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 anaemia24.07.01.088; 01.03.02.0180.000301%Not Available
Cardiac dysfunction02.11.01.0040.000361%Not Available
Catheter site injury12.07.02.021; 08.02.02.0210.000120%Not Available
Catheter site pruritus12.07.02.025; 23.03.12.011; 08.02.02.0250.000409%Not Available
Catheter site swelling12.07.02.005; 08.02.02.0050.000409%Not Available
Catheter site warmth12.07.02.031; 08.02.02.0310.000409%Not Available
Cerebral mass effect17.11.01.0190.000120%Not Available
Congestive hepatopathy09.01.06.027; 02.05.04.0180.000301%Not Available
Dependence on respirator22.02.07.0200.000120%Not Available
Disease complication08.01.03.0870.002515%Not Available
Gait inability17.02.05.069; 08.01.02.0110.002635%Not Available
Illness08.01.03.0910.006787%Not Available
Intra-abdominal fluid collection21.07.04.014; 07.07.01.0140.000590%Not Available
Mucosal disorder08.01.06.0290.000265%Not Available
Near death experience17.02.04.023; 19.10.05.0070.000469%Not Available
Periorbital swelling10.01.05.025; 06.08.03.032; 23.04.01.0250.000265%Not Available
Pharyngeal swelling22.04.05.0280.000325%Not Available
Primary biliary cholangitis10.04.09.004; 09.01.04.0100.000325%Not Available
Pulmonary artery aneurysm24.02.02.008; 22.06.03.0090.000120%Not Available
Pulmonary artery occlusion24.04.09.015; 22.06.03.0100.000120%Not Available
Right ventricular dilatation02.04.02.0500.000120%Not Available
Skin weeping23.03.03.1010.000325%Not Available
Swelling of eyelid23.04.01.026; 10.01.05.026; 06.04.04.0180.000409%Not Available
Systemic scleroderma24.03.03.052; 23.03.02.025; 15.06.01.024; 10.04.07.009; 07.11.02.0090.000181%Not Available
Therapeutic product ineffective08.06.01.0570.000385%Not Available
Therapy non-responder08.06.01.0630.013165%Not Available
Treatment noncompliance12.09.02.006; 08.06.01.0670.006655%Not Available
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