TERBINAFINE HYDROCHLORIDE

N/A

Manufactured by Aurobindo Pharma Limited

14,851 FDA adverse event reports analyzed

Last updated: 2026-04-14

About TERBINAFINE HYDROCHLORIDE

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

Top Adverse Reactions

DRUG INEFFECTIVE794 reports
RASH474 reports
PRURITUS401 reports
FATIGUE376 reports
NAUSEA368 reports
PAIN338 reports
AGEUSIA319 reports
OFF LABEL USE319 reports
HEADACHE291 reports
DIARRHOEA282 reports
DYSPNOEA256 reports
DRUG INTERACTION254 reports
MALAISE254 reports
ANXIETY246 reports
DIZZINESS233 reports
CHRONIC KIDNEY DISEASE229 reports
ARTHRALGIA224 reports
CONDITION AGGRAVATED220 reports
DYSGEUSIA218 reports
PRODUCT USE IN UNAPPROVED INDICATION218 reports
WEIGHT DECREASED218 reports
ACUTE KIDNEY INJURY212 reports
DEPRESSION210 reports
DRUG RESISTANCE201 reports
URTICARIA199 reports
DECREASED APPETITE197 reports
PYREXIA183 reports
ERYTHEMA179 reports
RENAL FAILURE177 reports
PATHOGEN RESISTANCE161 reports
TREATMENT FAILURE161 reports
SKIN EXFOLIATION160 reports
PERIPHERAL SWELLING156 reports
ASTHENIA155 reports
ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS151 reports
VOMITING148 reports
PAIN IN EXTREMITY146 reports
INSOMNIA145 reports
COUGH144 reports
PSORIASIS139 reports
FALL130 reports
PNEUMONIA129 reports
ABDOMINAL PAIN125 reports
ALOPECIA120 reports
ABDOMINAL PAIN UPPER119 reports
MYALGIA117 reports
DRUG INDUCED LIVER INJURY112 reports
ABDOMINAL DISCOMFORT106 reports
RASH ERYTHEMATOUS106 reports
BACK PAIN103 reports
RENAL IMPAIRMENT101 reports
CHEST PAIN99 reports
PARAESTHESIA99 reports
HYPERSENSITIVITY98 reports
LIP SWELLING98 reports
EMOTIONAL DISTRESS96 reports
DEATH95 reports
NEUTROPENIA94 reports
INFECTION93 reports
ONYCHOMYCOSIS92 reports
DRUG HYPERSENSITIVITY91 reports
FUNGAL INFECTION91 reports
CONFUSIONAL STATE90 reports
GAIT DISTURBANCE89 reports
PRODUCT DOSE OMISSION ISSUE88 reports
CONSTIPATION87 reports
MUSCLE SPASMS85 reports
BLISTER82 reports
NASOPHARYNGITIS81 reports
DISEASE PROGRESSION79 reports
FEELING ABNORMAL79 reports
HYPERHIDROSIS78 reports
PRODUCT USE ISSUE78 reports
JAUNDICE77 reports
WEIGHT INCREASED76 reports
BLOOD PRESSURE INCREASED75 reports
HYPERTENSION75 reports
LIVER FUNCTION TEST ABNORMAL75 reports
URINARY TRACT INFECTION75 reports
HEPATIC ENZYME INCREASED74 reports
ANHEDONIA72 reports
SKIN LESION72 reports
ARTHRITIS71 reports
CHROMATURIA71 reports
SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS71 reports
SWELLING FACE71 reports
VISION BLURRED71 reports
RASH PRURITIC70 reports
ABDOMINAL DISTENSION69 reports
COVID 1969 reports
SEPSIS67 reports
DRY SKIN65 reports
HYPOAESTHESIA64 reports
OROPHARYNGEAL PAIN64 reports
RASH PUSTULAR63 reports
BURNING SENSATION62 reports
OEDEMA PERIPHERAL62 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE62 reports
DEPRESSED MOOD61 reports
RASH MACULAR61 reports

Report Outcomes

Out of 8,493 classified reports for TERBINAFINE HYDROCHLORIDE:

Serious 77.0%Non-Serious 23.0%

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

Female3,911 (51.9%)
Male3,588 (47.6%)
Unknown37 (0.5%)

Reports by Age

Age 57154 reports
Age 68148 reports
Age 63147 reports
Age 72141 reports
Age 66137 reports
Age 67135 reports
Age 50134 reports
Age 64131 reports
Age 56129 reports
Age 62129 reports
Age 58126 reports
Age 71126 reports
Age 69125 reports
Age 59121 reports
Age 70119 reports
Age 48118 reports
Age 60118 reports
Age 65118 reports
Age 53117 reports
Age 55117 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 TERBINAFINE HYDROCHLORIDE?

This profile reflects 14,851 FDA FAERS reports that mention TERBINAFINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TERBINAFINE HYDROCHLORIDE?

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

Who manufactures TERBINAFINE HYDROCHLORIDE?

Labeling and FAERS entries often list Aurobindo Pharma Limited in connection with TERBINAFINE 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.