Lisinopril vs Ramipril: side effects in FDA adverse event reports
At a glance
| Lisinopril | Ramipril | |
|---|---|---|
| Drug class | – | Angiotensin Converting Enzyme Inhibitor |
| Brand names | – | – |
| FAERS reports | 304,208 | 123,136 |
| Serious | 61% | 93% |
| Death outcome | 25,263 | 13,282 |
| Boxed warning | Yes FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue lisinopril as soon as possible. ( 5.1 ) Drug | Yes FETAL TOXICITY WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning When pregnancy is detected, discontinue ramipril as soon as p |
Signals both drugs share
| Reaction | Lisinopril | Ramipril | Label screen (A / B) |
|---|---|---|---|
| Pemphigus | 1,629 · PRR 10.3 | 2,700 · PRR 47.1 | Not in label — unassessed / Labeled adverse reaction |
| Sleep disorder due to general medical condition, insomnia type | 800 · PRR 9.6 | 846 · PRR 25.7 | Not in label — unassessed / Labeled (related wording) |
| Subcutaneous drug absorption impaired | 203 · PRR 40.6 | 216 · PRR 112.1 | Labeled (related wording) / Labeled (related wording) |
| Hand deformity | 1,464 · PRR 8.6 | 2,329 · PRR 36.8 | Not in label — unassessed / Not in label — unassessed |
| Duodenal ulcer perforation | 1,428 · PRR 16.4 | 1,931 · PRR 60.7 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 1,456 · PRR 11.3 | 1,882 · PRR 38.4 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 1,193 · PRR 8.9 | 1,720 · PRR 33.9 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 1,150 · PRR 24.4 | 1,599 · PRR 98.5 | Not in label — unassessed / Not in label — unassessed |
| Muscle injury | 1,093 · PRR 10.4 | 1,567 · PRR 40.1 | Not in label — unassessed / Not in label — unassessed |
| Hypercholesterolaemia | 1,031 · PRR 8.2 | 1,381 · PRR 28.6 | Not in label — unassessed / Not in label — unassessed |
| Peripheral venous disease | 720 · PRR 15.0 | 1,119 · PRR 66.2 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 634 · PRR 17.1 | 1,077 · PRR 88.4 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 667 · PRR 35.2 | 815 · PRR 121.5 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 622 · PRR 26.5 | 643 · PRR 69.2 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 639 · PRR 31.7 | 625 · PRR 76.5 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 529 · PRR 54.9 | 526 · PRR 135.4 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 410 · PRR 22.2 | 404 · PRR 54.3 | Not in label — unassessed / Not in label — unassessed |
| Porphyria acute | 207 · PRR 12.0 | 233 · PRR 34.4 | Not in label — unassessed / Not in label — unassessed |
| Neurologic neglect syndrome | 179 · PRR 32.1 | 99 · PRR 36.4 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Lisinopril
- Chronic kidney disease — n=9,125, PRR 9.2 Labeled adverse reaction
- Angioedema — n=6,693, PRR 12.2 Labeled — boxed warning
- Intestinal angioedema — n=265, PRR 86.6 Labeled — boxed warning
Labeled signals distinctive to Ramipril
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Lisinopril or Ramipril?
Lisinopril has 304,208 FAERS reports and Ramipril 123,136. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (61% vs 93%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Lisinopril and Ramipril share?
Both drugs carry disproportionality signals for pemphigus, sleep disorder due to general medical condition, insomnia type, subcutaneous drug absorption impaired, hand deformity, duodenal ulcer perforation. Shared signals often reflect a shared drug class or the condition both are used for.
Is Lisinopril or Ramipril safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.