Opsumit Side Effects

Generic name: macitentan

Medically reviewed by Drugs.com. Last updated on Jul 30, 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.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can cause very serious birth defects. Use 2 forms of effective birth control to keep from getting pregnant while you are using this medicine (even if the medicine is temporarily stopped), and for at least 1 month after you stop taking the medicine. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap. If a woman has had a tubal ligation or has an IUD, she does not need to use a second form of birth control. If you think you have become pregnant while using this medicine, tell your doctor right away.

If you are a woman who can get pregnant, you must have a negative pregnancy test before you will be allowed to take this medicine. You will also be required to have a pregnancy test every month during your treatment. If you miss a period while you are using this medicine, tell your doctor right away.

Check with your doctor right away if you start to have nausea, vomiting, fever, dark-colored urine or pale stools, a loss of appetite, pain in your upper stomach, or yellow eyes or skin. These could be signs of liver injury.

This medicine may cause fluid retention in some patients. Tell your doctor right away if you have bloating or swelling of the face, arms, hands, lower legs, or feet, or rapid weight gain after using this medicine.

Pulmonary edema may occur with this medicine. Check with your doctor right away if you have chest pain, difficult, fast, or noisy breathing, blue lips and fingernails, pale skin, increased sweating, coughing that sometimes produces a pink frothy sputum, or trouble breathing.

This medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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]

See also:

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