MICONAZOLE NITRATE

N/A

Manufactured by H E B

14,417 FDA adverse event reports analyzed

Last updated: 2026-04-14

About MICONAZOLE NITRATE

MICONAZOLE NITRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by H E B. The most commonly reported adverse reactions for MICONAZOLE NITRATE include VULVOVAGINAL BURNING SENSATION, DRUG INEFFECTIVE, VULVOVAGINAL PAIN, VULVOVAGINAL PRURITUS, CONDITION AGGRAVATED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MICONAZOLE NITRATE.

Top Adverse Reactions

VULVOVAGINAL BURNING SENSATION1,670 reports
DRUG INEFFECTIVE1,129 reports
VULVOVAGINAL PAIN948 reports
VULVOVAGINAL PRURITUS568 reports
CONDITION AGGRAVATED525 reports
VAGINAL HAEMORRHAGE466 reports
VULVOVAGINAL DISCOMFORT422 reports
VULVOVAGINAL SWELLING304 reports
DRUG INTERACTION294 reports
PAIN263 reports
OFF LABEL USE241 reports
DIARRHOEA222 reports
NAUSEA208 reports
PRURITUS194 reports
INTERNATIONAL NORMALISED RATIO INCREASED177 reports
ABDOMINAL PAIN176 reports
RASH173 reports
BURNING SENSATION171 reports
DYSPNOEA169 reports
HYPERSENSITIVITY166 reports
FATIGUE150 reports
DIZZINESS146 reports
URINARY TRACT INFECTION139 reports
VAGINAL DISCHARGE135 reports
APPLICATION SITE PAIN132 reports
PYREXIA130 reports
HEADACHE127 reports
VOMITING127 reports
ASTHENIA112 reports
VULVOVAGINAL ERYTHEMA103 reports
ACUTE KIDNEY INJURY102 reports
CONSTIPATION101 reports
SEPSIS100 reports
DRUG HYPERSENSITIVITY97 reports
INSOMNIA97 reports
MALAISE97 reports
PNEUMONIA97 reports
PRODUCT USE IN UNAPPROVED INDICATION93 reports
DYSURIA92 reports
ANXIETY91 reports
BACK PAIN91 reports
DEATH87 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS87 reports
ANAEMIA86 reports
ERYTHEMA86 reports
UNDERDOSE86 reports
URTICARIA79 reports
ARTHRALGIA78 reports
WEIGHT DECREASED78 reports
CONFUSIONAL STATE77 reports
FALL76 reports
RENAL FAILURE74 reports
ABDOMINAL PAIN UPPER71 reports
DECREASED APPETITE71 reports
HYPERTENSION71 reports
CHRONIC KIDNEY DISEASE70 reports
DEPRESSION68 reports
PAIN IN EXTREMITY68 reports
VULVOVAGINAL INJURY68 reports
CHEMICAL BURN OF GENITALIA66 reports
PRODUCT USED FOR UNKNOWN INDICATION66 reports
MUSCULAR WEAKNESS63 reports
SLEEP DISORDER63 reports
EXPIRED PRODUCT ADMINISTERED62 reports
GAIT DISTURBANCE62 reports
HYPOTENSION62 reports
FUNGAL INFECTION61 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION61 reports
THROMBOCYTOPENIA61 reports
SEIZURE60 reports
SWELLING60 reports
BLOOD CREATININE INCREASED59 reports
DEHYDRATION59 reports
HAEMATURIA59 reports
APPLICATION SITE PRURITUS57 reports
CONTUSION56 reports
EXPOSURE DURING PREGNANCY54 reports
NEUROPATHY PERIPHERAL52 reports
ATRIAL FIBRILLATION51 reports
CHILLS50 reports
OEDEMA PERIPHERAL50 reports
PRODUCT USE ISSUE50 reports
SKIN EXFOLIATION50 reports
SOMNOLENCE50 reports
CELLULITIS49 reports
FEELING ABNORMAL49 reports
GASTROINTESTINAL HAEMORRHAGE49 reports
ACCIDENTAL EXPOSURE TO PRODUCT48 reports
HAEMORRHAGE48 reports
ABDOMINAL DISCOMFORT47 reports
COUGH47 reports
HYPONATRAEMIA47 reports
DYSPHAGIA46 reports
MUSCLE SPASMS46 reports
SWELLING FACE46 reports
TREMOR46 reports
CHEMICAL BURN45 reports
HYPOKALAEMIA45 reports
MATERNAL EXPOSURE DURING PREGNANCY45 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION44 reports

Report Outcomes

Out of 8,201 classified reports for MICONAZOLE NITRATE:

Serious 40.7%Non-Serious 59.3%

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

Female6,058 (80.9%)
Male1,413 (18.9%)
Unknown18 (0.2%)

Reports by Age

Age 6596 reports
Age 5790 reports
Age 6287 reports
Age 7587 reports
Age 7086 reports
Age 7485 reports
Age 6983 reports
Age 6680 reports
Age 6079 reports
Age 3577 reports
Age 5477 reports
Age 6777 reports
Age 6875 reports
Age 6474 reports
Age 5672 reports
Age 6372 reports
Age 7769 reports
Age 7668 reports
Age 6166 reports
Age 4964 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?

This profile reflects 14,417 FDA FAERS reports that mention MICONAZOLE NITRATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MICONAZOLE NITRATE?

Frequently reported terms in FAERS include VULVOVAGINAL BURNING SENSATION, DRUG INEFFECTIVE, VULVOVAGINAL PAIN, VULVOVAGINAL PRURITUS, CONDITION AGGRAVATED, VAGINAL HAEMORRHAGE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MICONAZOLE NITRATE?

Labeling and FAERS entries often list H E B in connection with MICONAZOLE NITRATE. 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.