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)
Blood loss anaemia01.03.02.018; 24.07.01.0880.000301%-
Cardiac dysfunction02.11.01.0040.000361%-
Catheter site injury08.02.02.021; 12.07.02.0210.000120%-
Catheter site pruritus08.02.02.025; 12.07.02.025; 23.03.12.0110.000409%-
Catheter site swelling08.02.02.005; 12.07.02.0050.000409%-
Catheter site warmth08.02.02.031; 12.07.02.0310.000409%-
Cerebral mass effect17.11.01.0190.000120%-
Congestive hepatopathy02.05.04.018; 09.01.06.0270.000301%-
Dependence on respirator22.02.07.0200.000120%-
Disease complication08.01.03.0870.002515%-
Gait inability08.01.02.011; 17.02.05.0690.002635%-
Illness08.01.03.0910.006787%-
Intra-abdominal fluid collection07.07.01.014; 21.07.04.0140.000590%-
Mucosal disorder08.01.06.0290.000265%-
Near death experience17.02.04.023; 19.10.05.0070.000469%-
Periorbital swelling06.08.03.032; 10.01.05.025; 23.04.01.0250.000265%-
Pharyngeal swelling22.04.05.0280.000325%-
Primary biliary cholangitis09.01.04.010; 10.04.09.0040.000325%-
Pulmonary artery aneurysm22.06.03.009; 24.02.02.0080.000120%-
Pulmonary artery occlusion22.06.03.010; 24.04.09.0150.000120%-
Right ventricular dilatation02.04.02.0500.000120%-
Skin weeping23.03.03.1010.000325%-
Swelling of eyelid06.04.04.018; 10.01.05.026; 23.04.01.0260.000409%-
Systemic scleroderma07.11.02.009; 10.04.07.009; 15.06.01.024; 23.03.02.025; 24.03.03.0520.000181%-
Therapeutic product ineffective08.06.01.0570.000385%-
Therapy non-responder08.06.01.0630.013165%-
Treatment noncompliance08.06.01.067; 12.09.02.0060.006655%-
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