Macitentan / Tadalafil Side Effects
Medically reviewed by Drugs.com. Last updated on Jun 10, 2025.
Applies to macitentan / tadalafil: oral tablets.
Important warnings
This medicine can cause some serious health issues
-
Embryofetal Toxicity
- Based on animal data, may cause fetal harm if used during pregnancy.1
- Exclude pregnancy in females of childbearing potential before initiation of therapy and prevent thereafter by using acceptable methods of contraception during and for 1 month following discontinuance of therapy.1
- When pregnancy is detected, discontinue macitentan/tadalafil as soon as possible. 1
Side effects include:
Most common adverse reactions (≥10%): edema/fluid retention, anemia, headache/migraine.
See also:
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:
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
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]
References
1. (2024) "Product Information. Opsynvi (macitentan-tadalafil)." Actelion Pharmaceuticals US Inc
More about macitentan / tadalafil
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- Dosage information
- During pregnancy
- Drug class: agents for pulmonary hypertension
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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.
