Lipitor: adverse event reports filed with FDA

55,172

reports as suspect product

0.3% of all reports · about 2,453 a year

356

reports, 12 months to June 2026

435 in the 12 months before

71.8%

marked serious by the reporter

74% across the class

6.6%

record death among outcomes, as reported

3,637 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 Lipitor reports recording the termmedian drug in hmg-coa reductase inhibitor

1. Type 2 diabetes mellitustype 2 diabetes18.5%10,180
2. Myalgiamuscle pain10.7%5,883
3. Drug hypersensitivityan allergic-type reaction to a medicine6.1%3,339
4. Pain in extremitypain in an arm or leg5.1%2,805
5. Muscle spasmsmuscle cramps4.3%2,396
6. Arthralgiajoint pain4.1%2,249
7. Painpain, site not specified3.9%2,171
8. Muscular weaknessmuscle weakness3.8%2,109
9. Fatiguetiredness3.7%2,039
10. Astheniaweakness or lack of energy3.7%2,029
11. Deaththe patient died; cause not stated by this term3.2%1,754
12. Blood cholesterol increasedraised cholesterol3%1,672
13. Drug ineffectivethe medicine did not work as expected2.9%1,602
14. Myocardial infarctionheart attack2.6%1,462
15. Headachehead pain2.6%1,421
16. Malaisegeneral feeling of being unwell2.6%1,419
17. Cerebrovascular accidentstroke2.6%1,418
18. Nauseafeeling sick2.4%1,346
19. Blood creatine phosphokinase increased2.1%1,132
20. Falla fall2.1%1,132
21. Dyspnoeashortness of breath2%1,119
22. Gait disturbancedifficulty walking2%1,117
23. Rhabdomyolysismuscle breakdown2%1,102
24. Weight decreasedweight loss2%1,096
25. Back painback pain2%1,087
26. Dizzinesslight-headedness or unsteadiness2%1,087
27. Hypertensionhigh blood pressure2%1,084
28. Diarrhoealoose or frequent stools1.8%986
29. Diabetes mellitusdiabetes1.7%961
30. Neuropathy peripheralnerve damage in hands or feet1.7%958

Top 30 of 2,284 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. 71.4% 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 55,172 reports.

Drugs most often listed in the same reports

Other products listed in reports where Lipitor 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 Lipitor as a suspect or interacting product; reports listing it only as a concomitant medication (123,761) 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.