What the label lists and what reports show
Pravastatin side effects
Pravastatin's FDA label: “In short-term clinical trials, the most commonly reported adverse reactions (≥2% and greater than placebo) were: musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache.” FAERS holds 19,683 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (1,338 reports).
- Generic listed
Check it at the source: the pravastatin FDA label on DailyMed (effective July 31, 2026, Apotex Corp.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsIn short-term clinical trials, the most commonly reported adverse reactions (≥2% and greater than placebo) were: musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | % Placebo N=411 | % Any Dose N=902 |
|---|---|---|
| Nausea/Vomiting | 7.1 | 7.4 |
| Diarrhea | 5.6 | 6.7 |
| Headache | 4.6 | 6.3 |
| Upper Respiratory Infection | 5.8 | 5.9 |
| Angina Pectoris | 3.4 | 4.5 |
| Rash | 1.4 | 4.5 |
| CPK Increased | 3.6 | 4.1 |
| Dizziness | 3.4 | 3.5 |
| ALT Increased | 1.2 | 2.9 |
| Chest Pain | 1.9 | 2.7 |
| Cough | 1.7 | 2.5 |
| Myalgia | 1.2 | 2.3 |
| Influenza | 0.7 | 2.0 |
| g-GT Increased | 1.2 | 2.0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 )] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions ( 5.2 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.3 )] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions ( 5.4 )] In short-term clinical trials, the most commonly reported adverse reactions (≥2% and greater than placebo) were: musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In pravastatin placebo-controlled clinical trials, 1,313 patients (age range 20 to 76 years, 32% women, 93.5% White, 5% Black, 0.9% Hispanic, 0.4% Asian, 0.2% Other) with a median treatment duration of 14 weeks, 3.3% of patients on pravastatin and 1.2% patients on placebo discontinued due to adverse reactions (regardless of causality). …
Source: FDA drug label, Apotex Corp., effective July 31, 2026 (SPL set dcf45e4f-b46e-6fbb-b67a-2ff619ab1780), via openFDA; the full label on DailyMed
What do FAERS reports show?
19,683 reports list pravastatin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,710 are coded as a death and 6,897 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Pravastatin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions