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Ketoconazole

Fungoral, Nizoral · ATC code D01AC08

Also known as: Ketoconazol, Ketokonazol · Brand names: Fungoral, Nizoral, Ketoconazol Klinge, Ketozolin, Nizoral ®, Terzolin, Terzolin®, Ketoderm, Ketoral %, Konazol, Ketodan

Key facts
Active substance
Ketoconazole
ATC code
D01AC08
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

Because ketoconazole tablets have been associated with serious adverse reactions (see WARNINGSsection), ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections.

Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.

Hepatotoxicity

Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation has occurred with the use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored. See WARNINGSsection.

QT Prolongation and Drug Interactions Leading to QT Prolongation

Coadministration of the following drugs with ketoconazole is contraindicated: dofetilide, quinidine, pimozide, lurasidone, cisapride, methadone, disopyramide, dronedarone, ranolazine. Ketoconazole can cause elevated plasma concentrations of these drugs and may prolong QT intervals, sometimes resulting in life-threatening ventricular dysrhythmias such as torsades de pointes. See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Drug Interactionssections.

Key facts

Ketoconazole is an azole antifungal. Per the US label, the tablets are only for certain systemic fungal infections when other therapies have failed or are not tolerated.

What it is used for

  • Systemic fungal infections after failure or intolerance of other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis
  • Not indicated for onychomycosis, cutaneous dermatophyte or Candida infections; not for fungal meningitis

Dosing

  • Adults: start 200 mg once daily; if response is insufficient, 400 mg once daily
  • The dose of 200 mg to 400 mg daily should not be exceeded
  • Usual duration for systemic infection is 6 months, until active infection has subsided
  • Children over 2 years: 3.3 to 6.6 mg/kg once daily has been used in small numbers

Contraindications

  • Acute or chronic liver disease
  • Coadministration of dofetilide, quinidine, pimozide, lurasidone, cisapride, methadone, disopyramide, dronedarone, ranolazine
  • Hypersensitivity to ketoconazole

Important warnings

  • Boxed warning: serious hepatotoxicity, including fatal cases or liver transplantation; lab tests before and during treatment, avoid alcohol
  • Boxed warning: QT prolongation and life-threatening arrhythmias due to drug interactions
  • Adrenal insufficiency: decreases corticosteroid secretion at doses of 400 mg and higher
  • Anaphylaxis reported after the first dose; lowers serum testosterone

Side effects

  • Reported reactions include nausea, vomiting, abdominal pain, diarrhea, headache, dizziness, rash, pruritus
  • Serious: hepatitis, jaundice, anaphylactoid reaction; also gynecomastia, menstrual disorder

Interactions

  • Strong CYP3A4 inhibition raises levels of many substrates; several combinations are contraindicated (see above)
  • Avoid other potentially hepatotoxic drugs where possible

Pregnancy and breastfeeding

  • Teratogenic in rats; no adequate studies in pregnant women
  • Excreted in milk; mothers on ketoconazole should not breast feed

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

Patient information (US) →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • FungoralKaro Pharma Ab · 1 register entry
  • NizoralStada Arzneimittel Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Ketoconazol KlingeAenova Ip Gmbh · 1 register entry
  • KetozolinDermapharm Ag · 1 register entry
  • Nizoral ®Stada Consumer Health Deutschland Gmbh · 1 register entry
  • TerzolinStada Consumer Health Deutschland Gmbh · 1 register entry
  • Terzolin®Stada Consumer Health Deutschland Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • FungoralBERKO İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • KetodermTERRA İLAÇ VE KİMYA SAN. TİC. A.Ş. · 1 register entry
  • Ketoral %BİLİM İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • KonazolKURTSAN İLAÇLARI A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • KetodanMedimetriks Pharmaceuticals, Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 28 more European countries
Belgium
Nizoral
Bulgaria
Ketoderm, Nizoral, Кетозал, Низорал
Croatia
Oronazol
Cyprus
Ilgem Med, Nizoral
Czechia
Ketokonazol Dr.Max, Nizoral
Denmark
Ketoconazole Actavis, Nizoral
Estonia
Ketoconazol Ratiopharm, Mikanisal, Nizoral
Finland
Ketoconazol Ratiopharm, Ketoconazole Stada, Ketokonazol Pinewood Laboratories, Konact, Nizoral
France
Kapanek, Ketoconazole Arrow, Ketoconazole Biogaran, Ketoconazole Cristers, Ketoconazole Eg, Ketoconazole Sandoz, Ketoconazole Teva, Ketoconazole Viatris, Ketoconazole Zentiva, Ketoconazole Zydus, Ketoderm
Greece
Botaderm, Ebersept, Fungoral, Ilgem, Neo-Egmol, Nyoxep, Αββα
Hungary
Nizoral
Iceland
Dermatín, Fungoral, Ketoconazole Esteve
Ireland
Ketoconazole Pinewood Laboratories, Nizoral
Italy
Ketonova, Nizoblue, Nizoral, Trosyd Dermatite Seborroica E Forfora
Latvia
Ketoconazol Ratiopharm, Mikanisal, Nizoral
Liechtenstein
Ketoconazole Esteve
Lithuania
Ketoconazol Ratiopharm, Nizoral
Luxembourg
Nizoral
Malta
Nizoral
Netherlands
Ketoconazol Cf, Ketoconazol Double-E Pharma, Ketoconazole Aurobindo, Nizoral
Norway
Fungoral, Ketoconazole Esteve
Poland
Ketoconazole Hasco, Nizax Activ, Nizoral, Sinazol, Zoxin-Med
Portugal
Cetoconazol Folicalm, Nizoral, Tedol
Romania
Ketoconazol Dr. Max, Ketoconazol Dr.Max, Ketoconazol Fiterman, Ketoconazol Tis Farmaceutic, Seboderm Med
Slovakia
Ketoconazol Dr. Max, Nizoral
Slovenia
Oronazol
Spain
Fungarest, Keto-Cure, Ketoconazol Abamed, Ketoconazol Cinfa, Ketoconazol Kern Pharma, Ketoconazol Korhispana, Ketoconazol Sandoz, Ketoisdin
Sweden
Fungoral, Ketoconazol Actavis, Ketokonazol Net

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. U.S. Food and Drug Administration. Ketoconazole (Sun Pharmaceutical Industries, Inc.) – Prescribing Information, 2025-09-02. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8ca815a8-bccb-4ee2-a042-922373329cae
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.