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)
Abdominal discomfort07.01.06.001---
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.010---
Abdominal pain upper07.01.05.003--
Alanine aminotransferase increased13.03.04.005--
Amylase increased13.05.01.009--
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001---
Back pain15.03.04.005--
Blood creatine phosphokinase increased13.04.01.001--
Body temperature increased13.15.01.001---
Chest discomfort02.02.02.009; 08.01.08.019; 22.12.02.002---
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Cough22.02.03.001--
Dermatitis23.03.04.002---
Diarrhoea07.02.01.001--
Discomfort08.01.08.003---
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspepsia07.01.02.001--
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014---
Flank pain08.01.08.007; 15.03.04.003; 20.02.03.006--
Frequent bowel movements07.02.04.002---
Gastritis07.08.02.001--
Gastrointestinal disorder07.11.01.001---
Gastrointestinal pain07.01.05.005--
Headache17.14.01.001--
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