CLOTRIMAZOLE TOPICAL

N/A

Manufactured by Novitium Pharma LLC

28,521 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CLOTRIMAZOLE TOPICAL

CLOTRIMAZOLE TOPICAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novitium Pharma LLC. The most commonly reported adverse reactions for CLOTRIMAZOLE TOPICAL include DRUG INEFFECTIVE, MACULAR DEGENERATION, NAUSEA, PAIN, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CLOTRIMAZOLE TOPICAL.

Top Adverse Reactions

DRUG INEFFECTIVE1,309 reports
MACULAR DEGENERATION795 reports
NAUSEA780 reports
PAIN760 reports
HEADACHE695 reports
OFF LABEL USE687 reports
DYSPNOEA674 reports
FATIGUE611 reports
DIARRHOEA571 reports
PYREXIA514 reports
MALAISE472 reports
WEIGHT DECREASED449 reports
ANXIETY446 reports
RASH438 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE422 reports
ACUTE KIDNEY INJURY418 reports
CONDITION AGGRAVATED417 reports
CHRONIC KIDNEY DISEASE392 reports
DIZZINESS386 reports
ABDOMINAL PAIN377 reports
PAIN IN EXTREMITY373 reports
VOMITING364 reports
CONSTIPATION360 reports
ANAEMIA354 reports
DEATH347 reports
PRURITUS341 reports
RENAL FAILURE334 reports
DRUG INTERACTION329 reports
ERYTHEMA329 reports
DYSPEPSIA328 reports
FALL303 reports
ASTHENIA301 reports
PNEUMONIA301 reports
ARTHRALGIA290 reports
ASTHMA273 reports
INFUSION RELATED REACTION256 reports
ORAL CANDIDIASIS255 reports
URINARY TRACT INFECTION252 reports
COUGH244 reports
CHRONIC SINUSITIS243 reports
RECTAL HAEMORRHAGE243 reports
BACK PAIN242 reports
PARAESTHESIA ORAL237 reports
HAEMATOCHEZIA234 reports
WHEEZING230 reports
ELECTROCARDIOGRAM QT PROLONGED228 reports
HYPERSENSITIVITY227 reports
DRUG LEVEL INCREASED220 reports
PROCEDURAL PAIN216 reports
SCHIZOAFFECTIVE DISORDER205 reports
DECREASED APPETITE202 reports
COLITIS200 reports
INSOMNIA200 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES199 reports
PRODUCT USE IN UNAPPROVED INDICATION198 reports
PRODUCT USE ISSUE195 reports
DEPRESSION192 reports
VAGINAL DISCHARGE192 reports
HYPOTHYROIDISM189 reports
FREQUENT BOWEL MOVEMENTS188 reports
LUNG DISORDER187 reports
PULMONARY FIBROSIS185 reports
VASCULITIS185 reports
PULMONARY EMBOLISM182 reports
COLITIS ULCERATIVE180 reports
HAEMOPTYSIS179 reports
FEMALE GENITAL TRACT FISTULA177 reports
HYPERTENSION177 reports
HYPOTENSION177 reports
RADICULOPATHY176 reports
WEIGHT INCREASED174 reports
ABDOMINAL PAIN UPPER173 reports
PULMONARY ALVEOLAR HAEMORRHAGE172 reports
HYPOXIA171 reports
OBSTRUCTIVE AIRWAYS DISORDER170 reports
PROCTITIS170 reports
PULMONARY VASCULITIS169 reports
VAGINAL FLATULENCE168 reports
NEURITIS167 reports
NEUROLOGICAL SYMPTOM166 reports
THROMBOSIS166 reports
RESPIRATORY SYMPTOM160 reports
CHEST PAIN159 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION159 reports
FULL BLOOD COUNT ABNORMAL156 reports
EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS154 reports
PRODUCTIVE COUGH153 reports
MYALGIA152 reports
PERIPHERAL SWELLING149 reports
JOINT SWELLING148 reports
TREMOR148 reports
SOMNOLENCE146 reports
CANDIDA INFECTION145 reports
CONFUSIONAL STATE145 reports
EMOTIONAL DISTRESS143 reports
THROMBOCYTOPENIA143 reports
OEDEMA PERIPHERAL142 reports
SWOLLEN TONGUE142 reports
END STAGE RENAL DISEASE140 reports
FEBRILE NEUTROPENIA139 reports

Report Outcomes

Out of 11,052 classified reports for CLOTRIMAZOLE TOPICAL:

Serious 78.0%Non-Serious 22.0%

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

Female6,543 (65.4%)
Male3,445 (34.4%)
Unknown12 (0.1%)

Reports by Age

Age 65369 reports
Age 71262 reports
Age 69175 reports
Age 72171 reports
Age 64164 reports
Age 66163 reports
Age 70163 reports
Age 60156 reports
Age 61151 reports
Age 62150 reports
Age 59137 reports
Age 76136 reports
Age 74135 reports
Age 67134 reports
Age 68133 reports
Age 78133 reports
Age 56132 reports
Age 73132 reports
Age 79131 reports
Age 58128 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 CLOTRIMAZOLE TOPICAL?

This profile reflects 28,521 FDA FAERS reports that mention CLOTRIMAZOLE TOPICAL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CLOTRIMAZOLE TOPICAL?

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

Who manufactures CLOTRIMAZOLE TOPICAL?

Labeling and FAERS entries often list Novitium Pharma LLC in connection with CLOTRIMAZOLE TOPICAL. 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.