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

• Body aches or pain
• cough
• difficulty with breathing
• ear congestion
• fever or chills
• headache
• loss of voice
• lower back or side pain
• nasal congestion
• painful or difficult urination
• pale skin
• runny nose
• sneezing
• sore throat
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Rare

• Black, tarry stools
• pale skin
• shortness of breath
• ulcers, sores, or white spots in the mouth

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

• Change in taste
• diarrhea
• dry mouth
• headache
• itching skin
• loss of taste
• nausea
• pain, redness, and swelling of the gums
• sores on the tongue
• toothache

Less common

• Abdominal or stomach pain
• loss of appetite
• pain
• upper abdominal or stomach pain
• weakness

For Healthcare Professionals

Applies to miconazole: buccal tablet, intravenous solution.

General

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]

Local

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:

-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]

Gastrointestinal

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]

Respiratory

Buccal tablets:

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

Oral gel:

-Postmarketing reports: Choking^[Ref]

Hematologic

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%): 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]

Other

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]

Dermatologic

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%): 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]

Hepatic

Buccal tablets:

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

Oral gel:

-Postmarketing reports: Hepatitis^[Ref]

Hypersensitivity

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

Metabolic

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]

Ocular

Oral gel:

-Postmarketing reports: Accommodation difficulty

IV formulation:

-Frequency not reported: Blurred vision

Cardiovascular

IV formulation:

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

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

Psychiatric

IV formulation:

-Frequency not reported: Euphoria

Renal

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

IV formulation:

-Frequency not reported: Acute renal failure^[Ref]