Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Telbivudine
Drug ID BADD_D02145
Description Telbivudine is a synthetic thymidine nucleoside analog with specific activity against the hepatitis B virus. Telbivudine is orally administered, with good tolerance, lack of toxicity and no dose-limiting side effects.
Indications and Usage For the treatment of chronic hepatitis B in adult and adolescent patients ≥16 years of age with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Marketing Status approved; investigational
ATC Code J05AF11
DrugBank ID DB01265
KEGG ID D06675
MeSH ID D000077712
PubChem ID 159269
TTD Drug ID D0CL9S
NDC Product Code Not Available
UNII 2OC4HKD3SF
Synonyms Telbivudine | 1-(2-Deoxy-beta-L-erythropentafuranosyl)-5-methyl-2,4(1H,3H)-pyrimidinedione | beta-L-2'-Deoxythymidine | beta L 2' Deoxythymidine | Telbivudin | Tyzeka
Chemical Information
Molecular Formula C10H14N2O5
CAS Registry Number 3424-98-4
SMILES CC1=CN(C(=O)NC1=O)C2CC(C(O2)CO)O
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)
Hepatic pain09.01.05.005--
Hepatitis09.01.07.004---
Hepatitis acute09.01.07.005---
Hepatitis B09.01.09.003; 11.05.28.003--
Hepatomegaly09.01.05.001---
Hypoaesthesia17.02.06.023; 23.03.03.081---
Influenza11.05.03.001; 22.07.02.001---
Influenza like illness08.01.03.010--
Insomnia17.15.03.002; 19.02.01.002--
Lactic acidosis14.01.01.002---
Laryngeal pain22.12.03.010--
Lipase increased13.05.01.003--
Malaise08.01.01.003--
Migraine17.14.02.001; 24.03.05.003---
Muscle spasms15.05.03.004--
Muscular weakness15.05.06.001; 17.05.03.005--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Myopathy15.05.05.001---
Myositis15.05.01.001--
Nasopharyngitis11.01.13.002; 22.07.03.002---
Nausea07.01.07.001--
Neck pain15.03.04.009--
Nervous system disorder17.02.10.001---
Neuropathy peripheral17.09.03.003---
Neutropenia01.02.03.004---
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Paraesthesia17.02.06.005; 23.03.03.094--
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
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