Rosuvastatin vs Ezetimibe: side effects in FDA adverse event reports
At a glance
| Rosuvastatin | Ezetimibe | |
|---|---|---|
| Drug class | – | Dietary Cholesterol Absorption Inhibitor |
| Brand names | – | – |
| FAERS reports | 82,998 | 74,507 |
| Serious | 77% | 65% |
| Death outcome | 5,613 | 4,305 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Rosuvastatin | Ezetimibe | Label screen (A / B) |
|---|---|---|---|
| Myopathy | 745 · PRR 9.6 | 431 · PRR 14.7 | Labeled adverse reaction / Labeled adverse reaction |
| Dyslipidaemia | 399 · PRR 8.7 | 221 · PRR 12.7 | Likely indication confounding / Labeled adverse reaction |
| Arterial occlusive disease | 486 · PRR 6.7 | 265 · PRR 9.7 | Not in label — unassessed / Not in label — unassessed |
| Nephrogenic anaemia | 487 · PRR 11.9 | 175 · PRR 10.9 | Not in label — unassessed / Not in label — unassessed |
| Hyperparathyroidism secondary | 290 · PRR 13.2 | 119 · PRR 13.8 | Not in label — unassessed / Not in label — unassessed |
| Carotid arteriosclerosis | 139 · PRR 16.1 | 49 · PRR 14.1 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Rosuvastatin
- Rhabdomyolysis — n=3,730, PRR 10.1 Labeled adverse reaction
Labeled signals distinctive to Ezetimibe
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Rosuvastatin or Ezetimibe?
Rosuvastatin has 82,998 FAERS reports and Ezetimibe 74,507. 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 65%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Rosuvastatin and Ezetimibe share?
Both drugs carry disproportionality signals for myopathy, dyslipidaemia, arterial occlusive disease, nephrogenic anaemia, hyperparathyroidism secondary. Shared signals often reflect a shared drug class or the condition both are used for.
Is Rosuvastatin or Ezetimibe 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.