Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sitaxentan
Drug ID BADD_D02031
Description Sitaxentan was marketed under the trade name Thelin for the treatment of pulmonary arterial hypertension (PAH) by Encysive Pharmaceuticals until Pfizer purchased Encysive in February 2008. In 2010, Pfizer voluntarily removed sitaxentan from the market over concerns of hepatotoxicity.
Indications and Usage Investigated for use/treatment in pulmonary hypertension, connective tissue diseases, hypertension, and congestive heart failure.
Marketing Status approved; investigational; withdrawn
ATC Code C02KX03
DrugBank ID DB06268
KEGG ID D07171
MeSH ID C106276
PubChem ID 216235
TTD Drug ID D0T1RG
NDC Product Code Not Available
UNII J9QH779MEM
Synonyms sitaxsentan | N-(4-chloro-3-methyl-5-isoxazolyl)-2-(3,4-(methylenedioxy)-6-methyl)phenylacetyl-3-thiophenesulfonamide | N-(4-chloro-3-methyl-5-isoxazolyl)-2-((4,5-(methylenedioxy)-O-toly)acetyl)-3-thiophenesulfonamide | TBC-11251 | TBC 11251 | TBC11251
Chemical Information
Molecular Formula C18H15ClN2O6S2
CAS Registry Number 184036-34-8
SMILES CC1=CC2=C(C=C1CC(=O)C3=C(C=CS3)S(=O)(=O)NC4=C(C(=NO4)C)Cl)OCO2
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)
Hypocalcaemia14.04.01.004--
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hypotension24.06.03.002--
Hypoxia22.02.02.003--
Immune system disorder10.02.01.001--Not Available
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Infection11.01.08.002--Not Available
Injection site dermatitis23.03.04.033; 12.07.03.041; 08.02.03.041--Not Available
Insomnia19.02.01.002; 17.15.03.002--
International normalised ratio increased13.01.02.008--
Intertrigo23.03.04.028--Not Available
Jaundice23.03.03.030; 01.06.04.004; 09.01.01.004--Not Available
Joint stiffness15.01.02.003--Not Available
Lacrimation increased06.08.02.004--
Lactic acidosis14.01.01.002--Not Available
Leukopenia01.02.02.001--Not Available
Ligament sprain12.01.07.008; 15.07.02.004--Not Available
Liver function test abnormal13.03.04.030--Not Available
Localised infection11.01.08.006--Not Available
Lower respiratory tract infection22.07.01.002; 11.01.09.002--Not Available
Lymphoma16.20.01.001; 01.12.01.001--Not Available
Malaise08.01.01.003--
Memory impairment19.20.01.003; 17.03.02.003--
Menopausal symptoms21.02.02.002--Not Available
Mental disability26.01.01.001--Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Mouth haemorrhage24.07.02.014; 07.05.02.001--
Muscle atrophy17.05.03.004; 15.05.03.003--Not Available
Muscle haemorrhage12.01.07.016; 24.07.01.037; 15.05.03.017--Not Available
Muscle spasms15.05.03.004--
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