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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Salivary gland calculus07.06.02.0030.000866%Not Available
Concomitant disease progression08.01.03.0640.000452%Not Available
Terminal state08.01.03.0790.001958%Not Available
Lumbar vertebral fracture15.08.05.007; 12.04.04.0070.000577%Not Available
Oesophagogastroduodenoscopy13.05.05.0060.000577%Not Available
Brain natriuretic peptide increased13.02.04.0110.002021%Not Available
Cardiac infection11.01.16.003; 02.01.05.0020.000226%Not Available
Clostridium difficile infection11.02.02.0090.002887%Not Available
Diabetic ulcer24.04.03.020; 23.07.03.014; 14.07.06.004; 05.07.06.0040.000577%Not Available
Gastric infection11.01.07.008; 07.19.03.0030.001732%Not Available
Right ventricular dysfunction02.04.02.0330.000866%
Ovarian mass21.11.02.0170.000577%Not Available
General physical condition abnormal13.15.01.0400.002021%Not Available
Oxygen consumption13.02.01.0250.000577%Not Available
Oxygen consumption increased13.02.01.0270.006640%Not Available
Escherichia infection11.02.10.0040.000151%Not Available
Foot deformity15.10.03.0050.000577%Not Available
Rhinovirus infection11.05.26.0010.000866%Not Available
Paracentesis13.18.01.0090.001443%Not Available
Foaming at mouth17.02.05.056; 08.01.03.070; 07.05.05.0190.000577%Not Available
Vital functions abnormal13.15.01.0150.000577%Not Available
Multimorbidity08.01.03.0750.000226%Not Available
Metapneumovirus infection22.07.05.007; 11.05.04.0270.000577%Not Available
Portopulmonary hypertension24.08.03.006; 22.06.01.006; 09.01.06.0260.000226%Not Available
Heart valve incompetence02.07.02.0030.001443%Not Available
Brain midline shift17.11.01.0110.000577%Not Available
Ventilation perfusion mismatch22.02.07.0180.000577%Not Available
Staphylococcus test positive13.08.01.0150.000577%Not Available
Unevaluable investigation13.18.01.0140.000577%Not Available
Walking distance test abnormal13.15.01.0480.001155%Not Available
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