Macitentan / Tadalafil Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 10, 2024.

Applies to macitentan / tadalafil: oral tablet.

Important warnings This medicine can cause some serious health issues

Do not use if you are pregnant.

Use effective birth control while using macitentan and tadalafil and for at least 30 days after your last dose.

Tell your doctor if you become pregnant.

Some drugs can cause unwanted or dangerous effects when used with this medicine.

Tell your doctor about all your other medicines.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• severe vision problems, including sudden vision loss;

• ringing in your ears or sudden hearing loss;

• a light-headed feeling, like you might pass out;

• a painful erection or one that lasts longer than 4 hours;

• low red blood cells (anemia)--pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet;

• symptoms of liver problems--loss of appetite, pain or swelling in your stomach, swelling in your legs, easy bleeding, drowsiness, confusion, or jaundice (yellowing of the skin or eyes);

• fluid retention--shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection); or

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Common side effects may include:

• fluid retention;

• anemia; or

• headache, migraine headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to macitentan / tadalafil: oral tablet.

General adverse events

The most commonly reported side effects included edema/fluid retention, anemia, and headache/migraine.^[Ref]

Cardiovascular

• Common (1% to 10%): Flushing, hypotension, palpitations

Macitentan:

• Postmarketing reports: Symptomatic hypotension

Tadalafil:

• Postmarketing reports: Cardiovascular events, myocardial infarction, sudden cardiac death, tachycardia^[Ref]

Dermatologic

Macitentan:

• Postmarketing reports: Angioedema, pruritus, rash

Tadalafil:

• Postmarketing reports: Exfoliative dermatitis, Stevens-Johnson syndrome, urticaria^[Ref]

Gastrointestinal

• Common (1% to 10%): Abdominal pain, nausea, vomiting

Tadalafil:

• Frequency not reported: Gastroesophageal reflux disease^[Ref]

Genitourinary

• Common (1% to 10%): Increased uterine bleeding
• Frequency not reported: Prolonged erection

Macitentan:

• Frequency not reported: Urinary tract infection

Tadalafil:

• Frequency not reported: Prolonged erection
• Postmarketing reports: Priapism^[Ref]

Hematologic

• Very common (10% or more): Anemia (up to 19%)
• Common (1% to 10%): Decreased hemoglobin
• Frequency not reported: Decreased hematocrit^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity

Macitentan:

• Postmarketing reports: Hypersensitivity reactions

Tadalafil:

• Postmarketing reports: Hypersensitivity reactions^[Ref]

Metabolic

• Very common (10% or more): Edema/fluid retention (up to 21%)^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, extremity pain, myalgia^[Ref]

Ocular

• Frequency not reported: Visual loss

Tadalafil:

• Frequency not reported: Blurred vision
• Postmarketing reports: Non-arteritic anterior ischemic optic neuropathy (NAION), retinal vascular occlusion, visual field defect^[Ref]

Other

• Common (1% to 10%): Peripheral edema/peripheral swelling
• Frequency not reported: Hearing loss

Tadalafil:

• Frequency not reported: Chest pain, facial swelling
• Postmarketing reports: Sudden hearing loss^[Ref]

Respiratory

• Common (1% to 10%): Epistaxis, nasopharyngitis

Macitentan:

• Frequency not reported: Bronchitis, influenza, pharyngitis

Tadalafil:

• Frequency not reported: Lower respiratory tract infection^[Ref]

Hepatic

• Common (1% to 10%): Hepatotoxicity

Macitentan:

• Frequency not reported: Increased transaminases
• Postmarketing reports: Liver injury

Endothelin receptor antagonists:

• Frequency not reported: Elevated aminotransferases, hepatotoxicity, liver failure^[Ref]

Elevated aminotransferases at least 3 times the upper limit of normal (3 x ULN) and at least 8 x ULN have been reported in up to 3.4% and 1.1% of patients, respectively.^[Ref]

Nervous system

• Very common (10% or more): Headache/migraine (up to 18%)

Tadalafil:

• Frequency not reported: Tinnitus
• Postmarketing reports: Cerebrovascular events, seizure, stroke, transient amnesia^[Ref]

Further information

Macitentan/tadalafil 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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer