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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
  • 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

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
  • 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 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

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

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

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

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

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 (the active ingredient contained in Oravig) [Ref]

Other

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

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

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

Hypersensitivity

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]

Metabolic

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

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

Ocular side effects associated with intravenous miconazole (the active ingredient contained in Oravig) have included blurred vision.

Psychiatric

Psychiatric side effects associated with intravenous miconazole (the active ingredient contained in Oravig) have included euphoria.

Renal

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]

References

1. Stevens D "Miconazole in the treatment of systemic fungal infections." Am Rev Respir Dis 116 (1977): 801-6

2. "Product Information. ORAVIG (miconazole)." Strativa Pharmaceuticals, a Division of Par Pharmaceuticals, Inc., Woodcliff Lake, NJ.

3. Heel RC, Brogden RN, Pakes GE, Speight TM, Avery GS "Miconazole: a preliminary review of its therapeutic efficacy in systemic fungal infections." Drugs 19 (1980): 7-30

4. Fischer TJ, Klein RB, Kershnar HE, Borut TC, Stiehm ER "Miconazole in the treatment of chronic mucocutaneous candidiasis: a preliminary report." J Pediatr 91 (1977): 815-9

5. Bodey GP "Topical and systemic antifungal agents." Med Clin North Am 72 (1988): 637-59

6. Wade TR, Jones HE, Chanda JJ "Intravenous miconazole therapy of mycotic infections." Arch Intern Med 139 (1979): 784-6

7. "Product Information. Monistat (miconazole)." Ortho Pharmaceutical Corporation, Raritan, NJ.

8. Marmion LC, Desser KB, Lilly RB, Stevens DA "Reversible thrombocytosis and anemia due to miconazole therapy." Antimicrob Agents Chemother 10 (1976): 447-9

9. Degreef H, Verhoeve L "Contact dermatitis to miconazole nitrate." Contact Dermatitis 1 (1975): 269-70

10. Barr RJ, Fujita WH, Graham JH "Eruptive xanthomas associated with intravenous miconazole therapy." Arch Dermatol 114 (1978): 1544-5

11. Fernandez L, Maquiera E, Rodriguez F, Picans I, Duque S "Systemic contact dermatitis from miconazole." Contact Dermatitis 34 (1996): 217

12. Fainstein V, Bodey GP "Cardiorespiratory toxicity due to miconazole." Ann Intern Med 93 (1980): 432-3

13. Baes H "Contact sensitivity to miconazole with ortho-chloro cross-sensitivity to other imidazoles." Contact Dermatitis 24 (1991): 89-93

14. Raulin C, Frosch PJ "Contact allergy to imidazole antimycotics." Contact Dermatitis 18 (1988): 76-80

15. Wade TR, Jones HE, Artis WA "Irritant and allergic reactions to topically applied Micatin cream." Contact Dermatitis 5 (1979): 168-70

16. Perret CM, Happle R "Contact allergy to miconazole." Contact Dermatitis 19 (1988): 75

17. Rose HD, Roth DA, Barboriak JJ "Hyperlipidemia related to miconazole therapy." Ann Intern Med 91 (1979): 491-2

18. Bagnarello AG, Lewis LA, McHenry MC, Weinstein AJ, Naito HK, McCullough AJ, Lederman RJ, Gavan TL "Unusual serum lipoprotein abnormality induced by the vehicle of miconazole." N Engl J Med 296 (1977): 497-9

19. Naito HK, McHenry MC, Lewis LA "Drug-induced dyslipoproteinemia: a report of two cases." Clin Chem 26 (1980): 163-8

20. Coley KC, Crain JL "Miconazole-induced fatal dysrhythmia." Pharmacotherapy 17 (1997): 379-82

21. Lai KN, Newton M, Seymour A, Pugsley D, Jones T "Miconazole treatment after renal transplantation." Lancet 4 (1981): 48-9

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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