Drug Safety Information for ONCOVIN (Vincristine sulfate)

Safety-related Labeling Changes for MARQIBO KIT (VINCRISTINE SULFATE) Rx Drug: FDA Link

Adverse Drug Reactions for ONCOVIN* (Vincristine sulfate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ONCOVIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Febrile neutropenia2514
2Neutropenia1866
3Pyrexia1703
4Death1238
5Sepsis1098
6Thrombocytopenia1039
7Vomiting977
8Anaemia973
9Pneumonia966
10Diarrhoea900
11Infection891
12Nausea863
13Hypotension759
14Mucosal inflammation716
15Pancytopenia713
16White blood cell count decreased702
17Platelet count decreased679
18Disease progression672
19Dyspnoea669
20Abdominal pain638

* This side effect also appears in "Top 10 Side Effects of ONCOVIN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ONCOVIN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Diffuse large b-cell lymphoma9232
2Acute lymphocytic leukaemia8978
3Non-hodgkin's lymphoma6101
4Multiple myeloma4925
5B-cell lymphoma4410
6Product used for unknown indication3283
7Lymphoma2470
8Mantle cell lymphoma1886
9Burkitt's lymphoma1698
10Hodgkin's disease1649

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ONCOVIN

Total Reports Filed with FDA: 109832


Number of FDA Adverse Event Reports by Patient Age for ONCOVIN

Total Reports Filed with FDA: 109832*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Vincristine sulfate (Vincasar pfs, Marqibo kit, Vincristina, Vincristine, Vincrisul, Vincrex, Vincristine sulfate, Oncovin)

Charts are based on 109832 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ONCOVIN Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.