Miconazole: uses, dosing, side effects & brands
Miconazole is an azole antifungal sold in the U.S. under 10 brand and generic names, for aspergillosis, cutaneous 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)
- Aspergillosis, Cutaneous Candidiasis and Vulvovaginal Candidiasis
- Available as
- Injectable · Kit · Suppository · Topical · Tampon · Tablet
- Sold as
- 10 products — Monistat, Monistat 3 and Monistat 3 Combination Pack, and others
- Prescription?
- Both Rx and OTC forms
- Generic available?
- Not in our catalog
- What the pharmacy pays
- about $0.12 per gm — not your price
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How Oravig is dosed
From the FDA label for Oravig (application NDA022404). Other miconazole products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Application of one ORAVIG 50 mg buccal tablet to the gum region once daily for 14 consecutive days (2.1) . Instruct patients not to crush, chew, or swallow tablets (2.2) . 2.1 Basic Dosing Information The recommended dosing schedule for ORAVIG is the application of one 50 mg buccal tablet to the upper gum region (canine fossa) once daily for 14 consecutive days. 2.2 Administration Instructions ORAVIG should be applied in the morning, after brushing the teeth. The tablet should be applied with dry hands. The rounded side surface of the tablet should be placed against the upper gum just above the incisor tooth (canine fossa) and held in place with slight pressure over the upper lip for 30 seconds to ensure adhesion. The tablet is round on one side for comfort, but either side of the tablet can be applied to the gum. Once applied, ORAVIG stays in position and gradually dissolves. [ See Clinical Pharmacology (12.3) ] Subsequent applications of ORAVIG should be made to alternate sides of the mouth. Before applying the next tablet, the patient should clear away any remaining tablet material. In addition, ORAVIG should not be crushed, chewed or swallowed. Food and drink can be taken normally when ORAVIG is in place but chewing gum should be avoided. If ORAVIG does not adhere or falls off within the first 6 hours, the same tablet should be repositioned immediately. If the tablet still…
Everything below is the FDA label for Oravig (tablet). Miconazole is also sold as injectable, kit, suppository, topical and tampon, and those are different medicines to take — follow the label for the one you were prescribed.
Oravig side effects
The following serious adverse drug reactions are discussed in detail in other sections of labeling: Hypersensitivity reactions [see Warnings and Precautions (5.1)] Most common adverse reactions (≥2%) are: diarrhea, headache, nausea, dysgeusia, upper abdominal pain, and vomiting (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Galt Pharmaceuticals, LLC Marietta, GA 30067 at 1-833-757-0904 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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 clinical practice. The overall safety of ORAVIG was assessed in 480 adult subjects: 315 HIV-infected subjects, 147 subjects with head and neck cancer, and 18 healthy subjects. HIV Infected Patients Two trials were conducted in immunocompromised HIV-infected patients: one randomized, double-blind, double-dummy, active-controlled design (N = 290 ORAVIG, 287 control) and one non-comparative trial (N = 25). In the randomized, double blind trial (Study 1), 290 HIV infected subjects used ORAVIG once daily for 14 days, and 287 subjects used 10 mg clotrimazole troches five times daily for 14 days. Adverse reactions occurring in ≥ 2% of patients in either treatment are…
Who shouldn’t take Oravig
ORAVIG is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to miconazole, milk protein concentrate, or any other component of the product. Known hypersensitivity to miconazole, milk protein concentrate, or any other component of the product.
Oravig drug interactions
Warfarin: Miconazole may enhance anticoagulant effect. Monitor prothrombin time, INR, and watch for bleeding (7.1). 7.1 Warfarin Concomitant administration of miconazole and warfarin has resulted in enhancement of anticoagulant effect. Cases of bleeding and bruising following the concomitant use of warfarin and topical, intravaginal, or oral miconazole were reported. Closely monitor prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests if ORAVIG is administered concomitantly with warfarin. Also monitor for evidence of bleeding. 7.2 Drugs Metabolized Through CYP 2C9 and 3A4 No formal drug interaction studies have been performed with ORAVIG. Miconazole is a known inhibitor of CYP2C9 and CYP3A4. Although the systemic absorption of miconazole following ORAVIG administration is minimal and plasma concentrations of miconazole are substantially lower than when given intravenously, the potential for interaction with drugs metabolized through CYP2C9 and CYP3A4 such as oral hypoglycemics, phenytoin, or ergot alkaloids cannot be ruled out.
Every miconazole product we track (10)
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 | 70/100 | Prescription | Injectable | Generic | $0 | View → | |
| 2 | 70/100 | Over-the-counter | Kit | No data | — | View → | |
| 3 | 70/100 | Over-the-counter | Kit | No data | — | View → | |
| 4 | 70/100 | Over-the-counter | Kit | No data | — | View → | |
| 5 | 70/100 | Over-the-counter | Suppository | No data | — | View → | |
| 6 | 70/100 | Over-the-counter | Suppository | No data | — | View → | |
| 7 | 70/100 | Prescription | Topical | No data | — | View → | |
| 8 | Not yet rated | Prescription | Tampon | No data | — | View → | |
| 9 | Not yet rated | Prescription | Suppository | No data | — | View → | |
| 10 | Not yet rated | Prescription | Tablet | Generic | $0 | View → |
Combination products containing miconazole
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.
How long miconazole keeps
No miconazole label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does miconazole expire? The in-use limits and storage rules from its labelsMiconazole and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for miconazole: levels in milk, effects in breastfed infants, and the drugs it would consider insteadBecause miconazole 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. However, miconazole ointment appears to have no advantage over lanolin for treating sore nipples during breastfeeding and a survey of members of the Academy of Breastfeeding Medicine found topical miconazole is rarely prescribed to nursing mothers to treat thrush. 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 miconazole
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 6,701 reports naming miconazole, and the FDA flagged 49% 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:
- vulvovaginal burning sensation1,134 reports
- vulvovaginal pain385 reports
- vulvovaginal pruritus332 reports
- vulvovaginal discomfort261 reports
- nausea201 reports
- diarrhoea192 reports
- international normalised ratio increased181 reports
- rash167 reports
Read these as a signal, not a rate. A report does not mean miconazole 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 section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Related calculators
Frequently asked questions
What is Oravig?
ORAVIG (miconazole) buccal tablets are applied topically to the gum once daily and release miconazole as the buccal tablet gradually dissolves [see Clinical Pharmacology (12.3)] .
What kind of drug is miconazole?
The FDA classifies miconazole 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 miconazole 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 miconazole 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 miconazole sold under?
We track 10 miconazole-containing products in the U.S.: Monistat, Monistat 3, Monistat 3 Combination Pack, Monistat 3 Combination Pack (Prefilled), Monistat 7, Monistat 7 Combination Pack, Monistat-Derm and Monistat 5, and 2 more. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does miconazole come in?
Across the brands we track, miconazole is currently marketed as injectable, kit, suppository, topical, tampon and tablet, 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 miconazole?
We do not currently list a generic-labelled miconazole product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Miconazole: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/miconazole
- MLA
- “Miconazole: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/miconazole.
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 miconazole on DailyMed (NIH) ↗.