Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Saquinavir mesylate
Drug ID BADD_D01989
Description Saquinavir is an HIV-1 protease inhibitor used in combination with [ritonavir] and other antiretrovirals for the treatment of human immunodeficiency virus-1 (HIV-1) infection. In 1995 it became the first protease inhibitor approved by the FDA, followed shortly by ritonavir in 1996, and remains in clinical use today due to a relatively benign adverse effect profile as compared to other antiretroviral therapies.[A214382] While its efficacy was initially limited by exceptionally poor oral bioavailability (approximately 4%),[L3450] its current indications require the co-administration of ritonavir - a potent enzyme inhibitor - that increases the bioavailability and subsequent serum concentrations of saquinavir, thus dramatically improving antiviral activity.[A214382,L3450,L14351]
Indications and Usage For the treatment of HIV-1 with advanced immunodeficiency together with antiretroviral nucleoside analogues.
Marketing Status Discontinued; Prescription
ATC Code J05AE01
DrugBank ID DB01232
KEGG ID D01160
MeSH ID D019258
PubChem ID 60934
TTD Drug ID D0WI3T
NDC Product Code 0004-0244
Synonyms Saquinavir | Saquinivir | Ro 31-8959 | Ro 31 8959 | Ro 318959 | Saquinavir Monomethanesulfonate | Monomethanesulfonate, Saquinavir | Saquinavir Mesylate | Invirase
Chemical Information
Molecular Formula C39H54N6O8S
CAS Registry Number 149845-06-7
SMILES CC(C)(C)NC(=O)C1CC2CCCCC2CN1CC(C(CC3=CC=CC=C3)NC(=O)C(CC(=O)N)NC(=O)C4=NC5=CC=CC =C5C=C4)O.CS(=O)(=O)O
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)
Rhinitis22.07.03.006; 11.01.13.004--
Rhinitis allergic22.04.04.003; 10.01.04.003--
Seborrhoeic dermatitis23.03.04.018--Not Available
Seizure17.12.03.001--
Shock24.06.02.002--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
Skin papilloma23.10.01.002; 16.26.01.002; 11.05.07.001--
Skin reaction23.03.03.013; 10.01.03.019--Not Available
Skin ulcer24.04.03.007; 23.07.03.003--
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder22.02.05.034; 19.19.02.002; 17.02.08.003--Not Available
Splenomegaly01.09.02.001--Not Available
Stevens-Johnson syndrome10.01.03.020; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Stomatitis07.05.06.005--
Suicide attempt19.12.01.004--
Syncope24.06.02.012; 17.02.04.008; 02.01.02.008--
Thirst14.03.02.007; 08.01.09.021--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombophlebitis24.01.02.001--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tonsillitis22.07.03.008; 11.01.13.006--Not Available
Tooth disorder07.09.05.001--Not Available
Toothache07.09.06.001--
Torsade de pointes02.03.04.005--Not Available
Tremor17.01.06.002--
Ulcer08.03.06.001--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
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