Drug Safety Information for MONISTAT-3 COMBINATION PACK (Miconazole nitrate)

Number of FDA Adverse Event Reports by Patient Age for MONISTAT-3 COMBINATION PACK

Total Reports Filed with FDA: 7682*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Miconazole nitrate (Desenex, M-zole 7 dual pack, Monistat 5, Miconazole 3, 7 day vaginal, Athletes foot spray, Baza antifungal, Bf-micozo, Critic aid clear af, Dg health miconazole, Elta trivase, Equate athletes foot, Femmesil, Femmesil creme, Hongo killer, Kendall antifungal, Remedy antifungal, Secura antifungal, Soothe and cool free, Sunmark miconazole 7, Terapie anti-fungal, Topcare miconazole 7, Athletes foot, Conazol, Leader medicated, Nail md, Clearly confident, Macerrx web, Miconole, Selan antifungal, Triple paste-af, Micro-guard, Lagicam, Miconazol, Lotrimin af, Mitrazol, Miconazole, Zeasorb, Azolen, Monistat-derm, Tineacide, Micatin, Fungoid tincture, Ting, Miconazole 7, Monistat 7, Monistat 3, Miconazole nitrate)

Charts are based on 7682 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.