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)
Eye swelling06.08.03.0030.000149%Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.0030.001266%
Faeces discoloured07.01.03.0020.000521%Not Available
Fatigue08.01.01.002--
Feeling hot08.01.09.0090.000521%Not Available
Feeling jittery08.01.09.0160.000372%Not Available
Flank pain08.01.08.007; 20.02.03.006; 15.03.04.0030.000149%
Flatulence07.01.04.0020.000402%
Flushing23.06.05.003; 24.03.01.002; 08.01.03.0250.000521%
Frequent bowel movements07.02.04.0020.000223%Not Available
Gait disturbance17.02.05.016; 08.01.02.002; 15.03.05.013--
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.000819%Not Available
Genital rash23.03.13.016; 21.10.01.0090.000149%Not Available
Gingival pain07.09.13.0100.000149%
Gingival swelling07.09.13.0130.000149%Not Available
Glossodynia07.14.02.0010.000149%Not Available
Gynaecomastia05.05.02.003; 21.05.04.0030.000223%
Haematemesis24.07.02.011; 07.12.02.0020.000298%Not Available
Haematochezia24.07.02.012; 07.12.02.0030.000298%Not Available
Head discomfort17.02.05.027--Not Available
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.0010.000149%Not Available
Hepatic failure09.01.03.0020.000298%
Hepatic function abnormal09.01.02.0010.000521%Not Available
Hepatic steatosis09.01.07.003; 14.08.04.0050.000223%Not Available
Hepatitis09.01.07.0040.001266%Not Available
Hepatitis acute09.01.07.0050.000521%Not Available
Hepatitis cholestatic09.01.01.0020.000968%Not Available
Hepatitis toxic12.03.01.016; 09.01.07.0170.000223%Not Available
Hepatocellular injury09.01.07.0080.001117%Not Available
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