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)
Medication residue present13.15.01.032--Not Available
Sinus node dysfunction02.03.03.0170.001447%
Multiple organ dysfunction syndrome08.01.03.0570.003774%
Frustration tolerance decreased19.04.02.0160.001447%Not Available
Alpha 1 foetoprotein abnormal13.09.01.0190.000377%Not Available
Alpha 1 foetoprotein increased13.09.01.0200.001447%Not Available
Angiosarcoma16.16.03.001; 24.03.06.0030.000377%Not Available
Bleeding varicose vein24.10.04.0020.004340%Not Available
Chronic hepatitis C11.05.06.008; 09.01.09.0120.000943%Not Available
Cryoglobulinaemia24.05.02.019; 10.04.04.0130.034719%Not Available
Dermatitis exfoliative generalised10.01.01.029; 23.03.07.0020.001447%Not Available
Double outlet right ventricle02.08.03.002; 03.07.08.0060.001447%Not Available
Full blood count decreased13.01.07.004--Not Available
Hepatitis C RNA positive13.08.03.0230.006510%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.000943%Not Available
Oral lichen planus23.03.08.012; 07.05.01.0180.001447%Not Available
Respiratory rate increased13.15.01.0040.001447%Not Available
Ruptured cerebral aneurysm24.02.04.005; 17.08.01.0590.001447%Not Available
Synovial rupture15.04.02.004; 12.04.03.0090.001447%Not Available
Tumour embolism16.32.03.030; 24.01.01.0340.002170%Not Available
Umbilical cord around neck18.04.14.0040.000377%Not Available
Vomiting in pregnancy18.02.02.017; 07.01.07.0150.001447%Not Available
Rash maculovesicular23.03.13.0220.001447%Not Available
Gastric varices24.10.02.005; 09.01.06.013; 07.15.03.0040.001447%Not Available
Enterococcal sepsis11.02.08.0050.000377%Not Available
Gastric varices haemorrhage24.07.02.044; 09.01.06.014; 07.12.01.0050.001447%Not Available
Viral test positive13.08.03.0370.003617%Not Available
Congenital coronary artery malformation03.07.09.003; 24.03.03.0230.001447%Not Available
Metastases to nervous system17.02.10.022; 16.22.02.0190.002170%Not Available
Viral load increased13.08.03.0350.016636%Not Available
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