CLOTRIMAZOLE

N/A

Manufactured by Bayer HealthCare LLC.

29,744 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CLOTRIMAZOLE

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

Top Adverse Reactions

DRUG INEFFECTIVE1,347 reports
NAUSEA825 reports
PAIN798 reports
MACULAR DEGENERATION796 reports
HEADACHE731 reports
DYSPNOEA726 reports
OFF LABEL USE708 reports
FATIGUE658 reports
DIARRHOEA618 reports
PYREXIA535 reports
MALAISE488 reports
WEIGHT DECREASED473 reports
ANXIETY472 reports
RASH466 reports
ACUTE KIDNEY INJURY447 reports
CONDITION AGGRAVATED435 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE423 reports
CHRONIC KIDNEY DISEASE420 reports
DIZZINESS410 reports
PAIN IN EXTREMITY395 reports
VOMITING395 reports
ABDOMINAL PAIN388 reports
CONSTIPATION386 reports
ANAEMIA367 reports
DEATH363 reports
RENAL FAILURE361 reports
PRURITUS355 reports
DYSPEPSIA339 reports
ERYTHEMA337 reports
ASTHENIA335 reports
DRUG INTERACTION331 reports
PNEUMONIA329 reports
FALL325 reports
ARTHRALGIA303 reports
ASTHMA279 reports
URINARY TRACT INFECTION273 reports
BACK PAIN270 reports
COUGH264 reports
ORAL CANDIDIASIS260 reports
INFUSION RELATED REACTION258 reports
RECTAL HAEMORRHAGE248 reports
CHRONIC SINUSITIS245 reports
PARAESTHESIA ORAL238 reports
HAEMATOCHEZIA237 reports
HYPERSENSITIVITY234 reports
WHEEZING231 reports
ELECTROCARDIOGRAM QT PROLONGED229 reports
INSOMNIA223 reports
DRUG LEVEL INCREASED222 reports
PROCEDURAL PAIN217 reports
DECREASED APPETITE213 reports
DEPRESSION212 reports
PRODUCT USE IN UNAPPROVED INDICATION210 reports
SCHIZOAFFECTIVE DISORDER205 reports
PRODUCT USE ISSUE204 reports
COLITIS203 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES201 reports
HYPERTENSION199 reports
HYPOTHYROIDISM192 reports
VAGINAL DISCHARGE192 reports
LUNG DISORDER191 reports
FREQUENT BOWEL MOVEMENTS189 reports
ABDOMINAL PAIN UPPER188 reports
HYPOTENSION188 reports
PULMONARY EMBOLISM188 reports
PULMONARY FIBROSIS185 reports
VASCULITIS185 reports
HAEMOPTYSIS183 reports
COLITIS ULCERATIVE181 reports
WEIGHT INCREASED179 reports
FEMALE GENITAL TRACT FISTULA177 reports
RADICULOPATHY176 reports
MYALGIA175 reports
HYPOXIA173 reports
PULMONARY ALVEOLAR HAEMORRHAGE172 reports
OBSTRUCTIVE AIRWAYS DISORDER171 reports
PROCTITIS170 reports
THROMBOSIS170 reports
PULMONARY VASCULITIS169 reports
VAGINAL FLATULENCE168 reports
CHEST PAIN167 reports
NEURITIS167 reports
NEUROLOGICAL SYMPTOM166 reports
PRODUCTIVE COUGH161 reports
RESPIRATORY SYMPTOM160 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION159 reports
CONFUSIONAL STATE158 reports
SOMNOLENCE158 reports
FULL BLOOD COUNT ABNORMAL156 reports
PERIPHERAL SWELLING156 reports
OEDEMA PERIPHERAL155 reports
EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS154 reports
JOINT SWELLING153 reports
EMOTIONAL DISTRESS152 reports
GAIT DISTURBANCE152 reports
TREMOR152 reports
THROMBOCYTOPENIA151 reports
END STAGE RENAL DISEASE150 reports
DRUG HYPERSENSITIVITY148 reports
CANDIDA INFECTION147 reports

Report Outcomes

Out of 11,754 classified reports for CLOTRIMAZOLE:

Serious 77.3%Non-Serious 22.7%

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

Female6,908 (64.8%)
Male3,744 (35.1%)
Unknown13 (0.1%)

Reports by Age

Age 65379 reports
Age 71266 reports
Age 69186 reports
Age 72180 reports
Age 66178 reports
Age 70178 reports
Age 64173 reports
Age 60162 reports
Age 61162 reports
Age 62162 reports
Age 56146 reports
Age 59146 reports
Age 76146 reports
Age 68142 reports
Age 74142 reports
Age 67141 reports
Age 73140 reports
Age 78140 reports
Age 79138 reports
Age 57137 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?

This profile reflects 29,744 FDA FAERS reports that mention CLOTRIMAZOLE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CLOTRIMAZOLE?

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

Who manufactures CLOTRIMAZOLE?

Labeling and FAERS entries often list Bayer HealthCare LLC. in connection with CLOTRIMAZOLE. 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.