Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Selexipag
Drug ID BADD_D02006
Description Selexipag was approved by the United States FDA on December 22, 2015 for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce risk of hospitalization. PAH is a relatively rare disease with usually a poor prognosis requiring more treatment options to prolong long-term outcomes. Marketed by Actelion Pharmaceuticals under brand name Uptravi, selexipag and its active metabolite, ACT-333679 (MRE-269), act as agonists of the prostacyclin receptor to increase vasodilation in the pulmonary circulation and decrease elevated pressure in the blood vessels supplying blood to the lungs.
Indications and Usage Selexipag is indicated for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce risk of hospitalization.
Marketing Status approved
ATC Code B01AC27
DrugBank ID DB11362
KEGG ID D09994
MeSH ID C523468
PubChem ID 9913767
TTD Drug ID D0N2SR
NDC Product Code 66215-718; 66215-602; 66215-612; 47848-060; 70600-007; 66215-606; 66215-616; 66215-610; 66215-614; 70600-029; 66215-628; 66215-604; 66215-608
UNII 5EXC0E384L
Synonyms selexipag | 2-(4-((5,6-diphenylpyrazin-2-yl)(isopropyl)amino)butoxy)-N-(methylsulfonyl)acetamide | Uptravi | NS-304 | ACT 293987 | ACT293987 | ACT-293987
Chemical Information
Molecular Formula C26H32N4O4S
CAS Registry Number 475086-01-2
SMILES CC(C)N(CCCCOCC(=O)NS(=O)(=O)C)C1=CN=C(C(=N1)C2=CC=CC=C2)C3=CC=CC=C3
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)
Peripheral swelling02.05.04.015; 08.01.03.0530.001892%Not Available
General physical health deterioration08.01.03.0180.000329%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.000839%Not Available
Musculoskeletal chest pain22.09.01.001; 15.03.04.0120.000123%
Lower gastrointestinal haemorrhage07.12.03.011; 24.07.02.0300.000082%
Respiratory tract congestion22.02.07.0030.000181%Not Available
Cardiac flutter02.03.02.0120.000181%Not Available
Haemorrhoidal haemorrhage24.10.02.001; 07.15.03.0020.000206%
Faecaloma07.01.03.0040.000123%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.000600%Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.0270.000206%
Adverse event08.06.01.0100.004729%Not Available
Cardiac disorder02.11.01.0030.000625%Not Available
Feeding disorder14.03.02.003; 19.09.01.0030.000642%Not Available
Limb discomfort15.03.04.0140.000502%Not Available
Decreased appetite08.01.09.028; 14.03.01.0050.005124%
Adverse drug reaction08.06.01.0090.001744%Not Available
Disease progression08.01.03.0380.001308%
Drug intolerance08.06.01.0130.003537%Not Available
Unevaluable event08.01.03.0510.002393%Not Available
Poor quality sleep19.02.05.005; 17.15.04.0020.000181%Not Available
Arterial occlusive disease24.04.02.0210.000082%Not Available
Pulmonary arterial hypertension24.08.03.003; 22.06.01.0020.002179%Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.0080.000181%Not Available
Anal incontinence17.05.01.021; 07.01.06.0290.000362%
Frustration tolerance decreased19.04.02.0160.000181%Not Available
Cardiac failure chronic02.05.01.0090.000123%Not Available
Concomitant disease aggravated08.01.03.0630.000247%Not Available
Terminal state08.01.03.0790.000082%Not Available
Internal haemorrhage24.07.01.0720.000206%Not Available
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