Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Macitentan
Drug ID BADD_D01336
Description Macitentan is a dual endothelin receptor antagonist used in the treatment of pulmonary arterial hypertension.[L35890] It was first approved by the FDA in 2013. Macitentan differs from its predecessor [bosentan] due to its lower risk of hepatotoxicity.
Indications and Usage Macitentan is indicated for the treatment of WHO group 1 pulmonary arterial hypertension (PAH) both alone and in combination with tadalafil.[L39105, L39105]
Marketing Status approved
ATC Code C02KX04
DrugBank ID DB08932
KEGG ID D10135
MeSH ID C533860
PubChem ID 16004692
TTD Drug ID D0S7JH
NDC Product Code 65015-872; 11722-058; 66215-501; 68225-070; 69037-0030; 76397-014; 59651-122; 82245-0117; 69766-006
UNII Z9K9Y9WMVL
Synonyms macitentan | N-(5-(4-bromophenyl)-6-(2-(5-bromopyrimidin-2-yloxy)ethoxy)pyrimidin-4-yl)-N'-propylaminosulfonamide | ACT 064992 | ACT064992 | ACT-064992 | Actelion-1 | opsumit
Chemical Information
Molecular Formula C19H20Br2N6O4S
CAS Registry Number 441798-33-0
SMILES CCCNS(=O)(=O)NC1=C(C(=NC=N1)OCCOC2=NC=C(C=N2)Br)C3=CC=C(C=C3)Br
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)
Large intestinal obstruction07.13.03.0030.000241%
Renal mass20.01.02.0070.000120%Not Available
Nasal disorder22.04.03.0040.000469%Not Available
Sinus disorder22.04.06.0020.004368%
Unevaluable event08.01.03.0510.014321%Not Available
Middle ear effusion04.05.03.0010.000241%Not Available
Arterial occlusive disease24.04.02.0210.000505%Not Available
Bowel movement irregularity07.02.03.0030.000505%Not Available
Gastrointestinal inflammation07.08.03.0070.000325%Not Available
Pulmonary arterial hypertension24.08.03.003; 22.06.01.0020.018954%Not Available
Infusion site haemorrhage24.07.01.058; 12.07.05.018; 08.02.05.0180.000409%Not Available
Cardiovascular insufficiency02.11.01.011; 24.06.03.0050.000120%Not Available
Bronchial secretion retention22.03.02.0080.000120%Not Available
Pharyngeal disorder22.04.05.0070.000120%Not Available
Adverse reaction08.06.01.0180.001264%Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.0080.000469%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.011830%
Upper-airway cough syndrome22.12.03.0360.001817%
Functional gastrointestinal disorder07.11.01.0160.000181%Not Available
Slow speech19.19.02.004; 17.02.08.0160.000120%Not Available
Peripheral venous disease24.04.02.0220.000265%Not Available
Mouth swelling07.05.04.007; 10.01.05.020; 23.04.01.0200.000120%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.002010%
Device related thrombosis24.01.01.027; 08.07.05.0010.000120%Not Available
Myeloproliferative neoplasm16.21.03.006; 01.13.03.0060.000120%Not Available
Frustration tolerance decreased19.04.02.0160.000325%Not Available
Arterial rupture24.03.02.027; 12.01.11.0100.000120%Not Available
Bone cancer16.29.02.002; 15.09.03.0120.000181%Not Available
Brain neoplasm malignant17.20.04.002; 16.30.04.0020.000181%Not Available
Breast cancer recurrent21.05.01.017; 16.10.01.0090.000181%Not Available
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