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 appetite08.01.09.028; 14.03.01.005--
Renal injury12.01.05.001; 20.01.03.0150.001835%-
Bone lesion15.02.04.0160.000847%-
Diabetic nephropathy05.07.02.003; 14.07.02.003; 20.05.03.0110.000282%-
Hepatic lesion09.01.08.0050.000423%-
Hepatobiliary disease09.01.08.003---
Renal impairment20.01.03.0100.007875%-
Unevaluable event08.01.03.0510.000762%-
Poor quality sleep17.15.04.002; 19.02.05.0050.000282%-
Chronic kidney disease20.01.03.0170.000706%
Bone marrow failure01.03.03.0050.000706%
Thyroid cancer05.02.05.001; 16.24.03.0010.001129%-
Cholestatic liver injury09.01.07.0160.000282%-
Penile curvature21.12.01.0090.000282%-
Drug-induced liver injury09.01.07.023; 12.03.01.0440.000423%-
Hepatic cancer09.04.02.008; 16.07.02.0040.002399%-
Hepatocellular carcinoma09.04.02.010; 16.07.02.0050.003952%-
Concomitant disease aggravated08.01.03.0630.000565%-
Hypermetabolism14.11.01.0180.000282%-
IgA nephropathy10.02.01.063; 20.05.01.0160.000706%-
Renal atrophy20.01.06.0010.000282%-
Renal glycosuria20.05.03.0200.001270%-
Renal tubular atrophy20.05.03.0220.000423%-
Gastric varices07.15.03.004; 09.01.06.013; 24.10.02.0050.000282%-
Bone marrow oedema01.05.01.019; 15.02.01.0050.000847%-
Hyperphosphatasaemia09.01.08.002; 14.11.01.002; 15.02.04.0110.000706%-
Prostatic calcification21.04.01.0080.000282%-
Spinal pain08.01.08.030; 15.02.01.008; 17.10.01.0200.000988%-
Acquired aminoaciduria14.10.02.002; 20.02.01.0310.000847%-
Gait inability08.01.02.011; 17.02.05.0690.000706%-
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