Drug class · FAERS comparison
Angiotensin Converting Enzyme Inhibitor side effects compared: 4 drugs, 136,744 FDA adverse event reports
How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous.
Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Ramipril | 123,136 | 93% | 13,282 | boxed | Pemphigus; Sleep disorder due to general medical condition, insomnia type; Subcutaneous drug absorption impaired | Hand deformity; Pericarditis |
| Captopril | 9,557 | 89% | 1,564 | boxed | Stasis dermatitis; Therapeutic product cross-reactivity | Reduced facial expression; Scleroderma renal crisis |
| Trandolapril | 2,026 | 87% | 195 | boxed | Hyperkalaemia; Renal failure acute; Cardiogenic shock | Lactic acidosis; Sleep disorder |
| Trandolapril | 2,025 | 87% | 195 | boxed | Hyperkalaemia; Renal failure acute; Cardiogenic shock | Lactic acidosis; Sleep disorder |
Class-wide signals (flagged in at least 2 of 4 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Lactic acidosis | 2/4 | 20.7 | 128 | 0/2 members' labels |
| Cardiogenic shock | 2/4 | 20.4 | 56 | 2/2 members' labels |
| Psychotic disorder | 2/4 | 15.8 | 90 | 0/2 members' labels |
| Sinus bradycardia | 2/4 | 13.9 | 26 | 0/2 members' labels |
| Hyperkalaemia | 2/4 | 13.4 | 90 | 2/2 members' labels |
| Spinal pain | 2/4 | 13.3 | 30 | 0/2 members' labels |
| Vaginal discharge | 2/4 | 12.4 | 24 | 0/2 members' labels |
| Libido decreased | 2/4 | 11.7 | 28 | 2/2 members' labels |
| Tachypnoea | 2/4 | 11.5 | 30 | 0/2 members' labels |
| Hypothermia | 2/4 | 11.2 | 22 | 0/2 members' labels |
| Coagulopathy | 2/4 | 11.2 | 36 | 0/2 members' labels |
| Intestinal perforation | 2/4 | 11.1 | 24 | 0/2 members' labels |
| Pulmonary congestion | 2/4 | 11.0 | 28 | 0/2 members' labels |
| Coronary artery occlusion | 2/4 | 10.5 | 28 | 0/2 members' labels |
| Inappropriate antidiuretic hormone secretion | 2/4 | 10.2 | 20 | 0/2 members' labels |
| Ventricular extrasystoles | 2/4 | 10.0 | 20 | 0/2 members' labels |
| Melaena | 2/4 | 9.4 | 40 | 0/2 members' labels |
| Ventricular tachycardia | 2/4 | 9.4 | 30 | 2/2 members' labels |
| Obstructive airways disorder | 2/4 | 9.3 | 20 | 0/2 members' labels |
| Cardiomegaly | 2/4 | 9.2 | 22 | 0/2 members' labels |
| Ankylosing spondylitis | 2/4 | 8.7 | 22 | 0/2 members' labels |
| Aggression | 2/4 | 8.7 | 84 | 0/2 members' labels |
| Renal failure acute | 2/4 | 8.7 | 72 | 2/2 members' labels |
| Orthostatic hypotension | 2/4 | 8.3 | 28 | 0/2 members' labels |
| Hypoglycaemia | 2/4 | 8.1 | 76 | 0/2 members' labels |
| Abscess | 2/4 | 7.8 | 24 | 0/2 members' labels |
| Hepatic steatosis | 2/4 | 7.8 | 28 | 0/2 members' labels |
| Obesity | 2/4 | 7.8 | 24 | 0/2 members' labels |
| Sleep apnoea syndrome | 2/4 | 7.6 | 28 | 0/2 members' labels |
| Pancreatitis acute | 2/4 | 7.4 | 32 | 2/2 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Congenital hiatus hernia | Ramipril | 156 | 413.7 | Not in label — unassessed |
| Grip strength | Ramipril | 135 | 239.9 | Not in label — unassessed |
| Swollen joint count | Ramipril | 113 | 145.2 | Not in label — unassessed |
| Lupus vulgaris | Ramipril | 526 | 135.4 | Not in label — unassessed |
| Deep vein thrombosis postoperative | Ramipril | 815 | 121.5 | Not in label — unassessed |
| Subcutaneous drug absorption impaired | Ramipril | 216 | 112.1 | Labeled (related wording) |
| Rheumatic fever | Ramipril | 1,599 | 98.5 | Not in label — unassessed |
| Hypocholesterolaemia | Ramipril | 109 | 93.4 | Not in label — unassessed |
| Facet joint syndrome | Ramipril | 1,077 | 88.4 | Not in label — unassessed |
| Adjustment disorder with depressed mood | Ramipril | 625 | 76.5 | Not in label — unassessed |
| Dislocation of vertebra | Ramipril | 643 | 69.2 | Not in label — unassessed |
| Peripheral venous disease | Ramipril | 1,119 | 66.2 | Not in label — unassessed |
| Duodenal ulcer perforation | Ramipril | 1,931 | 60.7 | Not in label — unassessed |
| Retinitis | Ramipril | 404 | 54.3 | Not in label — unassessed |
| Pemphigus | Ramipril | 2,700 | 47.1 | Labeled adverse reaction |
| Muscle injury | Ramipril | 1,567 | 40.1 | Not in label — unassessed |
| Helicobacter infection | Ramipril | 1,882 | 38.4 | Not in label — unassessed |
| Hand deformity | Ramipril | 2,329 | 36.8 | Not in label — unassessed |
| Neurologic neglect syndrome | Ramipril | 99 | 36.4 | Not in label — unassessed |
| Catarrh | Ramipril | 154 | 35.5 | Not in label — unassessed |
| Steroid dependence | Ramipril | 144 | 34.6 | Not in label — unassessed |
| Porphyria acute | Ramipril | 233 | 34.4 | Not in label — unassessed |
| Folliculitis | Ramipril | 1,720 | 33.9 | Not in label — unassessed |
| Breast cancer stage iii | Ramipril | 1,022 | 32.0 | Not in label — unassessed |
| Cardiac septal defect | Ramipril | 109 | 30.0 | Not in label — unassessed |
Common questions
Which angiotensin converting enzyme inhibitor has the most FDA adverse event reports?
Ramipril has the most FAERS co-reports in this class (123,136), followed by Captopril (9,557). 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 angiotensin converting enzyme inhibitor drugs?
Reaction terms flagged in at least half of the 4 members include lactic acidosis, cardiogenic shock, psychotic disorder, sinus bradycardia, hyperkalaemia. 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.