Atorvastatin vs Pravastatin: side effects in FDA adverse event reports
At a glance
| Atorvastatin | Pravastatin | |
|---|---|---|
| Drug class | – | – |
| Brand names | Atorvastatin Calcium | Pravastatin Sodium |
| FAERS reports | 245,741 | 19,671 |
| Serious | 65% | 68% |
| Death outcome | 18,671 | 1,710 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Atorvastatin | Pravastatin | Label screen (A / B) |
|---|---|---|---|
| Nephrogenic anaemia | 569 · PRR 11.7 | 58 · PRR 13.4 | Not in label — unassessed / Not in label — unassessed |
| Amaurosis fugax | 173 · PRR 16.3 | 156 · PRR 182.1 | Not in label — unassessed / Not in label — unassessed |
| Hyperparathyroidism secondary | 292 · PRR 11.0 | 28 · PRR 11.9 | Not in label — unassessed / Not in label — unassessed |
| Rebound acid hypersecretion | 242 · PRR 7.2 | 21 · PRR 7.3 | Not in label — unassessed / Not in label — unassessed |
| Essential hypertension | 199 · PRR 7.0 | 20 · PRR 8.3 | Likely indication confounding / Likely indication confounding |
| Chronic kidney disease-mineral and bone disorder | 143 · PRR 12.9 | 13 · PRR 13.0 | 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)
- Myopathy — n=791, PRR 8.5 Labeled adverse reaction
- 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 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, Atorvastatin or Pravastatin?
Atorvastatin has 245,741 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 (65% vs 68%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Atorvastatin and Pravastatin share?
Both drugs carry disproportionality signals for nephrogenic anaemia, amaurosis fugax, hyperparathyroidism secondary, rebound acid hypersecretion, essential hypertension. Shared signals often reflect a shared drug class or the condition both are used for.
Is Atorvastatin 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.