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Miconazole Side Effects

The most commonly reported side effects of miconazole include vulvovaginal burning sensation, vulvovaginal pain, and vulvovaginal pruritus, based on 9,529 FDA adverse event reports from 2004 to 2025. 13.0% of reports found the drug to be ineffective.

Miconazole side effects

Percentages show how often each reaction appears relative to total reports for miconazole.

1
Vulvovaginal Burning Sensation20.2%1,928
2
Drug Ineffective13.0%1,240
3
Vulvovaginal Pain11.5%1,094
4
Vulvovaginal Pruritus7.1%677
5
Condition Aggravated5.9%558
6
Vaginal Haemorrhage5.8%555
7
Vulvovaginal Discomfort5.3%504
8
Vulvovaginal Swelling4.6%434
9
Pain2.7%259
10
Off Label Use2.1%197
11
Burning Sensation2.0%194
12
Nausea2.0%194
13
Pruritus2.0%187
14
Hypersensitivity2.0%186
15
Drug Interaction1.8%176

These are voluntary reports and do not establish that miconazole caused these reactions.

Report severity

35.8%Serious3,416 reports
16.9%Hospitalizations1,609 reports
4.1%Fatal389 reports

Seriousness is determined by the reporter, not by OpenClaim.

Miconazole drug interactions

Other drugs that appear in adverse event reports alongside miconazole. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Fluconazole1.4%130
2
Warfarin1.1%108
3
Omeprazole0.9%85
4
Lenalidomide0.9%85
5
Ethinyl-estradiol0.8%78
6
Sertraline-hydrochloride0.8%78
7
Lansoprazole0.8%77
8
Dihydrocodeine-bitartrate0.7%70
9
Carboplatin0.7%63
10
Atezolizumab0.6%57
11
Zinc-oxide0.6%56
12
Methotrexate0.6%56
13
Acetaminophen0.6%55
14
Rituximab0.6%55
15
Sodium-oxybate0.6%54

Taken alongside

1
Acetaminophen10.6%1,009
2
Omeprazole7.3%699
3
Albuterol5.8%553
4
Aspirin5.6%535
5
Furosemide4.9%471
6
Ergocalciferol4.6%434
7
Levothyroxine-sodium4.3%410
8
Ondansetron4.3%408
9
Atorvastatin-calcium4.1%387
10
Metformin3.8%361
11
Hydrocortisone3.8%360
12
Amoxicillin3.7%355
13
Gabapentin3.7%352
14
Amlodipine3.6%342
15
Fluconazole3.6%340

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports miconazole side effects

77.0% of miconazole adverse event reports involve female patients and 12.8% involve male patients. The largest age group is adult at 66%. These figures reflect who reports side effects, not underlying risk.

Sex

Female77.0%
Male12.8%
Unknown10.2%

Age group

< 21.7%
2–111.2%
12–172.0%
18–6465.7%
65+29.5%

What is miconazole used for

Conditions and purposes for which patients were taking miconazole when the adverse event was reported.

Abdominal PainAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAdjuvant TherapyAdverse EventAnal FissureAnal Fungal InfectionAnal PruritusAngular CheilitisAntifungal ProphylaxisAntifungal TreatmentAphthous StomatitisAspergillosisAcanthamoeba Keratitis

Showing 15 of 299 indications

Miconazole brand names and reporting trend

Miconazole is sold under brand names including Oravig, Monistat 7.

Brand names

Oravig5,982
Monistat 71,848

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking miconazole with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.