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)
Dyspnoea02.11.05.003; 22.02.01.0040.138417%
Dyspnoea at rest02.11.05.004; 22.02.01.0250.000361%Not Available
Dyspnoea exertional02.11.05.005; 22.02.01.0050.013394%Not Available
Ear disorder04.03.01.0010.000325%Not Available
Ear pain04.03.01.0030.001035%
Electrolyte imbalance14.05.01.0020.000361%Not Available
Emphysema22.01.02.0020.000361%Not Available
Enterocolitis07.08.03.0030.000325%
Epistaxis24.07.01.005; 22.04.03.0010.009194%
Eructation07.01.02.0030.000325%
Eye disorder06.08.03.0010.001408%Not Available
Eye swelling06.08.03.0030.002323%Not Available
Facial pain08.01.08.0120.000469%
Facial paralysis17.04.03.0080.000445%Not Available
Faeces discoloured07.01.03.0020.001781%Not Available
Failure to thrive18.04.01.003; 14.03.02.008; 19.07.05.0010.000181%Not Available
Fatigue08.01.01.0020.044454%
Feeling abnormal08.01.09.0140.013394%Not Available
Feeling cold08.01.09.0080.001564%Not Available
Feeling of despair19.15.02.0060.000120%Not Available
Fibrosis08.03.01.0010.000120%Not Available
Fistula15.03.02.0010.000181%Not Available
Flank pain15.03.04.003; 20.02.03.006; 08.01.08.0070.000710%
Fluid retention20.01.02.003; 14.05.06.0020.040904%Not Available
Flushing24.03.01.002; 23.06.05.003; 08.01.03.0250.007329%
Food poisoning12.03.01.024; 11.07.02.001; 07.11.01.0070.000590%Not Available
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.0160.007473%
Gallbladder disorder09.03.02.0010.001011%Not Available
Gastric dilatation07.02.02.0020.000325%Not Available
Gastric haemorrhage24.07.02.007; 07.12.01.0010.000903%
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