Simvastatin vs Pravastatin: side effects in FDA adverse event reports
At a glance
| Simvastatin | Pravastatin | |
|---|---|---|
| Drug class | HMG-CoA Reductase Inhibitor | – |
| Brand names | – | Pravastatin Sodium |
| FAERS reports | 248,690 | 19,671 |
| Serious | 73% | 68% |
| Death outcome | 22,213 | 1,710 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Simvastatin | Pravastatin | Label screen (A / B) |
|---|---|---|---|
| Nephrogenic anaemia | 771 · PRR 16.5 | 58 · PRR 13.4 | Not in label — unassessed / Not in label — unassessed |
| Hyperparathyroidism secondary | 439 · PRR 17.5 | 28 · PRR 11.9 | Not in label — unassessed / Not in label — unassessed |
| Amaurosis fugax | 265 · PRR 27.5 | 156 · PRR 182.1 | Not in label — unassessed / Not in label — unassessed |
| Rebound acid hypersecretion | 399 · PRR 12.5 | 21 · PRR 7.3 | Not in label — unassessed / Not in label — unassessed |
| Chronic kidney disease-mineral and bone disorder | 219 · PRR 21.4 | 13 · PRR 13.0 | 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)
- Myopathy — n=1,268, PRR 14.3 Labeled adverse reaction
- 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 Pravastatin
- Diplopia — n=186, PRR 7.7 Labeled adverse reaction
- Urinary tract disorder — n=139, PRR 33.9 Labeled (related wording)
- Cholestatic liver injury — n=15, PRR 7.5 Labeled (related wording)
Common questions
Which has more reported side effects, Simvastatin or Pravastatin?
Simvastatin has 248,690 FAERS reports and Pravastatin 19,671. 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 68%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Simvastatin and Pravastatin share?
Both drugs carry disproportionality signals for nephrogenic anaemia, hyperparathyroidism secondary, amaurosis fugax, rebound acid hypersecretion, chronic kidney disease-mineral and bone disorder. Shared signals often reflect a shared drug class or the condition both are used for.
Is Simvastatin or Pravastatin 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.