Atorvastatin vs Rosuvastatin: side effects in FDA adverse event reports
At a glance
| Atorvastatin | Rosuvastatin | |
|---|---|---|
| Drug class | – | – |
| Brand names | Atorvastatin Calcium | – |
| FAERS reports | 245,741 | 82,998 |
| Serious | 65% | 77% |
| Death outcome | 18,671 | 5,613 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Atorvastatin | Rosuvastatin | Label screen (A / B) |
|---|---|---|---|
| Myopathy | 791 · PRR 8.5 | 745 · PRR 9.6 | Labeled adverse reaction / Labeled adverse reaction |
| Coronary artery occlusion | 1,105 · PRR 7.4 | 943 · PRR 7.5 | Likely indication confounding / Not in label — unassessed |
| Arterial occlusive disease | 685 · PRR 8.0 | 486 · PRR 6.7 | Not in label — unassessed / Not in label — unassessed |
| Nephrogenic anaemia | 569 · PRR 11.7 | 487 · PRR 11.9 | Not in label — unassessed / Not in label — unassessed |
| Coronary artery stenosis | 391 · PRR 7.1 | 317 · PRR 6.8 | Likely indication confounding / Not in label — unassessed |
| Hyperparathyroidism secondary | 292 · PRR 11.0 | 290 · PRR 13.2 | Not in label — unassessed / Not in label — unassessed |
| Rebound acid hypersecretion | 242 · PRR 7.2 | 264 · PRR 9.6 | Not in label — unassessed / Not in label — unassessed |
| Carotid artery stenosis | 277 · PRR 7.2 | 213 · PRR 6.6 | Not in label — unassessed / Not in label — unassessed |
| Carotid artery occlusion | 260 · PRR 6.5 | 217 · PRR 6.4 | Not in label — unassessed / Not in label — unassessed |
| Essential hypertension | 199 · PRR 7.0 | 152 · PRR 6.4 | Likely indication confounding / Likely indication confounding |
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 myositis — n=348, PRR 12.8 Labeled (related wording)
- Immune-mediated necrotising myopathy — n=149, PRR 31.6 Labeled (related wording)
Labeled signals distinctive to Rosuvastatin
- Rhabdomyolysis — n=3,730, PRR 10.1 Labeled adverse reaction
Common questions
Which has more reported side effects, Atorvastatin or Rosuvastatin?
Atorvastatin has 245,741 FAERS reports and Rosuvastatin 82,998. 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 77%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Atorvastatin and Rosuvastatin share?
Both drugs carry disproportionality signals for myopathy, coronary artery occlusion, arterial occlusive disease, nephrogenic anaemia, coronary artery stenosis. Shared signals often reflect a shared drug class or the condition both are used for.
Is Atorvastatin or Rosuvastatin 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.