Vincristine sulfate: adverse event reports filed with FDA

26,262

reports as suspect product

0.1% of all reports · about 1,168 a year

1,392

reports, 12 months to June 2026

2,005 in the 12 months before

96.9%

marked serious by the reporter

97.2% across the class

18.2%

record death among outcomes, as reported

4,792 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 Vincristine sulfate reports recording the termmedian drug in vinca alkaloid

1. Febrile neutropeniafever with low white blood cells15.8%4,143
2. Pyrexiafever6.6%1,728
3. Neutropenialow neutrophils, a type of white blood cell6.1%1,614
4. Off label useused for a purpose or in a way not on the label5.9%1,549
5. Sepsisa severe body-wide response to infection3.9%1,012
6. Disease progressionthe disease advanced3.5%920
7. Vomitingbeing sick3.5%915
8. Pancytopenialow counts of all blood cells3.3%874
9. Nauseafeeling sick3.2%848
10. Pneumonialung infection3.2%833
11. Hypotensionlow blood pressure3.1%816
12. Thrombocytopenialow platelets2.9%772
13. Drug ineffectivethe medicine did not work as expected2.9%751
14. Anaemialow red blood cells2.8%747
15. Deaththe patient died; cause not stated by this term2.7%714
16. Myelosuppression2.7%701
17. Abdominal painstomach or belly pain2.6%682
18. Diarrhoealoose or frequent stools2.6%682
19. White blood cell count decreasedlow white cell count2.5%661
20. Interstitial lung diseasescarring or inflammation of lung tissue2.5%646
21. Product use in unapproved indicationused for a purpose not on the label2.5%646
22. Septic shockshock arising from infection2.4%634
23. Neuropathy peripheralnerve damage in hands or feet2.4%625
24. Neoplasm progression2.4%622
25. Mucosal inflammation2.3%602
26. Second primary malignancy2.1%559
27. Platelet count decreasedlow platelet count2.1%557
28. Neutrophil count decreased2%521
29. Infectionan infection, type not specified2%517
30. Fatiguetiredness1.9%501

Top 30 of 2,320 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 vinca alkaloid 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 33,176 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. 30.8% 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 26,262 reports.

Drugs most often listed in the same reports

Other products listed in reports where Vincristine sulfate 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 vinca alkaloid 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 Vincristine sulfate as a suspect or interacting product; reports listing it only as a concomitant medication (2,974) 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.