Otrexup: adverse event reports filed with FDA

1,914

reports as suspect product

0% of all reports · about 156 a year

38

reports, 12 months to June 2026

38 in the 12 months before

9.8%

marked serious by the reporter

83.5% across the class

0.9%

record death among outcomes, as reported

18 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

Reactions recorded in the reports

share of Otrexup reports recording the termmedian drug in folate analog metabolic inhibitor

1. Device issuea problem with the device10.2%195
2. Drug ineffectivethe medicine did not work as expected8.5%162
3. Nauseafeeling sick5.8%111
4. Therapy cessation4%77
5. Painpain, site not specified3.7%71
6. Product dose omission issuea dose was missed3.4%66
7. Malaisegeneral feeling of being unwell3.2%61
8. Product use in unapproved indicationused for a purpose not on the label3.1%59
9. Fatiguetiredness3%58
10. Device deployment issuethe device did not deploy properly3%57
11. Off label useused for a purpose or in a way not on the label2.9%56
12. Arthralgiajoint pain2.7%52
13. Product dose omissiona dose was missed2.1%41
14. Alopeciahair loss2%39
15. Therapy interrupted1.9%37
16. Drug dose omissiona dose was missed1.9%36
17. Headachehead pain1.8%35
18. Pain in extremitypain in an arm or leg1.8%35
19. Pneumonialung infection1.8%35
20. Device leakagethe device leaked1.7%32
21. Sinusitissinus infection1.7%32
22. Device malfunctionthe device did not work properly1.6%31
23. Vomitingbeing sick1.6%31
24. Covid-19COVID-19 infection1.5%29
25. Diarrhoealoose or frequent stools1.5%29
26. Hospitalisationadmission to hospital1.4%26
27. Injection site painpain where the injection was given1.3%25
28. Peripheral swellingswelling of the arms or legs1.3%25
29. Dizzinesslight-headedness or unsteadiness1.3%24
30. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease1.3%24

Top 30 of 305 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. 99.5% 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 1,914 reports.

Drugs most often listed in the same reports

Other products listed in reports where Otrexup 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 Otrexup as a suspect or interacting product; reports listing it only as a concomitant medication (282) 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.