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 Saquinavir is indicated, in combination with ritonavir and other antiretroviral agents, for the treatment of HIV-1 infection in patients 16 years of age and older.[L3450]
Marketing Status approved; investigational
ATC Code J05AE01
DrugBank ID DB01232
KEGG ID D01160
MeSH ID D019258
PubChem ID 60934
TTD Drug ID D0WI3T
NDC Product Code 0004-0244
UNII UHB9Z3841A
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Rhinitis allergic10.01.04.003; 22.04.04.003--
Seborrhoeic dermatitis23.03.04.018---
Seizure17.12.03.001--
Shock24.06.02.002---
Sinusitis11.01.13.005; 22.07.03.007--
Skin disorder23.03.03.007---
Skin papilloma11.05.07.001; 16.26.01.002; 23.10.01.002--
Skin reaction10.01.03.019; 23.03.03.013---
Skin ulcer23.07.03.003; 24.04.03.007--
Sleep disorder19.02.04.001---
Somnolence17.02.04.006; 19.02.05.003--
Speech disorder17.02.08.003; 19.19.02.002; 22.12.03.027---
Splenomegaly01.09.02.001---
Stevens-Johnson syndrome10.01.01.045; 11.07.01.005; 12.03.01.014; 23.03.01.007--
Stomatitis07.05.06.005--
Suicide attempt19.12.01.004--
Syncope02.11.04.015; 17.02.04.008; 24.06.02.012--
Thirst08.01.09.021; 14.03.02.007---
Thrombocytopenia01.08.01.002---
Thrombophlebitis24.01.02.001---
Tinnitus04.04.01.002; 17.04.07.004--
Tonsillitis11.01.13.006; 22.07.03.008---
Tooth disorder07.09.05.001---
Toothache07.09.06.001--
Torsade de pointes02.03.04.005---
Tremor17.01.06.002--
Ulcer08.03.06.001---
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urethral disorder20.07.01.002---
Urinary tract disorder20.08.01.001---
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