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)
Hepatomegaly09.01.05.0010.000223%Not Available
Hepatosplenomegaly09.01.05.002; 01.09.03.0010.000223%Not Available
Hepatotoxicity09.01.07.009; 12.03.01.0080.000849%Not Available
Hiccups22.12.01.001; 07.01.06.0090.000149%
Hyperaesthesia23.03.03.080; 17.02.06.0040.000298%Not Available
Hyperbilirubinaemia09.01.01.003; 01.06.04.003; 14.11.01.010--Not Available
Hypercholesterolaemia14.08.01.001--Not Available
Hypercoagulation01.01.02.0070.000223%Not Available
Hyperhidrosis08.01.03.028; 23.02.03.0040.001192%
Hyperkeratosis23.01.01.0010.000223%
Hypersensitivity10.01.03.0030.001951%
Hypersensitivity vasculitis24.12.04.013; 23.06.02.005; 10.02.02.017; 01.01.04.0080.000223%Not Available
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Ileus07.13.01.0010.000372%
Impaired healing08.03.02.0010.000149%Not Available
Influenza like illness08.01.03.0100.000626%
Insomnia19.02.01.002; 17.15.03.0020.001668%
Irritability19.04.02.013; 08.01.03.011--
Jarisch-Herxheimer reaction10.02.01.0020.000149%Not Available
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.002755%Not Available
Jaundice cholestatic09.01.01.0050.000372%Not Available
Joint swelling15.01.02.0040.000372%Not Available
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.000670%
Leukocytosis01.02.01.0020.000670%
Leukopenia01.02.02.0010.000968%Not Available
Lichen planus23.03.08.0010.000521%Not Available
Linear IgA disease23.03.01.015; 10.04.02.0060.000596%Not Available
Lip dry07.06.01.0030.000149%Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.001147%Not Available
Liver disorder09.01.08.0010.001609%Not Available
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