Lisinopril vs Valsartan: side effects in FDA adverse event reports
At a glance
| Lisinopril | Valsartan | |
|---|---|---|
| Drug class | – | Angiotensin 2 Receptor Blocker |
| Brand names | – | – |
| FAERS reports | 304,208 | 104,469 |
| Serious | 61% | 76% |
| Death outcome | 25,263 | 9,543 |
| 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 • When pregnancy is detected, discontinue valsartan tablets as soon as possible. (5.1) • Drugs that act directly on the r |
Signals both drugs share
| Reaction | Lisinopril | Valsartan | Label screen (A / B) |
|---|---|---|---|
| End stage renal disease | 2,831 · PRR 12.4 | 706 · PRR 8.0 | Not in label — unassessed / Not in label — unassessed |
| Nephrogenic anaemia | 1,334 · PRR 27.2 | 433 · PRR 20.4 | Not in label — unassessed / Not in label — unassessed |
| Hyperparathyroidism secondary | 682 · PRR 25.1 | 215 · PRR 18.5 | Not in label — unassessed / Not in label — unassessed |
| Rebound acid hypersecretion | 729 · PRR 21.3 | 135 · PRR 9.2 | Not in label — unassessed / Not in label — unassessed |
| Chronic kidney disease-mineral and bone disorder | 386 · PRR 38.3 | 84 · PRR 16.9 | Not in label — unassessed / Not in label — unassessed |
| Brash syndrome | 211 · PRR 12.5 | 73 · PRR 11.4 | 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
- Subcutaneous drug absorption impaired — n=203, PRR 40.6 Labeled (related wording)
Labeled signals distinctive to Valsartan
- Blood pressure inadequately controlled — n=795, PRR 30.2 Labeled (related wording)
- Infarction — n=332, PRR 10.1 Labeled — boxed warning
- Oligohydramnios — n=270, PRR 17.5 Labeled — boxed warning
- Foetal disorder — n=87, PRR 22.9 Labeled (related wording)
- Renal artery stenosis — n=82, PRR 12.6 Labeled adverse reaction
Common questions
Which has more reported side effects, Lisinopril or Valsartan?
Lisinopril has 304,208 FAERS reports and Valsartan 104,469. 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 76%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Lisinopril and Valsartan share?
Both drugs carry disproportionality signals for end stage renal disease, nephrogenic anaemia, hyperparathyroidism secondary, rebound acid hypersecretion, chronic kidney disease-mineral and bone disorder. Shared signals often reflect a shared drug class or the condition both are used for.
Is Lisinopril or Valsartan 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.