Pravastatin sodium: adverse event reports filed with FDA

3,767

reports as suspect product

0% of all reports · about 167 a year

156

reports, 12 months to June 2026

229 in the 12 months before

77.6%

marked serious by the reporter

74% across the class

12.6%

record death among outcomes, as reported

474 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Pravastatin sodium reports recording the termmedian drug in hmg-coa reductase inhibitor

1. Myalgiamuscle pain13%489
2. Fatiguetiredness7.8%295
3. Arthralgiajoint pain7.7%290
4. Dyspnoeashortness of breath7.3%276
5. Diarrhoealoose or frequent stools7.2%270
6. Pruritusitching6.5%243
7. Nauseafeeling sick6.4%241
8. Drug interactionan interaction between medicines6.3%238
9. Dizzinesslight-headedness or unsteadiness6.2%234
10. Headachehead pain6.1%228
11. Falla fall5.9%221
12. Astheniaweakness or lack of energy5.8%218
13. Drug ineffectivethe medicine did not work as expected5.7%215
14. Coughcough5.6%211
15. Malaisegeneral feeling of being unwell5.5%208
16. Vomitingbeing sick5.3%199
17. Insomniadifficulty sleeping5%189
18. Haemorrhagic stroke4.8%180
19. Chillschills or shivering4.7%177
20. Cardio-respiratory arrestthe heart and breathing stopped4.6%174
21. Pain in extremitypain in an arm or leg4.6%172
22. Sepsisa severe body-wide response to infection4.6%172
23. Pyrexiafever4.5%171
24. Abdominal painstomach or belly pain4.5%170
25. Altered state of consciousness4.4%166
26. Decreased appetitereduced appetite4.4%165
27. Tachycardiafast heart rate4.2%160
28. Abdominal pain upperupper stomach pain4.2%159
29. Ascitesfluid in the abdomen4.2%159
30. Diplopiadouble vision4.2%158

Top 30 of 804 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 13 drugs in the hmg-coa reductase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 204,462 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 35.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 3,767 reports.

Drugs most often listed in the same reports

Other products listed in reports where Pravastatin sodium is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the hmg-coa reductase inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Pravastatin sodium as a suspect or interacting product; reports listing it only as a concomitant medication (16,264) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.