Drug Safety Information for MYLERAN (Busulfan)

Safety-related Labeling Changes for BUSULFEX (BUSULFAN) Rx Drug: FDA Link

Adverse Drug Reactions for MYLERAN* (Busulfan)

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 MYLERAN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Acute graft versus host disease591
2Graft versus host disease532
5Chronic graft versus host disease337
6Venoocclusive liver disease294
8Cytomegalovirus infection280
10Mucosal inflammation264
12Acute graft versus host disease in skin253
13Febrile neutropenia245
16Decreased appetite216
18Multi-organ failure195
19Venoocclusive disease193

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

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

Reason # of FDA Reports
1Stem cell transplant8047
2Bone marrow conditioning regimen2859
3Acute myeloid leukaemia1255
4Bone marrow transplant873
5Product used for unknown indication572
6Cord blood transplant therapy431
7Acute lymphocytic leukaemia246
8Non-hodgkin's lymphoma208
10Prophylaxis against graft versus host disease179

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

Types of Adverse Events for MYLERAN

Total Reports Filed with FDA: 23501

Number of FDA Adverse Event Reports by Patient Age for MYLERAN

Total Reports Filed with FDA: 23501*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Busulfan (Busulfex, Myleran)

Charts are based on 23501 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 MYLERAN Reviews and Review Summary .

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.

Visit   DrugInformer.com more on MYLERAN's side effects.