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 patients with pulmonary arterial hypertension.
Marketing Status Prescription
ATC Code C02KX04
DrugBank ID DB08932
KEGG ID D10135
MeSH ID C533860
PubChem ID 16004692
TTD Drug ID D0S7JH
NDC Product Code 11722-058; 65015-872; 69766-006; 68225-070; 82245-0117; 69037-0030; 66215-501; 76397-014; 46708-893; 59651-122
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Dysphagia07.01.06.003--
Dysphonia17.02.08.004; 22.02.05.005; 19.19.03.0020.005196%
Dyspnoea22.02.01.004; 02.01.03.0020.265869%
Dyspnoea at rest22.02.01.025; 02.01.03.0070.000866%Not Available
Dyspnoea exertional22.02.01.005; 02.01.03.0030.025981%Not Available
Dysuria20.02.02.002--
Ear disorder04.03.01.0010.000577%Not Available
Ear infection11.01.05.001; 04.03.01.0060.004330%Not Available
Ear pain04.03.01.0030.001443%
Eating disorder14.03.01.008; 19.09.01.008--Not Available
Electrocardiogram abnormal13.14.05.001--Not Available
Electrolyte imbalance14.05.01.0020.001732%Not Available
Emphysema22.01.02.0020.000151%Not Available
Endocarditis02.09.01.001; 11.01.16.0010.000301%
Epilepsy17.12.03.002--Not Available
Epistaxis24.07.01.005; 22.04.03.0010.014722%
Erythema23.03.06.001--Not Available
Eye discharge06.04.05.0010.000577%Not Available
Eye disorder06.08.03.001--Not Available
Eye haemorrhage06.07.02.001; 24.07.05.0020.001155%Not Available
Eye infection11.01.06.001; 06.04.05.0070.001443%
Eye irritation06.04.05.003--Not Available
Eye pain06.08.03.002--
Eye swelling06.08.03.0030.003464%Not Available
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.004--Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Facial bones fracture15.08.04.001; 12.04.05.0020.000577%Not Available
Facial pain08.01.08.0120.000577%
Facial paralysis17.04.03.0080.001443%Not Available
Faeces discoloured07.01.03.0020.003175%Not Available
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