Applies to miconazole: buccal mucosa tablet.
Serious side effects of Miconazole
Along with its needed effects, miconazole 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 Miconazole
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]
