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Macitentan Side Effects

For the Consumer

Applies to macitentan: oral tablet

In addition to its needed effects, some unwanted effects may be caused by macitentan. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking macitentan:

More common:
  • Pale skin
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common:
  • Abdominal or stomach pain or tenderness
  • clay colored stools
  • dark urine
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • lower back or side pain
  • muscle aches and pains
  • difficulty with breathing
  • tightness in the chest
  • yellow eyes or skin

Minor Side Effects

Some of the side effects that can occur with macitentan may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Chills or fever
  • cough
  • sore throat
  • stuffy or runny nose

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." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Opsumit (macitentan)." Actelion Pharmaceuticals US Inc, South San Francisco, CA.

Not all side effects for macitentan may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.