KETOCONAZOLE

N/A

Manufactured by Kramer Laboratories

31,685 FDA adverse event reports analyzed

Last updated: 2026-04-14

About KETOCONAZOLE

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

Top Adverse Reactions

DRUG INEFFECTIVE1,582 reports
OFF LABEL USE1,174 reports
FATIGUE929 reports
PRURITUS902 reports
NAUSEA834 reports
RASH802 reports
DIARRHOEA759 reports
PAIN726 reports
HEADACHE708 reports
PSORIASIS645 reports
DYSPNOEA601 reports
DIZZINESS589 reports
PRODUCT USE IN UNAPPROVED INDICATION548 reports
ARTHRALGIA541 reports
CHRONIC KIDNEY DISEASE520 reports
ASTHENIA473 reports
ANXIETY469 reports
CONDITION AGGRAVATED447 reports
VOMITING446 reports
FALL429 reports
RENAL FAILURE421 reports
DEATH420 reports
ALOPECIA416 reports
DRUG INTERACTION401 reports
ACUTE KIDNEY INJURY384 reports
WEIGHT DECREASED379 reports
ERYTHEMA369 reports
PNEUMONIA369 reports
PRODUCT DOSE OMISSION ISSUE362 reports
DEPRESSION345 reports
MALAISE343 reports
PAIN IN EXTREMITY343 reports
BACK PAIN317 reports
DRY SKIN317 reports
COUGH314 reports
SKIN EXFOLIATION311 reports
PYREXIA307 reports
INSOMNIA301 reports
URINARY TRACT INFECTION290 reports
CONSTIPATION276 reports
PERIPHERAL SWELLING259 reports
PRODUCT USE ISSUE251 reports
ANAEMIA244 reports
MUSCLE SPASMS238 reports
ABDOMINAL PAIN236 reports
DECREASED APPETITE236 reports
HYPERTENSION233 reports
WEIGHT INCREASED232 reports
CHEST PAIN221 reports
GAIT DISTURBANCE221 reports
HYPERSENSITIVITY221 reports
TREMOR218 reports
MYALGIA210 reports
EMOTIONAL DISTRESS206 reports
FEELING ABNORMAL205 reports
SOMNOLENCE205 reports
COVID 19199 reports
ABDOMINAL PAIN UPPER198 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION194 reports
INJECTION SITE PAIN190 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE190 reports
HYPOTENSION189 reports
NASOPHARYNGITIS186 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION183 reports
DRUG HYPERSENSITIVITY182 reports
DEHYDRATION178 reports
HYPOAESTHESIA177 reports
MUSCULAR WEAKNESS176 reports
DERMATITIS ATOPIC168 reports
URTICARIA164 reports
GASTROOESOPHAGEAL REFLUX DISEASE163 reports
HAIR TEXTURE ABNORMAL163 reports
INFECTION163 reports
OEDEMA PERIPHERAL163 reports
ANHEDONIA162 reports
CONFUSIONAL STATE161 reports
PARAESTHESIA157 reports
SINUSITIS156 reports
ABDOMINAL DISCOMFORT155 reports
LOSS OF CONSCIOUSNESS155 reports
END STAGE RENAL DISEASE153 reports
BLOOD PRESSURE INCREASED148 reports
DYSPEPSIA146 reports
TREATMENT FAILURE145 reports
ASTHMA144 reports
JOINT SWELLING144 reports
NEUROPATHY PERIPHERAL144 reports
ARTHRITIS143 reports
SKIN IRRITATION143 reports
VISION BLURRED138 reports
MEMORY IMPAIRMENT137 reports
ADVERSE DRUG REACTION135 reports
BLOOD GLUCOSE INCREASED135 reports
ECZEMA135 reports
THROMBOCYTOPENIA135 reports
SEPSIS131 reports
BURNING SENSATION129 reports
MIGRAINE129 reports
CELLULITIS127 reports
CONTUSION127 reports

Report Outcomes

Out of 16,221 classified reports for KETOCONAZOLE:

Serious 55.4%Non-Serious 44.6%

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

Female7,428 (50.9%)
Male7,101 (48.7%)
Unknown57 (0.4%)

Reports by Age

Age 70248 reports
Age 63228 reports
Age 66209 reports
Age 56206 reports
Age 64205 reports
Age 72202 reports
Age 73202 reports
Age 60199 reports
Age 62199 reports
Age 69199 reports
Age 71198 reports
Age 61196 reports
Age 68191 reports
Age 59190 reports
Age 77188 reports
Age 76187 reports
Age 54186 reports
Age 65186 reports
Age 67179 reports
Age 75179 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?

This profile reflects 31,685 FDA FAERS reports that mention KETOCONAZOLE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for KETOCONAZOLE?

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

Who manufactures KETOCONAZOLE?

Labeling and FAERS entries often list Kramer Laboratories in connection with KETOCONAZOLE. 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.