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)
Painful respiration22.12.02.0110.000325%Not Available
Palpitations02.11.04.0120.006799%
Pancreatic disorder07.18.02.0010.000241%Not Available
Pancreatitis07.18.01.0010.001324%
Pericardial effusion02.06.01.0020.002648%
Peripheral vascular disorder24.03.01.0030.000241%Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pituitary tumour16.24.01.003; 05.03.05.0020.000120%Not Available
Pleural effusion22.05.02.0020.004441%
Pleurisy22.05.01.0010.000385%Not Available
Pleuritic pain22.12.01.0070.000445%
Pneumonitis22.01.01.0060.001564%
Pneumothorax22.05.02.0030.001143%
Pollakiuria20.02.02.0070.001564%
Polyuria20.02.03.0020.001011%Not Available
Portal hypertension24.08.06.001; 09.01.06.0060.000120%
Presyncope24.06.02.010; 17.02.05.009; 02.11.04.0130.001685%
Productive cough22.02.03.0050.008183%
Prostatic disorder21.04.01.0010.000181%Not Available
Pruritus23.03.12.001--
Pulmonary congestion24.03.08.001; 22.01.03.002; 02.05.02.0020.002527%Not Available
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pulmonary fibrosis22.01.02.0060.002190%
Pulmonary haemorrhage22.12.01.009; 24.07.01.0160.000301%
Pulmonary hypertension24.08.03.002; 22.06.01.0010.012371%
Pulmonary oedema22.01.03.003; 02.05.02.0030.011023%
Pulmonary thrombosis24.01.06.002; 22.06.02.0030.001673%Not Available
Pulmonary veno-occlusive disease24.01.06.008; 22.06.03.0030.000361%Not Available
Pyrexia08.05.02.0030.013671%
Rales22.12.01.0110.000181%Not Available
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