Cialis (Tadalafil) and Alcohol and Food
Cialis and Alcohol (Ethanol)
Moderate Drug Interaction
Generally Avoid: Additive hypotensive effects may occur when
phosphodiesterase-5 (PDE5) inhibitors are used with alcohol, as both are mild systemic
vasodilators. In clinical pharmacology studies, more subjects administered alcohol at a dose of 0.7 g/kg
(equivalent to approximately 6 ounces of 80-proof vodka in an 80-kg male; consumed within 10 minutes in study
subjects, providing blood alcohol levels of 0.08%)
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 in an 80-kg male), 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.
Administration of avanafil 200 mg with alcohol at a dose of 0.5 g/kg
(equivalent to approximately 3 ounces of 80-proof vodka in a 70-kg male; consumed within 15 minutes in study subjects,
providing blood alcohol levels of 0.057%) resulted in
additional maximum supine systolic/diastolic blood pressure decreases of 3.5/4.5 mm Hg and additional maximum pulse
rate increase of 9.3 bpm compared to alcohol alone, but did not cause orthostatic hypotension or dizziness.
The plasma concentrations of alcohol were not affected. 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.
Alcohol and vardenafil plasma levels were not altered when dosed simultaneously.
Management: Patients taking PDE5 inhibitors should 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.
Moderate Food Interaction
Generally Avoid: Additive hypotensive effects may occur when
phosphodiesterase-5 (PDE5) inhibitors such as tadalafil are used with alcohol, as both are mild systemic vasodilators.
In clinical pharmacology studies, more subjects administered
alcohol at a dose of 0.7 g/kg
(equivalent to approximately 6 ounces of 80-proof vodka in an 80-kg male; consumed within 10 minutes in study subjects,
providing blood alcohol levels of 0.08%) 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 in an 80-kg male), 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.
Generally Avoid: Coadministration with grapefruit juice is likely to increase the plasma concentrations of tadalafil, which is
primarily metabolized by CYP450 3A4.
However, the interaction has not been studied.
The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain
compounds present in grapefruit.
Management: Patients taking tadalafil should 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. It may also be appropriate to avoid consuming large amounts of grapefruit juice.
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