MICONAZOLE NITRATE 2%

N/A

Manufactured by Akron Pharma Inc.

16 FDA adverse event reports analyzed

Last updated: 2026-04-15

About MICONAZOLE NITRATE 2%

MICONAZOLE NITRATE 2% is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Akron Pharma Inc.. The most commonly reported adverse reactions for MICONAZOLE NITRATE 2% include ACCIDENTAL EXPOSURE TO PRODUCT, BACTERAEMIA, CELLULITIS, DEHYDRATION, DIABETIC KETOACIDOSIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MICONAZOLE NITRATE 2%.

Top Adverse Reactions

ACCIDENTAL EXPOSURE TO PRODUCT1 reports
BACTERAEMIA1 reports
CELLULITIS1 reports
DEHYDRATION1 reports
DIABETIC KETOACIDOSIS1 reports
DISEASE PROGRESSION1 reports
DYSGEUSIA1 reports
ENVIRONMENTAL EXPOSURE1 reports
HYPERGLYCAEMIA1 reports
LUNG DISORDER1 reports
MIGRAINE1 reports
PRODUCT USE ISSUE1 reports
RENAL FAILURE1 reports
SCROTAL DISORDER1 reports
UNEVALUABLE EVENT1 reports
VISUAL IMPAIRMENT1 reports

Report Outcomes

Out of 3 classified reports for MICONAZOLE NITRATE 2%:

Serious 66.7%Non-Serious 33.3%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male2 (66.7%)
Female1 (33.3%)

Reports by Age

Age 311 reports
Age 761 reports
Age 821 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with MICONAZOLE NITRATE 2%?

This profile reflects 16 FDA FAERS reports that mention MICONAZOLE NITRATE 2%. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MICONAZOLE NITRATE 2%?

Frequently reported terms in FAERS include ACCIDENTAL EXPOSURE TO PRODUCT, BACTERAEMIA, CELLULITIS, DEHYDRATION, DIABETIC KETOACIDOSIS, DISEASE PROGRESSION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MICONAZOLE NITRATE 2%?

Labeling and FAERS entries often list Akron Pharma Inc. in connection with MICONAZOLE NITRATE 2%. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.