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)
Hypotension24.06.03.0020.020266%
Hypovolaemia14.05.05.0020.000975%Not Available
Hypoxia22.02.02.0030.007401%
Idiopathic pulmonary fibrosis22.01.02.014; 10.02.01.0340.000361%Not Available
Impaired gastric emptying07.02.02.0040.000241%
Incoherent17.02.08.002; 19.10.03.0060.000505%Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Influenza like illness08.01.03.0100.007882%
Ingrowing nail23.02.05.0110.000409%Not Available
Inguinal hernia07.16.02.0010.000120%Not Available
Interstitial lung disease22.01.02.003; 10.02.01.0330.002130%Not Available
Intestinal obstruction07.13.01.0020.001203%Not Available
Intestinal perforation07.04.06.0020.000301%Not Available
Intracranial aneurysm24.02.04.001; 17.08.06.0010.000181%Not Available
Iron deficiency14.13.02.0020.000975%Not Available
Iron deficiency anaemia01.03.01.002; 14.13.02.0010.000951%Not Available
Joint effusion15.01.02.0050.000120%
Joint swelling15.01.02.0040.007931%Not Available
Lacrimation increased06.08.02.0040.002323%
Left ventricular failure02.05.02.0010.001227%Not Available
Leukaemia16.01.03.001; 01.10.03.0010.000542%
Lip pain07.05.05.0290.000265%
Listless08.01.01.012; 19.04.04.0030.000265%Not Available
Liver disorder09.01.08.0010.002816%Not Available
Loss of consciousness17.02.04.0040.004741%Not Available
Lung disorder22.02.07.0010.007269%Not Available
Lung infiltration22.01.02.0040.000481%Not Available
Macular degeneration06.09.03.0010.000505%Not Available
Malaise08.01.01.0030.047222%
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