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---
Hepatitis B e antigen positive13.08.03.007---
Fanconi syndrome acquired14.01.01.013; 20.05.03.0120.003269%-
Transaminases increased13.03.04.036---
Chronic inflammatory demyelinating polyradiculoneuropathy10.04.10.004; 17.09.04.0040.003269%-
Toxic skin eruption10.01.01.008; 12.03.01.073; 23.03.05.0030.003269%-
Lung neoplasm malignant16.19.02.001; 22.08.01.0010.009806%-
Viraemia11.01.11.009--
Drug resistance08.06.01.0050.011441%-
Adverse event08.06.01.0100.037591%-
Cardiac disorder02.11.01.0030.004903%-
Feeding disorder14.03.02.003; 19.09.01.0030.003269%-
Malnutrition14.03.02.004---
Mental disorder19.07.01.0020.008826%-
Decreased appetite08.01.09.028; 14.03.01.0050.024843%
Blood disorder01.05.01.004---
Immunodeficiency10.03.02.002---
Hepatobiliary disease09.01.08.003---
Renal impairment20.01.03.0100.057204%-
Chronic kidney disease20.01.03.0170.003269%
Bone marrow failure01.03.03.0050.003269%
Renal cell carcinoma16.08.02.002; 20.01.04.0030.004903%-
Oropharyngeal pain07.05.05.004; 22.12.03.0160.008826%
Product taste abnormal27.02.02.001---
Rheumatic disorder10.02.01.048; 15.03.04.0180.004903%-
Hepatic cancer09.04.02.008; 16.07.02.0040.070280%-
Hepatocellular carcinoma09.04.02.010; 16.07.02.0050.045763%-
Lung adenocarcinoma16.19.01.002; 22.08.01.0070.004903%-
Normal newborn18.08.06.0010.008826%-
Cardiac perforation02.11.01.006; 12.02.01.0200.003269%-
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ADReCS-Target
Drug Name ADR Term Target
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