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 Indicated for the treatment of chronic hepatitis B in adult patients with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease; this is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.
Marketing Status approved; investigational
ATC Code J05AF08
DrugBank ID DB00718
KEGG ID D01655
MeSH ID C106812
PubChem ID 60871
TTD Drug ID D0ML1F
NDC Product Code 53104-7602; 42794-003; 60505-3947; 61958-0501
UNII U6Q8Z01514
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
*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)
Joint swelling15.01.02.0040.000988%Not Available
Kyphosis15.10.04.0020.000282%
Lactic acidosis14.01.01.0020.000565%Not Available
Liver disorder09.01.08.0010.000565%Not Available
Liver function test abnormal13.03.04.030--Not Available
Metabolic acidosis14.01.01.0030.002258%Not Available
Metastases to lung22.08.01.005; 16.22.02.0020.000282%Not Available
Microalbuminuria20.02.01.026; 14.07.02.002; 05.07.02.0020.000282%Not Available
Movement disorder17.01.02.0100.001411%Not Available
Multiple fractures15.08.02.005; 12.04.02.009--Not Available
Muscle atrophy17.05.03.004; 15.05.03.0030.000282%Not Available
Muscular weakness15.05.06.001; 17.05.03.0050.005786%
Musculoskeletal pain15.03.04.0070.001835%
Myalgia15.05.02.0010.001976%
Myopathy15.05.05.0010.000847%Not Available
Myositis15.05.01.0010.000423%
Nausea07.01.07.001--
Neoplasm malignant16.16.01.0010.000706%Not Available
Nephritis20.05.02.0010.000423%Not Available
Nephrolithiasis20.04.01.0020.001129%
Nephropathy20.05.03.0010.000706%Not Available
Nephropathy toxic20.05.03.002; 12.03.01.0100.001891%Not Available
Nervous system disorder17.02.10.001--Not Available
Nocturia20.02.03.0010.000565%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.000847%
Oesophageal varices haemorrhage24.07.02.022; 09.01.06.004; 07.12.01.0030.000282%
Oliguria20.01.03.0040.000282%Not Available
Osteoarthritis15.01.04.0010.000282%Not Available
Osteomalacia20.01.01.002; 15.02.03.001; 14.04.04.0010.035282%Not Available
Osteonecrosis24.04.05.004; 15.02.04.0070.000988%
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