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)
Cardiac failure chronic02.05.01.0090.000181%Not Available
Chronic respiratory failure22.02.06.005; 14.01.04.0050.000566%Not Available
Concomitant disease aggravated08.01.03.0630.001528%Not Available
CREST syndrome10.04.07.003; 07.11.02.003; 24.03.03.009; 23.03.02.013; 15.06.01.0100.000181%Not Available
Incarcerated hernia08.01.04.0040.000120%Not Available
Pancreatic cyst16.05.01.005; 07.18.03.0030.000265%Not Available
Salivary gland calculus07.06.02.0030.000325%Not Available
Concomitant disease progression08.01.03.0640.000361%Not Available
Terminal state08.01.03.0790.001865%Not Available
Right ventricular dysfunction02.04.02.0330.000181%
Ovarian mass21.11.02.0170.000120%Not Available
Diabetic foot24.04.03.015; 23.07.03.008; 17.09.04.006; 14.07.06.001; 05.07.06.0010.000301%Not Available
Foaming at mouth07.05.05.019; 17.02.05.056; 08.01.03.0700.000120%Not Available
Acute left ventricular failure02.05.02.0050.000120%Not Available
Acute right ventricular failure02.05.03.0030.000120%Not Available
Multimorbidity08.01.03.0750.000181%Not Available
Portopulmonary hypertension24.08.03.006; 22.06.01.006; 09.01.06.0260.000241%Not Available
Right atrial dilatation02.04.02.0320.000120%Not Available
Heart valve incompetence02.07.02.0030.000542%Not Available
Cerebral amyloid angiopathy24.03.05.010; 17.08.02.017; 10.02.05.0030.000265%Not Available
Ventilation perfusion mismatch22.02.07.0180.000325%Not Available
Sensitivity to weather change08.01.03.0770.000915%Not Available
Large intestinal stenosis07.13.03.0040.000120%
Gastrointestinal polyp haemorrhage16.05.01.008; 24.07.02.046; 07.20.01.0110.000241%Not Available
Pulmonary pain22.12.01.0100.000830%Not Available
Internal haemorrhage24.07.01.0720.001865%Not Available
Lower respiratory tract congestion22.12.01.0040.000181%Not Available
Critical illness08.01.03.0650.000361%Not Available
End stage renal disease20.01.03.0190.000686%Not Available
Biliary obstruction09.02.02.0050.000181%Not Available
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