2.7 · calibrated p 0.748 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Nitrate Vasodilators: PRR 3.3 (3.1–3.5) | Not in label — unassessed | age-adj. PRR 1.9 · serious PRR 2.3 | not reported in cached trials |
| Hypotension (low blood pressure) | 2,299 | 4.6 4.4–4.7ROR 4.7 · calibrated p 0.268 | 4.5 EB05 4.4 · IC025 +2.1 3/3 methods agree vs other Nitrate Vasodilators: PRR 2.9 (2.7–3.1) | Labeled adverse reaction exact term | age-adj. PRR 3.7 · serious PRR 3.6 | NCT03158532: 13/510 (2.5%) on Nitroglycerin; 6/510 (1.2%) control |
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.
- Heart sounds — n=54, PRR 497.8
- Vaginal flatulence — n=162, PRR 448.0
- Congenital hiatus hernia — n=52, PRR 120.6
- Amaurosis fugax — n=246, PRR 117.6
- Prolonged expiration — n=58, PRR 110.6
- Bronchopulmonary aspergillosis allergic — n=161, PRR 83.8
- Reversible airways obstruction — n=52, PRR 44.2
- Female genital tract fistula — n=173, PRR 43.9
- Chronic kidney disease-mineral and bone disorder — n=101, PRR 40.7
- Hyperparathyroidism secondary — n=227, PRR 38.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Nitroglycerin ↔ Hypotension.
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 Nitroglycerin?
In FDA FAERS, the most frequently co-reported reaction terms for Nitroglycerin are dyspnoea, pain, fatigue, myocardial infarction, nausea, 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 Nitroglycerin have an FDA boxed warning?
No. The FDA label retrieved for Nitroglycerin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nitroglycerin 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 2bad7976-4eb0-d064-e063-6394a90a75de, effective 20250114; matched on
openfda.generic_name.exact:"NITROGLYCERIN") - 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, 1,227 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
NITROGLYCERIN, 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.