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).
Serious side effects of Macitentan
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
Other side effects of Macitentan
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]
