Amlodipine vs Enalapril: side effects in FDA adverse event reports
At a glance
| Amlodipine | Enalapril | |
|---|---|---|
| Drug class | – | – |
| Brand names | Katerzia | Enalapril Maleate |
| FAERS reports | 267,918 | 55,275 |
| Serious | 77% | 84% |
| Death outcome | 29,515 | 5,996 |
| Boxed warning | No | Yes FETAL TOXICITY When pregnancy is detected, discontinue enalapril maleate as soon as possible [see Warnings and Precautions (5.1) ]. Drugs that act directly on t |
Signals both drugs share
| Reaction | Amlodipine | Enalapril | Label screen (A / B) |
|---|---|---|---|
| Nephrogenic anaemia | 961 · PRR 20.0 | 122 · PRR 10.1 | Not in label — unassessed / Not in label — unassessed |
| Hypertensive crisis | 677 · PRR 5.0 | 220 · PRR 7.6 | Likely indication confounding / Likely indication confounding |
| Hyperparathyroidism secondary | 546 · PRR 21.3 | 49 · PRR 7.5 | Not in label — unassessed / Not in label — unassessed |
| Gingival hypertrophy | 446 · PRR 32.8 | 37 · PRR 9.6 | Likely indication confounding / Likely indication confounding |
| Rebound acid hypersecretion | 347 · PRR 9.9 | 55 · PRR 6.9 | Not in label — unassessed / Not in label — unassessed |
| Left ventricular hypertrophy | 301 · PRR 5.8 | 100 · PRR 9.0 | Likely indication confounding / Likely indication confounding |
Labeled signals distinctive to Amlodipine
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Enalapril
- Hyperkalaemia — n=1,086, PRR 12.2 Labeled — boxed warning
- Renal failure acute — n=925, PRR 8.3 Labeled (related wording)
- Cardiac failure acute — n=110, PRR 6.4 Labeled (related wording)
- Cardiac failure chronic — n=103, PRR 9.4 Labeled (related wording)
- Tongue oedema — n=89, PRR 9.0 Labeled (related wording)
- Concomitant disease progression — n=61, PRR 12.1 Labeled (related wording)
- Ischaemic cardiomyopathy — n=56, PRR 7.0 Labeled (related wording)
Common questions
Which has more reported side effects, Amlodipine or Enalapril?
Amlodipine has 267,918 FAERS reports and Enalapril 55,275. 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 (77% vs 84%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Amlodipine and Enalapril share?
Both drugs carry disproportionality signals for nephrogenic anaemia, hypertensive crisis, hyperparathyroidism secondary, gingival hypertrophy, rebound acid hypersecretion. Shared signals often reflect a shared drug class or the condition both are used for.
Is Amlodipine or Enalapril 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.