Prescription and over-the-counter medicine

Ketoconazole Brand names: Nizoral, Ketodan

Ketoconazole (Nizoral) is a prescription and over-the-counter medicine with an FDA approval on record since 1981. FDA's NDC Directory lists it from 30 generic labelers, and pharmacies paid $0.249 per gram (Ketoconazole 2% cream) in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the NDA 18533 record on Drugs@FDA; every ketoconazole label on DailyMed.

Highlights of the record

FDA label of January 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: 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.

Forms and strengths

200 mg
1 g/100ml
2 g/100g
10 mg/ml
20 mg/g
20 mg/ml

Cream; shampoo (suspension); tablet; aerosol (foam); shampoo.

On the market

Earliest approval on file: June 12, 1981 Nizoral, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 21 first June 15, 1999; 14 with a marketed status in Drugs@FDA
Labelers listed (NDC): 31 of which 30 under generic applications, 1 under brand applications, repackagers included; 10 more under the over-the-counter monograph, without an application

Supply and safety

Pharmacy cost (NADAC): $0.249 per gram Ketoconazole 2% cream
Shortage (FDA): No current entry
Recalls by its makers (FDA): 3 since 2012 0 Class I among all firms' recalls; latest April 13, 2022
FAERS reports: 17,282 through July 30, 2026

What is ketoconazole used for?

From the label: 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); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.

Conditions named in the indications of ketoconazole's FDA labels, with every medicine labeled for each:

Fungal infections

From other ketoconazole labels
Fungal infections: 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; …

FDA pharmacologic class: Azole Antifungal.

Source: FDA drug label (ketoconazole), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set cad7c647-34a9-4e4e-83b3-8d78e58f588f), via openFDA; the full label on DailyMed

What does the patient leaflet for ketoconazole say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about ketoconazole tablets?
Ketoconazole tablets are not the only medicine available to treat fungal infections and should only be used when other medicines are not right for you. Talk to your healthcare provider to find out if ketoconazole tablets are right for you. Ketoconazole tablets can cause serious side effects, including: liver problems (hepatotoxicity). Some people who were treated with ketoconazole the active ingredient in ketoconazole tablets, had serious liver problems that led to death or the need for a liver transplant. Call your healthcare provider right away if you have any of the following symptoms: loss of appetite or start losing weight (anorexia) nausea or vomiting feel tired stomach pain or tenderness dark urine or light colored stools yellowing of your skin or the whites of your eyes fever or rash changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heart beats that can be life threatening. This can happen when ketoconazole tablets are taken with certain medicines, such as dofetilide, quinidine, pimozide, lurasidone, cisapride, methadone, disopyramide, dronedarone, and ranolazine. Talk to your healthcare provider about other medicines you are taking before you start taking ketoconazole tablets. Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast. These may be symptoms related to QT prolongation.

From the patient leaflet: What should I avoid while taking ketoconazole tablets?
Do not drink alcohol while taking ketoconazole tablets.

From the patient leaflet: How should I store ketoconazole tablets?
Store ketoconazole tablets at room temperature between 68° and 77° F (20° and 25° C) Keep ketoconazole tablets dry.

Source: FDA drug label (KETOCONAZOLE), Strides Pharma Science Limited, effective December 17, 2025 (SPL set 6d4be760-c723-4f54-a854-12c61cf91703), via openFDA; the full label on DailyMed

Is there a generic for ketoconazole (Nizoral)?

The FDA approved the first generic ketoconazole on June 15, 1999. 21 generic applications are approved; 14 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists ketoconazole from 30 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

1981 earliest approval on file
1999 first generic approved
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for ketoconazole (Nizoral)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.249 per gram (Ketoconazole 2% cream), down 11% from $0.280 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Ketoconazole 2% cream (generic)

$0.283

$0.195

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Ketoconazole 2% cream	Generic	$0.249 per gram	n/a	-11%
Ketoconazole 2% foam	Generic	$4.52 per gram	n/a	+12%
Ketoconazole 2% shampoo	Generic	$0.0754 per mL	n/a	-12%
Ketoconazole 200 mg tablet	Generic	$0.646 per tablet	$19.37	-0.9%
Ketodan 2% foam	Generic	$3.44 per gram	n/a	+43%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has ketoconazole been recalled?

The FDA's Enforcement Report lists 3 recalls naming ketoconazole since 2012: 0 Class I (the most serious), 1 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
April 13, 2022	Class II	Mckesson Medical-Surgical Inc. Corporate Office	cGMP deviations: Temperature abuse
November 18, 2013	Class III	Fougera Pharmaceuticals Inc.	Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
July 18, 2012	Class III	Fougera Pharmaceuticals Inc.	Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the ketoconazole label say about other medicines?

The ketoconazole label names no other medicine on this site. The labels of 35 other medicines name ketoconazole. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Other labels that name ketoconazole

Check ketoconazole against other medicines

What do FAERS reports show for ketoconazole?

The FDA Adverse Event Reporting System holds 17,282 reports that list ketoconazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,119 are coded as a death and 3,823 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Drug Ineffective (a use or a product term, not a reaction)1,766
Off Label Use (a use or a product term, not a reaction)1,240
Pruritus (named in the label)984
Fatigue975
Nausea (named in the label)873
Rash (named in the label)858
Diarrhoea (named in the label)814
Headache (named in the label)754

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as ketoconazole?

18 other medicines are given the same way (topical) and in the same FDA class as ketoconazole or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (topical)	Pharmacy cost	Shortage
Clotrimazole	Fungal infections	13 labelers	$0.133 per gram 1% topical cream	No current entry
Miconazole	Fungal infections	none listed	$0.120 per gram 2% topical cream	No current entry
Betamethasone and clotrimazole	Fungal infections	16 labelers	$0.190 per gram Clotrimazole-betamethasone cream	No current entry
Econazole	Fungal infections	6 labelers	$0.351 per gram 1% cream	No current entry
Sulconazole	Fungal infections	none listed	n/a	A presentation being discontinued
Oxiconazole	Fungal infections	1 labeler	$3.92 per gram 1% cream	No current entry
Luliconazole	Fungal infections	none listed	n/a	No current entry
Miconazole and petrolatum and zinc oxide	Fungal infections	none listed	$9.12 per gram 0.25-15%	No current entry

Every medicine labeled for the same conditions as ketoconazole

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does ketoconazole compare with medicines for the same use?

9 side-by-side pages set ketoconazole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to ketoconazole: 18 medicines for the same use
Other azole antifungals: the pharmacologic class, with prices and generics
Ketoconazole side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other