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Butoconazole Side Effects

The most commonly reported side effects of butoconazole include pain, foetal exposure during pregnancy, and congenital anomaly, based on 96 FDA adverse event reports from 2004 to 2025. 12.5% of reports found the drug to be ineffective.

Butoconazole side effects

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

1
Drug Ineffective12.5%12
2
Pain6.3%6
3
Foetal Exposure During Pregnancy6.3%6
4
Congenital Anomaly6.3%6
5
Atrial Septal Defect6.3%6
6
Patent Ductus Arteriosus6.3%6
7
Maternal Exposure Timing Unspecified6.3%6
8
Deep Vein Thrombosis5.2%5
9
Headache4.2%4
10
Cholelithiasis4.2%4
11
Cholecystitis Chronic4.2%4
12
Pain In Extremity4.2%4
13
Pulmonary Embolism4.2%4
14
Cardiomegaly4.2%4
15
Talipes4.2%4

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

Report severity

68.8%Serious66 reports
35.4%Hospitalizations34 reports
1.0%Fatal1 reports

Seriousness is determined by the reporter, not by OpenClaim.

Butoconazole drug interactions

Other drugs that appear in adverse event reports alongside butoconazole. 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
Ethinyl-estradiol19.8%19
2
Drospirenone16.7%16
3
Sertraline-hydrochloride12.5%12
4
Risedronate-sodium3.1%3
5
Alendronate-sodium3.1%3
6
Paroxetine3.1%3
7
Etonogestrel2.1%2
8
Gadopentetate-dimeglumine2.1%2
9
Levetiracetam2.1%2
10
Metoclopramide-hydrochloride2.1%2
11
Cholecalciferol2.1%2
12
Ambrisentan2.1%2
13
Treprostinil2.1%2
14
Esomeprazole2.1%2
15
Lansoprazole2.1%2

Taken alongside

1
Metronidazole19.8%19
2
Acetaminophen18.8%18
3
Fluconazole17.7%17
4
Azithromycin16.7%16
5
Levothyroxine-sodium15.6%15
6
Hydrocodone15.6%15
7
Clindamycin12.5%12
8
Promethazine-hydrochloride12.5%12
9
Ibuprofen11.5%11
10
Aspirin10.4%10
11
Albuterol10.4%10
12
Fluticasone10.4%10
13
Folic-acid9.4%9
14
Amoxicillin9.4%9
15
Prednisone9.4%9

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 butoconazole side effects

85.4% of butoconazole adverse event reports involve female patients and 9.4% involve male patients. The largest age group is adult at 74%. These figures reflect who reports side effects, not underlying risk.

Sex

Female85.4%
Male9.4%
Unknown5.2%

Age group

< 211.3%
2–110.0%
12–174.8%
18–6474.2%
65+9.7%

What is butoconazole used for

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

Candida InfectionDrug Use For Unknown IndicationFoetal Exposure During PregnancyFungal InfectionFungal InfectionHypertonic BladderInfectionProduct Used For Unknown IndicationProduct Used For Unknown IndicationVaginal DischargeVulvovaginal CandidiasisVulvovaginal DiscomfortVulvovaginal Mycotic InfectionVulvovaginitisVulvovaginal Mycotic Infection

Butoconazole brand names and reporting trend

Butoconazole is sold under the brand name Femstat.

Brand names

Femstat10

Quarterly reports (20042025)

2004201020152025

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

Taking butoconazole with another medication?

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