Miconazole Side Effects

Some side effects of miconazole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to miconazole: buccal tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking miconazole: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe burning or pain in your mouth;

• new sores in your mouth or on your tongue;

• tooth problems;

• pain or swelling in your gums; or

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Less serious side effects of miconazole may include:

• decreased sense of taste;

• unusual or unpleasant taste;

• mild pain or discomfort in your mouth or tongue;

• cough, dry mouth;

• nausea, vomiting, diarrhea;

• headache; or

• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to miconazole: buccal tablet, intravenous solution

General

The overall safety of miconazole 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.

Although intravenous miconazole has been discontinued in the U.S., side effects associated with this formulation have been included.

Local

Local side effects have included oral discomfort, oral burning, oral pain, gingival pain, gingival swelling, gingival pruritus, tongue ulceration, mouth ulceration, glossodynia, dry mouth, application site pain or discomfort, toothache, loss of taste, and altered taste in 12.1% of HIV-infected patients. Oral discomfort, oral pain, dry mouth, glossodynia, loss of taste, altered taste, tongue ulceration, mouth ulceration, tooth disorder, and application site discomfort or pain have been reported in 9.5% of patients with head and neck cancer. Phlebitis has been reported in at least one-third of patients treated with intravenous miconazole.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 9%), nausea (up to 6.6%), vomiting (up to 3.8%), dry mouth (2.8%), oral discomfort (2.7%), upper abdominal pain (up to 2.5%), and gastroenteritis (1.4%). Nausea, vomiting, anorexia, and diarrhea have been reported with intravenous miconazole.

Nervous system

Nervous system side effects have included headache (up to 7.6%), dysgeusia (up to 4.1%), and ageusia (2.4%). Dizziness has been reported with intravenous miconazole.

Respiratory

Respiratory side effects have included cough (2.8%), upper respiratory infection (2.1%), and pharyngeal pain (0.7%).

Hematologic

Hematologic side effects have included anemia (2.8%), lymphopenia (1.7%), and neutropenia (0.7%). Transient decreases in hematocrit, thrombocytosis, thrombocytopenia, and erythrocyte aggregation have been reported with intravenous miconazole.

Other

Other side effects have included fatigue (2.8%) and pain (1%). Fever and chills have been reported with intravenous miconazole.

Dermatologic

Dermatologic side effects have included pruritus (2%). Pruritus (which may have been accompanied by maculopapular rash) has been reported with intravenous miconazole, and in some cases, severe pruritus developed after weeks of therapy or after therapy was completed.

Hepatic

Hepatic side effects have included elevated gamma glutamyltransferase (1%).

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (including anaphylactic reactions and hypersensitivity). Contact dermatitis has been reported when intravenous miconazole was used topically. Anaphylaxis has been reported rarely with intravenous miconazole.

Metabolic

Increases in cholesterol and triglycerides reported in patients receiving intravenous miconazole were due to its vehicle, and were reversible upon discontinuation of the drug. Hyperlipidemia due to Cremophor EL had the atypical appearance of gamma-2 globulin.

Hyponatremia associated with intravenous miconazole therapy resulted in a mean decrease in sodium of 10 mEq/L, but usually was not a reason to discontinue therapy. Miconazole was usually administered in normal saline solution to help minimize decreases in sodium.

Metabolic side effects associated with intravenous miconazole have included hyperlipidemia, which was associated with the vehicle of miconazole (Cremophor EL [polyethoxylated castor oil]), and hyponatremia.

Cardiovascular

Cardiovascular side effects associated with intravenous miconazole have included cardiac arrhythmias, tachycardia, and cardiac arrest. These effects may have been associated with rapid infusion of miconazole and due to the Cremophor EL vehicle.

Ocular

Ocular side effects associated with intravenous miconazole have included blurred vision.

Psychiatric

Psychiatric side effects associated with intravenous miconazole have included euphoria.

Renal

Renal side effects have included acute renal failure, possibly due to intravenous miconazole administration, in one patient with a renal allograft.

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