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Macitentan Side Effects

Medically reviewed by Last updated on Oct 14, 2023.

Applies to macitentan: oral tablet.


Oral route (Tablet)

Do not administer macitentan to a pregnant female because it may cause fetal harm. Exclude pregnancy before treatment initiation, monthly during treatment, and one month after treatment discontinuation in females of reproductive potential. Use acceptable contraception to prevent pregnancy during treatment and for one month after stopping treatment. Macitentan is only available for female patients through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).

Serious side effects of Macitentan

Along with its needed effects, macitentan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking macitentan:

More common

Less common

Other side effects of Macitentan

Some side effects of macitentan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to macitentan: oral tablet.


The most common adverse reactions are peripheral edema, upper respiratory tract infection, nasopharyngitis, headache, anemia, and bronchitis.[Ref]


Very common (10% or more): Upper respiratory tract infection (15.3%), nasopharyngitis (14%), bronchitis (11.6%)

Common (1% to 10%): Viral respiratory tract infection, pharyngitis, sinusitis, rhinitis, lower respiratory tract infection, tracheitis, tonsillitis, rhinorrhea, productive cough, bronchial hyperreactivity

Frequency not reported: Pulmonary edema

Postmarketing reports: Nasal congestion[Ref]


Very common (10% or more): Anemia (13.2%)

Common (1% to 10%): Thrombocytopenia, hemoglobin decreased, hematocrit decreased

Frequency not reported: Decrease in mean leukocyte count, decrease in mean platelet count[Ref]


Very common (10% or more): Peripheral edema (18.2%)

Common (1% to 10%): Hypotension, flushing[Ref]

Nervous system

Very common (10% or more): Headache (13.6%)

Common (1% to 10%): Migraine[Ref]


Common (1% to 10%): Diarrhea, upper abdominal pain, gastroenteritis, abdominal pain, irritable bowel syndrome, hemorrhoids, viral gastroenteritis[Ref]


Common (1% to 10%): Urinary tract infection, metrorrhagia, menorrhagia, ovarian cyst

Frequency not reported: Adverse effects on spermatogenesis affecting male fertility[Ref]


Common (1% to 10%): Skin ulcer, pruritus, eczema, urticaria

Postmarketing reports: Angioedema, rash[Ref]


Common (1% to 10%): Arthralgia, myalgia, systemic sclerosis, costochondritis[Ref]


Common (1% to 10%): Cholelithiasis, elevated aminotransferases

Frequency not reported: Hepatotoxicity, liver failure[Ref]


Common (1% to 10%): Hypokalemia, blood urea increased[Ref]


Common (1% to 10%): Insomnia, depression[Ref]


Common (1% to 10%): Pyrexia, gynecomastia[Ref]


Common (1% to 10%): Influenza[Ref]


Common (1% to 10%): Conjunctivitis[Ref]


1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Opsumit (macitentan). Actelion Pharmaceuticals US Inc. 2013.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.