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)
Muscle spasms15.05.03.004--
Muscular weakness15.05.06.001; 17.05.03.0050.028933%
Musculoskeletal pain15.03.04.0070.004340%
Myalgia15.05.02.0010.008680%
Myopathy15.05.05.0010.002893%Not Available
Nasopharyngitis11.01.13.002; 22.07.03.0020.002170%Not Available
Nausea07.01.07.001--
Neoplasm malignant16.16.01.0010.000566%Not Available
Nephrolithiasis20.04.01.0020.004340%
Nephropathy20.05.03.0010.003617%Not Available
Nephropathy toxic12.03.01.010; 20.05.03.002--Not Available
Nervous system disorder17.02.10.001--Not Available
Neuropathy peripheral17.09.03.0030.002170%Not Available
Nocturia20.02.03.0010.002893%Not Available
Oedema08.01.07.006; 14.05.06.0100.001447%Not Available
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.0110.004340%
Oesophageal varices haemorrhage07.12.01.003; 09.01.06.004; 24.07.02.0220.001447%
Oliguria20.01.03.0040.001447%Not Available
Osteomalacia14.04.04.001; 15.02.03.001; 20.01.01.0020.168533%Not Available
Osteonecrosis15.02.04.007; 24.04.05.0040.005063%
Osteoporosis14.04.04.002; 15.02.03.0020.078118%
Pain08.01.08.0040.039783%
Pain in extremity15.03.04.0100.020253%
Palpitations02.01.02.003--
Pancreatitis07.18.01.001--
Pathogen resistance11.01.08.0490.000377%Not Available
Pathological fracture12.04.02.006; 15.08.02.008; 16.32.03.0070.007233%Not Available
Pelvic pain07.01.06.012; 20.02.03.007; 21.10.01.0010.002170%
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Platelet count decreased13.01.04.0010.003617%
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