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Macitentan Side Effects

For the Consumer

Applies to macitentan: oral tablet

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
  • Decrease in the amount of urine
  • noisy, rattling breathing
  • pale skin
  • swelling of the fingers, hands, feet, or lower legs
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weight gain
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

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
  • Chills or fever
  • cough
  • sore throat
  • stuffy or runny nose

For Healthcare Professionals

Applies to macitentan: oral tablet

General

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

Respiratory

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]

Hematologic

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]

Cardiovascular

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]

Gastrointestinal

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

Genitourinary

Common (1% to 10%): Urinary tract infection, metrorrhagia, menorrhagia, ovarian cyst
Frequency not reported: Adverse effects on spermatogenesis affecting male fertility[Ref]

Dermatologic

Common (1% to 10%): Skin ulcer, pruritus, eczema, urticaria
Postmarketing reports: Angioedema, rash[Ref]

Musculoskeletal

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

Hepatic

Common (1% to 10%): Cholelithiasis, elevated aminotransferases
Frequency not reported: Hepatotoxicity, liver failure[Ref]

Metabolic

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

Psychiatric

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

Other

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

Immunologic

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

Ocular

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

References

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.

Some side effects of macitentan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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. Drugs.com 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.

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