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)
Seizure17.12.03.001--
Sepsis11.01.11.0030.013679%
Skin disorder23.03.03.007--Not Available
Somnolence17.02.04.006; 19.02.05.003--
Stomatitis07.05.06.005--
Subdural haematoma17.08.05.002; 12.01.10.003; 24.07.04.0050.003908%Not Available
Suicidal ideation19.12.01.003--
Syncope24.06.02.012; 17.02.04.008; 02.01.02.008--
Thrombocytopenia01.08.01.002--Not Available
Upper gastrointestinal haemorrhage24.07.02.024; 07.12.02.006--
Upper respiratory tract infection22.07.03.011; 11.01.13.0090.014982%
Urticaria23.04.02.001; 10.01.06.001--
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
White blood cell count decreased13.01.06.012--
Blood phosphorus decreased13.11.01.0150.022473%Not Available
Foetal heart rate abnormal13.21.01.0010.022473%Not Available
Lymphatic disorder01.09.01.003--Not Available
Hepatitis B e antigen positive13.08.03.007--Not Available
Fanconi syndrome acquired14.01.01.013; 20.05.03.0120.014982%Not Available
Helicobacter infection11.02.18.0010.029964%Not Available
Transaminases increased13.03.01.0150.029964%Not Available
Gastric disorder07.11.01.0030.022473%Not Available
Chronic inflammatory demyelinating polyradiculoneuropathy17.09.04.004; 10.04.10.0040.014982%Not Available
Toxic skin eruption23.03.05.003; 10.01.01.0080.014982%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.009771%Not Available
Viraemia11.01.11.009--
Drug resistance08.06.01.0050.011725%Not Available
Adverse event08.06.01.010--Not Available
Cardiac disorder02.01.01.0030.005863%Not Available
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