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)
Gastroenteritis viral11.05.04.005; 07.19.03.0050.002170%Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009--Not Available
Generalised oedema14.05.06.007; 08.01.07.0040.002170%
Generalised tonic-clonic seizure17.12.01.002--Not Available
Genital herpes21.10.03.008; 11.05.02.0120.002170%Not Available
Gingival bleeding24.07.02.010; 07.09.07.0010.002170%Not Available
Glomerular filtration rate decreased13.13.01.0090.008680%Not Available
Glomerulonephritis20.05.01.001; 10.02.01.0060.002170%Not Available
Glomerulonephritis membranoproliferative20.05.01.0120.004717%Not Available
Gout15.01.06.001; 14.09.01.001--Not Available
Groin pain15.03.02.0040.002170%Not Available
Haematemesis24.07.02.011; 07.12.02.0020.012296%Not Available
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Haematoma24.07.01.001--
Haematuria24.07.01.047; 20.02.01.006--
Blood urine present13.13.02.002--Not Available
Haemoglobin13.01.05.018--Not Available
Haemoglobin decreased13.01.05.0030.025316%Not Available
Haemolytic anaemia01.06.03.0020.002893%Not Available
Haemoptysis24.07.01.006; 22.02.03.004; 02.01.02.006--Not Available
Haemorrhoids24.10.02.002; 07.15.03.0010.002170%
Hallucination19.10.02.002--
Hallucination, auditory19.10.02.003--Not Available
Headache17.14.01.0010.249545%
Heart rate increased13.14.04.002--Not Available
Heart rate irregular13.14.04.0030.004340%Not Available
Hepatic artery thrombosis24.01.03.002; 09.01.06.0050.000566%Not Available
Hepatic cirrhosis09.01.04.0010.012454%Not Available
Hepatic encephalopathy17.13.01.003; 09.01.03.0060.035443%Not Available
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