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)
Abdominal discomfort07.01.06.0010.001430%Not Available
Abdominal distension07.01.04.0010.001504%
Abdominal pain07.01.05.0020.001921%
Abdominal pain upper07.01.05.0030.002517%
Abdominal tenderness07.01.05.0040.000372%Not Available
Abnormal faeces07.01.03.0010.000149%Not Available
Abnormal weight gain14.03.02.0100.000447%Not Available
Acne23.02.01.001--Not Available
Acute hepatic failure09.01.03.0010.000596%Not Available
Administration site reaction12.07.04.011; 08.02.04.0110.000149%Not Available
Affective disorder19.04.04.0010.000149%Not Available
Ageusia07.14.03.003; 17.02.07.0010.009100%Not Available
Agranulocytosis01.02.03.0010.000596%Not Available
Alopecia23.02.02.0010.002011%
Amenorrhoea21.01.02.001; 05.05.01.0020.000402%
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anger19.04.02.0010.000328%Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.0090.000819%Not Available
Anosmia22.04.03.006; 17.04.04.0010.002189%
Anxiety19.06.02.0020.001564%
Aphthous ulcer07.05.06.0020.000149%Not Available
Aplastic anaemia01.03.03.0020.000447%Not Available
Application site erythema08.02.01.001; 23.03.06.005; 12.07.01.0010.000298%Not Available
Application site pain12.07.01.004; 08.02.01.0040.000223%Not Available
Application site pruritus23.03.12.004; 12.07.01.005; 08.02.01.0050.000149%Not Available
Arteritis24.12.02.0010.000149%Not Available
Arthralgia15.01.02.0010.002041%
Arthritis15.01.01.0010.000745%
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.000298%
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