Pravastatin side effects: what 19,671 FDA adverse event reports show
Drug class
Hmg-coa reductase inhibitor (statin)
Label matched
Pravastatin Sodium (Pravastatin Sodium)
Who reports
19,671 reports · 68% serious · 1,710 with death outcome · 57% female
Used for
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
What it is
Pravastatin sodium is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,105 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Amaurosis fugax | 156 | 182.1 153.7–215.7ROR 183.5 · χ² 23,786 / p <1e-300 | 152.4 EB05 133.4 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=156 · 94% clinician | not reported in cached trials |
| Microsporidia infection | 23 | 73.6 48.3–112.4ROR 73.7 · χ² 1,473 / p <1e-300 | 65.3 EB05 45.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 57%) | not reported in cached trials |
| Catarrh | 41 | 51.4 37.6–70.4ROR 51.6 · χ² 1,886 / p <1e-300 | 48.1 EB05 36.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=41 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Steroid dependence | 36 | 47.1 33.7–65.7ROR 47.2 · χ² 1,510 / p <1e-300 | 44.1 EB05 33.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Urinary tract disorder | 139 | 33.9 28.7–40.2ROR 34.2 · χ² 4,274 / p <1e-300 | 32.8 EB05 28.5 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=136 · 93% clinician | NCT00221104: 2/780 (0.3%) on Pravastatin; 2/785 (0.3%) control (serious AE) |
| Periorbital pain | 21 | 28.6 18.5–44.1ROR 28.6 · χ² 518 / p 5e-115 | 27.3 EB05 18.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Haemorrhagic stroke | 204 | 28.4 24.7–32.6ROR 28.7 · χ² 5,219 / p <1e-300 | 27.6 EB05 24.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 23.5 | not reported in cached trials |
| Burns second degree | 41 | 25.5 18.7–34.8ROR 25.6 · χ² 920 / p 2e-202 | 24.7 EB05 19.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=41 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Pneumocystis jirovecii infection | 24 | 22.6 15.1–33.9ROR 22.7 · χ² 465 / p 2e-103 | 21.8 EB05 15.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 0% (drug 57%) · 71% consumer | not reported in cached trials |
| Diaphragmatic disorder | 15 | 21.1 12.7–35.2ROR 21.1 · χ² 262 / p 3e-59 | 20.1 EB05 12.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Ocular discomfort | 183 | 18.2 15.8–21.1ROR 18.4 · χ² 2,916 / p <1e-300 | 17.9 EB05 15.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=156 | not reported in cached trials |
| Alcohol poisoning | 40 | 16.3 11.9–22.3ROR 16.3 · χ² 550 / p 5e-122 | 15.9 EB05 12.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Hypopnoea | 44 | 13.7 10.2–18.5ROR 13.7 · χ² 499 / p 7e-111 | 13.3 EB05 10.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=43 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Nephrogenic anaemia | 58 | 13.4 10.3–17.3ROR 13.4 · χ² 643 / p 3e-142 | 13.0 EB05 10.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=58 | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 13 | 13.0 7.5–22.5ROR 13.0 · χ² 131 / p 1e-30 | 11.5 EB05 6.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Infusion site discharge | 20 | 12.6 8.1–19.6ROR 12.6 · χ² 200 / p 1e-45 | 11.6 EB05 7.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Generalised oedema | 143 | 12.5 10.6–14.7ROR 12.6 · χ² 1,485 / p <1e-300 | 12.3 EB05 10.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · 96% clinician | not reported in cached trials |
| Coma scale abnormal | 33 | 12.4 8.8–17.5ROR 12.4 · χ² 331 / p 3e-74 | 11.8 EB05 8.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 0% (drug 57%) · 72% consumer | not reported in cached trials |
| Hyperparathyroidism secondary | 28 | 11.9 8.2–17.3ROR 11.9 · χ² 266 / p 5e-60 | 11.2 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=28 | not reported in cached trials |
| Loss of control of legs | 41 | 11.5 8.5–15.7ROR 11.6 · χ² 380 / p 6e-85 | 11.0 EB05 8.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=39 · ♀ 0% (drug 57%) | not reported in cached trials |
| Altered state of consciousness | 227 | 11.3 9.9–12.9ROR 11.5 · χ² 2,107 / p <1e-300 | 11.2 EB05 10.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · 90% clinician | NCT00221104: 1/785 (0.1%) control (serious AE) |
| Eyelid pain | 20 | 11.1 7.1–17.2ROR 11.1 · χ² 172 / p 2e-39 | 10.0 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Head discomfort | 174 | 10.6 9.2–12.3ROR 10.7 · χ² 1,493 / p <1e-300 | 10.4 EB05 9.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 | not reported in cached trials |
| Echocardiogram abnormal | 13 | 10.0 5.8–17.3ROR 10.0 · χ² 96 / p 7e-23 | 8.3 EB05 4.8 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious n=12 | not reported in cached trials |
| Acute sinusitis | 16 | 10.0 6.1–16.3ROR 10.0 · χ² 119 / p 4e-28 | 8.6 EB05 5.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=15 | NCT00221104: 1/785 (0.1%) control (serious AE) |
| Infusion site bruising | 19 | 9.6 6.1–15.1ROR 9.6 · χ² 137 / p 8e-32 | 8.4 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 12 | 9.2 5.2–16.3ROR 9.2 · χ² 79 / p 3e-19 | 7.5 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Photophobia (light sensitivity) | 160 | 9.2 7.9–10.7ROR 9.3 · χ² 1,152 / p 8e-253 | 9.0 EB05 7.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | not reported in cached trials |
| Pre-existing condition improved | 54 | 9.2 7.0–12.0ROR 9.2 · χ² 383 / p 2e-85 | 8.7 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=39 · ♀ 78% (drug 57%) | not reported in cached trials |
| Essential hypertension | 20 | 8.3 5.3–12.9ROR 8.3 · χ² 120 / p 3e-28 | 7.2 EB05 4.8 · IC025 +2.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | not reported in cached trials |
| Haematemesis (vomiting blood) | 188 | 7.9 6.9–9.1ROR 8.0 · χ² 1,124 / p 8e-247 | 7.8 EB05 6.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | not reported in cached trials |
| Diplopia (double vision) | 186 | 7.7 6.6–8.9ROR 7.7 · χ² 1,067 / p 3e-234 | 7.5 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 | not reported in cached trials |
| Bronchiectasis | 47 | 7.6 5.7–10.1ROR 7.6 · χ² 259 / p 1e-58 | 7.1 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=47 · ♀ 0% (drug 57%) · 91% clinician | not reported in cached trials |
| Cholestatic liver injury | 15 | 7.5 4.5–12.5ROR 7.5 · χ² 78 / p 6e-19 | 6.3 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | not reported in cached trials |
| Vascular pseudoaneurysm | 12 | 7.4 4.2–13.0ROR 7.4 · χ² 59 / p 6e-15 | 5.9 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Rebound acid hypersecretion | 21 | 7.3 4.8–11.3ROR 7.3 · χ² 108 / p 1e-25 | 6.4 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Lumbar spinal stenosis | 20 | 7.3 4.7–11.3ROR 7.3 · χ² 102 / p 3e-24 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=18 | NCT00221104: 1/780 (0.1%) on Pravastatin; 3/785 (0.4%) control (serious AE) |
| Gingival pain | 54 | 7.3 5.6–9.5ROR 7.3 · χ² 284 / p 6e-64 | 6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 18% (drug 57%) | not reported in cached trials |
| Seasonal allergy | 95 | 7.2 5.9–8.8ROR 7.2 · χ² 499 / p 8e-111 | 7.0 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=59 · 74% consumer | not reported in cached trials |
| Ascites | 196 | 7.1 6.2–8.2ROR 7.2 · χ² 1,023 / p 8e-225 | 7.0 EB05 6.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 91% clinician | NCT00221104: 1/785 (0.1%) control (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Pravastatin as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (5 of 40 signal terms matched).
- NCT00221104 — Japan Statin Treatment Against Recurrent Stroke (J-STARS) (N=1578, PHASE3; 260 AE terms posted; arms: Pravastatin Group; Control Group)
- NCT00257686 — Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients (N=962, PHASE3; 22 AE terms posted; arms: Pitavastatin 1 mg; Pravastatin 10 mg; Pitavastatin 2 mg; Pravastatin 20 mg)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 1,338 | 1.8 1.7–1.9ROR 1.9 · χ² 528 / p 5e-117 | 1.8 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.9 | NCT00257686: 4/103 (3.9%) on Pravastatin |
| Diarrhoea (diarrhea) | 1,172 | 1.9 1.8–2.1ROR 2.0 · χ² 551 / p 3e-122 | 1.9 EB05 1.8 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.0 | not reported in cached trials |
| Nausea | 1,000 | 1.4 1.3–1.4ROR 1.4 · χ² 94 / p 1e-22 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.5 | NCT00257686: 1/96 (1.0%) on Pravastatin |
| Dyspnoea (shortness of breath) | 985 | 1.9 1.7–2.0ROR 1.9 · χ² 399 / p 5e-89 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.7 | not reported in cached trials |
| Headache | 901 | 1.5 1.4–1.6ROR 1.6 · χ² 172 / p 2e-39 | 1.5 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00221104: 3/780 (0.4%) on Pravastatin (serious AE) |
| Drug ineffective (drug did not work) | 879 | 0.7 0.7–0.8ROR 0.7 · χ² 110 / p 6e-26 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Fall | 867 | 2.8 2.6–3.0ROR 2.9 · χ² 1,002 / p 4e-220 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | not reported in cached trials |
| Dizziness | 789 | 1.7 1.6–1.8ROR 1.7 · χ² 226 / p 2e-51 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.8 | NCT00221104: 4/780 (0.5%) on Pravastatin; 4/785 (0.5%) control (serious AE) |
| Arthralgia (joint pain) | 735 | 1.9 1.8–2.0ROR 1.9 · χ² 314 / p 2e-70 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.1 | NCT00221104: 1/785 (0.1%) control (serious AE) |
| Asthenia (weakness) | 727 | 2.1 1.9–2.2ROR 2.1 · χ² 403 / p 7e-90 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.0 | NCT00221104: 1/780 (0.1%) on Pravastatin; 2/785 (0.3%) control (serious AE) |
| Cough | 722 | 2.8 2.6–3.0ROR 2.8 · χ² 813 / p 3e-179 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | not reported in cached trials |
| Pain | 721 | 1.2 1.2–1.3ROR 1.3 · χ² 36 / p 8e-10 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.0 | NCT00221104: 1/780 (0.1%) on Pravastatin (serious AE) |
| Pruritus (itching) | 674 | 1.9 1.8–2.0ROR 1.9 · χ² 292 / p 9e-66 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.3 | not reported in cached trials |
| Myalgia (muscle pain) | 656 | 4.1 3.8–4.4ROR 4.2 · χ² 1,556 / p <1e-300 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | NCT00221104: 2/780 (0.3%) on Pravastatin (serious AE) |
| Malaise (feeling unwell) | 642 | 1.6 1.4–1.7ROR 1.6 · χ² 130 / p 2e-30 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00221104: 4/780 (0.5%) on Pravastatin (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Amaurosis fugax — n=156, PRR 182.1
- Microsporidia infection — n=23, PRR 73.6
- Catarrh — n=41, PRR 51.4
- Steroid dependence — n=36, PRR 47.1
- Periorbital pain — n=21, PRR 28.6
- Haemorrhagic stroke — n=204, PRR 28.4
- Burns second degree — n=41, PRR 25.5
- Pneumocystis jirovecii infection — n=24, PRR 22.6
- Ocular discomfort — n=183, PRR 18.2
- Alcohol poisoning — n=40, PRR 16.3
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Pravastatin?
In FDA FAERS, the most frequently co-reported reaction terms for Pravastatin are fatigue, diarrhoea, nausea, dyspnoea, headache, fall. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Pravastatin have an FDA boxed warning?
No. The FDA label retrieved for Pravastatin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pravastatin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 01beb7e2-ba01-4f2f-8554-4a8ec0941c9f, effective 20240814; matched on
openfda.generic_name.exact:"PRAVASTATIN SODIUM") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,145 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
PRAVASTATIN, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.