Simvastatin vs Rosuvastatin: side effects in FDA adverse event reports
At a glance
| Simvastatin | Rosuvastatin | |
|---|---|---|
| Drug class | HMG-CoA Reductase Inhibitor | – |
| Brand names | – | – |
| FAERS reports | 248,690 | 82,998 |
| Serious | 73% | 77% |
| Death outcome | 22,213 | 5,613 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Simvastatin | Rosuvastatin | Label screen (A / B) |
|---|---|---|---|
| Rhabdomyolysis | 5,389 · PRR 12.4 | 3,730 · PRR 10.1 | Labeled adverse reaction / Labeled adverse reaction |
| Myopathy | 1,268 · PRR 14.3 | 745 · PRR 9.6 | Labeled adverse reaction / Labeled adverse reaction |
| Nephrogenic anaemia | 771 · PRR 16.5 | 487 · PRR 11.9 | Not in label — unassessed / Not in label — unassessed |
| Carotid artery occlusion | 574 · PRR 15.5 | 217 · PRR 6.4 | Not in label — unassessed / Not in label — unassessed |
| Hyperparathyroidism secondary | 439 · PRR 17.5 | 290 · PRR 13.2 | Not in label — unassessed / Not in label — unassessed |
| Coronary artery stenosis | 380 · PRR 6.8 | 317 · PRR 6.8 | Likely indication confounding / Not in label — unassessed |
| Rebound acid hypersecretion | 399 · PRR 12.5 | 264 · PRR 9.6 | Not in label — unassessed / Not in label — unassessed |
| Carotid artery stenosis | 238 · PRR 6.1 | 213 · PRR 6.6 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Simvastatin
- Renal failure acute — n=3,263, PRR 6.8 Labeled (related wording)
- Myositis — n=731, PRR 7.4 Labeled adverse reaction
- Renal failure chronic — n=525, PRR 6.0 Labeled (related wording)
- Chronic sinusitis — n=263, PRR 6.3 Labeled (related wording)
- Immune-mediated myositis — n=183, PRR 6.2 Labeled (related wording)
Labeled signals distinctive to Rosuvastatin
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Simvastatin or Rosuvastatin?
Simvastatin has 248,690 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 (73% vs 77%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Simvastatin and Rosuvastatin share?
Both drugs carry disproportionality signals for rhabdomyolysis, myopathy, nephrogenic anaemia, carotid artery occlusion, hyperparathyroidism secondary. Shared signals often reflect a shared drug class or the condition both are used for.
Is Simvastatin 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.