ketoconazole
Brand names: Nizoral
Ketoconazole shampoo is an antifungal medicine. It treats a fungal infection on your skin.
Drug Pricing (NADAC)
Generic Price
$0.16/unit
Generic Available
Yes (14 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This shampoo treats tinea versicolor, a fungal infection.
Common side effects
No common side effects listed.
Key warnings
You should not use this shampoo if you are allergic to ketoconazole or any of the other ingredients.
How It Works
Ketoconazole is an antifungal medicine. It works by stopping the growth of the fungus. This helps to clear up the infection.
How to Take It
Apply the shampoo to the damp skin of the affected area and a wide margin around it. Lather the shampoo and leave it on for 5 minutes. Then, rinse it off with water. Usually, one application is enough.
Pregnancy & Breastfeeding
It is not known if ketoconazole shampoo can harm an unborn baby. Talk to your doctor if you are pregnant or breastfeeding before using this medicine.
Missed Dose
Since you only use this once, you don't have to worry about a missed dose.
Storage
Store at room temperature, between 68° to 77°F. Protect from light.
Side Effects (from patient reports)
Based on 9,063 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 16,231 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
16,231
Death-Related Reports
1,079
Hospitalization Reports
3,676
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 1,582 |
| 2 | OFF LABEL USE | 1,174 |
| 3 | FATIGUE | 929 |
| 4 | PRURITUS | 902 |
| 5 | NAUSEA | 834 |
| 6 | RASH | 802 |
| 7 | DIARRHOEA | 760 |
| 8 | PAIN | 727 |
| 9 | HEADACHE | 708 |
| 10 | PSORIASIS | 645 |
| 11 | DYSPNOEA | 601 |
| 12 | DIZZINESS | 589 |
| 13 | PRODUCT USE IN UNAPPROVED INDICATION | 548 |
| 14 | ARTHRALGIA | 541 |
| 15 | CHRONIC KIDNEY DISEASE | 520 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
You should not use this shampoo if you are allergic to ketoconazole or any of the other ingredients.
Known Drug Interactions
7 DRUG INTERACTIONS Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists, including alfuzosin hydrochloride extended-release tablets, can potentially cause symptomatic hypotension ( 5.4 , 7.4) 7.1 CYP3A4 Inhibitors Alfuzosin hydrochloride extended-release tablets are contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir, since alfuzosin blood levels are increased [see Contraindications ( 4 ), Warnings and Precautions ( 5.4) and Clinical Pharmacology ( 12.3) ].
Mechanism: Ketoconazole blocks the enzyme that breaks down alfuzosin, which causes the amount of alfuzosin in your blood to rise to unsafe levels.
What to do: Do not take these two medicines together as the combination is unsafe.
7.2 Effects of Other Drugs on Dronedarone Ketoconazole and Other Potent CYP3A Inhibitors Concomitant use of ketoconazole as well as other potent CYP3A inhibitors such as itraconazole, voriconazole, ritonavir, clarithromycin, and nefazodone is contraindicated because exposure to dronedarone is significantly increased [see Contraindications (4) , Clinical Pharmacology (12.3) ] .
Mechanism: Ketoconazole stops the liver enzyme that breaks down dronedarone from working. This causes dronedarone to build up to much higher levels in your body.
What to do: Do not use these medications at the same time. This combination is contraindicated by the manufacturer.
( 7.2 ) 7.1 Effects of Other Drugs on Ranolazine Strong CYP3A Inhibitors Do not use ranolazine with strong CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir [see Contraindications (4) , Clinical Pharmacology (12.3) ].
Mechanism: Ketoconazole stops the body from breaking down ranolazine, which can cause the drug to build up to unsafe levels in your blood.
What to do: Do not use these two medications together because the risk of side effects is too high.
7 DRUG INTERACTIONS Table 3: Clinically Relevant Interactions with QTERN Strong Inhibitors of CYP3A4/5 Enzymes Clinical Impact Ketoconazole significantly increased saxagliptin exposure. • Strong CYP3A4/5 Inhibitors (e.g., Ketoconazole): Do not coadminister QTERN with strong cytochrome P450 3A4/5 inhibitors.
Mechanism: Ketoconazole blocks the enzymes that clear saxagliptin from your body, which significantly increases the amount of drug in your blood.
What to do: Do not take these two medications at the same time.
7 DRUG INTERACTIONS Sildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1 , 5.5 , 7.1 , 7.2 , 7.3 , 12.2 ) With concomitant use of alpha blockers, initiate sildenafil at 25 mg dose ( 2.3 ) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4 , 7.4 , 12.3 ) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4 , 5.6 ) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg ( 2.4 , 7.4 ...
Mechanism: Ketoconazole slows down the breakdown of sildenafil, which can lead to higher levels of the drug in your system.
What to do: Your doctor should consider starting you on a lower dose of 25 mg of sildenafil.
Common Questions
How long will it take to see results?
Is tinea versicolor contagious?
Can tinea versicolor come back?
What should I do if the shampoo gets in my eyes?
Can I use this shampoo on my face?
How often can I use this shampoo?
Can I use other skin products while using this shampoo?
What are the ingredients in this shampoo?
What does the shampoo look like?
Where is this medicine made?
Does ketoconazole interact with other medications?
What drug class is ketoconazole?
Is ketoconazole safe during pregnancy?
Related Medications in Azole Antifungal
Other drugs grouped near ketoconazole — same-class peers and common alternatives.
adapalene
Differin
Adapalene and benzoyl peroxide gel is a medicine used on the skin to treat acne.
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apremilast
Otezla
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azelaic acid
Finacea, Azelex
Azelaic acid gel is a topical medicine that helps treat rosacea.
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benzoyl peroxide
Benzac, PanOxyl
Benzoyl peroxide is a topical medicine that fights germs on your skin.
Compare with ketoconazole →
betamethasone
Diprosone, Luxiq
Betamethasone dipropionate cream is a strong steroid medicine used on the skin.
Compare with ketoconazole →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
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Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Related Health & Safety Data
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💉 Procedure Costs
Medicare procedure pricing for 9,297 procedures
What the FDA Data Shows for ketoconazole
The FDA label for ketoconazole (sold under brand names such as Nizoral) classifies it as an over-the-counter product in the Azole Antifungal class. This shampoo treats tinea versicolor, a fungal infection. Labeling covers dosing, contraindications, and monitoring requirements derived from clinical trials.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 9,063 voluntary reports. The database also lists 113 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.16.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: January 29, 2026
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages