KETOCONAZOLE CREAM, 2%

N/A

Manufactured by Encube Ethicals, Inc.

27,109 FDA adverse event reports analyzed

Last updated: 2026-04-14

About KETOCONAZOLE CREAM, 2%

KETOCONAZOLE CREAM, 2% is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Encube Ethicals, Inc.. The most commonly reported adverse reactions for KETOCONAZOLE CREAM, 2% 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 CREAM, 2%.

Top Adverse Reactions

DRUG INEFFECTIVE1,377 reports
OFF LABEL USE1,041 reports
FATIGUE788 reports
PRURITUS767 reports
RASH698 reports
NAUSEA690 reports
DIARRHOEA640 reports
PAIN608 reports
HEADACHE603 reports
PSORIASIS595 reports
DYSPNOEA515 reports
DIZZINESS510 reports
PRODUCT USE IN UNAPPROVED INDICATION496 reports
CHRONIC KIDNEY DISEASE487 reports
ARTHRALGIA479 reports
ANXIETY404 reports
CONDITION AGGRAVATED389 reports
RENAL FAILURE384 reports
ASTHENIA372 reports
DRUG INTERACTION370 reports
FALL369 reports
VOMITING350 reports
ACUTE KIDNEY INJURY348 reports
DEATH348 reports
PRODUCT DOSE OMISSION ISSUE341 reports
ERYTHEMA329 reports
ALOPECIA311 reports
PNEUMONIA309 reports
MALAISE308 reports
WEIGHT DECREASED307 reports
DRY SKIN292 reports
DEPRESSION289 reports
SKIN EXFOLIATION287 reports
COUGH272 reports
PAIN IN EXTREMITY268 reports
URINARY TRACT INFECTION254 reports
BACK PAIN244 reports
PYREXIA244 reports
INSOMNIA241 reports
CONSTIPATION235 reports
PERIPHERAL SWELLING215 reports
PRODUCT USE ISSUE211 reports
DECREASED APPETITE201 reports
TREMOR192 reports
GAIT DISTURBANCE189 reports
ANAEMIA188 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION187 reports
MUSCLE SPASMS187 reports
EMOTIONAL DISTRESS186 reports
HYPERTENSION185 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE183 reports
COVID 19180 reports
INJECTION SITE PAIN180 reports
SOMNOLENCE180 reports
WEIGHT INCREASED178 reports
HYPERSENSITIVITY175 reports
FEELING ABNORMAL174 reports
CHEST PAIN170 reports
ABDOMINAL PAIN166 reports
DERMATITIS ATOPIC163 reports
NASOPHARYNGITIS159 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION157 reports
HYPOTENSION156 reports
MUSCULAR WEAKNESS154 reports
MYALGIA154 reports
DEHYDRATION153 reports
INFECTION153 reports
ANHEDONIA151 reports
HYPOAESTHESIA148 reports
ABDOMINAL PAIN UPPER145 reports
SINUSITIS144 reports
DRUG HYPERSENSITIVITY142 reports
PARAESTHESIA139 reports
END STAGE RENAL DISEASE136 reports
OEDEMA PERIPHERAL136 reports
ABDOMINAL DISCOMFORT135 reports
URTICARIA134 reports
CONFUSIONAL STATE133 reports
SKIN IRRITATION132 reports
BLOOD PRESSURE INCREASED131 reports
GASTROOESOPHAGEAL REFLUX DISEASE131 reports
ADVERSE DRUG REACTION130 reports
NEUROPATHY PERIPHERAL128 reports
ASTHMA127 reports
LOSS OF CONSCIOUSNESS127 reports
ECZEMA124 reports
PSORIATIC ARTHROPATHY124 reports
VISION BLURRED122 reports
TREATMENT FAILURE120 reports
ARTHRITIS119 reports
THROMBOCYTOPENIA118 reports
MEMORY IMPAIRMENT117 reports
DISEASE PROGRESSION115 reports
BURNING SENSATION112 reports
MIGRAINE111 reports
VISUAL IMPAIRMENT111 reports
BLOOD GLUCOSE INCREASED110 reports
JOINT SWELLING108 reports
HYPOKALAEMIA107 reports
ILLNESS107 reports

Report Outcomes

Out of 13,961 classified reports for KETOCONAZOLE CREAM, 2%:

Serious 54.1%Non-Serious 45.9%

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

Female6,361 (50.8%)
Male6,111 (48.8%)
Unknown49 (0.4%)

Reports by Age

Age 70217 reports
Age 63198 reports
Age 56188 reports
Age 72178 reports
Age 71176 reports
Age 64175 reports
Age 66174 reports
Age 73173 reports
Age 69170 reports
Age 59169 reports
Age 61168 reports
Age 62168 reports
Age 75168 reports
Age 68167 reports
Age 60162 reports
Age 65161 reports
Age 54159 reports
Age 76159 reports
Age 67158 reports
Age 58154 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 CREAM, 2%?

This profile reflects 27,109 FDA FAERS reports that mention KETOCONAZOLE CREAM, 2%. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for KETOCONAZOLE CREAM, 2%?

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 CREAM, 2%?

Labeling and FAERS entries often list Encube Ethicals, Inc. in connection with KETOCONAZOLE CREAM, 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.