terbinafine Side Effects
Also known as: Lamisil
Analysis of 6,848 adverse event reports submitted to the FDA from 2003 to 2025.
Total Reports
6,848
Death-Related
428
6.3% of reports
Hospitalizations
1,849
27.0% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 428 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 103 |
| DEATH | 76 |
| OFF LABEL USE | 43 |
| SCEDOSPORIUM INFECTION | 37 |
| ACUTE KIDNEY INJURY | 29 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 29 |
| RENAL FAILURE | 27 |
| PRODUCT USE IN UNAPPROVED INDICATION | 26 |
| CONDITION AGGRAVATED | 25 |
| DISEASE PROGRESSION | 25 |
| DRUG INEFFECTIVE FOR UNAPPROVED INDICATION | 23 |
| SEPTIC SHOCK | 23 |
| RESPIRATORY FAILURE | 22 |
| FUNGAEMIA | 17 |
| DRUG RESISTANCE | 16 |
| PNEUMONIA | 16 |
| PYREXIA | 16 |
| CARDIAC ARREST | 15 |
| CHRONIC KIDNEY DISEASE | 15 |
| INFECTION | 14 |
Reactions in Hospitalization Reports
Top reactions in 1,849 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 148 |
| ACUTE KIDNEY INJURY | 100 |
| DRUG INTERACTION | 97 |
| ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS | 93 |
| RASH | 91 |
| PAIN | 90 |
| DYSPNOEA | 88 |
| FATIGUE | 85 |
| PYREXIA | 83 |
| MALAISE | 81 |
| PRURITUS | 81 |
| OFF LABEL USE | 75 |
| NAUSEA | 67 |
| PNEUMONIA | 64 |
| ABDOMINAL PAIN | 63 |
| RENAL FAILURE | 60 |
| ANXIETY | 59 |
| COUGH | 57 |
| VOMITING | 57 |
| DIARRHOEA | 56 |
Nearby — Related Medications
What the FAERS Data Reveals About terbinafine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 6,848 voluntary reports linked to terbinafine and its brand equivalents (Lamisil), spanning 2003 through 2025. Of those, 428 (6.3%) listed death as an outcome and 1,849 (27.0%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 51% were female and 48% male; age distribution skews toward 45-64, with 1,917 reports in that bracket. The single most reported reaction is drug ineffective with 685 submissions, followed by rash and pruritus.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.