Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Adefovir dipivoxil
Drug ID BADD_D00044
Description Adefovir dipivoxil, previously called bis-POM PMEA, with trade names Preveon and Hepsera, is an orally-administered acyclic nucleotide analog reverse transcriptase inhibitor (ntRTI) used for treatment of hepatitis B. It is ineffective against HIV-1. Adefovir dipivoxil is the diester prodrug of adefovir.
Indications and Usage For the treatment of chronic hepatitis B 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 J05AF08
DrugBank ID DB00718
KEGG ID D01655
MeSH ID C106812
PubChem ID 60871
TTD Drug ID D0ML1F
NDC Product Code 60505-3947; 53104-7602; 61958-0501; 42794-003; 65977-0051
Synonyms adefovir dipivoxil | adefovir depivoxil | 9-(2-((-bis((pivaloyloxy)methoxy)phosphinyl)methoxy)ethyl)adenine | Hepsera | Preveon | GS 840 | GS-0840
Chemical Information
Molecular Formula C20H32N5O8P
CAS Registry Number 142340-99-6
SMILES CC(C)(C)C(=O)OCOP(=O)(COCCN1C=NC2=C(N=CN=C21)N)OCOC(=O)C(C)(C)C
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hepatic cirrhosis09.01.04.0010.001132%Not Available
Hepatic cyst09.01.08.008; 16.06.02.0010.001447%Not Available
Hepatic encephalopathy09.01.03.006; 17.13.01.0030.001447%Not Available
Hepatic failure09.01.03.0020.000377%
Hepatic function abnormal09.01.02.0010.001447%Not Available
Hepatitis09.01.07.0040.000566%Not Available
Hepatitis B09.01.09.003; 11.05.06.0020.010126%
Hepatocellular injury09.01.07.0080.001447%Not Available
Hypercalcaemia05.04.01.002; 14.04.01.0030.001447%
Hyperchloraemia14.05.08.0010.002170%Not Available
Hyperkalaemia14.05.03.001--
Hyperplasia08.03.04.0080.001447%Not Available
Hypoaesthesia17.02.06.0230.005063%Not Available
Hypoalbuminaemia09.01.02.003; 14.10.01.0020.001447%
Hypocalcaemia14.04.01.0040.002893%
Hypokalaemia14.05.03.0020.005787%
Hypokinesia17.01.02.0090.004340%Not Available
Hypophosphataemia14.04.03.0010.116454%
Hypouricaemia14.09.01.0060.013020%Not Available
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.0300.002170%Not Available
Joint effusion15.01.02.0050.002170%
Joint swelling15.01.02.0040.004340%Not Available
Lactic acidosis14.01.01.0020.000755%Not Available
Liver disorder09.01.08.0010.001447%Not Available
Liver function test abnormal13.03.01.013--Not Available
Malaise08.01.01.003--
Metabolic acidosis14.01.01.0030.008680%Not Available
Movement disorder17.01.02.0100.007233%Not Available
Multiple fractures12.04.02.009; 15.08.02.0050.023146%Not Available
Muscle atrophy15.05.03.003; 17.05.03.0040.001447%Not Available
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