Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Terbinafine
Drug ID BADD_D02160
Description Terbinafine hydrochloride (Lamisil) is a synthetic allylamine antifungal.[L9065,L9068] It is highly lipophilic in nature and tends to accumulate in skin, nails, and fatty tissues.[A1279] Like other allylamines, terbinafine inhibits ergosterol synthesis by inhibiting the fungal squalene monooxygenase (also called squalene epoxidase), an enzyme that is part of the fungal cell wall synthesis pathway.[A1279,A1281,L9068] Terbinafine hydrochloride was granted FDA approval on 30 December 1992.[L9064]
Indications and Usage Terbinafine hydrochloride is indicated to treat fungal skin and nail infections caused by _Trichophyton_ species, _Microsporum canis_, _Epidermophyton floccosum_,[L9068] and _Tinea_ species.[L9065] Terbinafine hydrochloride also treats yeast infections of the skin caused by _Candida_ species and _Malassezia furfur_.[L9068]
Marketing Status approved; investigational; vet_approved
ATC Code D01AE15; D01BA02
DrugBank ID DB00857
KEGG ID D02375
MeSH ID D000077291
PubChem ID 1549008
TTD Drug ID D01AYJ
NDC Product Code 71205-152; 71335-1668; 69097-859; 62135-572; 63187-213; 76282-209; 72189-243; 59349-0008; 70518-1191
UNII G7RIW8S0XP
Synonyms Terbinafine | Terbinafine, (Z)-isomer | Terbinafine, (Z)- | Lamisil | (E)-N-(6,6-Dimethyl-2-heptenynyl)-N-methyl-1-naphthalenementhamin hydrochloride | TDT-067 | TDT 067 | TDT067 | DA 5505 | SF 86-327 | SF 86 327 | SF 86327 | SF-86-327 | SF86327 | Terbinafine Hydrochloride
Chemical Information
Molecular Formula C21H25N
CAS Registry Number 91161-71-6
SMILES CC(C)(C)C#CC=CCN(C)CC1=CC=CC2=CC=CC=C21
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Stress19.06.02.0040.000298%Not Available
Suicidal ideation19.12.01.0030.000819%
Swelling08.01.03.0150.001594%Not Available
Swelling face10.01.05.018; 08.01.03.100; 23.04.01.0180.000626%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.000149%Not Available
Syncope17.02.04.008; 02.11.04.015; 24.06.02.0120.000894%
Systemic lupus erythematosus23.03.02.006; 15.06.02.003; 10.04.03.0040.000894%Not Available
Systemic lupus erythematosus rash23.03.13.007; 15.06.02.005; 10.04.03.0050.000596%Not Available
Tachycardia02.03.02.007--Not Available
Therapeutic response decreased08.06.01.0160.000298%Not Available
Therapeutic response unexpected08.06.01.0010.000328%Not Available
Thirst14.03.02.007; 08.01.09.0210.000149%Not Available
Throat tightness22.12.03.031; 19.01.02.0050.000223%Not Available
Thrombocytopenia01.08.01.0020.000745%Not Available
Thrombophlebitis24.01.02.0010.000521%Not Available
Thrombotic thrombocytopenic purpura23.06.01.011; 24.07.06.014; 01.08.01.0050.000223%
Tinnitus17.04.07.004; 04.04.01.0020.001296%
Tongue blistering07.14.02.0140.000223%Not Available
Tongue ulceration07.14.01.0030.000298%Not Available
Toxic epidermal necrolysis10.01.01.006; 23.03.01.008; 12.03.01.015; 11.07.01.0060.000298%
Tremor17.01.06.0020.000923%
Urinary retention20.02.02.0110.001415%
Urticaria23.04.02.001; 10.01.06.0010.006136%
Vaginal haemorrhage24.07.03.005; 21.08.01.0010.000596%
Vasculitis24.12.04.027; 10.02.02.006--
Ventricular extrasystoles02.03.04.0070.000447%Not Available
Vertigo17.02.12.002; 04.04.01.0030.000447%
Vision blurred06.02.06.007; 17.17.01.010--
Visual acuity reduced06.02.10.012; 17.17.01.011--
Visual field defect17.17.01.001; 06.02.07.003--Not Available
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