Amlodipine vs Losartan: side effects in FDA adverse event reports
At a glance
| Amlodipine | Losartan | |
|---|---|---|
| Drug class | – | – |
| Brand names | Katerzia | Losartan Potassium |
| FAERS reports | 267,918 | 173,627 |
| Serious | 77% | 63% |
| Death outcome | 29,515 | 12,522 |
| Boxed warning | No | 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 |
Signals both drugs share
| Reaction | Amlodipine | Losartan | Label screen (A / B) |
|---|---|---|---|
| Acute kidney injury | 9,810 · PRR 5.3 | 4,669 · PRR 3.8 | Not in label — unassessed / Labeled — boxed warning |
| Chronic kidney disease | 5,408 · PRR 5.9 | 4,187 · PRR 6.9 | Likely indication confounding / Labeled — boxed warning |
| End stage renal disease | 1,985 · PRR 9.3 | 1,263 · PRR 8.8 | Not in label — unassessed / Likely indication confounding |
| Nephrogenic anaemia | 961 · PRR 20.0 | 650 · PRR 19.4 | Not in label — unassessed / Likely indication confounding |
| Hyperparathyroidism secondary | 546 · PRR 21.3 | 364 · PRR 20.1 | Not in label — unassessed / Not in label — unassessed |
| Rebound acid hypersecretion | 347 · PRR 9.9 | 339 · PRR 14.9 | Not in label — unassessed / Not in label — unassessed |
| Blood pressure inadequately controlled | 449 · PRR 6.2 | 222 · PRR 4.5 | Likely indication confounding / Likely indication confounding |
| Chronic kidney disease-mineral and bone disorder | 221 · PRR 20.0 | 185 · PRR 24.9 | Not in label — unassessed / Not in label — unassessed |
| Brash syndrome | 245 · PRR 17.1 | 135 · PRR 13.2 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Amlodipine
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Losartan
- 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
Common questions
Which has more reported side effects, Amlodipine or Losartan?
Amlodipine has 267,918 FAERS reports and Losartan 173,627. 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 63%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Amlodipine and Losartan share?
Both drugs carry disproportionality signals for acute kidney injury, chronic kidney disease, end stage renal disease, nephrogenic anaemia, hyperparathyroidism secondary. Shared signals often reflect a shared drug class or the condition both are used for.
Is Amlodipine or Losartan 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.