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)
Gastroenteritis07.19.03.001; 11.01.07.0040.001155%Not Available
Gastroenteritis viral11.05.04.005; 07.19.03.0050.002887%Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal infection11.01.07.012; 07.19.02.0050.001155%Not Available
Gastrointestinal necrosis24.04.08.006; 07.15.01.0030.000151%
Gastrointestinal pain07.01.05.0050.000866%
Generalised oedema14.05.06.007; 08.01.07.0040.002598%
Gingival bleeding24.07.02.010; 07.09.07.001--Not Available
Gingival swelling07.05.04.0030.000577%Not Available
Gingivitis11.01.04.013; 07.09.03.0030.000577%
Glaucoma06.03.01.002--
Glioblastoma17.20.02.002; 16.30.02.0020.000151%Not Available
Gout15.01.06.001; 14.09.01.0010.008372%Not Available
Haematemesis24.07.02.011; 07.12.02.0020.003464%Not Available
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Haematocrit decreased13.01.05.0010.003753%Not Available
Haematoma24.07.01.001--
Haematuria24.07.01.047; 20.02.01.006--
Blood urine present13.13.02.0020.002021%Not Available
Haemoglobin decreased13.01.05.0030.022517%Not Available
Haemoglobin increased13.01.05.0040.000866%
Haemoptysis22.02.03.004; 24.07.01.006; 02.01.02.0060.004907%Not Available
Hallucination19.10.02.002--
Hand fracture15.08.03.014; 12.04.01.0140.001155%Not Available
Head discomfort17.02.05.0270.002021%Not Available
Headache17.14.01.0010.071303%
Heart disease congenital03.07.07.001; 02.01.01.009--Not Available
Heart rate abnormal13.14.04.0060.001443%Not Available
Heart rate decreased13.14.04.0010.002887%Not Available
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