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)
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.000149%Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.001117%Not Available
Dermatitis psoriasiform23.03.14.004--Not Available
Skin oedema23.06.04.0010.000447%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.000372%Not Available
Bicytopenia01.03.03.0100.000298%Not Available
Epidermal necrosis23.03.03.035--Not Available
Drug resistance08.06.01.0050.003798%Not Available
Hepatic enzyme13.03.04.025--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000760%Not Available
Inflammation10.02.01.089; 08.01.05.0070.000819%Not Available
Limb discomfort15.03.04.0140.000447%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.002562%
Erectile dysfunction19.08.04.001; 21.03.01.007--
Disease recurrence08.01.03.0500.000149%Not Available
Food intolerance14.02.01.0050.000506%Not Available
Poor quality sleep19.02.05.005; 17.15.04.0020.000149%Not Available
Hepatic enzyme abnormal13.03.04.026--Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.010--Not Available
Lichenoid keratosis23.01.01.0040.000402%Not Available
Skin haemorrhage24.07.01.103; 23.06.07.001--Not Available
Exfoliative rash23.03.07.0060.000149%Not Available
Application site burn08.02.01.038; 23.03.11.013; 12.07.01.038--Not Available
Treatment failure08.06.01.0170.003575%Not Available
Liver injury12.01.17.012; 09.01.07.0220.000968%Not Available
Type 1 diabetes mellitus14.06.01.010; 10.04.08.007; 05.06.01.0100.000223%Not Available
Cholestatic liver injury09.01.07.0160.000521%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.000998%
Acute kidney injury20.01.03.0160.001043%
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