Ketoconazole

Pronunciation: kee-toe-KOE-na-zole.

Generic name
ketoconazole
Brand names
Nizoral (topical, multiple markets), Ketoconazole Esteve / Ketoconazole HRA (oral, EU/UK, Cushing's syndrome only), Sebizole (topical, New Zealand)
Drug class
Imidazole antifungal (azole class)
Form
Tablet (oral); cream, shampoo, foam, or gel (topical)
Route
Oral (tablet) or topical (skin/scalp)
Legal status
Prescription-only for oral tablets and for 2% topical strengths in most markets; a 1% shampoo is available over-the-counter in some countries (e.g. Nizoral A-D in the US) for dandruff.

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Nizoral (oral, 200 mg) -- discontinued 2013 (8), Nizoral / topical ketoconazole creams and anti-dandruff shampoos (9) · Full directory

What ketoconazole is and how it works

Ketoconazole is an antifungal medicine of the azole class, available as oral tablets and as topical creams, shampoos, foams, or gels. It works by interfering with the fungal cell membrane, stopping the fungus from growing. (1) (3)

Oral ketoconazole tablets carry a serious risk of liver injury and are now reserved, in most countries, for serious internal fungal infections or for endogenous Cushing's syndrome under specialist supervision -- ordinary fungal skin, nail, or scalp infections are treated with topical ketoconazole or other antifungals instead. Topical ketoconazole (cream, shampoo) is widely used and has a much lower systemic risk, but can still cause local skin irritation. Always use exactly the formulation your prescriber or pharmacist has directed.

Mechanism of action: how ketoconazole works

Ketoconazole is an imidazole antifungal that inhibits fungal cytochrome P450-dependent synthesis of ergosterol, a key component of the fungal cell membrane; at higher oral doses it also inhibits mammalian CYP450 enzymes involved in steroidogenesis (accounting for its adrenal and cortisol-lowering effects) and is a potent inhibitor of human CYP3A4. (1)

What ketoconazole is used for

Topical: fungal infections of the skin, scalp, and dandruff

Topical ketoconazole (cream, shampoo, foam, or gel) is used for fungal skin infections such as tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor, for cutaneous candidiasis, and for dandruff and seborrhoeic dermatitis of the scalp. (2)

Oral: serious systemic fungal infections (restricted use)

Oral ketoconazole tablets are reserved for serious systemic (deep) fungal infections such as blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis, used only when other effective antifungal therapy is not available or not tolerated. It is not effective for fungal meningitis and is not indicated for ordinary skin, hair, or nail fungal infections. (1)

Oral: endogenous Cushing's syndrome (specialist-supervised, EU/UK)

A separate oral ketoconazole 200 mg tablet product (Ketoconazole HRA/Esteve) is authorised in the EU and UK specifically for endogenous Cushing's syndrome in adults and adolescents over 12, under specialist endocrinology supervision, working by reducing excess cortisol production. (4) (5)

Before taking ketoconazole

Do not take / not appropriate for

  • Oral ketoconazole should not be used if you have acute or chronic liver disease. (oral tablets, all countries) (1)
  • Oral ketoconazole has a long list of medicines it must not be combined with because of serious interaction risks, including certain heart-rhythm medicines (dofetilide, quinidine, pimozide, disopyramide, dronedarone, ranolazine), cisapride, methadone, ergot medicines, certain statins (lovastatin, simvastatin), some benzodiazepines taken by mouth (midazolam, alprazolam, triazolam), felodipine, nisoldipine, tolvaptan, eplerenone, irinotecan, and colchicine. Give your prescriber and pharmacist a full list of everything you take before starting oral ketoconazole. (oral tablets, all countries) (1)
  • Do not use ketoconazole (any form) if you have had an allergic reaction to ketoconazole or another azole/imidazole antifungal. (all forms, all countries) (1) (2)

Tell your clinician about

  • Any personal or family history of liver disease, or heavy alcohol use.
  • Any heart rhythm problems or history of an abnormal heart tracing (QT prolongation).
  • Any adrenal gland problems.
  • Every other medicine, herbal product, and supplement you take, since oral ketoconazole interacts with many drugs.
  • Whether you are pregnant, could become pregnant, or are breastfeeding.
  • Whether you are using topical or oral ketoconazole, since the risks and precautions are different for each.
(1)

How to take ketoconazole

  • Take oral ketoconazole tablets exactly as your prescriber directs, at the dose and for the duration they specify -- this is individualised and clinician-directed, not a fixed regimen for everyone.
  • Oral tablets are generally taken with food to help absorption; ask your pharmacist about timing with antacids or acid-reducing medicines, since these can reduce absorption.
  • For topical cream, apply a thin layer to the clean, affected skin area as directed on the label or by your prescriber, usually once or twice daily.
  • For topical shampoo, apply to wet hair/scalp, work into a lather, leave in place for the time stated on the product label (commonly a few minutes), then rinse thoroughly.
  • Complete the full course your prescriber recommends, even if symptoms improve early, so the infection is fully treated.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)

Missed dose

If you miss a dose of oral ketoconazole, take it as soon as you remember unless it is close to your next scheduled dose, in which case skip the missed dose -- do not double up. For missed topical applications, simply apply at the next scheduled time. If you are ever unsure, ask your pharmacist or prescriber.

Overdose

Seek urgent medical attention or contact a poison control service if an overdose of oral ketoconazole is suspected. Reported effects of overdose include nausea, vomiting, abdominal pain, and severe liver toxicity. Accidental ingestion of a topical product should also prompt urgent medical advice. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Oral: nausea, vomiting, abdominal pain, headache, and itching.

What to notice: Oral: nausea, vomiting, abdominal pain, headache, and itching.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Topical: local skin or scalp irritation, itching; increased hair loss has been reported uncommonly with shampoo use.

What to notice: Topical: local skin or scalp irritation, itching; increased hair loss has been reported uncommonly with shampoo use.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Serious warnings

Signs of serious liver injury (oral ketoconazole) — boxed_warning

Symptoms: Yellowing of the skin or eyes (jaundice), dark urine, pale stools, persistent nausea or vomiting, unusual tiredness, or loss of appetite.

Action: Contact your prescriber promptly for evaluation, including liver function testing, if any of these symptoms develop while taking oral ketoconazole; this needs prompt clinician assessment rather than waiting to see if it improves. (1)

Signs of an abnormal heart rhythm (oral ketoconazole) — emergency

Symptoms: Fainting, severe dizziness, or a rapid or irregular heartbeat.

Action: Seek emergency medical help, since oral ketoconazole can prolong the QT interval and, in combination with certain other drugs, cause life-threatening heart rhythm problems. (1)

Signs of adrenal insufficiency (oral ketoconazole, higher doses) — high caution

Symptoms: Severe weakness, dizziness, fainting, or low blood pressure, particularly during illness, injury, or surgery.

Action: Tell your prescriber promptly, since oral ketoconazole can reduce the adrenal glands' cortisol production at higher doses. (1)

Signs of a serious allergic reaction (any form) — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash, blistering, or hives.

Action: Seek emergency medical help immediately. (1)

Interactions

  • Oral ketoconazole is a potent inhibitor of the CYP3A4 liver enzyme and interacts with a large number of medicines, increasing their blood levels and side-effect risk -- always give your prescriber and pharmacist a complete medicine list before starting. (1)
  • Antacids, acid-reducing medicines (H2 blockers, proton pump inhibitors), and some other drugs can reduce absorption of oral ketoconazole; timing may need to be separated on your prescriber's or pharmacist's advice. (1)
  • Topical ketoconazole has a much lower potential for drug interactions because of its low systemic absorption, but tell your prescriber about other topical products used on the same skin area. (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Oral ketoconazole should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus, as teratogenic effects have been seen in animal studies; discuss any pregnancy or plans for pregnancy with your prescriber before starting oral treatment. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)

Breastfeeding

Discuss breastfeeding with your prescriber before using oral ketoconazole. For topical use, avoid applying products directly to the nipple/areola area unless your prescriber advises otherwise. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)

Children

Oral use in children is individually determined by a specialist and weight-based; some topical products have a minimum age (commonly 12 years for OTC anti-dandruff shampoo) -- check the product label or ask your pharmacist. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)

Elderly

No specific age-based dose adjustment is described in the sources reviewed, but liver function and other medicines should be reviewed carefully before starting oral ketoconazole in any older adult. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)

Hepatic_impairment

Oral ketoconazole is contraindicated in acute or chronic liver disease and requires liver function monitoring during treatment. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)

Renal_impairment

Not specifically addressed as a major dose-adjustment factor in the sources reviewed; tell your prescriber about any kidney problems regardless. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)

Monitoring

Before starting

  • Baseline liver function tests (oral ketoconazole)
  • Review of all other medicines for interaction risk (oral ketoconazole)
  • ECG if there is any personal or family history of heart rhythm problems (oral ketoconazole)

During treatment

  • Periodic liver function testing during oral ketoconazole treatment, as directed by the prescriber.
  • Watching for symptoms of liver injury, heart rhythm problems, or adrenal insufficiency during oral treatment.
  • Watching topical application sites for irritation or worsening symptoms.
(1)

Storage

Store oral tablets and topical products at room temperature, away from excess heat and moisture, out of reach of children, as directed on the product label.

Professional information

Clinician-facing context only, sourced from the current US FDA labels for oral and topical ketoconazole plus EU/UK/Canada/Australia/New Zealand regulatory sources; verify against the current full label before prescribing.

United States (oral)

Indication: Serious systemic fungal infections, restricted use

Dose summary: 200 mg once daily, may increase to 400 mg once daily if response is inadequate; individualised, clinician-directed, treatment duration may extend to several months for systemic infection.

Renal context: Not established as a major adjustment factor in the source reviewed. (1)

European Union / United Kingdom (oral, Cushing's syndrome)

Indication: Endogenous Cushing's syndrome, specialist-supervised

Dose summary: Individualised dosing under endocrinology specialist supervision, titrated to cortisol response; not licensed for ordinary fungal infections.

Renal context: Not established in the sources reviewed for this indication. (4) (5)

Mechanism of action

Hepatic guidance

Contraindicated in active liver disease; monitor liver enzymes before and during oral therapy and discontinue oral treatment on the clinician's assessment if significant elevation occurs.

Overdose note

Manage suspected oral overdose supportively with attention to hepatic function; contact a poison control service for guidance. (1)

Frequently asked questions

Is ketoconazole available in the US, UK, Europe, Canada, Australia, and New Zealand?

Topical ketoconazole (cream, shampoo) is available in all 6 of these markets. Oral ketoconazole tablets are available in the US (restricted to serious systemic infections) and, as a separate specialist product, in the EU/UK for Cushing's syndrome; oral ketoconazole for ordinary fungal infections was suspended in the EU/UK and discontinued in Australia and New Zealand in 2013 because of liver-injury risk. Availability of generic oral tablets in Canada should be confirmed with a local pharmacist, since Health Canada's listing differs from the other markets reviewed. (1) (3) (8) (10)

Why was oral ketoconazole restricted in so many countries?

Regulators found that oral ketoconazole caused serious, sometimes fatal, liver injury more often and more severely than other antifungal medicines, and that this risk could occur early in treatment even at recommended doses. Because safer antifungal alternatives are available for most fungal infections, several regulators concluded the risk outweighed the benefit for ordinary use, while preserving oral ketoconazole for situations (serious systemic infections, or Cushing's syndrome) where its specific effect is still needed. (3)

Is topical ketoconazole (shampoo or cream) as risky as the tablets?

No. Topical ketoconazole is absorbed into the bloodstream only in very small amounts, so it does not carry the same liver, heart-rhythm, or drug-interaction risks as the oral tablets. It is used for conditions like dandruff, seborrhoeic dermatitis, and skin or scalp fungal infections. Local skin or scalp irritation is the main side effect to watch for. (2)

What is the mechanism of action of ketoconazole?

Ketoconazole is an imidazole antifungal that inhibits fungal cytochrome P450-dependent synthesis of ergosterol, a key component of the fungal cell membrane; at higher oral doses it also inhibits mammalian CYP450 enzymes involved in steroidogenesis (accounting for its adrenal and cortisol-lowering effects) and is a potent inhibitor of human CYP3A4. (1)

What is the generic name of Ketoconazole?

The generic name is ketoconazole. It is sold under brand names including Nizoral (topical, multiple markets), Ketoconazole Esteve / Ketoconazole HRA (oral, EU/UK, Cushing's syndrome only), Sebizole (topical, New Zealand). (1) (2)

What class of drug is ketoconazole?

Ketoconazole is classed as: Imidazole antifungal (azole class). (1) (2)

References

  1. KETOCONAZOLE tablets -- full prescribing information (boxed warning revision)U.S. Food and Drug Administration / DailyMed (NIH), full prescribing information · United States · accessed 2026-07-29 · source 1
  2. NIZORAL (ketoconazole) 2% shampoo and 2% cream -- prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information · United States · accessed 2026-07-29 · source 2
  3. European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazoleEuropean Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP) · European Union · accessed 2026-07-29 · source 3
  4. Ketoconazole HRA / Ketoconazole Esteve -- EPAR (orphan medicine for Cushing's syndrome)European Medicines Agency (EMA) · European Union · accessed 2026-07-29 · source 4
  5. Ketoconazole Esteve 200 mg Tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Esteve · United Kingdom · accessed 2026-07-29 · source 5
  6. Nizoral 2% Shampoo and Nizoral 2% Cream -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Thornton & Ross · United Kingdom · accessed 2026-07-29 · source 6
  7. TEVA-KETOCONAZOLE / APO-KETOCONAZOLE (Ketoconazole Tablets USP, 200 mg) -- Product MonographHealth Canada product monograph · Canada · accessed 2026-07-29 · source 7
  8. Oral ketoconazole (Nizoral) 200 mg tablets -- safety alert and deregistrationTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-29 · source 8
  9. Nizoral 2% Anti-Dandruff Treatment and topical ketoconazole 2% creams -- ARTG entriesTherapeutic Goods Administration (TGA), Australia -- Australian Register of Therapeutic Goods · Australia · accessed 2026-07-29 · source 9
  10. Discontinuation of oral ketoconazole (Nizoral) 200 mg tabletsMedsafe (New Zealand regulator) · New Zealand · accessed 2026-07-29 · source 10
  11. Sebizole 2% w/w Shampoo -- New Zealand Data SheetMedsafe (New Zealand regulator) · New Zealand · accessed 2026-07-29 · source 11

Brand names by country

Single-ingredient ketoconazole names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Nizoral10 mg/mL, 1 g00mL · kramer laboratories
  • Tagrit Antifungal Treament Ketoconazole 1%10 mg000g · tagrid llc
  • Anti-Fungal1 mg00mL · shenzhen mengyue technology co., ltd.
  • Anti Dandruff1 g00mL · guangzhou chuanma international trading co.,ltd.
  • Gembooxt Ketoconazole 1% Medicated Shampoos.01 g/mL · guangdong quadrant ecological technology co., ltd.
  • Cysndra Ketoconazole 1% Medicated Shampoos.01 g/mL · guangzhou xinhongda trading service co., ltd.
  • iShanCare Balanitis Cleansing1 g00g · shenzhen ishan technology co., ltd
  • Gemachlich ZuHause Ketoconazole 1% Anti-dandruff Shampoos.01 g/mL · guangzhou xinhongda trading service co., ltd.
  • Ketodan20 mg/g · medimetriks pharmaceuticals, inc.

United Kingdom

  • Ketoconazole Esteve (oral, Cushing's syndrome only) (5)MHRA licensed specialist indication · 200 mg · Esteve
  • Nizoral (shampoo/cream) (6)MHRA licensed emc smpc confirmed · 2%, 1% OTC · Thornton & Ross

Canada

  • NIZORAL -
  • KETODERM

Australia

  • Nizoral (oral, 200 mg) -- discontinued 2013 (8)TGA deregistered 2013-12-01 · 200 mg · Janssen-Cilag (historical)
  • Nizoral / topical ketoconazole creams and anti-dandruff shampoos (9)TGA ARTG registered current · 2%, 1% · multiple sponsors

New Zealand

  • Nizoral (oral, 200 mg) -- discontinued 2013 (10)Medsafe discontinued 2013-12-01 · 200 mg · Janssen-Cilag (historical)
  • Nizoral / Sebizole (topical shampoo) (11)Medsafe approved current · 1%, 2% · multiple sponsors
View brands in additional countries.

European Union

Ketoconazole HRA / Ketoconazole Esteve (oral, Cushing's syndrome only) (4), Topical ketoconazole (national brands, creams/shampoos) (3)

This page provides general reference information about ketoconazole (oral and topical) and is not a substitute for advice from the prescriber or pharmacist managing your treatment. All dosing and treatment decisions should be made with your prescriber, especially given the different risks of oral versus topical forms.

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