BUTENAFINE HYDROCHLORIDE

N/A

Manufactured by Bayer Healthcare LLC.

901 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BUTENAFINE HYDROCHLORIDE

BUTENAFINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bayer Healthcare LLC.. The most commonly reported adverse reactions for BUTENAFINE HYDROCHLORIDE include DRUG INEFFECTIVE, OFF LABEL USE, PRODUCT USE ISSUE, PRODUCT USE IN UNAPPROVED INDICATION, PRURITUS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUTENAFINE HYDROCHLORIDE.

Top Adverse Reactions

DRUG INEFFECTIVE180 reports
OFF LABEL USE59 reports
PRODUCT USE ISSUE43 reports
PRODUCT USE IN UNAPPROVED INDICATION34 reports
PRURITUS31 reports
CONDITION AGGRAVATED29 reports
RASH21 reports
DRUG EFFECT DECREASED19 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION19 reports
ERYTHEMA19 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION17 reports
PRODUCT ADMINISTERED AT INAPPROPRIATE SITE13 reports
BURNING SENSATION12 reports
PAIN12 reports
PRODUCT PRESCRIBING ISSUE12 reports
SKIN IRRITATION12 reports
APPLICATION SITE PAIN11 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR9 reports
DRUG ADMINISTERED AT INAPPROPRIATE SITE9 reports
EXPIRED PRODUCT ADMINISTERED8 reports
INCORRECT DRUG ADMINISTRATION DURATION8 reports
NAUSEA8 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS8 reports
ACCIDENTAL EXPOSURE TO PRODUCT7 reports
BLISTER7 reports
DIARRHOEA7 reports
DRY SKIN7 reports
SKIN EXFOLIATION7 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE7 reports
THERAPEUTIC RESPONSE UNEXPECTED7 reports
UNEVALUABLE EVENT7 reports
APPLICATION SITE ERYTHEMA6 reports
DIZZINESS6 reports
FATIGUE6 reports
HYPERSENSITIVITY6 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION6 reports
INCORRECT PRODUCT ADMINISTRATION DURATION6 reports
INSOMNIA6 reports
PAIN IN EXTREMITY6 reports
PARAESTHESIA6 reports
PERIPHERAL SWELLING6 reports
RASH ERYTHEMATOUS6 reports
ANXIETY5 reports
DISTURBANCE IN ATTENTION5 reports
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE5 reports
DRUG PRESCRIBING ERROR5 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION5 reports
RASH PAPULAR5 reports
SKIN BURNING SENSATION5 reports
SKIN DISCOLOURATION5 reports
ASPARTATE AMINOTRANSFERASE INCREASED4 reports
BACK PAIN4 reports
FULL BLOOD COUNT DECREASED4 reports
INCORRECT DOSE ADMINISTERED4 reports
NAIL DISORDER4 reports
POLLAKIURIA4 reports
PRODUCT QUALITY ISSUE4 reports
SKIN DISORDER4 reports
TINEA CRURIS4 reports
WEIGHT DECREASED4 reports
ABDOMINAL DISCOMFORT3 reports
ABDOMINAL PAIN UPPER3 reports
ALANINE AMINOTRANSFERASE INCREASED3 reports
APPLICATION SITE PRURITUS3 reports
ARTHRALGIA3 reports
ASTHENIA3 reports
BLOOD CREATININE INCREASED3 reports
DECREASED APPETITE3 reports
DEPRESSION3 reports
DISCOMFORT3 reports
DRUG EFFECT INCOMPLETE3 reports
DYSPEPSIA3 reports
DYSPNOEA3 reports
EXPIRED DRUG ADMINISTERED3 reports
EXTRA DOSE ADMINISTERED3 reports
FEBRILE NEUTROPENIA3 reports
FUNGAL INFECTION3 reports
HEADACHE3 reports
HYPOAESTHESIA3 reports
INCORRECT DOSAGE ADMINISTERED3 reports
MUSCLE TWITCHING3 reports
MYALGIA3 reports
PRODUCT LOT NUMBER ISSUE3 reports
PYREXIA3 reports
RASH PRURITIC3 reports
VOMITING3 reports
ACNE2 reports
ANAEMIA2 reports
APPLICATION SITE DISCOMFORT2 reports
APPLICATION SITE IRRITATION2 reports
APPLICATION SITE VESICLES2 reports
BLOOD LACTATE DEHYDROGENASE INCREASED2 reports
BLOOD PRESSURE DECREASED2 reports
BLOOD PRESSURE INCREASED2 reports
CEREBRAL INFARCTION2 reports
CHEST PAIN2 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO DEVICE USE ERROR2 reports
CONFUSIONAL STATE2 reports
CONSTIPATION2 reports
DEATH2 reports

Report Outcomes

Out of 563 classified reports for BUTENAFINE HYDROCHLORIDE:

Serious 11.0%Non-Serious 89.0%

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

Male283 (59.8%)
Female187 (39.5%)
Unknown3 (0.6%)

Reports by Age

Age 6515 reports
Age 777 reports
Age 807 reports
Age 556 reports
Age 666 reports
Age 746 reports
Age 796 reports
Age 535 reports
Age 595 reports
Age 675 reports
Age 685 reports
Age 705 reports
Age 725 reports
Age 765 reports
Age 825 reports
Age 895 reports
Age 164 reports
Age 424 reports
Age 604 reports
Age 624 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 BUTENAFINE HYDROCHLORIDE?

This profile reflects 901 FDA FAERS reports that mention BUTENAFINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BUTENAFINE HYDROCHLORIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, OFF LABEL USE, PRODUCT USE ISSUE, PRODUCT USE IN UNAPPROVED INDICATION, PRURITUS, CONDITION AGGRAVATED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BUTENAFINE HYDROCHLORIDE?

Labeling and FAERS entries often list Bayer Healthcare LLC. in connection with BUTENAFINE HYDROCHLORIDE. 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.