Vinorelbine: adverse event reports filed with FDA

5,307

reports as suspect product

0% of all reports · about 236 a year

247

reports, 12 months to June 2026

292 in the 12 months before

98.4%

marked serious by the reporter

97.2% across the class

20.4%

record death among outcomes, as reported

1,082 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 Vinorelbine reports recording the termmedian drug in vinca alkaloid

1. Disease progressionthe disease advanced11.3%598
2. Neutropenialow neutrophils, a type of white blood cell11.1%591
3. Malignant neoplasm progression11.1%590
4. Off label useused for a purpose or in a way not on the label9.3%496
5. Drug ineffectivethe medicine did not work as expected7.9%420
6. Nauseafeeling sick7.6%403
7. Diarrhoealoose or frequent stools7.2%380
8. Anaemialow red blood cells7%373
9. Fatiguetiredness6.4%340
10. Febrile neutropeniafever with low white blood cells6.2%331
11. Thrombocytopenialow platelets5.9%314
12. Vomitingbeing sick5.6%299
13. Pyrexiafever5.2%278
14. Dyspnoeashortness of breath4.8%257
15. Astheniaweakness or lack of energy4.1%219
16. Deaththe patient died; cause not stated by this term3.9%209
17. Metastases to liver3.7%196
18. Product use in unapproved indicationused for a purpose not on the label3.7%196
19. Pneumonialung infection3.6%191
20. Metastases to bone3.6%189
21. Palmar-plantar erythrodysaesthesia syndrome3.5%188
22. Leukopenialow white blood cells3.4%181
23. Breast cancer metastatic3.3%175
24. Neuropathy peripheralnerve damage in hands or feet3.2%172
25. Mucosal inflammation3.1%167
26. Coughcough3.1%166
27. Pleural effusionfluid around the lung2.9%153
28. General physical health deteriorationgeneral decline in health2.9%152
29. Constipationconstipation2.8%149
30. Decreased appetitereduced appetite2.8%148

Top 30 of 947 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. 12.1% 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 5,307 reports.

Drugs most often listed in the same reports

Other products listed in reports where Vinorelbine 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 Vinorelbine as a suspect or interacting product; reports listing it only as a concomitant medication (1,626) 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.