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Miconazole (Oral)

Generic name: miconazole systemic

Brand names: Oravig

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Buccal:

Oravig: 50 mg [contains corn starch, milk protein concentrate]


Mechanism of Action

Inhibits biosynthesis of ergosterol, damaging the fungal cell wall membrane, which increases permeability causing leaking of nutrients




Duration of Action

Buccal adhesion: 15 hours

Use: Labeled Indications

Treatment of oropharyngeal candidiasis


Hypersensitivity to miconazole, milk protein concentrate, or any component of the formulation

Dosage and Administration

Dosing: Adult

Oropharyngeal candidiasis (mild): Buccal tablet: 50 mg (1 tablet) applied to the upper gum region (canine fossa) once daily for 7 to 14 days (HHS [OI adult 2017]; IDSA [Pappas 2016])

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Oropharyngeal candidiasis (mild): Adolescents ≥16 years: Refer to adult dosing.


Oral: Apply in the morning after brushing teeth. With dry hands, place either side of the tablet against the upper gum above the incisor tooth; hold with slight pressure over the upper lip for 30 seconds. Placing the rounded side of the tablet against the gum may be more comfortable. Alternate sides of the mouth with each application; do not crush, chew, or swallow. Avoid chewing gum while in place.

If the tablet does not adhere to the gum or falls off within 6 hours of application, the same tablet should be repositioned immediately. If the tablet does not adhere, use a new tablet. If the tablet is swallowed within 6 hours of application, the patient should drink a glass of water and apply a new tablet (only once). If the tablet falls off or is swallowed >6 hours after application, a new tablet should not be applied until the next regularly scheduled dose.

Dietary Considerations

Should be taken whole; do not crush, chew, or swallow. Food and drink can be taken normally; chewing gum should be avoided.


Store at 20°C to 25°C (68°F to 77°F); excursions permitted to15°C to 30°C (59°F to 86°F). Protect from moisture.

Drug Interactions

Fosphenytoin: Miconazole (Oral) may increase the serum concentration of Fosphenytoin. Monitor therapy

Phenytoin: Miconazole (Oral) may increase the serum concentration of Phenytoin. Monitor therapy

Saccharomyces boulardii: Antifungal Agents (Systemic, Oral) may diminish the therapeutic effect of Saccharomyces boulardii. Avoid combination

Sulfonylureas: Miconazole (Oral) may enhance the hypoglycemic effect of Sulfonylureas. Miconazole (Oral) may increase the serum concentration of Sulfonylureas. Monitor therapy

Warfarin: Miconazole (Oral) may increase the serum concentration of Warfarin. Monitor therapy

Adverse Reactions

>10%: Local: Application site reaction (10% to 12%; including glossalgia, local discomfort, local pain, local pruritus, localized burning, localized edema, oral mucosa ulcer, toothache)

1% to 10%:

Central nervous system: Headache (5% to 8%), fatigue (3%), pain (1%)

Dermatologic: Pruritus (2%)

Endocrine & metabolic: Increased gamma-glutamyl transferase (1%)

Gastrointestinal: Diarrhea (6% to 9%), nausea (1% to 7%), dysgeusia (3% to 4%), vomiting (1% to 4%), oral discomfort (3%), xerostomia (3%), abdominal pain (1% to 3%), ageusia (2%), gastroenteritis (1%), sore throat (1%)

Hematologic & oncologic: Anemia (3%), lymphocytopenia (2%), neutropenia (1%)

Respiratory: Cough (3%), upper respiratory tract infection (2%)


Concerns related to adverse effects:

  • Hypersensitivity reactions: Hypersensitivity reactions (including anaphylactic reactions) have been reported. There is no information regarding cross-reactivity between miconazole and other azole antifungals. Monitor patients with a history of azole hypersensitivity.

Disease-related concerns:

  • Hepatic impairment: Although systemic absorption is typically minimal, use with caution in patients with hepatic impairment.


Pregnancy Risk Factor


Pregnancy Considerations

Adverse events were observed in some animal reproduction studies. There is minimal systemic absorption following buccal application.

Patient Education

What is this drug used for?

  • It is used to treat fungal infections in the mouth.

Frequently reported side effects of this drug

  • Headache
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Change in taste

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

  • Application site pain or swelling
  • Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Source: Wolters Kluwer Health. Last updated December 16, 2019.