Plaquenil: adverse event reports filed with FDA

21,540

reports as suspect product

0.1% of all reports · about 958 a year

554

reports, 12 months to June 2026

601 in the 12 months before

86.7%

marked serious by the reporter

92.5% across the class

7.2%

record death among outcomes, as reported

1,550 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 Plaquenil reports recording the termmedian drug in antimalarial

1. Drug ineffectivethe medicine did not work as expected55.2%11,890
2. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease38.3%8,249
3. Painpain, site not specified25.9%5,587
4. Drug intolerancethe medicine was not tolerated25.4%5,470
5. Joint swellinga swollen joint22.6%4,876
6. Fatiguetiredness20.6%4,435
7. Arthralgiajoint pain20.2%4,358
8. Contraindicated product administered20.2%4,356
9. Abdominal discomfortstomach discomfort19.1%4,121
10. Alopeciahair loss17.7%3,802
11. Rashskin rash17.1%3,676
12. Arthropathy16.8%3,608
13. Treatment failurethe treatment did not work16.6%3,577
14. Drug hypersensitivityan allergic-type reaction to a medicine15.8%3,398
15. Systemic lupus erythematosuslupus, an autoimmune disease15.6%3,357
16. Off label useused for a purpose or in a way not on the label15.6%3,350
17. Condition aggravatedthe condition being treated got worse15.1%3,257
18. Swellingswelling14.7%3,176
19. Synovitis14.7%3,159
20. Pemphigus14.3%3,087
21. Nauseafeeling sick14%3,017
22. Hypersensitivityan allergic-type reaction13.4%2,884
23. Glossodynia12.7%2,746
24. Hand deformity12.5%2,697
25. Therapeutic product effect decreased12.4%2,666
26. Hepatic enzyme increasedraised liver enzymes12.2%2,626
27. Peripheral swellingswelling of the arms or legs11.3%2,442
28. Wound10.9%2,347
29. Maternal exposure during pregnancythe mother took the medicine during pregnancy10.5%2,265
30. Infusion related reactiona reaction during or soon after an infusion10.4%2,246

Top 30 of 1,866 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 7 drugs in the antimalarial 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 92,320 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. 20.7% 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 21,540 reports.

Drugs most often listed in the same reports

Other products listed in reports where Plaquenil 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 antimalarial 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 Plaquenil as a suspect or interacting product; reports listing it only as a concomitant medication (40,649) 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.