KETOCONAZOLE FOAM

N/A

Manufactured by Xiromed, LLC

27,017 FDA adverse event reports analyzed

Last updated: 2026-04-14

About KETOCONAZOLE FOAM

KETOCONAZOLE FOAM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Xiromed, LLC. The most commonly reported adverse reactions for KETOCONAZOLE FOAM include DRUG INEFFECTIVE, OFF LABEL USE, FATIGUE, PRURITUS, RASH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for KETOCONAZOLE FOAM.

Top Adverse Reactions

DRUG INEFFECTIVE1,353 reports
OFF LABEL USE1,043 reports
FATIGUE788 reports
PRURITUS763 reports
RASH695 reports
NAUSEA689 reports
DIARRHOEA640 reports
PAIN605 reports
HEADACHE603 reports
PSORIASIS595 reports
DYSPNOEA514 reports
DIZZINESS509 reports
PRODUCT USE IN UNAPPROVED INDICATION497 reports
CHRONIC KIDNEY DISEASE487 reports
ARTHRALGIA479 reports
ANXIETY404 reports
CONDITION AGGRAVATED386 reports
RENAL FAILURE384 reports
ASTHENIA372 reports
DRUG INTERACTION370 reports
FALL369 reports
VOMITING350 reports
ACUTE KIDNEY INJURY348 reports
DEATH348 reports
PRODUCT DOSE OMISSION ISSUE341 reports
ERYTHEMA323 reports
ALOPECIA309 reports
PNEUMONIA309 reports
WEIGHT DECREASED307 reports
MALAISE306 reports
DEPRESSION288 reports
DRY SKIN288 reports
SKIN EXFOLIATION283 reports
COUGH272 reports
PAIN IN EXTREMITY266 reports
URINARY TRACT INFECTION254 reports
BACK PAIN244 reports
PYREXIA243 reports
INSOMNIA239 reports
CONSTIPATION235 reports
PERIPHERAL SWELLING212 reports
PRODUCT USE ISSUE211 reports
DECREASED APPETITE200 reports
TREMOR192 reports
ANAEMIA188 reports
GAIT DISTURBANCE188 reports
MUSCLE SPASMS187 reports
EMOTIONAL DISTRESS186 reports
HYPERTENSION185 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION184 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE182 reports
COVID 19180 reports
INJECTION SITE PAIN180 reports
SOMNOLENCE180 reports
WEIGHT INCREASED177 reports
FEELING ABNORMAL174 reports
HYPERSENSITIVITY173 reports
CHEST PAIN170 reports
ABDOMINAL PAIN166 reports
DERMATITIS ATOPIC163 reports
NASOPHARYNGITIS158 reports
HYPOTENSION156 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION154 reports
MUSCULAR WEAKNESS154 reports
MYALGIA154 reports
DEHYDRATION153 reports
INFECTION153 reports
ANHEDONIA151 reports
HYPOAESTHESIA147 reports
ABDOMINAL PAIN UPPER145 reports
SINUSITIS144 reports
DRUG HYPERSENSITIVITY142 reports
END STAGE RENAL DISEASE136 reports
OEDEMA PERIPHERAL136 reports
PARAESTHESIA135 reports
ABDOMINAL DISCOMFORT134 reports
CONFUSIONAL STATE133 reports
URTICARIA133 reports
BLOOD PRESSURE INCREASED131 reports
GASTROOESOPHAGEAL REFLUX DISEASE131 reports
ADVERSE DRUG REACTION130 reports
SKIN IRRITATION129 reports
ASTHMA127 reports
LOSS OF CONSCIOUSNESS127 reports
NEUROPATHY PERIPHERAL127 reports
ECZEMA124 reports
PSORIATIC ARTHROPATHY124 reports
VISION BLURRED122 reports
TREATMENT FAILURE120 reports
ARTHRITIS119 reports
THROMBOCYTOPENIA118 reports
MEMORY IMPAIRMENT117 reports
DISEASE PROGRESSION115 reports
MIGRAINE111 reports
VISUAL IMPAIRMENT111 reports
BLOOD GLUCOSE INCREASED110 reports
BURNING SENSATION108 reports
JOINT SWELLING108 reports
HYPOKALAEMIA107 reports
ILLNESS107 reports

Report Outcomes

Out of 13,899 classified reports for KETOCONAZOLE FOAM:

Serious 54.2%Non-Serious 45.8%

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

Female6,336 (50.8%)
Male6,084 (48.8%)
Unknown49 (0.4%)

Reports by Age

Age 70217 reports
Age 63198 reports
Age 56188 reports
Age 72176 reports
Age 64175 reports
Age 66173 reports
Age 73173 reports
Age 71172 reports
Age 69170 reports
Age 59169 reports
Age 61168 reports
Age 62168 reports
Age 75167 reports
Age 68166 reports
Age 60162 reports
Age 65161 reports
Age 54158 reports
Age 76158 reports
Age 67157 reports
Age 58153 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 KETOCONAZOLE FOAM?

This profile reflects 27,017 FDA FAERS reports that mention KETOCONAZOLE FOAM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for KETOCONAZOLE FOAM?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, OFF LABEL USE, FATIGUE, PRURITUS, RASH, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures KETOCONAZOLE FOAM?

Labeling and FAERS entries often list Xiromed, LLC in connection with KETOCONAZOLE FOAM. 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.