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Oravig Side Effects

Generic name: miconazole

Medically reviewed by Last updated on Jun 4, 2023.

Note: This document contains side effect information about miconazole. Some dosage forms listed on this page may not apply to the brand name Oravig.

Applies to miconazole: buccal mucosa tablet.

Serious side effects of Oravig

Along with its needed effects, miconazole (the active ingredient contained in Oravig) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking miconazole:

Less common


Other side effects of Oravig

Some side effects of miconazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

For Healthcare Professionals

Applies to miconazole: buccal tablet, intravenous solution.


The overall safety of the buccal tablets was assessed in 480 adult subjects, including 315 HIV-infected subjects, 147 subjects with head and neck cancer, and 18 healthy subjects. Discontinuation due to side effects occurred in 0.6% of subjects overall.

The most common side effects reported with the oral gel were nausea, abnormal product taste, vomiting, oral discomfort, regurgitation, dry mouth, and dysgeusia.

Although the IV product has been discontinued in the US, side effects associated with this formulation have been included.[Ref]


Buccal tablets:

-Very common (10% or more): Local side effects (including oral discomfort, oral burning, oral pain, gingival pain, gingival swelling, gingival pruritus, tongue ulceration, mouth ulceration, glossodynia, dry mouth, application site pain/discomfort, toothache, loss of taste, altered taste, tooth disorder)

IV formulation:

-Very common (10% or more): Phlebitis (at least 33%)[Ref]

Local side effects (including oral discomfort, oral burning, oral pain, gingival pain, gingival swelling, gingival pruritus, tongue ulceration, mouth ulceration, glossodynia, dry mouth, application site pain/discomfort, toothache, loss of taste, altered taste) have been reported in 12.1% of HIV-infected patients. Local side effects (including oral discomfort, oral pain, dry mouth, glossodynia, loss of taste, altered taste, tongue ulceration, mouth ulceration, tooth disorder, application site discomfort/pain) have been reported in 9.5% of patients with head and neck cancer.[Ref]


Buccal tablets:

-Common (1% to 10%): Diarrhea, nausea, vomiting, dry mouth, oral discomfort, upper abdominal pain, gastroenteritis

Oral gel:

-Common (1% to 10%): Dry mouth, nausea, oral discomfort, vomiting, regurgitation

-Postmarketing reports: Diarrhea, stomatitis, tongue discoloration

IV formulation:

-Frequency not reported: Nausea, vomiting, anorexia, diarrhea[Ref]

Nervous system

Buccal tablets:

-Common (1% to 10%): Headache, dysgeusia, ageusia

Oral gel:

-Common (1% to 10%): Dysgeusia

IV formulation:

-Frequency not reported: Dizziness[Ref]


Buccal tablets:

-Common (1% to 10%): Cough, upper respiratory infection, pharyngeal pain

Oral gel:

-Postmarketing reports: Choking[Ref]


Buccal tablets:

-Common (1% to 10%): Anemia, lymphopenia

-Uncommon (0.1% to 1%): Neutropenia

Oral gel:

-Frequency not reported: Increase in INR, increase in bleeding events (e.g., epistaxis, contusion, hematuria, melena, hematemesis, hematoma, hemorrhages)

IV formulation:

-Frequency not reported: Transient decreases in hematocrit, thrombocytosis, thrombocytopenia, erythrocyte aggregation[Ref]

Increases in INR and bleeding events (e.g., epistaxis, contusion, hematuria, melena, hematemesis, hematoma, hemorrhages) have been reported in patients treated with oral anticoagulants (e.g., warfarin) and this oral gel; some events had fatal outcomes.[Ref]


Buccal tablets:

-Common (1% to 10%): Fatigue, pain

Oral gel:

-Common (1% to 10%): Abnormal product taste

-Postmarketing reports: Malaise, chills

IV formulation:

-Frequency not reported: Fever, chills[Ref]


Buccal tablets:

-Common (1% to 10%): Pruritus

Oral gel:

-Postmarketing reports: Angioedema, toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome, urticaria, rash, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms

IV formulation:

-Frequency not reported: Pruritus, maculopapular rash[Ref]

Pruritus (which may have been accompanied by maculopapular rash) has been reported with the IV formulation, and in some cases, severe pruritus developed after weeks of therapy or after therapy was completed.[Ref]


Buccal tablets:

-Common (1% to 10%): Elevated GGT

Oral gel:

-Postmarketing reports: Hepatitis[Ref]


Buccal tablets:

-Frequency not reported: Allergic reaction (including anaphylactic reactions, hypersensitivity)

Oral gel:

-Postmarketing reports: Allergic conditions (including angioneurotic edema, anaphylactic reaction), hypersensitivity

IV formulation:

-Frequency not reported: Anaphylaxis, contact dermatitis[Ref]

Contact dermatitis has been reported when the IV formulation was used topically.[Ref]


Increases in cholesterol and triglycerides reported in patients receiving the IV formulation were due to its vehicle (Cremophor EL [polyethoxylated castor oil]), and were reversible upon discontinuation of the drug. Hyperlipidemia due to Cremophor EL had the atypical appearance of gamma-2 globulin.

Hyponatremia associated with the IV formulation resulted in a mean decrease in sodium of 10 mEq/L, but usually was not a reason to discontinue therapy. This drug was usually administered in normal saline solution to help minimize decreases in sodium.[Ref]

Oral gel:

-Postmarketing reports: Anorexia

IV formulation:

-Frequency not reported: Hyperlipidemia, hyponatremia[Ref]


Oral gel:

-Postmarketing reports: Accommodation difficulty

IV formulation:

-Frequency not reported: Blurred vision


Cardiac arrhythmias, tachycardia, and cardiac arrest may have been associated with rapid infusion of the drug and due to the Cremophor EL vehicle.[Ref]

IV formulation:

-Frequency not reported: Cardiac arrhythmias, tachycardia, cardiac arrest[Ref]


IV formulation:

-Frequency not reported: Euphoria


IV formulation:

-Frequency not reported: Acute renal failure[Ref]

Acute renal failure, possibly due to the IV formulation, was reported in 1 patient with a renal allograft.[Ref]

Frequently asked questions


1. Stevens D. Miconazole in the treatment of systemic fungal infections. Am Rev Respir Dis. 1977;116:801-6.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

4. Product Information. ORAVIG (miconazole). Strativa Pharmaceuticals, a Division of Par Pharmaceuticals, Inc. 2010.

5. Heel RC, Brogden RN, Pakes GE, Speight TM, Avery GS. Miconazole: a preliminary review of its therapeutic efficacy in systemic fungal infections. Drugs. 1980;19:7-30.

6. Wade TR, Jones HE, Chanda JJ. Intravenous miconazole therapy of mycotic infections. Arch Intern Med. 1979;139:784-6.

7. Fischer TJ, Klein RB, Kershnar HE, Borut TC, Stiehm ER. Miconazole in the treatment of chronic mucocutaneous candidiasis: a preliminary report. J Pediatr. 1977;91:815-9.

8. Bodey GP. Topical and systemic antifungal agents. Med Clin North Am. 1988;72:637-59.

9. Product Information. Monistat 7 (miconazole topical). Ortho McNeil Pharmaceutical.

10. Marmion LC, Desser KB, Lilly RB, Stevens DA. Reversible thrombocytosis and anemia due to miconazole therapy. Antimicrob Agents Chemother. 1976;10:447-9.

11. Barr RJ, Fujita WH, Graham JH. Eruptive xanthomas associated with intravenous miconazole therapy. Arch Dermatol. 1978;114:1544-5.

12. Degreef H, Verhoeve L. Contact dermatitis to miconazole nitrate. Contact Dermatitis. 1975;1:269-70.

13. Fernandez L, Maquiera E, Rodriguez F, Picans I, Duque S. Systemic contact dermatitis from miconazole. Contact Dermatitis. 1996;34:217.

14. Fainstein V, Bodey GP. Cardiorespiratory toxicity due to miconazole. Ann Intern Med. 1980;93:432-3.

15. Perret CM, Happle R. Contact allergy to miconazole. Contact Dermatitis. 1988;19:75.

16. Baes H. Contact sensitivity to miconazole with ortho-chloro cross-sensitivity to other imidazoles. Contact Dermatitis. 1991;24:89-93.

17. Wade TR, Jones HE, Artis WA. Irritant and allergic reactions to topically applied Micatin cream. Contact Dermatitis. 1979;5:168-70.

18. Raulin C, Frosch PJ. Contact allergy to imidazole antimycotics. Contact Dermatitis. 1988;18:76-80.

19. Naito HK, McHenry MC, Lewis LA. Drug-induced dyslipoproteinemia: a report of two cases. Clin Chem. 1980;26:163-8.

20. Rose HD, Roth DA, Barboriak JJ. Hyperlipidemia related to miconazole therapy. Ann Intern Med. 1979;91:491-2.

21. Bagnarello AG, Lewis LA, McHenry MC, Weinstein AJ, Naito HK, McCullough AJ, Lederman RJ, Gavan TL. Unusual serum lipoprotein abnormality induced by the vehicle of miconazole. N Engl J Med. 1977;296:497-9.

22. Coley KC, Crain JL. Miconazole-induced fatal dysrhythmia. Pharmacotherapy. 1997;17:379-82.

23. Lai KN, Newton M, Seymour A, Pugsley D, Jones T. Miconazole treatment after renal transplantation. Lancet. 1981;4:48-9.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.