Drug Safety Information for VFEND (Voriconazole)

Safety-related Labeling Changes for VFEND (VORICONAZOLE) Rx Drug: FDA Link

Adverse Drug Reactions for VFEND* (Voriconazole)

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 VFEND
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Death644
2Drug interaction498
3Pyrexia462
4Pneumonia459
5Drug ineffective409
6Respiratory failure302
7Sepsis297
8Febrile neutropenia271
9Bronchopulmonary aspergillosis269
10Renal failure acute261
11Renal failure253
12Multi-organ failure241
13Dyspnoea236
14Hallucination230
15Diarrhoea227
16Nausea226
17Platelet count decreased217
18Condition aggravated215
19Neutropenia211
20Photosensitivity reaction206

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

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

Reason # of FDA Reports
1Aspergillosis2664
2Bronchopulmonary aspergillosis2620
3Product used for unknown indication2521
4Fungal infection1735
5Antifungal prophylaxis1147
6Prophylaxis1049
7Infection prophylaxis531
8Candidiasis499
9Ill-defined disorder348
10Pneumonia fungal322

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


Types of Adverse Events for VFEND

Total Reports Filed with FDA: 35888


Number of FDA Adverse Event Reports by Patient Age for VFEND

Total Reports Filed with FDA: 35888*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Voriconazole (Voriconazole, Vfend)

Charts are based on 35888 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 VFEND 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 VFEND's side effects.