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)
Visual impairment06.02.10.0130.000879%-
Vitreous opacities06.09.01.0070.000372%-
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Withdrawal syndrome08.06.02.012; 19.07.06.023---
Yellow skin08.01.03.046; 09.01.01.009; 23.03.03.0420.000149%-
Tubulointerstitial nephritis20.05.02.0020.000149%-
Multiple sclerosis relapse17.16.01.0030.000298%-
Acute generalised exanthematous pustulosis10.01.01.034; 11.07.01.018; 12.03.01.005; 23.03.10.0020.003798%-
Hypoacusis04.02.01.0060.000402%
Onychoclasis23.02.05.0050.000506%-
Application site vesicles08.02.01.009; 12.07.01.009; 23.03.01.0090.000223%-
Paradoxical drug reaction08.06.01.0140.000298%-
Peripheral swelling02.05.04.015; 08.01.03.0530.001996%-
Gingival blister07.09.13.0010.000149%-
Lip blister07.05.01.007; 23.03.01.0160.000149%-
General physical health deterioration08.01.03.0180.000968%-
Balance disorder08.01.03.081; 17.02.02.007---
Idiosyncratic drug reaction08.06.01.002---
Lupus-like syndrome10.04.03.003; 15.06.02.004; 23.03.02.0040.000670%-
Deep vein thrombosis24.01.02.0030.000596%-
Bile duct stenosis09.02.02.0010.000149%
Ear discomfort04.03.01.005---
Musculoskeletal stiffness15.03.05.027---
Musculoskeletal discomfort15.03.04.0010.000223%-
Skin swelling23.03.03.0390.000298%-
Type IV hypersensitivity reaction10.01.03.0220.000149%-
Vanishing bile duct syndrome09.02.03.0030.000149%-
Skin burning sensation17.02.06.009; 23.03.03.0210.000700%-
Cutaneous lupus erythematosus10.04.03.007; 15.06.02.007; 23.03.02.0080.000968%-
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