Opsumit Side Effects

Generic name: macitentan

Medically reviewed by Drugs.com. Last updated on Jul 28, 2024.

Note: This document provides detailed information about Opsumit Side Effects associated with macitentan. Some dosage forms listed on this page may not apply specifically to the brand name Opsumit.

Applies to macitentan: oral tablet.

Important warnings This medicine can cause some serious health issues

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 Opsumit

Along with its needed effects, macitentan (the active ingredient contained in Opsumit) 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 side effects

• 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 side effects

• 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

Other side effects of Opsumit

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 side effects

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

For healthcare professionals

Applies to macitentan: oral tablet.

General adverse events

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]

Further information

Opsumit side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer