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 patients with pulmonary arterial hypertension.
Marketing Status Prescription
ATC Code C02KX04
DrugBank ID DB08932
KEGG ID D10135
MeSH ID C533860
PubChem ID 16004692
TTD Drug ID D0S7JH
NDC Product Code 11722-058; 65015-872; 69766-006; 68225-070; 82245-0117; 69037-0030; 66215-501; 76397-014; 46708-893; 59651-122
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
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.015588%
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abdominal rigidity07.01.05.0110.000577%Not Available
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Abnormal faeces07.01.03.0010.000577%Not Available
Abnormal sensation in eye06.01.01.0010.000577%Not Available
Abscess11.01.08.0010.001155%Not Available
Acidosis14.01.03.0020.001155%
Acne23.02.01.001--Not Available
Acute myeloid leukaemia01.10.05.001; 16.01.05.001--Not Available
Acute myocardial infarction02.02.02.001; 24.04.04.001--Not Available
Acute respiratory distress syndrome22.01.03.001--
Acute respiratory failure14.01.04.004; 22.02.06.0010.002636%Not Available
Ageusia07.14.03.003; 17.02.07.001--Not Available
Agitation17.02.05.012; 19.06.02.001--
Alanine aminotransferase abnormal13.03.01.0010.000577%Not Available
Alanine aminotransferase increased13.03.01.0030.009526%
Alcohol abuse19.07.02.0070.000151%Not Available
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.003--Not Available
Amenorrhoea05.05.01.002; 21.01.02.001--
Ammonia increased13.03.01.0230.001155%Not Available
Amnesia17.03.02.001; 19.20.01.001--
Anaemia01.03.02.0010.047054%
Aneurysm24.02.01.0010.000226%Not Available
Anger19.04.02.001--Not Available
Angioedema10.01.05.009; 23.04.01.001--Not Available
Ankle fracture12.04.01.005; 15.08.03.0050.004330%
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