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)
Deficiency of bile secretion09.01.01.0110.000223%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.003783%Not Available
Drug reaction with eosinophilia and systemic symptoms12.03.01.064; 23.03.05.005; 10.01.01.0210.001489%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000447%
Abnormal loss of weight14.03.02.0190.000298%Not Available
Alcohol interaction08.06.03.003--Not Available
Cholangitis acute09.02.01.0060.000298%Not Available
Concomitant disease aggravated08.01.03.0630.000223%Not Available
Dermatitis exfoliative generalised23.03.07.002; 10.01.01.0290.000447%Not Available
Faeces pale07.01.03.0050.000298%Not Available
Hairy cell leukaemia16.01.06.002; 01.10.06.0020.000298%Not Available
Nikolsky's sign23.03.07.0090.000149%Not Available
Pityriasis rosea23.03.08.0030.000372%Not Available
Rash papulosquamous23.03.08.0140.000223%Not Available
Urticarial vasculitis24.12.04.025; 23.04.02.012; 10.01.06.0120.000223%Not Available
Subacute cutaneous lupus erythematosus23.03.02.020; 15.06.02.012; 10.04.03.0120.002234%Not Available
Onychalgia23.02.05.0260.000149%Not Available
Skin plaque23.03.03.0440.000670%Not Available
Herbal interaction08.06.03.0050.000223%Not Available
Small fibre neuropathy17.09.03.021; 14.07.04.007; 05.07.04.0070.000223%Not Available
Tongue discomfort07.14.02.019--Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.038--Not Available
Hepatic cytolysis09.01.07.0360.000596%Not Available
Intermenstrual bleeding21.01.01.0150.000477%Not Available
Palmoplantar pustulosis23.03.14.011; 10.02.01.0990.000298%Not Available
Pharyngeal swelling22.04.05.028--Not Available
Symmetrical drug-related intertriginous and flexural exanthema10.01.01.046; 23.03.05.0120.000149%Not Available
Taste disorder17.02.07.029; 07.14.03.0040.000477%Not Available
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