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 approved; investigational
ATC Code J05AF10
DrugBank ID DB00442
KEGG ID D04008; D07896
MeSH ID C413685
PubChem ID 135398508
TTD Drug ID D0KR2J
NDC Product Code 63285-887; 60687-216; 65862-841; 17381-031; 71921-195; 42806-659; 43547-436; 43547-437; 68382-920; 76397-001; 31722-833; 70771-1020; 68382-921; 65862-798; 71921-194; 16729-388; 42291-261; 63126-102; 16714-717; 50771-014; 63126-101; 70771-1019; 0003-1611; 16729-389; 42291-262; 69097-426; 13612-0020; 0003-1612; 0003-1614; 63285-888; 31722-834; 65162-446; 69097-425; 51991-895; 65162-449; 65862-842; 53104-7692; 65977-0086; 66406-0331; 16714-718; 42806-658; 50268-289; 50771-013; 51991-896
UNII 5968Y6H45M
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
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---
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Oesophageal carcinoma07.21.06.001; 16.13.06.0010.004903%-
Oesophageal stenosis07.13.02.0010.003269%
Osteoporosis14.04.04.002; 15.02.03.0020.003269%
Pancreatic carcinoma07.21.09.002; 16.13.10.0010.004903%-
Pancreatitis07.18.01.0010.003269%
Pancytopenia01.03.03.0030.008172%-
Platelet count decreased13.01.04.001--
Pleural effusion22.05.02.0020.004903%
Pollakiuria20.02.02.0070.007191%
Pregnancy18.08.02.0040.004903%-
Premature baby18.04.02.0010.004903%-
Prostatic disorder21.04.01.0010.003269%-
Proteinuria20.02.01.0110.003269%
Rash23.03.13.0010.070280%-
Rectal cancer07.21.05.002; 16.13.01.0030.003269%-
Renal disorder20.01.02.0020.009806%-
Renal failure20.01.03.0050.009806%-
Respiratory disorder22.02.07.0020.003269%-
Rhabdomyolysis15.05.05.0020.004903%
Skin disorder23.03.03.007---
Somnolence17.02.04.006; 19.02.05.003--
Therapeutic response decreased08.06.01.0160.004903%-
Therapeutic response unexpected08.06.01.0010.007191%-
Thrombocytopenia01.08.01.0020.008172%-
Upper gastrointestinal haemorrhage07.12.02.006; 24.07.02.024--
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Vomiting07.01.07.003--
General physical health deterioration08.01.03.0180.012095%-
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ADReCS-Target
Drug Name ADR Term Target
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