ketoconazole

What is Ketoconazole?

From the FDA label: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. Ketoconazole is cis -1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H -imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula: Structural Formula

How to use

Side effects

Warnings

Who should not take Ketoconazole

Frequently asked questions

What does Ketoconazole treat?

Ketoconazole (Ketoconazole) may be used to treat blastomycosis, chronic mucocutaneous candidiasis, cutaneous candidiasis, oral candidiasis, vulvovaginal candidiasis, coccidioidomycosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.

How does Ketoconazole work?

Ketoconazole is a 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.

How is Ketoconazole rated?

pharmaranks gives Ketoconazole a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.

How much does Ketoconazole cost?

Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.26 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.

Is there a coupon or discount for Ketoconazole?

pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ketoconazole. To pay less, Ketoconazole is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.

Who makes Ketoconazole?

Ketoconazole is marketed by Fougera Pharms. You can see Fougera Pharms's full profile, rating, and other products on pharmaranks.

Is Ketoconazole a brand-name or generic drug?

Ketoconazole is a generic medication; its active ingredient is Ketoconazole. Generics contain the same active ingredient as the brand-name original and are usually lower cost.

Is Ketoconazole available over the counter?

No. Ketoconazole is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.

What forms does Ketoconazole come in?

Ketoconazole is currently marketed as tablet, per the FDA's National Drug Code Directory.

What class of drug is Ketoconazole?

Ketoconazole is classified as azole antifungal, per the FDA's Established Pharmacologic Class.

Is Ketoconazole FDA-registered?

Ketoconazole is on record with the U.S. FDA under application number ANDA076294. You can verify this on its official FDA label.

Has Ketoconazole been recalled by the FDA?

Yes. Ketoconazole has 3 recorded FDA recall events in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.

Is Ketoconazole safe?

There's no single safe-or-not verdict. pharmaranks gives Ketoconazole a recall-safety score of 72/100, based on its FDA recall history (3 recorded recall events) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.

What are the side effects of Ketoconazole?

Ketoconazole's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.