Alimta: adverse event reports filed with FDA

11,274

reports as suspect product

0.1% of all reports · about 503 a year

432

reports, 12 months to June 2026

452 in the 12 months before

89.8%

marked serious by the reporter

83.5% across the class

20.4%

record death among outcomes, as reported

2,303 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 Alimta reports recording the termmedian drug in folate analog metabolic inhibitor

1. Off label useused for a purpose or in a way not on the label9.3%1,044
2. Malignant neoplasm progression8.1%909
3. Pancytopenialow counts of all blood cells6%672
4. Anaemialow red blood cells5.5%618
5. Nauseafeeling sick5.4%613
6. Diarrhoealoose or frequent stools5.2%584
7. Thrombocytopenialow platelets5%560
8. Neutropenialow neutrophils, a type of white blood cell4.9%550
9. Deaththe patient died; cause not stated by this term4.9%547
10. Fatiguetiredness4.1%457
11. Dyspnoeashortness of breath3.9%445
12. Vomitingbeing sick3.9%442
13. Rashskin rash3.9%437
14. Pyrexiafever3.9%436
15. Acute kidney injurysudden loss of kidney function3.6%406
16. Astheniaweakness or lack of energy3.4%381
17. Febrile neutropeniafever with low white blood cells3%338
18. Renal failurekidney failure2.9%331
19. Interstitial lung diseasescarring or inflammation of lung tissue2.8%317
20. Decreased appetitereduced appetite2.7%307
21. Pneumonialung infection2.7%307
22. General physical health deteriorationgeneral decline in health2.7%299
23. Dehydrationdehydration2.4%267
24. Mucosal inflammation2.2%250
25. Platelet count decreasedlow platelet count2.1%241
26. Sepsisa severe body-wide response to infection2%226
27. Bone marrow failure1.9%219
28. Pleural effusionfluid around the lung1.9%213
29. Neoplasm progression1.8%206
30. White blood cell count decreasedlow white cell count1.7%191

Top 30 of 1,125 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. 36% 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 11,274 reports.

Drugs most often listed in the same reports

Other products listed in reports where Alimta 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 Alimta as a suspect or interacting product; reports listing it only as a concomitant medication (1,699) 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.