Ketoconazole: uses, dosing, side effects & brands
Ketoconazole is an azole antifungal sold in the U.S. under 5 brand and generic names, for blastomycosis, chronic mucocutaneous candidiasis and cutaneous candidiasis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Azole Antifungal
- Treats (across its forms)
- Blastomycosis, Chronic Mucocutaneous Candidiasis and Cutaneous Candidiasis
- Available as
- Spray/Inhaler · Topical · Tablet
- Sold as
- 5 products — Extina, Ketoconazole and Nizoral, and others
- Prescription?
- Both Rx and OTC forms
- Generic available?
- Yes
- What the pharmacy pays
- about $0.26 per gm — not your price
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How Ketoconazole is dosed
From the FDA label for Ketoconazole (application ANDA076294). Other ketoconazole products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis and tinea (pityriasis) versicolor: It is recommended that Ketoconazole Cream 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment. Seborrheic dermatitis: Ketoconazole Cream 2% should be applied to the affected area twice daily for four weeks or until clinical clearing. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.
Everything below is the FDA label for Ketoconazole (tablet). Ketoconazole is also sold as spray/inhaler and topical, and those are different medicines to take — follow the label for the one you were prescribed.
Ketoconazole side effects
During clinical trials 45 (5.0%) of 905 patients treated with Ketoconazole Cream 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with Ketoconazole Cream developed a painful allergic reaction. In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with Ketoconazole Cream or one of its excipients, namely sodium sulfite or propylene glycol.
Who shouldn’t take Ketoconazole
Ketoconazole Cream 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.
Every ketoconazole product we track (5)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Topical | Generic | $0 | View → | |
| 2 | 70/100 | Prescription | Tablet | Generic | $0 | View → | |
| 3 | 70/100 | Prescription | Topical | Generic | $0 | View → | |
| 4 | 70/100 | Over-the-counter | Topical | Generic | $0 | View → | |
| 5 | Not yet rated | Prescription | Topical | Generic | $0 | View → |
Can you crush or split ketoconazole?
At least one ketoconazoleproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each ketoconazole label says about crushing, splitting and chewingKetoconazole and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for ketoconazole: levels in milk, effects in breastfed infants, and the drugs it would consider insteadBecause there is little published experience with ketoconazole or levoketoconazole during breastfeeding and its potential liver enzyme inhibition and liver toxicity, other agents are preferred. The manufacturers recommend that mothers taking ketoconazole or levoketoconazole avoid breastfeeding during treatment and for 1 day after the last dose.
National Institute of Child Health and Human Development, record revised May 15, 2023. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about ketoconazole
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 15,131 reports naming ketoconazole, and the FDA flagged 54% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fatigue837 reports
- pruritus828 reports
- rash762 reports
- nausea742 reports
- diarrhoea702 reports
- headache651 reports
- psoriasis607 reports
- dyspnoea557 reports
Read these as a signal, not a rate. A report does not mean ketoconazole caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is Ketoconazole?
Ketoconazole Cream 2%, for topical administration only, contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of propylene glycol, stearyl and cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl myristate, sodium sulfite anhydrous, polysorbate 80 and purified water.
What kind of drug is ketoconazole?
The FDA classifies ketoconazole as an azole antifungal. Azole antifungals block a fungal enzyme (lanosterol 14-alpha-demethylase) that the fungus needs to make ergosterol, a key building block of its cell membrane. Without enough ergosterol the membrane becomes leaky and unstable, which stops the fungus from growing and can cause it to break apart and die. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take ketoconazole with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ketoconazole against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is ketoconazole sold under?
We track 5 ketoconazole-containing products in the U.S.: Extina, Ketoconazole, Nizoral, Nizoral Anti-Dandruff and Xolegel. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does ketoconazole come in?
Across the brands we track, ketoconazole is currently marketed as spray/inhaler, topical and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic ketoconazole?
Yes. Our catalog lists 1 generic ketoconazole product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Ketoconazole: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ketoconazole
- MLA
- “Ketoconazole: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ketoconazole.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for ketoconazole on DailyMed (NIH) ↗.