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)
Lymphatic disorder01.09.01.003--Not Available
Hepatitis B e antigen positive13.08.03.007--Not Available
Fanconi syndrome acquired14.01.01.013; 20.05.03.0120.003269%Not Available
Transaminases increased13.03.04.036--Not Available
Chronic inflammatory demyelinating polyradiculoneuropathy17.09.04.004; 10.04.10.0040.003269%Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.003269%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.009806%Not Available
Viraemia11.01.11.009--
Drug resistance08.06.01.0050.011441%Not Available
Adverse event08.06.01.0100.037591%Not Available
Cardiac disorder02.11.01.0030.004903%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.003269%Not Available
Malnutrition14.03.02.004--Not Available
Mental disorder19.07.01.0020.008826%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.024843%
Blood disorder01.05.01.004--Not Available
Immunodeficiency10.03.02.002--Not Available
Hepatobiliary disease09.01.08.003--Not Available
Renal impairment20.01.03.0100.057204%Not Available
Chronic kidney disease20.01.03.0170.003269%
Bone marrow failure01.03.03.0050.003269%
Renal cell carcinoma20.01.04.003; 16.08.02.0020.004903%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.008826%
Product taste abnormal27.02.02.001--Not Available
Rheumatic disorder15.03.04.018; 10.02.01.0480.004903%Not Available
Hepatic cancer16.07.02.004; 09.04.02.0080.070280%Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.0100.045763%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.004903%Not Available
Normal newborn18.08.06.0010.008826%Not Available
Cardiac perforation02.11.01.006; 12.02.01.0200.003269%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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