Clotrimazole: uses, dosing, side effects & brands
Clotrimazole is an azole antifungal sold in the U.S. under 12 brand and generic names, for cutaneous candidiasis, oral candidiasis and vulvovaginal 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)
- Cutaneous Candidiasis, Oral Candidiasis and Vulvovaginal Candidiasis
- Available as
- Topical · Lozenge · Solution · Spray/Inhaler · Tablet · Liquid
- Sold as
- 12 products — Clotrimazole, Gyne-Lotrimin and Gyne-Lotrimin 3, and others
- Prescription?
- Both Rx and OTC forms
- Generic available?
- Yes
- What the pharmacy pays
- about $0.21 per ml — not your price
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How Clotic is dosed
From the FDA label for Clotic (application NDA217628). Other clotrimazole products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
CLOTIC is for otic use only. ( 2 ) Instill the contents of one single-dose CLOTIC vial into the affected ear canal twice daily, morning and evening, preferably 12 hours apart for 14 consecutive days. ( 2 ) See full prescribing information for preparation and administration instructions 2.1 Recommended Dosage and Administration CLOTIC is for otic use only. Instill the contents of one single-dose CLOTIC vial into the affected ear canal twice daily morning and evening, preferably 12 hours apart, for 14 consecutive days. 2.2 Preparation and Administration Instructions Warm the solution by holding the vial in the hand for 1 to 2 minutes. This is to avoid dizziness which may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward, and then instill the medication. Gently pull the outer ear lobe upward and outward. This will allow the ear drops to flow down into the ear canal. Maintain this position for 1 minute after the drug administration. Repeat, if necessary, for the opposite ear [see Instructions for Use ].
Everything below is the FDA label for Clotic (liquid). Clotrimazole is also sold as topical, lozenge, solution, spray/inhaler and tablet, and those are different medicines to take — follow the label for the one you were prescribed.
Clotic side effects
The most common adverse reactions that occurred in ≥ 1 patient were headache, application site pain, tinnitus, tympanic membrane perforation, and paresthesia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Carwin Pharmaceutical Associates, LLC at phone 1-844-700-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two randomized, placebo-controlled, phase 3 trials, 393 adult patients with otomycosis and intact tympanic membranes were treated with CLOTIC or placebo (Trial 1 and Trial 2) twice daily for a median duration of 14 days. There were 261 patients who received at least one dose of CLOTIC and 132 patients received at least one dose of placebo. These patients had a mean age of 51 years (range 19 to 89 years); 55% were male, 87% were White, and 26% were Hispanic or Latino ethnicity. Adverse Reactions Leading to Discontinuation Treatment discontinuation due to an adverse reaction occurred in 1% (3/261) of patients receiving CLOTIC and 3% (4/132) of patients receiving placebo. Adverse reactions leading to discontinuation of CLOTIC were application site pain in two patients…
Who shouldn’t take Clotic
CLOTIC is contraindicated in patients with known hypersensitivity to clotrimazole. CLOTIC is contraindicated in patients with known hypersensitivity to clotrimazole. ( 4 )
Every clotrimazole product we track (12)
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 | 68/100 | Prescription | Topical | Generic | $0 | View → | |
| 3 | 68/100 | Prescription | Topical | Generic | $0 | View → | |
| 4 | 68/100 | Prescription | Tablet | Generic | $0 | View → | |
| 5 | 68/100 | Prescription | Topical | Generic | $0 | View → | |
| 6 | 68/100 | Prescription | Tablet | Generic | $0 | View → | |
| 7 | Not yet rated | Prescription | Liquid | Generic | $0 | View → | |
| 8 | Not yet rated | Prescription | Topical | Generic | $0 | View → | |
| 9 | Not yet rated | Over-the-counter | Spray/Inhaler | Generic | $0 | View → | |
| 10 | Not yet rated | Over-the-counter | Lozenge | Generic | $0 | View → |
Combination products containing clotrimazole
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Clotrimazole recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Clotrimazole and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for clotrimazole: levels in milk, effects in breastfed infants, and the drugs it would consider insteadBecause has poor absorption from the skin and vagina and has poor oral bioavailability, it is unlikely to adversely affect the breastfed infant, including after topical application to the nipples. It has been used orally in infants with thrush, sometimes successfully after nystatin has failed. Any excess cream or ointment should be removed from the nipples before nursing. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.
National Institute of Child Health and Human Development, record revised September 19, 2022. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about clotrimazole
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 15,513 reports naming clotrimazole, and the FDA flagged 72% 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:
- nausea1,032 reports
- fatigue939 reports
- headache921 reports
- dyspnoea866 reports
- macular degeneration818 reports
- diarrhoea802 reports
- rash631 reports
- anxiety591 reports
Read these as a signal, not a rate. A report does not mean clotrimazole 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.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
Related calculators
Frequently asked questions
What is Clotic?
CLOTIC is a sterile preservative-free otic solution containing clotrimazole, an azole antifungal agent, at a concentration of 1% in polyethylene glycol (PEG) 400. The solution is clear colorless to slightly yellow. Each single-dose vial of CLOTIC delivers approximately 0.17 mL of solution equivalent to 1.7 mg of clotrimazole.
What kind of drug is clotrimazole?
The FDA classifies clotrimazole 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 clotrimazole 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 clotrimazole 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 clotrimazole sold under?
We track 12 clotrimazole-containing products in the U.S.: Clotrimazole, Gyne-Lotrimin, Gyne-Lotrimin 3, Gyne-Lotrimin Combination Pack, Mycelex-7, Mycelex-7 Combination Pack, Clotic and Lotrimin, and 4 more. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does clotrimazole come in?
Across the brands we track, clotrimazole is currently marketed as topical, lozenge, solution, spray/inhaler, tablet and liquid, 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 clotrimazole?
Yes. Our catalog lists 1 generic clotrimazole 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.
Has clotrimazole been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions clotrimazole. The most recent: Globe Clotrimazole Cream (Oct 31, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Clotrimazole: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/clotrimazole
- MLA
- “Clotrimazole: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/clotrimazole.
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 clotrimazole on DailyMed (NIH) ↗.