Interactions between tadalafil and Alcohol (ethanol)
ethanol and tadalafil (Moderate Drug-Drug)
GENERALLY AVOID: Alcohol may potentiate the hypotensive effects of phosphodiesterase-5 (PDE5) inhibitors, and vice versa, as both are mild systemic vasodilators. In clinical pharmacology studies using tadalafil, more subjects administered alcohol at a dose of 0.7 g/kg (consumed within 10 minutes; equivalent to approximately 6 ounces of 80-proof vodka in an 80-kg male) in combination with tadalafil 10 or 20 mg single doses had clinically significant decreases in blood pressure than with alcohol alone. There were reports of postural dizziness, and orthostatic hypotension was observed in some. When tadalafil 20 mg was administered with alcohol at a lower dose of 0.6 g/kg (equivalent to approximately 4 ounces of 80-proof vodka), orthostatic hypotension was not observed, dizziness occurred with similar frequency relative to alcohol alone, and the hypotensive effects of alcohol were not potentiated. Neither tadalafil nor alcohol affected the plasma concentrations of the other. Sildenafil 50 mg and vardenafil 20 mg reportedly did not potentiate the hypotensive effect of alcohol in healthy volunteers with mean maximum blood alcohol levels of 0.08% and in healthy volunteers administered alcohol at a dose of 0.5 g/kg, respectively.
MANAGEMENT: Based on known pharmacology of the drugs, patients taking PDE5 inhibitors should probably avoid consuming large amounts of alcohol, which may increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.
