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)
Decreased appetite14.03.01.005; 08.01.09.028--
Renal injury20.01.03.015; 12.01.05.0010.001835%Not Available
Bone lesion15.02.04.0160.000847%Not Available
Diabetic nephropathy05.07.02.003; 20.05.03.011; 14.07.02.0030.000282%Not Available
Hepatic lesion09.01.08.0050.000423%Not Available
Hepatobiliary disease09.01.08.003--Not Available
Renal impairment20.01.03.0100.007875%Not Available
Unevaluable event08.01.03.0510.000762%Not Available
Poor quality sleep17.15.04.002; 19.02.05.0050.000282%Not Available
Chronic kidney disease20.01.03.0170.000706%
Bone marrow failure01.03.03.0050.000706%
Thyroid cancer16.24.03.001; 05.02.05.0010.001129%Not Available
Cholestatic liver injury09.01.07.0160.000282%Not Available
Penile curvature21.12.01.0090.000282%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000423%Not Available
Hepatic cancer16.07.02.004; 09.04.02.0080.002399%Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.0100.003952%Not Available
Concomitant disease aggravated08.01.03.0630.000565%Not Available
Hypermetabolism14.11.01.0180.000282%Not Available
IgA nephropathy10.02.01.063; 20.05.01.0160.000706%Not Available
Renal atrophy20.01.06.0010.000282%Not Available
Renal glycosuria20.05.03.0200.001270%Not Available
Renal tubular atrophy20.05.03.0220.000423%Not Available
Gastric varices24.10.02.005; 09.01.06.013; 07.15.03.0040.000282%Not Available
Bone marrow oedema15.02.01.005; 01.05.01.0190.000847%Not Available
Hyperphosphatasaemia15.02.04.011; 09.01.08.002; 14.11.01.0020.000706%Not Available
Prostatic calcification21.04.01.0080.000282%Not Available
Spinal pain17.10.01.020; 15.02.01.008; 08.01.08.0300.000988%Not Available
Acquired aminoaciduria20.02.01.031; 14.10.02.0020.000847%Not Available
Gait inability17.02.05.069; 08.01.02.0110.000706%Not Available
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