Oravig Side Effects
Generic Name: miconazole
Note: This page contains side effects data for the generic drug miconazole. It is possible that some of the dosage forms included below may not apply to the brand name Oravig.
For the Consumer
Applies to miconazole: buccal mucosa tablet
As well as its needed effects, miconazole (the active ingredient contained in Oravig) may cause unwanted side effects that require medical attention.
Major Side Effects
If any of the following side effects occur while taking miconazole, check with your doctor immediately:Less common:
- Body aches or pain
- difficulty with breathing
- ear congestion
- fever or chills
- loss of voice
- lower back or side pain
- nasal congestion
- painful or difficult urination
- pale skin
- runny nose
- sore throat
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- Black, tarry stools
- pale skin
- shortness of breath
- ulcers, sores, or white spots in the mouth
Minor Side Effects
Some miconazole side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:More common:
- Change in taste
- dry mouth
- itching skin
- loss of taste
- pain, redness, and swelling of the gums
- sores on the tongue
- Abdominal or stomach pain
- loss of appetite
- upper abdominal or stomach pain
For Healthcare Professionals
Applies to miconazole: buccal tablet, intravenous solution
The overall safety of miconazole (the active ingredient contained in Oravig) 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.[Ref]
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 (the active ingredient contained in Oravig) [Ref]
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 (the active ingredient contained in Oravig) [Ref]
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 (the active ingredient contained in Oravig) [Ref]
Respiratory side effects have included cough (2.8%), upper respiratory infection (2.1%), and pharyngeal pain (0.7%).[Ref]
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 (the active ingredient contained in Oravig) [Ref]
Other side effects have included fatigue (2.8%) and pain (1%). Fever and chills have been reported with intravenous miconazole (the active ingredient contained in Oravig) [Ref]
Dermatologic side effects have included pruritus (2%). Pruritus (which may have been accompanied by maculopapular rash) has been reported with intravenous miconazole (the active ingredient contained in Oravig) and in some cases, severe pruritus developed after weeks of therapy or after therapy was completed.[Ref]
Hepatic side effects have included elevated gamma glutamyltransferase (1%).[Ref]
Hypersensitivity side effects have included allergic reaction (including anaphylactic reactions and hypersensitivity). Contact dermatitis has been reported when intravenous miconazole (the active ingredient contained in Oravig) was used topically. Anaphylaxis has been reported rarely with intravenous miconazole.[Ref]
Increases in cholesterol and triglycerides reported in patients receiving intravenous miconazole (the active ingredient contained in Oravig) 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.[Ref]
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.[Ref]
Cardiovascular side effects associated with intravenous miconazole (the active ingredient contained in Oravig) 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.[Ref]
Ocular side effects associated with intravenous miconazole (the active ingredient contained in Oravig) have included blurred vision.
Psychiatric side effects associated with intravenous miconazole (the active ingredient contained in Oravig) have included euphoria.
Renal side effects have included acute renal failure, possibly due to intravenous miconazole (the active ingredient contained in Oravig) administration, in one patient with a renal allograft.[Ref]
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It is possible that some side effects of Oravig may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
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