Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Terbinafine hydrochloride
Drug ID BADD_D02161
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 D02219
MeSH ID D000077291
PubChem ID 5282481
TTD Drug ID D01AYJ
NDC Product Code 82982-046; 49386-007; 49452-7627; 56062-080; 61047-120; 61919-451; 71335-0918; 53069-0530; 59349-0007; 24385-524; 51672-2083; 14501-0012; 52562-600; 55111-024; 65862-364; 50066-080; 0363-2080; 63629-1993; 68071-2579; 71335-9677; 55111-250; 63187-111; 69452-351; 71205-061; 71205-492; 71335-0257; 62991-3085; 66039-859; 70159-006; 41250-080; 43063-598; 50090-1278; 51991-526; 65862-079; 68016-080; 70518-2941; 71335-1836; 38779-3253; 48087-0079; 59349-0037; 53002-0550; 60429-222; 68071-1640; 68788-9814; 71335-1124; 38779-2481; 45201-526; 51927-4856; 59349-0038; 66039-817; 43353-893; 49035-080; 50066-208; 50090-5810; 0067-3998; 0067-6297; 11822-0080; 50090-3575; 51672-2140; 68788-7187; 71205-127; 53104-7577; 68554-0002; 21130-080; 41520-080; 49348-790; 59779-080; 0363-2083; 70000-0338; 70677-1003; 70934-947; 0067-8114; 66219-0001; 37808-080; 42043-410; 63187-792; 63629-8137; 68071-4500; 68788-7450; 0067-3999; 0067-6296; 0067-8100; 52286-0007; 69037-0049; 73309-177; 16714-795; 30142-080; 36800-080; 43063-906; 51672-2080
UNII 012C11ZU6G
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 C21H26ClN
CAS Registry Number 78628-80-5
SMILES CC(C)(C)C#CC=CCN(C)CC1=CC=CC2=CC=CC=C21.Cl
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)
Neutropenia01.02.03.004--Not Available
Pancreatitis07.18.01.001--
Pancytopenia01.03.03.003--Not Available
Paraesthesia17.02.06.005; 23.03.03.094--
Parosmia22.04.03.007; 17.04.04.002--Not Available
Photosensitivity reaction23.03.09.003--
Pruritus23.03.12.001--
Psoriasis23.03.14.002; 10.02.01.036--Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rhabdomyolysis15.05.05.002--
Serum sickness-like reaction10.01.03.005; 08.01.03.003--Not Available
Skin reaction23.03.03.013; 10.01.03.019--Not Available
Stevens-Johnson syndrome12.03.01.014; 11.07.01.005; 10.01.01.045; 23.03.01.007--
Systemic lupus erythematosus23.03.02.006; 15.06.02.003; 10.04.03.004--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
Urticaria23.04.02.001; 10.01.06.001--
Vasculitis24.12.04.027; 10.02.02.006--
Vertigo04.04.01.003; 17.02.12.002--
Visual acuity reduced06.02.10.012; 17.17.01.011--
Visual field defect17.17.01.001; 06.02.07.003--Not Available
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Acute generalised exanthematous pustulosis11.07.01.018; 10.01.01.034; 23.03.10.002; 12.03.01.005--Not Available
Hypoacusis04.02.01.006--
Idiosyncratic drug reaction08.06.01.002--Not Available
Cutaneous lupus erythematosus23.03.02.008; 15.06.02.007; 10.04.03.007--Not Available
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