Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tenofovir alafenamide
Drug ID BADD_D02477
Description Tenofovir alafenamide is a novel [tenofovir] prodrug developed in order to improve renal safety when compared to the counterpart [tenofovir disoproxil].[A178060] Both of these prodrugs were first created to cover the polar phosphonic acid group on tenofovir by using a novel oxycarbonyloxymethyl linkers to improve the oral bioavailability and intestinal diffusion.[T239] Tenofovir alafenamide is an alanine ester form characterized for presenting low systemic levels but high intracellular concentration.[A178219] It has been reported to produce a large antiviral efficacy at doses ten times lower than tenofovir disoproxil.[A178327] Tenofovir alafenamide is indicated to treat chronic hepatitis B,[L6241] treat HIV-1,[L4388,L6277,L6280,L6283] and prevent HIV-1 infections.[L4388,L9010] Tenofovir alafenamide was developed by Gilead Sciences Inc and granted FDA approval on 5 November 2015.[L6271]
Indications and Usage For use in the treatment of HIV infection and chronic hepatitis B.
Marketing Status Not Available
ATC Code J05AF13
DrugBank ID DB09299
KEGG ID D10428
MeSH ID C442442
PubChem ID 461543
TTD Drug ID D0D1BR
NDC Product Code 61958-2301
Synonyms tenofovir alafenamide | L-alanine, N-((S)-(((1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy)methyl)phenoxyphosphinyl)-, 1-methylethyl ester | Vemlidy | GS-7340 | GS-734003
Chemical Information
Molecular Formula C21H29N6O5P
CAS Registry Number 379270-37-8
SMILES CC(C)OC(=O)C(C)NP(=O)(COC(C)CN1C=NC2=C(N=CN=C21)N)OC3=CC=CC=C3
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Urine odour abnormal20.02.01.0200.001447%Not Available
Hepatic enzyme increased13.03.01.0190.001447%Not Available
Mental disorder19.07.01.0020.001447%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Renal impairment20.01.03.0100.002893%Not Available
Unevaluable event08.01.03.0510.001447%Not Available
Chronic kidney disease20.01.03.0170.002170%
Liver injury12.01.02.003; 09.01.07.0220.001447%Not Available
Oral herpes11.05.02.005; 07.05.07.0020.001447%Not Available
Acute kidney injury20.01.03.016--
Hepatitis B virus test positive13.08.03.0100.001447%Not Available
Hepatic cancer16.07.02.004; 09.04.02.0080.000755%Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.0100.000377%Not Available
Liver function test increased13.03.01.0440.002170%Not Available
Hepatitis B DNA assay positive13.08.03.0180.001447%Not Available
Viral load increased13.08.03.0350.004340%Not Available
Hepatitis B DNA increased13.08.03.0190.003617%Not Available
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