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Opsumit

Generic Name: macitentan (MA si TEN tan)
Brand Names: Opsumit
Opsumit (macitentan) is used to treat pulmonary arterial hypertension. Includes Opsumit side effects, interactions and indications.
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Drug Information:
Opsumit (macitentan) lowers blood pressure in your lungs, helping your heart pump blood more efficiently. Opsumit is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse. Opsumit is available to women only under a special program from a certified pharmacy. You must be registered in the program and understand the risks and benefits of taking this medication. Do not use Opsumit if you are pregnant. Tell your doctor right away if you miss a menstrual period or think you may have become pregnant during treatment. You must use highly effective birth control methods to prevent pregnancy while you are using this medication and for at least 30 days after your treatment ends. Learn more

Opsumit Side Effects

Opsumit Side Effects

Note: This document contains side effect information about macitentan. Some of the dosage forms listed on this page may not apply to the brand name Opsumit.

For the Consumer

Applies to macitentan: oral tablet

Warning

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).

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

  • 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.

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

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

Cardiovascular

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

Common (1% to 10%): Hypotension, flushing

Nervous system

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

Common (1% to 10%): Migraine

Gastrointestinal

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

Genitourinary

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

Frequency not reported: Adverse effects on spermatogenesis affecting male fertility

Dermatologic

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

Postmarketing reports: Angioedema, rash

Musculoskeletal

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

Hepatic

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

Frequency not reported: Hepatotoxicity, liver failure

Metabolic

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

Psychiatric

Common (1% to 10%): Insomnia, depression

Other

Common (1% to 10%): Pyrexia, gynecomastia

Immunologic

Common (1% to 10%): Influenza

Ocular

Common (1% to 10%): Conjunctivitis

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Opsumit