Substance / Medication

Macitentan

Overview

Active Ingredient
macitentan
RxNorm CUI
1442132
Labeler: Actelion Pharmaceuticals US, Inc.Updated: 2025-04-11T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

Contraindications (4.1) Warnings and Precautions (5.1) Use in Specific Populations (8.1) [see,,]. OPSUMIT is contraindicated for use during pregnancy because it may cause fetal harm based on animal data Dosage and Administration (2.2) Use in Specific Populations (8.3) [see,]. Warnings and Precaution

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Clinical Trials

3 trials linked to this intervention

3
Total Trials
0
Recruiting
3
With Results

Research Evidence

Published studies and systematic reviews

Sort:
Long-term safety of macitentan in patients with pulmonary hypertension: A meta-analysis of randomised controlled trials.
Wang Guizuo, Qin Jinlv, Han Dong · Eur J Clin Invest · 2023
PMID: 37392063Meta-Analysis
Efficacy and safety of macitentan for pulmonary hypertension: A meta-analysis.
Du Dan, Yuan Ya-Dong · Clin Respir J · 2023
PMID: 37427711Meta-AnalysisFull text (PMC)
Efficacy and safety of macitentan in Fontan-palliated patients: 52-week randomized, placebo-controlled RUBATO Phase 3 trial and open-label extension.
Clift Paul, Berger Felix, Sondergaard Lars et al. · J Thorac Cardiovasc Surg · 2025
PMID: 39216715RCT
Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension.
Grünig Ekkehard, Jansa Pavel, Fan Fenling et al. · J Am Coll Cardiol · 2024
PMID: 38267108RCT

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Macitentan (substance)
SNOMED CT
710283008
UMLS CUI
C2606556
RxNorm CUI
1442132
Labeler
Actelion Pharmaceuticals US, Inc.

Clinical Data

This intervention maps to 1 entities in the Healos knowledge graph.

1
Conditions
0
Biomarkers
0
Specialists
0
Symptoms
3
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.