Losartan vs Enalapril: side effects in FDA adverse event reports
At a glance
| Losartan | Enalapril | |
|---|---|---|
| Drug class | – | – |
| Brand names | Losartan Potassium | Enalapril Maleate |
| FAERS reports | 173,627 | 55,275 |
| Serious | 63% | 84% |
| Death outcome | 12,522 | 5,996 |
| Boxed warning | Yes FETAL TOXICITY When pregnancy is detected, discontinue losartan potassium tablets as soon as possible. Drugs that act directly on the renin-angiotensin system c | 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 | Losartan | Enalapril | Label screen (A / B) |
|---|---|---|---|
| Nephrogenic anaemia | 650 · PRR 19.4 | 122 · PRR 10.1 | Likely indication confounding / Not in label — unassessed |
| Hyperparathyroidism secondary | 364 · PRR 20.1 | 49 · PRR 7.5 | Not in label — unassessed / Not in label — unassessed |
| Rebound acid hypersecretion | 339 · PRR 14.9 | 55 · PRR 6.9 | Not in label — unassessed / Not in label — unassessed |
| Loss of employment | 124 · PRR 5.1 | 113 · PRR 14.6 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Losartan
- Acute kidney injury — n=4,669, PRR 3.8 Labeled — boxed warning
- Chronic kidney disease — n=4,187, PRR 6.9 Labeled — boxed warning
- Renal injury — n=930, PRR 3.8 Labeled (related wording)
- Vasculitis — n=456, PRR 4.9 Labeled adverse reaction
- Tension headache — n=408, PRR 12.6 Labeled (related wording)
- Oligohydramnios — n=100, PRR 3.7 Labeled — boxed warning
- Essential hypertension — n=96, PRR 4.6 Labeled adverse reaction
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, Losartan or Enalapril?
Losartan has 173,627 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 (63% vs 84%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Losartan and Enalapril share?
Both drugs carry disproportionality signals for nephrogenic anaemia, hyperparathyroidism secondary, rebound acid hypersecretion, loss of employment. Shared signals often reflect a shared drug class or the condition both are used for.
Is Losartan 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.