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)
Neoplasm malignant16.16.01.0010.015633%Not Available
Nephrolithiasis20.04.01.0020.014982%
Nervous system disorder17.02.10.001--Not Available
Neuropathy peripheral17.09.03.0030.022473%Not Available
Neutropenia01.02.03.004--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oesophageal carcinoma16.13.06.001; 07.21.06.0010.003908%Not Available
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Palpitations02.01.02.003--
Pancreatic carcinoma16.13.10.001; 07.21.09.0020.005863%Not Available
Pancreatitis07.18.01.0010.014982%
Pancytopenia01.03.03.0030.037455%Not Available
Pathogen resistance11.01.08.0490.003908%Not Available
Plasma cell myeloma16.23.02.004; 01.14.02.004--Not Available
Platelet count decreased13.01.04.001--
Pleural effusion22.05.02.0020.022473%
Pneumonia11.01.09.003; 22.07.01.0030.089892%Not Available
Pneumonia aspiration22.01.01.0050.005863%Not Available
Pollakiuria20.02.02.0070.014982%
Premature baby18.04.02.0010.022473%Not Available
Prostatic disorder21.04.01.0010.014982%Not Available
Proteinuria20.02.01.0110.014982%
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.0010.142330%Not Available
Rectal cancer16.13.01.003; 07.21.05.0020.003908%Not Available
Renal disorder20.01.02.0020.044946%Not Available
Renal failure20.01.03.0050.011725%Not Available
Rhabdomyolysis15.05.05.0020.022473%
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