Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sofosbuvir
Drug ID BADD_D02053
Description Sofosbuvir (tradename Sovaldi) is a direct acting antiviral medication used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV). HCV is a single-stranded RNA virus that is categorized into nine distinct genotypes, with genotype 1 being the most common in the United States, and affecting 72% of all chronic HCV patients [L852]. Treatment options for chronic Hepatitis C have advanced significantly since 2011, with the development of Direct Acting Antivirals (DAAs) such as sofosbuvir. As a prodrug nucleotide analog, Sofosbuvir is metabolized into its active form as the antiviral agent 2'-deoxy-2'-α-fluoro-β-C-methyluridine-5'-triphosphate (also known as GS-461203), which acts as a defective substrate for NS5B (non-structural protein 5B) [synthesis]. NS5B, an RNA-dependent RNA polymerase, is essential for the transcription of Hepatitis C viral RNA and for its high replicative rate and genetic diversity [A19594]. Sofosbuvir and other direct acting antivirals are therefore very potent options for the treatment of Hepatitis C, as they exhibit a high barrier to the development of resistance [A19593]. This is an important advantage relative to HCV drugs that target other viral enzymes such as the protease, for which rapid development of resistance has proven to be an important cause of therapeutic failure.
Indications and Usage Resistance: Reduced susceptibility to sofosbuvir has been associated with the NS5B substitution mutation S282T [A19634].
Marketing Status Prescription
ATC Code J05AP08
DrugBank ID DB08934
KEGG ID D10366
MeSH ID D000069474
PubChem ID 45375808
TTD Drug ID D0D4YZ
NDC Product Code 46708-900; 63285-752; 68554-0086; 73637-1505; 73675-001; 59116-4670; 61958-1504; 48087-0120; 73637-1504; 61958-1505; 69218-0200; 50683-0412; 69037-0014; 61958-1503; 61958-1501
Synonyms Sofosbuvir | 2-((5-(2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-ylmethoxy)phenoxyphosphorylamino)propionic acid isopropyl ester | PSI 7977 | 7977, PSI | PSI7977 | PSI-7977 | GS-7977 | GS 7977 | GS7977 | Sovaldi
Chemical Information
Molecular Formula C22H29FN3O9P
CAS Registry Number 1190307-88-0
SMILES CC(C)OC(=O)C(C)NP(=O)(OCC1C(C(C(O1)N2C=CC(=O)NC2=O)(C)F)O)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)
Arrhythmia02.03.02.0010.008680%Not Available
Arthralgia15.01.02.0010.046292%
Arthropathy15.01.01.003--Not Available
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.041229%
Aspartate aminotransferase increased13.03.01.0060.009403%
Aspiration22.02.07.0070.000566%
Asthenia08.01.01.0010.054249%Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Atrial fibrillation02.03.03.002--
Atrial septal defect03.07.02.002; 02.04.02.009--Not Available
Atrioventricular block02.03.01.002--Not Available
Atrioventricular block second degree02.03.01.0050.001447%
Autoimmune hepatitis09.01.07.019; 10.04.09.0010.002170%Not Available
B-cell lymphoma16.28.01.001; 01.15.01.0010.000943%Not Available
Back pain15.03.04.005--
Bacteraemia11.01.11.0010.002170%
Blister12.01.06.002; 23.03.01.0010.013020%Not Available
Blood albumin decreased13.09.01.0010.003617%Not Available
Blood bilirubin increased13.03.01.0080.047016%
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.0040.015913%
Blood glucose abnormal13.02.02.0080.002170%Not Available
Blood glucose increased13.02.02.002--Not Available
Blood potassium increased13.11.01.0110.002893%Not Available
Blood pressure decreased13.14.03.002--Not Available
Blood pressure increased13.14.03.005--Not Available
Blood sodium decreased13.11.01.012--Not Available
Blood urea increased13.13.01.006--Not Available
Blood uric acid increased13.02.04.0010.001447%Not Available
Body temperature increased13.15.01.0010.002170%Not Available
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