Ketoconazole
Active ingredient · 4 therapeutic classes
Sold as Danil · NIZORAL
- Drug class
- Imidazole Derivatives
- Availability
- Prescription and OTC
- Routes
- Oral, Topical
- Markets covered
- 4
- Products on record
- 36
- FDA reports (12 mo)
- 1,418
Overview
Ketoconazole is an active pharmaceutical ingredient in the Imidazole Derivatives group (G01AF). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 26 | May 15, 2026 |
| CA Canada | Health Canada | 5 | March 22, 2025 |
| US United States | FDA | 4 | January 29, 2026 |
| EU European Union | EMA | 1 | May 5, 2025 |
GBUnited Kingdom· MHRA
26 products
Uses
Treatment of tinea (pityriasis) versicolor.
How to take
CACanada· Health Canada
5 products
Uses
KETOCONAZOLE (ketoconazole) may be indicated for the treatment of serious or life- threatening systemic fungal infections in normal, predisposed, or immunocompromised patients where alternate therapy is considered inappropriate or has been unsuccessful: systemic candidiasis, chronic mucocutaneous candidiasis, coccidioidomycosis and paracoccidioidomycosis, histoplasmosis and chromomycosis.
The use of KETOCONAZOLE may also be considered in the treatment of severe, recalcitrant dermatophytoses unresponsive to other forms of therapy. The type of organism responsible for the infection should be identified; however, therapy may be initiated prior to obtaining these results, when clinically warranted.
: The treatment of fungal infections of the CNS is not recommended; ketoconazole penetrates poorly into the CNS. CONTRAINDICATIONS KETOCONAZOLE (ketoconazole) is contraindicated in patients with known hypersensitivity to the drug and in patients with hepatic dysfunction.
USUnited States· FDA
4 products
Uses
INDICATIONS AND USAGE
Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum , T. mentagrophytes and Epidermophyton floccosum ; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare) ; and in the treatment of cutaneous candidiasis caused by Candida spp .
How to take
EUEuropean Union· EMA
1 product
Uses
Ketoconazole Esteve is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.
How to take
Drug interactions
Known interactions involving Ketoconazole. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL002400451 · revised November 22, 2024
- [2]Health Canada (DPD) · 02122197 · revised March 22, 2025
- [3]FDA DailyMed · 02a348b0-1325-42… · revised January 11, 2024 [PDF]
- [4]European Medicines Agency · EMEA/H/C/003906 · revised May 5, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.