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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.0030.044946%
Abortion18.01.01.0010.022473%Not Available
Abortion spontaneous18.01.04.0010.067419%Not Available
Acute hepatic failure09.01.03.0010.005863%Not Available
Alanine aminotransferase increased13.03.01.0030.044946%
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Aneurysm24.02.01.0010.003908%Not Available
Anxiety19.06.02.002--
Aplastic anaemia01.03.03.0020.005863%Not Available
Arthralgia15.01.02.001--
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.052437%
Aspartate aminotransferase increased13.03.01.0060.014982%
Asthenia08.01.01.0010.074910%Not Available
Atrioventricular block02.03.01.0020.014982%Not Available
Back pain15.03.04.005--
Bladder cancer20.03.04.001; 16.08.01.001--Not Available
Blood bicarbonate decreased13.11.01.019--
Blood bilirubin increased13.03.01.0080.022473%
Blood creatine phosphokinase increased13.04.01.0010.067419%
Blood creatinine increased13.13.01.0040.029964%
Blood lactate dehydrogenase increased13.04.02.0020.014982%
Body temperature increased13.15.01.001--Not Available
Bone disorder15.02.04.0040.014982%Not Available
Breast cancer21.05.01.003; 16.10.01.0010.022473%Not Available
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