Over-the-counter medication · Azole Antifungal
ketoconazole
Also sold as Nizoral. This shampoo treats tinea versicolor, a fungal infection.
Data updated 2026-05-15
- 16,231
- FDA reportsModerately reported
- 113
- InteractionsMany interactions
- $0.16
- Generic price (NADAC)
What the data shows
ketoconazole (Nizoral) is an over-the-counter Azole Antifungal, reported at a middle-of-the-pack volume (16,231 FDA reports), with 113 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
ketoconazole (Nizoral) is an over-the-counter Azole Antifungal. This shampoo treats tinea versicolor, a fungal infection.
Ketoconazole shampoo is an antifungal medicine. It treats a fungal infection on your skin.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from ketoconazole's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Ketoconazole is an antifungal medicine. It works by stopping the growth of the fungus. This helps to clear up the infection.
Side Effects (from patient reports)
Based on 16,231 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for ketoconazole, by number of reports
- Fatigue
Fatigue
929 reports
- Pruritus
Pruritus
902 reports
- Nausea
Nausea
834 reports
- Rash
Rash
802 reports
- Diarrhoea
Diarrhoea
760 reports
- Pain
Pain
727 reports
- Headache
Headache
708 reports
- Psoriasis
Psoriasis
645 reports
- Dyspnoea
Dyspnoea
601 reports
- Dizziness
Dizziness
589 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for ketoconazole each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where ketoconazole sits
ketoconazole has more FDA adverse-event reports than 50% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is ketoconazole; the line is the median (50th percentile).
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
Reports Mentioning Death
1,079
6.6% of reports — not proof of cause
Hospitalization Reports
3,676
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 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 |
| 14 | ARTHRALGIA | 541 |
| 15 | CHRONIC KIDNEY DISEASE | 520 |
| 16 | ASTHENIA | 472 |
| 17 | ANXIETY | 469 |
| 18 | CONDITION AGGRAVATED | 448 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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.
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.
( 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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for ketoconazole?
Related Medications in Azole Antifungal
Other drugs grouped near ketoconazole - same-class peers and common alternatives.
adapalene
Differin
Compare with ketoconazole →
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Otezla
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azelaic acid
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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.
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betamethasone
Diprosone, Luxiq
Betamethasone dipropionate cream is a strong steroid medicine used on the skin.
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for ketoconazole: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 16,231.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 6.65%.
- polyethylene glycol 3350 Δ 0.00 pts · 91,655 reports · Osmotic Laxative 6.65%death share
- dronedarone Δ 0.00 pts · 9,899 reports · Class III Antiarrhythmic 6.65%death share
- cefixime Δ 0.01 pts · 2,824 reports · Third-Generation Cephalosporin 6.66%death share
- ibuprofen Δ 0.02 pts · 262,453 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 6.66%death share
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
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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 16,231 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: January 29, 2026
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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