Opsumit Side Effects
Generic name: macitentan
Medically reviewed by Drugs.com. Last updated on Dec 18, 2020.
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
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).
Side effects requiring immediate medical attention
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:
- 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
- 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
Side effects not requiring immediate medical attention
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
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
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%)
Very common (10% or more): Headache (13.6%)
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%): Cholelithiasis, elevated aminotransferases
Frequency not reported: Hepatotoxicity, liver failure[Ref]
Common (1% to 10%): Pyrexia, gynecomastia[Ref]
More about Opsumit (macitentan)
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- 7 Reviews
- Drug class: agents for pulmonary hypertension
- FDA Approval History
Related treatment guides
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. "Product Information. Opsumit (macitentan)." Actelion Pharmaceuticals US Inc, South San Francisco, CA.
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.