Simvastatin vs Atorvastatin: side effects in FDA adverse event reports
At a glance
| Simvastatin | Atorvastatin | |
|---|---|---|
| Drug class | HMG-CoA Reductase Inhibitor | – |
| Brand names | – | Atorvastatin Calcium |
| FAERS reports | 248,690 | 245,741 |
| Serious | 73% | 65% |
| Death outcome | 22,213 | 18,671 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Simvastatin | Atorvastatin | Label screen (A / B) |
|---|---|---|---|
| Myopathy | 1,268 · PRR 14.3 | 791 · PRR 8.5 | Labeled adverse reaction / Labeled adverse reaction |
| Chronic sinusitis | 263 · PRR 6.3 | 321 · PRR 7.9 | Labeled (related wording) / Not in label — unassessed |
| Immune-mediated myositis | 183 · PRR 6.2 | 348 · PRR 12.8 | Labeled (related wording) / Labeled (related wording) |
| Hyperlipidaemia | 874 · PRR 6.6 | 870 · PRR 6.6 | Likely indication confounding / Likely indication confounding |
| Nephrogenic anaemia | 771 · PRR 16.5 | 569 · PRR 11.7 | Not in label — unassessed / Not in label — unassessed |
| Diabetic neuropathy | 362 · PRR 6.5 | 509 · PRR 9.6 | Likely indication confounding / Likely indication confounding |
| Carotid artery occlusion | 574 · PRR 15.5 | 260 · PRR 6.5 | Not in label — unassessed / Not in label — unassessed |
| Coronary artery stenosis | 380 · PRR 6.8 | 391 · PRR 7.1 | Likely indication confounding / Likely indication confounding |
| Hyperparathyroidism secondary | 439 · PRR 17.5 | 292 · PRR 11.0 | Not in label — unassessed / Not in label — unassessed |
| Rebound acid hypersecretion | 399 · PRR 12.5 | 242 · PRR 7.2 | Not in label — unassessed / Not in label — unassessed |
| Ischaemic cardiomyopathy | 254 · PRR 7.4 | 289 · PRR 8.7 | Not in label — unassessed / Likely indication confounding |
| Carotid artery stenosis | 238 · PRR 6.1 | 277 · PRR 7.2 | Not in label — unassessed / Not in label — unassessed |
| Radiculopathy | 231 · PRR 8.0 | 263 · PRR 9.3 | Not in label — unassessed / Not in label — unassessed |
| Amaurosis fugax | 265 · PRR 27.5 | 173 · PRR 16.3 | Not in label — unassessed / Not in label — unassessed |
| Chronic kidney disease-mineral and bone disorder | 219 · PRR 21.4 | 143 · PRR 12.9 | Not in label — unassessed / Not in label — unassessed |
| Female genital tract fistula | 158 · PRR 8.4 | 175 · PRR 9.5 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Simvastatin
- Rhabdomyolysis — n=5,389, PRR 12.4 Labeled adverse reaction
- 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)
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)
Common questions
Which has more reported side effects, Simvastatin or Atorvastatin?
Simvastatin has 248,690 FAERS reports and Atorvastatin 245,741. 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 65%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Simvastatin and Atorvastatin share?
Both drugs carry disproportionality signals for myopathy, chronic sinusitis, immune-mediated myositis, hyperlipidaemia, nephrogenic anaemia. Shared signals often reflect a shared drug class or the condition both are used for.
Is Simvastatin or Atorvastatin 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.