Arava: adverse event reports filed with FDA

34,203

reports as suspect product

0.2% of all reports · about 1,521 a year

1,424

reports, 12 months to June 2026

2,110 in the 12 months before

89.8%

marked serious by the reporter

92.1% across the class

12.5%

record death among outcomes, as reported

4,262 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 Arava reports recording the termmedian drug in antirheumatic agent

1. Drug ineffectivethe medicine did not work as expected53.3%18,223
2. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease40.9%13,995
3. Painpain, site not specified32.8%11,235
4. Drug intolerancethe medicine was not tolerated27.4%9,367
5. Fatiguetiredness26.1%8,938
6. Abdominal discomfortstomach discomfort26%8,905
7. Joint swellinga swollen joint25.9%8,853
8. Alopeciahair loss25.2%8,633
9. Contraindicated product administered24.4%8,361
10. Rashskin rash23.5%8,022
11. Systemic lupus erythematosuslupus, an autoimmune disease23.2%7,949
12. Arthralgiajoint pain23.1%7,888
13. Pemphigus22.5%7,695
14. Arthropathy22.2%7,607
15. Swellingswelling21.5%7,340
16. Glossodynia20.3%6,928
17. Off label useused for a purpose or in a way not on the label18.7%6,401
18. Hand deformity18.7%6,395
19. Condition aggravatedthe condition being treated got worse18.5%6,332
20. Synovitis18.4%6,287
21. Treatment failurethe treatment did not work17.9%6,112
22. Hypersensitivityan allergic-type reaction17.8%6,077
23. Drug hypersensitivityan allergic-type reaction to a medicine16.9%5,789
24. Wound16.1%5,507
25. Hepatic enzyme increasedraised liver enzymes16%5,483
26. Infusion related reactiona reaction during or soon after an infusion15.1%5,179
27. Maternal exposure during pregnancythe mother took the medicine during pregnancy15%5,115
28. Nauseafeeling sick14.8%5,058
29. Peripheral swellingswelling of the arms or legs14.6%4,988
30. Therapeutic product effect decreased14.5%4,947

Top 30 of 2,035 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 2 drugs in the antirheumatic agent 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 71,196 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. 12.7% 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 34,203 reports.

Drugs most often listed in the same reports

Other products listed in reports where Arava 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 antirheumatic agent 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 Arava as a suspect or interacting product; reports listing it only as a concomitant medication (18,730) 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.