Leucovorin calcium: adverse event reports filed with FDA

11,894

reports as suspect product

0.1% of all reports · about 529 a year

1,211

reports, 12 months to June 2026

1,233 in the 12 months before

93.3%

marked serious by the reporter

94.8% across the class

14.4%

record death among outcomes, as reported

1,710 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 Leucovorin calcium reports recording the termmedian drug in folate analog

1. Diarrhoealoose or frequent stools10.6%1,256
2. Nauseafeeling sick7.3%867
3. Neutropenialow neutrophils, a type of white blood cell7.1%839
4. Vomitingbeing sick6.7%798
5. Pyrexiafever5.4%647
6. Disease progressionthe disease advanced5.3%629
7. Fatiguetiredness4.8%571
8. Febrile neutropeniafever with low white blood cells4.4%524
9. Neuropathy peripheralnerve damage in hands or feet4%473
10. Abdominal painstomach or belly pain3.9%468
11. Dehydrationdehydration3.9%467
12. Off label useused for a purpose or in a way not on the label3.9%462
13. Thrombocytopenialow platelets3.6%426
14. Astheniaweakness or lack of energy3.3%397
15. Anaemialow red blood cells3.2%375
16. Sepsisa severe body-wide response to infection3.1%372
17. Pulmonary embolisma blood clot in the lung2.9%345
18. Drug ineffectivethe medicine did not work as expected2.9%344
19. Dyspnoeashortness of breath2.9%343
20. Hypotensionlow blood pressure2.5%295
21. Pneumonialung infection2.4%291
22. Mucosal inflammation2.3%275
23. Malignant neoplasm progression2.2%266
24. Decreased appetitereduced appetite2.2%263
25. Hypertensionhigh blood pressure2.1%250
26. Condition aggravatedthe condition being treated got worse2.1%246
27. Acute kidney injurysudden loss of kidney function2%241
28. Haemoglobin decreasedlow haemoglobin2%239
29. Myelosuppression2%232
30. Neutrophil count decreased1.9%231

Top 30 of 1,613 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 3 drugs in the folate analog 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 16,736 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. 38.1% 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 11,894 reports.

Drugs most often listed in the same reports

Other products listed in reports where Leucovorin calcium 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 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 Leucovorin calcium as a suspect or interacting product; reports listing it only as a concomitant medication (7,732) 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.