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)
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.0030.023209%
Abortion18.01.01.0010.004903%Not Available
Abortion spontaneous18.01.04.0010.016344%Not Available
Acute hepatic failure09.01.03.0010.004903%Not Available
Alopecia23.02.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction10.01.07.003; 24.06.03.007--Not Available
Aneurysm24.02.01.0010.003269%Not Available
Aplastic anaemia01.03.03.0020.004903%Not Available
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.011441%
Asthenia08.01.01.001--Not Available
Atrioventricular block02.03.01.0020.003269%Not Available
Blood bicarbonate decreased13.02.01.035--
Blood creatinine increased13.13.01.004--
Body temperature increased13.15.01.001--Not Available
Bone disorder15.02.04.0040.003269%Not Available
Breast cancer21.05.01.003; 16.10.01.0010.006538%Not Available
Cardiac failure02.05.01.0010.008172%
Cardio-respiratory arrest22.02.06.007; 02.03.04.0020.003269%Not Available
Cataract06.06.01.0010.003269%
Cerebral haemorrhage24.07.04.001; 17.08.01.0030.009806%Not Available
Cerebral infarction24.04.06.002; 17.08.01.0040.003269%Not Available
Chest discomfort02.02.02.009; 22.12.02.002; 08.01.08.0190.008826%Not Available
Colon cancer16.13.01.001; 07.21.01.0010.003269%Not Available
Coma hepatic09.01.03.005; 17.02.09.0020.003269%Not Available
Deafness04.02.01.0010.004903%Not Available
Death08.04.01.0010.082374%
Dementia19.20.02.001; 17.03.01.0010.004903%Not Available
Dermatitis23.03.04.002--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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