Drug · FAERS side-effect profile with label screen
Ramipril side effects: what 123,136 FDA adverse event reports show
Drug class
Angiotensin Converting Enzyme Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Who reports
123,136 reports · 93% serious · 13,282 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics ( 1.1 ).
FDA label, Indications and Usage
What it is
Ramipril is a dipeptide that is the prodrug for ramiprilat, the active metabolite obtained by hydrolysis of the ethyl ester group. An angiotensin-converting enzyme (ACE) inhibitor, used to treat high blood pressure and congestive heart failure.
PubChem CID 5362129 (ChEBI)
Boxed warning
FETAL TOXICITY WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 ).
FDA 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) 2Reporting / coding artifact 1Lab value / disease marker 7Not in label — unassessed 29
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.
- 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). 1,194 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 |
|---|---|---|---|---|---|---|
| Congenital hiatus hernia | 156 | 413.7 308.7–554.2ROR 414.2 · calibrated p 1e-12 ✓ | 118.0 EB05 103.3 · IC025 +6.2 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=156 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Grip strength | 135 | 239.9 184.4–312.2ROR 240.2 · calibrated p 2e-10 ✓ | 97.7 EB05 84.7 · IC025 +5.9 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=135 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Swollen joint count | 113 | 145.2 112.9–186.8ROR 145.3 · calibrated p 1e-8 ✓ | 77.2 EB05 65.9 · IC025 +5.6 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=113 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Lupus vulgaris | 526 | 135.4 120.7–151.9ROR 136.0 · calibrated p 1e-8 ✓ | 75.0 EB05 69.8 · IC025 +6.0 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=526 · ♀ 100% (drug 48%) · 94% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 815 | 121.5 111.0–132.9ROR 122.3 · calibrated p 3e-8 ✓ | 70.6 EB05 66.7 · IC025 +6.0 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=815 · ♀ 100% (drug 48%) · 94% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 216 | 112.1 94.3–133.1ROR 112.3 · calibrated p 6e-8 ✓ | 67.1 EB05 59.9 · IC025 +5.6 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Labeled (related wording) related wording | serious n=216 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Rheumatic fever | 1,599 | 98.5 92.6–104.7ROR 99.7 · calibrated p 1e-7 ✓ | 62.3 EB05 59.8 · IC025 +5.9 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=1,599 · ♀ 100% (drug 48%) · 93% clinician | not reported in cached trials |
| C-reactive protein | 327 | 96.0 83.8–110.0ROR 96.3 · calibrated p 2e-7 ✓ | 61.1 EB05 55.8 · IC025 +5.6 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Lab value / disease marker | serious n=327 · ♀ 100% (drug 48%) · 94% clinician | not reported in cached trials |
| Hypocholesterolaemia | 109 | 93.4 73.9–118.0ROR 93.5 · calibrated p 3e-7 ✓ | 59.7 EB05 50.8 · IC025 +5.3 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=108 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Swollen joint count increased | 1,096 | 92.3 85.8–99.4ROR 93.1 · calibrated p 2e-7 ✓ | 59.8 EB05 56.8 · IC025 +5.8 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Lab value / disease marker | serious n=1,096 · ♀ 100% (drug 48%) · 95% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 231 | 90.2 76.8–105.8ROR 90.3 · calibrated p 3e-7 ✓ | 58.6 EB05 52.6 · IC025 +5.5 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Lab value / disease marker | serious n=231 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 1,077 | 88.4 82.1–95.2ROR 89.2 · calibrated p 3e-7 ✓ | 58.1 EB05 55.2 · IC025 +5.7 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=1,077 · ♀ 100% (drug 48%) · 93% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 625 | 76.5 69.6–84.1ROR 76.9 · calibrated p 8e-7 ✓ | 52.7 EB05 49.3 · IC025 +5.5 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=625 · ♀ 100% (drug 48%) · 95% clinician | not reported in cached trials |
| X-ray abnormal | 538 | 73.4 66.4–81.2ROR 73.7 · calibrated p 1e-6 ✓ | 51.2 EB05 47.7 · IC025 +5.5 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Lab value / disease marker | serious n=538 · ♀ 100% (drug 48%) · 96% clinician | NCT00153101: 1/8,576 (0.0%) on Ramipril (serious AE) |
| Dislocation of vertebra | 643 | 69.2 63.1–75.8ROR 69.5 · calibrated p 2e-6 ✓ | 49.1 EB05 46.0 · IC025 +5.4 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=643 · ♀ 100% (drug 48%) · 93% clinician | NCT00153101: 1/2,972 (0.0%) control (serious AE) |
| Peripheral venous disease | 1,119 | 66.2 61.8–70.9ROR 66.8 · calibrated p 2e-6 ✓ | 47.7 EB05 45.4 · IC025 +5.4 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: PRR 181.6 (107.2–307.6) | Not in label — unassessed | serious n=1,118 · ♀ 100% (drug 48%) · 95% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 1,876 | 61.0 57.9–64.3ROR 61.9 · calibrated p 3e-6 ✓ | 44.9 EB05 43.2 · IC025 +5.4 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Lab value / disease marker | serious PRR 27.8 · ♀ 100% (drug 48%) · 94% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 1,931 | 60.7 57.6–63.9ROR 61.6 · calibrated p 3e-6 ✓ | 44.8 EB05 43.1 · IC025 +5.4 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious PRR 27.6 · ♀ 100% (drug 48%) · 94% clinician | NCT00153101: 1/8,576 (0.0%) on Ramipril (serious AE) |
| Rheumatoid factor positive | 1,450 | 57.1 53.8–60.6ROR 57.7 · calibrated p 5e-6 ✓ | 42.8 EB05 40.9 · IC025 +5.3 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Lab value / disease marker | serious n=1,450 · ♀ 100% (drug 48%) · 95% clinician | not reported in cached trials |
| Retinitis | 404 | 54.3 48.5–60.7ROR 54.4 · calibrated p 8e-6 ✓ | 41.1 EB05 37.9 · IC025 +5.1 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=404 · ♀ 100% (drug 48%) · 92% clinician | not reported in cached trials |
| Pemphigus | 2,700 | 47.1 45.2–49.2ROR 48.2 · calibrated p 2e-5 ✓ | 37.0 EB05 35.8 · IC025 +5.1 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: PRR 2,045.1 (659.2–6,344.6) | Labeled adverse reaction exact term | serious PRR 22.9 · ♀ 100% (drug 48%) · 95% clinician | NCT00153101: 2/8,502 (0.0%) on Ramipril (serious AE) |
| Muscle injury | 1,567 | 40.1 37.9–42.3ROR 40.6 · calibrated p 5e-5 ✓ | 32.5 EB05 31.2 · IC025 +4.9 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious PRR 21.7 · ♀ 100% (drug 48%) · 94% clinician | NCT00153101: 1/8,576 (0.0%) on Ramipril (serious AE) |
| C-reactive protein abnormal | 1,199 | 39.1 36.7–41.6ROR 39.5 · calibrated p 6e-5 ✓ | 31.8 EB05 30.4 · IC025 +4.9 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Lab value / disease marker | serious n=1,199 · ♀ 100% (drug 48%) · 93% clinician | not reported in cached trials |
| Helicobacter infection | 1,882 | 38.4 36.6–40.4ROR 39.0 · calibrated p 6e-5 ✓ | 31.4 EB05 30.2 · IC025 +4.9 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: PRR 534.6 (267.0–1,070.4) | Not in label — unassessed | serious PRR 20.5 · ♀ 100% (drug 48%) · 94% clinician | NCT00153101: 1/8,576 (0.0%) on Ramipril (serious AE) |
| Hand deformity | 2,329 | 36.8 35.2–38.4ROR 37.4 · calibrated p 8e-5 ✓ | 30.3 EB05 29.3 · IC025 +4.8 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: PRR 352.8 (212.4–586.1) | Not in label — unassessed | serious PRR 20.3 · ♀ 100% (drug 48%) · 93% clinician | not reported in cached trials |
| Neurologic neglect syndrome | 99 | 36.4 29.3–45.3ROR 36.5 · calibrated p 1e-4 ✓ | 29.9 EB05 25.3 · IC025 +4.4 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=99 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Catarrh | 154 | 35.5 29.9–42.3ROR 35.6 · calibrated p 1e-4 ✓ | 29.4 EB05 25.7 · IC025 +4.5 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=154 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Steroid dependence | 144 | 34.6 28.9–41.4ROR 34.7 · calibrated p 1e-4 ✓ | 28.7 EB05 25.0 · IC025 +4.4 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=144 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Porphyria acute | 233 | 34.4 29.9–39.7ROR 34.5 · calibrated p 1e-4 ✓ | 28.7 EB05 25.7 · IC025 +4.5 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=233 · ♀ 100% (drug 48%) · 91% clinician | not reported in cached trials |
| Folliculitis | 1,720 | 33.9 32.2–35.7ROR 34.4 · calibrated p 1e-4 ✓ | 28.3 EB05 27.2 · IC025 +4.7 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious PRR 20.5 · ♀ 100% (drug 48%) · 95% clinician | not reported in cached trials |
| Product monitoring error | 232 | 32.7 28.4–37.7ROR 32.8 · calibrated p 2e-4 ✓ | 27.5 EB05 24.6 · IC025 +4.5 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Reporting / coding artifact | serious n=232 · 100% clinician | not reported in cached trials |
| Breast cancer stage iii | 1,022 | 32.0 30.0–34.2ROR 32.3 · calibrated p 2e-4 ✓ | 27.0 EB05 25.7 · IC025 +4.6 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=1,022 · ♀ 100% (drug 48%) · 96% clinician | NCT02924727: 1/2,820 (0.0%) on Ramipril (serious AE) |
| Cardiac septal defect | 109 | 30.0 24.5–36.8ROR 30.1 · calibrated p 3e-4 ✓ | 25.5 EB05 21.7 · IC025 +4.2 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=109 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Overlap syndrome | 102 | 29.4 23.8–36.3ROR 29.5 · calibrated p 3e-4 ✓ | 25.1 EB05 21.2 · IC025 +4.2 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=102 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Hypercholesterolaemia | 1,381 | 28.6 27.0–30.3ROR 28.9 · calibrated p 3e-4 ✓ | 24.6 EB05 23.5 · IC025 +4.5 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: PRR 108.2 (74.9–156.3) | Not in label — unassessed | serious PRR 16.0 · ♀ 84% (drug 48%) · 91% clinician | not reported in cached trials |
| Onychomadesis | 569 | 26.9 24.6–29.4ROR 27.0 · calibrated p 5e-4 ✓ | 23.3 EB05 21.7 · IC025 +4.4 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=565 · ♀ 100% (drug 48%) · 91% clinician | not reported in cached trials |
| Pericarditis | 2,276 | 26.8 25.7–28.0ROR 27.3 · calibrated p 4e-4 ✓ | 23.3 EB05 22.5 · IC025 +4.5 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: PRR 574.7 (298.7–1,105.7) | Not in label — unassessed | serious PRR 14.4 · ♀ 97% (drug 48%) · 94% clinician | NCT00153101: 4/8,576 (0.0%) on Ramipril; 1/2,972 (0.0%) control (serious AE) |
| Lip dry | 1,211 | 26.5 25.0–28.2ROR 26.8 · calibrated p 5e-4 ✓ | 23.0 EB05 21.9 · IC025 +4.4 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=1,209 · ♀ 100% (drug 48%) · 92% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 846 | 25.7 23.9–27.6ROR 25.8 · calibrated p 6e-4 ✓ | 22.4 EB05 21.1 · IC025 +4.4 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Labeled (related wording) related wording | serious n=846 · ♀ 100% (drug 48%) · 96% clinician | not reported in cached trials |
| Granuloma skin | 104 | 24.3 19.8–29.9ROR 24.4 · calibrated p 9e-4 ✓ | 21.3 EB05 18.1 · IC025 +4.0 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: only this drug | Not in label — unassessed | serious n=104 · ♀ 100% (drug 48%) · 100% clinician | 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 |
|---|---|---|---|
| Hyponatraemia | 2,803 | 6.15.9–6.3 | signal |
| Rhabdomyolysis / myopathy | 2,128 | 4.64.4–4.8 | signal |
| Kidney injury | 10,551 | 4.03.9–4.1 | signal |
| Interstitial lung disease | 2,152 | 3.93.7–4.1 | signal |
| Liver injury | 6,598 | 3.83.7–3.9 | signal |
| Arrhythmia / qt | 3,995 | 3.63.5–3.7 | signal |
| Gi bleeding | 3,594 | 3.43.3–3.5 | signal |
| Heart failure | 3,297 | 3.23.1–3.3 | signal |
| Anaphylaxis / angioedema | 2,286 | 3.13.0–3.3 | signal |
| Pancreatitis | 1,251 | 2.72.5–2.8 | signal |
| Hypoglycaemia | 1,455 | 2.62.5–2.7 | signal |
| Anaemia | 4,417 | 2.52.5–2.6 | signal |
| Hyperglycaemia / diabetes | 5,030 | 2.52.4–2.6 | signal |
| Fall / fracture | 5,256 | 2.42.3–2.4 | signal |
| Severe cutaneous reaction | 949 | 2.22.1–2.3 | signal |
| Myocardial infarction | 2,551 | 2.12.1–2.2 | signal |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ramipril 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 (8 of 40 signal terms matched).
- NCT00153101 — Effectiveness and Safety of Ramipril Alone Compared With Telmisartan Alone and in Combination With Ramipril in (N=31546, PHASE4; 2505 AE terms posted; arms: Telmisartan/Ramipril (ONTARGET); Telmisartan (ONTARGET); Ramipril (ONTARGET); Telmisartan (TRANSCEND))
- NCT02924727 — Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI (N=5669, PHASE3; 862 AE terms posted; arms: LCZ696 Pre-treatment; Ramipril Pre-treatment; LCZ696; Ramipril)
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) | 8,362 | 2.5 2.5–2.6ROR 2.7 · calibrated p 0.750 | 2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: PRR 31.2 (28.7–33.8) | Labeled adverse reaction exact term | age-adj. PRR 2.1 · serious PRR 2.1 | NCT00153101: 52/8,576 (0.6%) on Ramipril; 10/2,972 (0.3%) control (serious AE) |
| Fatigue (tiredness) | 8,166 | 1.8 1.8–1.8ROR 1.9 · calibrated p 0.862 | 1.8 EB05 1.8 · IC025 +0.8 vs other Angiotensin Converting Enzyme Inhibitors: PRR 47.5 (42.9–52.5) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 2.0 | NCT00153101: 1/2,972 (0.0%) control (serious AE) |
| Nausea | 7,571 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.758 | 1.6 EB05 1.6 · IC025 +0.7 vs other Angiotensin Converting Enzyme Inhibitors: PRR 34.1 (31.2–37.3) | Labeled — boxed warning exact term | age-adj. PRR 1.5 · serious PRR 1.9 · ♀ 71% (drug 48%) | NCT00153101: 20/8,576 (0.2%) on Ramipril; 7/2,972 (0.2%) control (serious AE) |
| Diarrhoea (diarrhea) | 7,184 | 1.9 1.9–2.0ROR 2.0 · calibrated p 0.927 | 1.9 EB05 1.9 · IC025 +0.9 vs other Angiotensin Converting Enzyme Inhibitors: PRR 35.3 (32.1–38.7) | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 2.0 | NCT00153101: 32/8,576 (0.4%) on Ramipril; 3/2,972 (0.1%) control (serious AE) |
| Off label use (used outside approved label) | 6,830 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.550 | 1.3 EB05 1.3 · IC025 +0.4 vs other Angiotensin Converting Enzyme Inhibitors: PRR 55.8 (49.6–62.9) | Reporting / coding artifact | age-adj. PRR 1.2 · serious PRR 1.5 | not reported in cached trials |
| Dizziness | 6,765 | 2.3 2.3–2.4ROR 2.4 · calibrated p 0.852 | 2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: PRR 34.4 (31.3–37.8) | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 2.4 | NCT00153101: 40/8,576 (0.5%) on Ramipril; 10/2,972 (0.3%) control (serious AE) |
| Drug ineffective (drug did not work) | 6,584 | 0.9 0.8–0.9ROR 0.8 · calibrated p 0.208 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC vs other Angiotensin Converting Enzyme Inhibitors: PRR 25.0 (23.0–27.1) | Reporting / coding artifact | age-adj. PRR 1.0 · serious PRR 1.4 | not reported in cached trials |
| Vomiting | 6,310 | 2.3 2.3–2.4ROR 2.4 · calibrated p 0.866 | 2.3 EB05 2.2 · IC025 +1.2 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: PRR 36.2 (32.7–40.0) | Labeled — boxed warning exact term | age-adj. PRR 2.1 · serious PRR 2.1 · ♀ 71% (drug 48%) | NCT00153101: 29/8,576 (0.3%) on Ramipril; 6/2,972 (0.2%) control (serious AE) |
| Pain | 5,927 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.756 | 1.6 EB05 1.6 · IC025 +0.7 vs other Angiotensin Converting Enzyme Inhibitors: PRR 29.6 (26.9–32.5) | Labeled — boxed warning exact term | age-adj. PRR 1.6 · serious PRR 1.5 · ♀ 75% (drug 48%) | NCT00153101: 1/8,576 (0.0%) on Ramipril (serious AE) |
| Headache | 5,628 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.681 | 1.5 EB05 1.5 · IC025 +0.6 vs other Angiotensin Converting Enzyme Inhibitors: PRR 32.1 (29.1–35.5) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.9 · ♀ 71% (drug 48%) | NCT00153101: 1/8,576 (0.0%) on Ramipril (serious AE) |
| Acute kidney injury (sudden kidney damage) | 5,486 | 6.3 6.2–6.5ROR 6.6 · calibrated p 0.117 | 6.1 EB05 6.0 · IC025 +2.6 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: PRR 67.4 (58.2–78.0) | Labeled — boxed warning synonym match | age-adj. PRR 4.7 · serious PRR 3.8 · 95% clinician | NCT02924727: 30/2,816 (1.1%) on Ramipril (serious AE) |
| General physical health deterioration | 5,367 | 8.3 8.1–8.5ROR 8.6 · calibrated p 0.052 | 8.0 EB05 7.8 · IC025 +2.9 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: PRR 75.3 (64.4–88.0) | Reporting / coding artifact | age-adj. PRR 6.7 · serious PRR 5.7 · 91% clinician | NCT00153101: 1/8,576 (0.0%) on Ramipril; 1/2,972 (0.0%) control (serious AE) |
| Asthenia (weakness) | 5,253 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.830 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: PRR 28.2 (25.6–31.1) | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 2.0 | NCT00153101: 20/8,576 (0.2%) on Ramipril; 4/2,972 (0.1%) control (serious AE) |
| Arthralgia (joint pain) | 5,186 | 2.1 2.1–2.2ROR 2.2 · calibrated p 0.953 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Angiotensin Converting Enzyme Inhibitors: PRR 39.0 (34.8–43.8) | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 2.3 · ♀ 75% (drug 48%) | NCT00153101: 7/8,576 (0.1%) on Ramipril; 1/2,972 (0.0%) control (serious AE) |
| Malaise (feeling unwell) | 5,158 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.974 | 2.0 EB05 2.0 · IC025 +1.0 vs other Angiotensin Converting Enzyme Inhibitors: PRR 34.0 (30.5–37.8) | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 2.0 · ♀ 69% (drug 48%) | NCT00153101: 2/8,576 (0.0%) on Ramipril (serious AE) |
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.
- Congenital hiatus hernia — n=156, PRR 413.7
- Grip strength — n=135, PRR 239.9
- Swollen joint count — n=113, PRR 145.2
- Lupus vulgaris — n=526, PRR 135.4
- Deep vein thrombosis postoperative — n=815, PRR 121.5
- Rheumatic fever — n=1,599, PRR 98.5
- Hypocholesterolaemia — n=109, PRR 93.4
- Facet joint syndrome — n=1,077, PRR 88.4
- Adjustment disorder with depressed mood — n=625, PRR 76.5
- Dislocation of vertebra — n=643, PRR 69.2 (also seen in trial arm)
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 Ramipril?
In FDA FAERS, the most frequently co-reported reaction terms for Ramipril are dyspnoea, fatigue, nausea, diarrhoea, dizziness, vomiting. 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 Ramipril have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 ).
Do FAERS signals prove that Ramipril 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 055bb582-67cd-425a-8823-d543c14305ce, effective 20260605; matched on
openfda.generic_name.exact:"RAMIPRIL" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 5362129 description (ChEBI)
- 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, 1,234 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
RAMIPRIL, 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.