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%Not Available
Catheter site erythema23.03.06.014; 12.07.02.003; 08.02.02.0030.000674%Not Available
Catheter site pain12.07.02.004; 08.02.02.0040.000818%Not Available
Lymphatic disorder01.09.01.003--Not Available
Diastolic dysfunction02.04.02.0220.000409%Not Available
Nasal discomfort22.12.03.0120.000469%Not Available
Paranasal sinus discomfort22.12.03.0180.000830%Not Available
Cardiac flutter02.03.02.0120.000505%Not Available
Organ failure08.01.03.0410.000626%Not Available
Secretion discharge08.01.03.0190.001528%Not Available
Infusion site pain12.07.05.002; 08.02.05.0140.000878%Not Available
Infusion site warmth12.07.05.012; 08.02.05.0110.000409%Not Available
Infusion site swelling12.07.05.003; 08.02.05.0020.000409%Not Available
Vascular occlusion24.04.02.0150.000265%Not Available
Cardiac discomfort02.11.04.0010.000469%Not Available
Varices oesophageal24.10.02.004; 09.01.06.009; 07.15.05.0010.000181%Not Available
Faecaloma07.01.03.0040.000325%Not Available
Pulmonary mass22.02.07.0040.000746%Not Available
Vulvovaginal pruritus21.08.02.004; 23.03.12.0090.000614%Not Available
Urine odour abnormal20.02.01.0200.000120%Not Available
Paranasal sinus hypersecretion22.04.06.0040.000469%Not Available
Chronic hepatic failure09.01.03.0090.000120%Not Available
Ocular icterus06.08.03.009; 01.06.04.007; 09.01.01.0070.000999%Not Available
Pulseless electrical activity02.03.04.0200.000782%Not Available
Dysgraphia17.02.03.0060.000469%Not Available
Lung neoplasm malignant16.19.02.001; 22.08.01.0010.002046%Not Available
Thyroid mass05.02.01.0030.000120%Not Available
Venous occlusion24.04.02.0090.000120%Not Available
Intestinal haemorrhage07.12.03.005; 24.07.02.0310.000301%Not Available
Angiopathy24.03.02.007--Not Available
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