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)
Mobility decreased08.01.03.030; 15.03.05.023; 17.02.05.0180.000987%-
Fibromyalgia15.05.02.0020.000385%-
Infusion site erythema08.02.05.008; 12.07.05.009; 23.03.06.0160.001227%-
Energy increased08.01.03.0170.000409%-
Deafness unilateral04.02.01.0110.000120%-
Underweight14.03.02.0170.000120%-
Hypoacusis04.02.01.0060.009086%
Seasonal allergy06.04.01.013; 10.01.04.001; 22.04.04.0080.004019%-
Peripheral swelling02.05.04.015; 08.01.03.0530.031963%-
Localised oedema02.05.04.006; 08.01.07.011; 14.05.06.0090.000794%
Carotid artery occlusion17.08.01.012; 24.04.06.0080.000181%-
Weight fluctuation14.03.02.0020.000265%-
Nocturnal dyspnoea02.11.05.009; 22.02.01.0190.000181%-
Sudden cardiac death02.03.04.016; 08.04.01.0080.000181%-
General physical health deterioration08.01.03.0180.005271%-
Muscle fatigue15.05.03.0060.000265%-
Left ventricular dysfunction02.04.02.0110.000301%
Breast discomfort21.05.05.007---
Dysstasia08.01.03.089; 15.03.05.011; 17.02.02.0120.000626%-
Intervertebral disc protrusion15.10.01.0040.000650%-
Musculoskeletal chest pain15.03.04.012; 22.09.01.0010.000445%
Lower gastrointestinal haemorrhage07.12.03.011; 24.07.02.0300.000421%
Cardiopulmonary failure02.05.01.004; 22.02.06.0040.000361%-
Catheter site haemorrhage08.02.02.002; 12.07.02.002; 24.07.01.0030.000530%-
Exercise tolerance decreased08.01.03.0360.000686%-
Prostatomegaly21.04.01.0020.000265%-
Gastrointestinal hypomotility07.02.02.0050.000120%-
Ear congestion04.03.01.0100.001408%-
Ear discomfort04.03.01.0050.001408%-
Respiratory tract congestion22.02.07.0030.003406%-
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