Atorvastatin vs Ezetimibe: side effects in FDA adverse event reports
At a glance
| Atorvastatin | Ezetimibe | |
|---|---|---|
| Drug class | – | Dietary Cholesterol Absorption Inhibitor |
| Brand names | Atorvastatin Calcium | – |
| FAERS reports | 245,741 | 74,507 |
| Serious | 65% | 65% |
| Death outcome | 18,671 | 4,305 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Atorvastatin | Ezetimibe | Label screen (A / B) |
|---|---|---|---|
| Myopathy | 791 · PRR 8.5 | 431 · PRR 14.7 | Labeled adverse reaction / Labeled adverse reaction |
| Immune-mediated myositis | 348 · PRR 12.8 | 95 · PRR 10.5 | Labeled (related wording) / Not in label — unassessed |
| Arterial occlusive disease | 685 · PRR 8.0 | 265 · PRR 9.7 | Not in label — unassessed / Not in label — unassessed |
| Angina unstable | 524 · PRR 7.3 | 247 · PRR 11.0 | Not in label — unassessed / Not in label — unassessed |
| Nephrogenic anaemia | 569 · PRR 11.7 | 175 · PRR 10.9 | Not in label — unassessed / Not in label — unassessed |
| Personality disorder | 293 · PRR 10.6 | 177 · PRR 20.2 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder | 261 · PRR 21.1 | 166 · PRR 40.9 | Not in label — unassessed / Not in label — unassessed |
| Carotid artery thrombosis | 255 · PRR 36.1 | 172 · PRR 70.9 | Not in label — unassessed / Not in label — unassessed |
| Neurologic neglect syndrome | 253 · PRR 70.1 | 171 · PRR 123.8 | Not in label — unassessed / Not in label — unassessed |
| Amaurosis fugax | 173 · PRR 16.3 | 239 · PRR 80.9 | Not in label — unassessed / Not in label — unassessed |
| Hyperparathyroidism secondary | 292 · PRR 11.0 | 119 · PRR 13.8 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Atorvastatin
- Type 2 diabetes mellitus — n=11,260, PRR 42.4 Labeled (related wording)
- Muscle disorder — n=733, PRR 8.4 Labeled (related wording)
- Immune-mediated necrotising myopathy — n=149, PRR 31.6 Labeled (related wording)
Labeled signals distinctive to Ezetimibe
- Dyslipidaemia — n=221, PRR 12.7 Labeled adverse reaction
Common questions
Which has more reported side effects, Atorvastatin or Ezetimibe?
Atorvastatin has 245,741 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 (65% vs 65%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Atorvastatin and Ezetimibe share?
Both drugs carry disproportionality signals for myopathy, immune-mediated myositis, arterial occlusive disease, angina unstable, nephrogenic anaemia. Shared signals often reflect a shared drug class or the condition both are used for.
Is Atorvastatin 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.