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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Abscess11.01.08.001--Not Available
Acne23.02.01.001--Not Available
Acute leukaemia16.01.02.001; 01.10.02.001--Not Available
Acute myeloid leukaemia16.01.05.001; 01.10.05.001--Not Available
Agitation17.02.05.012; 19.06.02.001--
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Amnesia19.20.01.001; 17.03.02.001--
Amylase increased13.05.01.009--
Anaemia01.03.02.001--
Anxiety19.06.02.002--
Aphthous ulcer07.05.06.002--Not Available
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Ascites09.01.05.003; 07.07.01.001; 02.05.04.002--
Aspartate aminotransferase abnormal13.03.01.004--Not Available
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Back pain15.03.04.005--
Basedow's disease10.04.08.004; 06.09.04.003; 05.02.02.003--Not Available
Blepharitis23.03.04.012; 06.04.04.001--Not Available
Blood bilirubin increased13.03.01.008--
Blood creatine phosphokinase increased13.04.01.001--
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