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)
Osteoporosis15.02.03.002; 14.04.04.0020.017218%
Pain08.01.08.0040.008186%
Pain in extremity15.03.04.0100.004375%
Pancreatitis07.18.01.001--
Parotid gland enlargement07.06.03.0010.000423%Not Available
Pathological fracture16.32.03.007; 15.08.02.008; 12.04.02.0060.001552%Not Available
Pelvic pain21.10.01.001; 20.02.03.007; 07.01.06.0120.000565%
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pollakiuria20.02.02.0070.000423%
Proteinuria20.02.01.0110.004234%
Prurigo23.03.04.0170.000423%Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rash morbilliform23.03.13.0050.000423%Not Available
Renal disorder20.01.02.0020.003020%Not Available
Renal failure20.01.03.0050.001750%Not Available
Renal tubular acidosis20.05.03.003; 14.01.01.0050.001270%Not Available
Renal tubular disorder20.05.03.0040.004940%Not Available
Rhabdomyolysis15.05.05.0020.000988%
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
Sneezing22.12.03.0240.000565%
Spider naevus24.03.03.008; 23.06.03.0030.000282%Not Available
Spinal osteoarthritis15.01.04.0030.000847%Not Available
Swelling08.01.03.0150.000423%Not Available
Tenderness08.01.08.0050.000988%Not Available
Therapeutic response decreased08.06.01.0160.000565%Not Available
Thrombocytopenia01.08.01.002--Not Available
Tricuspid valve incompetence02.07.05.0010.000282%Not Available
Ulcer08.03.06.0010.000282%Not Available
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