Nitrate Vasodilator side effects compared: 3 drugs, 93,319 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Nitroglycerin | 53,297 | 79% | 7,013 | – | – | Angina unstable; Nephrogenic anaemia |
| Isosorbide Mononitrate | 20,611 | 84% | 2,596 | – | Ventricular tachycardia; Atrial tachycardia; Tension headache | Subarachnoid haemorrhage; Muscle twitching |
| Isosorbide Dinitrate | 19,411 | 75% | 2,553 | – | Tension headache; Silent myocardial infarction | Transient ischaemic attack; Ventricular tachycardia |
Class-wide signals (flagged in at least 2 of 3 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Cardiospasm | 3/3 | 2,269.2 | 810 | 0/3 members' labels |
| Palmoplantar keratoderma | 3/3 | 1,112.8 | 787 | 0/3 members' labels |
| Chronic kidney disease-mineral and bone disorder | 3/3 | 46.0 | 193 | 0/3 members' labels |
| Nephrogenic anaemia | 3/3 | 36.8 | 720 | 0/3 members' labels |
| Hyperparathyroidism secondary | 3/3 | 34.9 | 388 | 0/3 members' labels |
| Prinzmetal angina | 3/3 | 24.0 | 101 | 0/3 members' labels |
| Left atrial dilatation | 3/3 | 19.9 | 123 | 0/3 members' labels |
| Immunisation | 2/3 | 1,371.4 | 488 | 0/2 members' labels |
| Atrial tachycardia | 2/3 | 234.9 | 771 | 1/2 members' labels |
| Pruritus genital | 2/3 | 202.0 | 752 | 0/2 members' labels |
| Carotid artery occlusion | 2/3 | 124.2 | 775 | 0/2 members' labels |
| Sleep terror | 2/3 | 102.0 | 746 | 0/2 members' labels |
| Tension headache | 2/3 | 99.2 | 743 | 2/2 members' labels |
| Facial pain | 2/3 | 46.5 | 758 | 0/2 members' labels |
| Subarachnoid haemorrhage | 2/3 | 45.5 | 850 | 0/2 members' labels |
| Vasculitis | 2/3 | 36.3 | 782 | 0/2 members' labels |
| Ventricular tachycardia | 2/3 | 30.6 | 940 | 1/2 members' labels |
| Anosmia | 2/3 | 27.9 | 751 | 0/2 members' labels |
| Mucosal erosion | 2/3 | 27.7 | 47 | 0/2 members' labels |
| Pericarditis | 2/3 | 25.2 | 784 | 0/2 members' labels |
| Ischaemic cardiomyopathy | 2/3 | 25.1 | 268 | 0/2 members' labels |
| Angina unstable | 2/3 | 22.9 | 531 | 0/2 members' labels |
| Rebound acid hypersecretion | 2/3 | 21.8 | 222 | 0/2 members' labels |
| Muscle twitching | 2/3 | 18.5 | 803 | 0/2 members' labels |
| Atrioventricular block first degree | 2/3 | 16.9 | 139 | 0/2 members' labels |
Member-specific signals (flagged in exactly one drug)
No strong single-member signals (n ≥ 50) in this class.
Common questions
Which nitrate vasodilator has the most FDA adverse event reports?
Nitroglycerin has the most FAERS co-reports in this class (53,297), followed by Isosorbide Mononitrate (20,611). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across nitrate vasodilator drugs?
Reaction terms flagged in at least half of the 3 members include cardiospasm, palmoplantar keratoderma, chronic kidney disease-mineral and bone disorder, nephrogenic anaemia, hyperparathyroidism secondary. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.