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)
Upper respiratory tract congestion22.12.03.0330.000590%-
Catheter site erythema08.02.02.003; 12.07.02.003; 23.03.06.0140.000674%-
Catheter site pain08.02.02.004; 12.07.02.0040.000818%-
Lymphatic disorder01.09.01.003---
Diastolic dysfunction02.04.02.0220.000409%-
Nasal discomfort22.12.03.0120.000469%-
Paranasal sinus discomfort22.12.03.0180.000830%-
Cardiac flutter02.03.02.0120.000505%-
Organ failure08.01.03.0410.000626%-
Secretion discharge08.01.03.0190.001528%-
Infusion site pain08.02.05.014; 12.07.05.0020.000878%-
Infusion site warmth08.02.05.011; 12.07.05.0120.000409%-
Infusion site swelling08.02.05.002; 12.07.05.0030.000409%-
Vascular occlusion24.04.02.0150.000265%-
Cardiac discomfort02.11.04.0010.000469%-
Varices oesophageal07.15.05.001; 09.01.06.009; 24.10.02.0040.000181%-
Faecaloma07.01.03.0040.000325%-
Pulmonary mass22.02.07.0040.000746%-
Vulvovaginal pruritus21.08.02.004; 23.03.12.0090.000614%-
Urine odour abnormal20.02.01.0200.000120%-
Paranasal sinus hypersecretion22.04.06.0040.000469%-
Chronic hepatic failure09.01.03.0090.000120%-
Ocular icterus01.06.04.007; 06.08.03.009; 09.01.01.0070.000999%-
Pulseless electrical activity02.03.04.0200.000782%-
Dysgraphia17.02.03.0060.000469%-
Lung neoplasm malignant16.19.02.001; 22.08.01.0010.002046%-
Thyroid mass05.02.01.0030.000120%-
Venous occlusion24.04.02.0090.000120%-
Intestinal haemorrhage07.12.03.005; 24.07.02.0310.000301%-
Angiopathy24.03.02.007---
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