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)
Adverse event08.06.01.0100.014537%Not Available
Ventricular failure02.05.01.0070.000120%Not Available
Appetite disorder19.09.01.002; 14.03.01.0040.000469%Not Available
Arterial disorder24.03.02.0200.000445%Not Available
Bladder disorder20.03.01.0020.000794%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000241%Not Available
Cardiac disorder02.11.01.0030.010939%Not Available
Connective tissue disorder10.04.04.026; 15.06.01.0060.000181%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Inflammation10.02.01.089; 08.01.05.0070.002660%Not Available
Limb discomfort15.03.04.0140.001095%Not Available
Intra-abdominal haemorrhage12.01.17.011; 24.07.02.035; 07.12.02.0080.000120%
Ischaemia24.04.02.0040.000325%Not Available
Metastatic neoplasm16.16.01.0070.000241%Not Available
Oesophageal disorder07.11.02.0010.000120%Not Available
Spondylitis15.01.09.0020.000265%Not Available
Vaginal disorder21.08.01.0050.000409%Not Available
Cardiac valve disease02.07.02.0010.000782%Not Available
Pulmonary vascular disorder24.03.08.003; 22.06.03.0020.000120%Not Available
Intervertebral disc disorder15.10.01.0030.000120%Not Available
Lip and/or oral cavity cancer16.13.07.001; 07.21.07.0010.000120%Not Available
Inner ear disorder04.04.02.0020.000409%Not Available
Polyp08.01.06.010; 16.02.02.0050.000481%Not Available
Ulcer haemorrhage24.07.01.040; 08.03.06.0030.000542%Not Available
Blood disorder01.05.01.0040.000385%Not Available
Immunodeficiency10.03.02.0020.000241%Not Available
Autoimmune disorder10.04.04.0030.000385%
Disease progression08.01.03.0380.010085%
Obstructive airways disorder22.03.01.0110.000120%Not Available
Lung neoplasm22.08.01.006; 16.19.04.0010.000120%Not Available
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