Methotrexate: adverse event reports filed with FDA

207,259

reports as suspect product

1% of all reports · about 9,214 a year

11,503

reports, 12 months to June 2026

13,680 in the 12 months before

90.7%

marked serious by the reporter

83.5% across the class

11%

record death among outcomes, as reported

22,839 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 Methotrexate reports recording the termmedian drug in folate analog metabolic inhibitor

1. Drug ineffectivethe medicine did not work as expected26.3%54,411
2. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease12.6%26,126
3. Painpain, site not specified10.2%21,109
4. Off label useused for a purpose or in a way not on the label10%20,753
5. Arthralgiajoint pain9.2%18,999
6. Drug intolerancethe medicine was not tolerated9%18,631
7. Fatiguetiredness8.5%17,573
8. Joint swellinga swollen joint7.6%15,852
9. Nauseafeeling sick7.4%15,314
10. Rashskin rash6.9%14,220
11. Treatment failurethe treatment did not work6.1%12,660
12. Contraindicated product administered6%12,397
13. Condition aggravatedthe condition being treated got worse6%12,362
14. Alopeciahair loss6%12,332
15. Abdominal discomfortstomach discomfort5.7%11,846
16. Diarrhoealoose or frequent stools5.5%11,408
17. Headachehead pain5.2%10,798
18. Synovitis5.1%10,643
19. Pyrexiafever5%10,355
20. Arthropathy4.9%10,259
21. Vomitingbeing sick4.9%10,170
22. Drug hypersensitivityan allergic-type reaction to a medicine4.9%10,102
23. Swellingswelling4.9%10,073
24. Infectionan infection, type not specified4.8%9,923
25. Pneumonialung infection4.7%9,712
26. Peripheral swellingswelling of the arms or legs4.6%9,549
27. Hypersensitivityan allergic-type reaction4.5%9,430
28. Systemic lupus erythematosuslupus, an autoimmune disease4.5%9,251
29. Hepatic enzyme increasedraised liver enzymes4.4%9,109
30. Musculoskeletal stiffnessstiffness in muscles or joints4.2%8,680

Top 30 of 7,218 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 folate analog metabolic 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 312,274 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. 23.6% 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 207,259 reports.

Drugs most often listed in the same reports

Other products listed in reports where Methotrexate 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 folate analog metabolic 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 Methotrexate as a suspect or interacting product; reports listing it only as a concomitant medication (215,449) 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.