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: tablets
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking miconazole:
Diarrhea; headache; mild mouth discomfort; nausea; stomach pain; taste changes; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, pain, or swelling at the application site; sores on the mouth or tongue; unusual tiredness or weakness.
For Healthcare Professionals
Applies to miconazole: buccal tablet, intravenous solution
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 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 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 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 side effects have included cough (2.8%), upper respiratory infection (2.1%), and pharyngeal pain (0.7%).
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 side effects have included fatigue (2.8%) and pain (1%). Fever and chills have been reported with intravenous miconazole.
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 side effects have included elevated gamma glutamyltransferase (1%).
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.
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 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 side effects associated with intravenous miconazole have included blurred vision.
Psychiatric side effects associated with intravenous miconazole have included euphoria.
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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