Drug Safety Information for FLUCONAZOLE (Fluconazole)

Safety-related Labeling Changes for DIFLUCAN (FLUCONAZOLE) Rx Drug: FDA Link

Safety-related Labeling Changes for DIFLUCAN IN SODIUM CHLORIDE 0.9% (FLUCONAZOLE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER (FLUCONAZOLE) Discontinued Drug: FDA Link

Adverse Drug Reactions for FLUCONAZOLE* (Fluconazole)

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 FLUCONAZOLE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia1657
2Nausea*1276
3Diarrhoea1253
4Pneumonia1056
5Pain*1043
6Vomiting1041
7Dyspnoea975
8Drug interaction966
9Anaemia924
10Febrile neutropenia918
11Sepsis890
12Thrombocytopenia834
13Fatigue814
14Renal failure acute804
15Asthenia783
16Neutropenia740
17Drug ineffective737
18Death731
19Hypotension716
20Rash*697

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

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

Reason # of FDA Reports
1Product used for unknown indication10446
2Fungal infection*4252
3Prophylaxis3639
4Antifungal prophylaxis3003
5Candidiasis*2389
6Infection prophylaxis2185
7Oral candidiasis*2065
8Infection*999
9Ill-defined disorder842
10Oesophageal candidiasis784

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


Types of Adverse Events for FLUCONAZOLE

Total Reports Filed with FDA: 134086


Number of FDA Adverse Event Reports by Patient Age for FLUCONAZOLE

Total Reports Filed with FDA: 134086*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fluconazole (Apo-fluconazole, Lavisa, Flucanazole, Triflucan, Loitin, Diflucan, Fluconazole)

Charts are based on 134086 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 FLUCONAZOLE 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.