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)
Back pain15.03.04.0050.011276%
Bile duct stone09.02.02.0030.000120%Not Available
Biliary colic09.02.01.0010.000181%Not Available
Blindness06.02.10.003; 17.17.01.0030.000987%Not Available
Blood pressure fluctuation24.06.01.0020.001444%Not Available
Bradycardia02.03.02.002--Not Available
Breast cancer stage IV21.05.01.010; 16.10.01.0030.000120%Not Available
Breath odour07.01.06.0020.000409%Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Bursitis12.04.03.010; 15.04.01.0010.000734%Not Available
Calcinosis08.03.04.0020.000265%Not Available
Calcium deficiency14.04.01.013; 05.04.02.0040.000120%Not Available
Cardiac arrest02.03.04.0010.004212%
Cardiac failure02.05.01.0010.011348%
Cardiac failure acute02.05.01.0050.000662%Not Available
Cardiac failure congestive02.05.01.0020.012022%Not Available
Cardiogenic shock24.06.02.006; 02.05.01.0030.000722%Not Available
Cardiomegaly02.04.02.0010.001336%Not Available
Cataract06.06.01.0010.002130%
Cerebral thrombosis24.01.04.003; 17.08.01.0060.000181%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.0070.006137%
Chest discomfort22.12.02.002; 08.01.08.019; 02.02.02.0090.011601%Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.018581%Not Available
Chills15.05.03.016; 08.01.09.0010.006474%
Choking22.12.03.0030.001227%Not Available
Choking sensation22.12.03.004; 19.01.02.0020.000746%Not Available
Cholangiocarcinoma16.07.01.002; 09.04.02.0090.000120%Not Available
Cholecystitis09.03.01.0010.000361%
Cholecystitis acute09.03.01.0030.000301%Not Available
Cholelithiasis09.03.01.0020.001817%Not Available
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