Drug Safety Information for SPORANOX (Itraconazole)

Safety-related Labeling Changes for SPORANOX (ITRACONAZOLE) Rx Drug: FDA Link

Adverse Drug Reactions for SPORANOX* (Itraconazole)

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 SPORANOX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug interaction373
2Pyrexia335
3Drug ineffective259
4Pneumonia212
5Febrile neutropenia202
6Platelet count decreased186
7Diarrhoea171
8Nausea*166
9Dyspnoea163
10Sepsis161
11Neutropenia148
12White blood cell count decreased145
13Anaemia139
14Death134
15Renal impairment125
16Oedema peripheral124
17Thrombocytopenia123
18Condition aggravated117
19Vomiting113
20Alanine aminotransferase increased112

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

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

Reason # of FDA Reports
1Product used for unknown indication1728
2Antifungal prophylaxis1440
3Prophylaxis1235
4Onychomycosis895
5Infection prophylaxis631
6Bronchopulmonary aspergillosis547
7Fungal infection*545
8Aspergillosis315
9Histoplasmosis*301
10Bronchopulmonary aspergillosis allergic214

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


Types of Adverse Events for SPORANOX

Total Reports Filed with FDA: 21148


Number of FDA Adverse Event Reports by Patient Age for SPORANOX

Total Reports Filed with FDA: 21148*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Itraconazole (Onmel, Sporanox, Itraconazole, Orungal)

Charts are based on 21148 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 SPORANOX 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.