Methotrexate sodium: adverse event reports filed with FDA

67,497

reports as suspect product

0.3% of all reports · about 3,001 a year

2,458

reports, 12 months to June 2026

3,703 in the 12 months before

61%

marked serious by the reporter

83.5% across the class

5.7%

record death among outcomes, as reported

3,820 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 sodium reports recording the termmedian drug in folate analog metabolic inhibitor

1. Drug ineffectivethe medicine did not work as expected27.8%18,764
2. Drug hypersensitivityan allergic-type reaction to a medicine11.3%7,635
3. Off label useused for a purpose or in a way not on the label8.6%5,799
4. Drug intolerancethe medicine was not tolerated8.1%5,447
5. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease7.5%5,074
6. Nauseafeeling sick7.2%4,875
7. Painpain, site not specified6.5%4,402
8. Arthralgiajoint pain6.4%4,349
9. Condition aggravatedthe condition being treated got worse6.2%4,192
10. Fatiguetiredness5.8%3,943
11. Joint swellinga swollen joint4.8%3,231
12. Treatment failurethe treatment did not work4.6%3,121
13. Alopeciahair loss4.6%3,104
14. Rashskin rash4.3%2,899
15. Abdominal discomfortstomach discomfort3.7%2,488
16. Diarrhoealoose or frequent stools3.7%2,464
17. Vomitingbeing sick3.5%2,344
18. Headachehead pain3.3%2,251
19. Malaisegeneral feeling of being unwell3.2%2,183
20. Synovitis3%2,038
21. Musculoskeletal stiffnessstiffness in muscles or joints3%2,019
22. Pain in extremitypain in an arm or leg3%2,014
23. Peripheral swellingswelling of the arms or legs3%1,999
24. Contraindicated product administered2.9%1,960
25. Hepatic enzyme increasedraised liver enzymes2.8%1,921
26. Arthropathy2.8%1,877
27. Dyspnoeashortness of breath2.7%1,809
28. Gastrointestinal disorder2.6%1,768
29. Infectionan infection, type not specified2.6%1,766
30. Swellingswelling2.6%1,764

Top 30 of 3,636 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. 47.1% 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 67,497 reports.

Drugs most often listed in the same reports

Other products listed in reports where Methotrexate 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 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 sodium as a suspect or interacting product; reports listing it only as a concomitant medication (8,287) 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.