Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Entecavir
Drug ID BADD_D00774
Description Entecavir is an oral antiviral drug used in the treatment of hepatitis B infection. It is marketed under the trade name Baraclude (BMS). Entecavir is a guanine analogue that inhibits all three steps in the viral replication process, and the manufacturer claims that it is more efficacious than previous agents used to treat hepatitis B (lamivudine and adefovir). It was approved by the U.S. Food and Drug Administration (FDA) in March 2005.
Indications and Usage For the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Marketing Status Prescription
ATC Code J05AF10
DrugBank ID DB00442
KEGG ID D04008
MeSH ID C413685
PubChem ID 135398508
TTD Drug ID D0KR2J
NDC Product Code 42291-261; 31722-833; 69097-425; 60050-057; 43547-437; 16729-389; 60687-216; 51991-895; 42291-262; 0003-1614; 42806-659; 65862-842; 50268-289; 71921-194; 0003-1611; 63285-888; 63285-887; 68382-921; 65862-798; 70771-1020; 42806-658; 51407-065; 51991-896; 16714-718; 68382-920; 16729-388; 71921-195; 62227-101; 53104-7692; 31722-834; 16714-717; 65862-841; 0003-1612; 13612-0020; 70771-1019; 65977-0086; 62227-102; 69097-426; 51407-064; 17381-031; 66406-0331; 60050-077; 76397-001; 65162-446; 65162-449; 43547-436
Synonyms entecavir | Baraclude
Chemical Information
Molecular Formula C12H15N5O3
CAS Registry Number 142217-69-4
SMILES C=C1C(CC(C1CO)O)N2C=NC3=C2N=C(NC3=O)N
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Gastric ulcer07.04.03.0020.014982%
Gastrooesophageal reflux disease07.02.02.0030.014982%
Gastrointestinal disorder07.11.01.0010.029964%Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal pain07.01.05.005--
Gestational diabetes18.02.04.001; 14.06.01.008; 05.06.01.0080.014982%Not Available
Gingival disorder07.09.03.0010.014982%Not Available
Glomerular filtration rate decreased13.13.01.0090.014982%Not Available
Glycosuria20.02.01.005--
Haemarthrosis24.07.01.046; 15.01.01.004; 12.04.03.0010.014982%Not Available
Haematoma24.07.01.0010.014982%
Haematuria24.07.01.047; 20.02.01.0060.014982%
Hand fracture12.04.01.014; 15.08.03.0140.014982%Not Available
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.0010.019542%Not Available
Hepatic encephalopathy17.13.01.003; 09.01.03.0060.037455%Not Available
Hepatic failure09.01.03.0020.060580%
Hepatic function abnormal09.01.02.0010.052437%Not Available
Hepatic steatosis09.01.07.003; 14.08.04.0050.014982%Not Available
Hepatitis09.01.07.0040.014982%Not Available
Hepatitis B09.01.09.003; 11.05.06.0020.033221%
Hepatitis C11.05.06.004; 09.01.09.0050.014982%Not Available
Hepatomegaly09.01.05.001--Not Available
Hepatorenal syndrome20.01.03.012; 09.01.03.007--Not Available
Hernia08.01.04.0010.014982%Not Available
Hyperglycaemia14.06.02.002; 05.06.02.0020.014982%
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hyperthyroidism05.02.02.001; 14.11.01.0110.014982%
Hypoaesthesia17.02.06.023--Not Available
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