Macitentan / Tadalafil Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 10, 2025.

Applies to macitentan / tadalafil: oral tablets.

Important warnings This medicine can cause some serious health issues

REMS:

FDA approved a REMS for macitentan-containing products to ensure that the benefits outweigh the risks.¹ The REMS consists of the following: elements to assure safe use and implementation system.¹ See the FDA REMS page ([Web]).

Side effects include:

Most common adverse reactions (≥10%): edema/fluid retention, anemia, headache/migraine.

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.

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