Administration of LEVITRA with nitrates and nitric oxide donors is contraindicated. Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, including LEVITRA, may potentiate the hypotensive effects of nitrates

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Success Achieved (SEP2)*
and Maintained (SEP3) in ED "scrollbars=yes, resizable=yes, width=500, height=300,top=100, left=100"[1]

Men taking LEVITRA were twice as likely to maintain an erection long enough for successful intercourse (SEP3) vs placebo over a 12-week trial "scrollbars=yes, resizable=yes, width=500, height=300,top=100, left=100"[1]

 

SEP3 Success Rate (%) LEVITRA 10 mg and 20 mg vs placebo

LEVITRA 20 mg also demonstrated significant improvement in SEP2 and IIEF-EF "scrollbars=yes, resizable=yes, width=400, height=400,top=100, left=100"[1]§

LEVITRA 10 mg also demonstrated significant improvement in SEP2 success rate (75% vs 52% for placebo) and IIEF-EF domain score (21 vs 15 for placebo); (P<0.0001) "scrollbars=yes, resizable=yes, width=400, height=400,top=100, left=100"[1]

* Success = "yes" to Sexual Encounter Profile question 2 (SEP2): "Were you able to insert your penis into your partner's vagina?"
Success = "yes" to Sexual Encounter Profile question 3 (SEP3): "Did your erection last long enough to have successful intercourse?"
Results based on a double-blind, randomized, placebo-controlled, fixed-dose trial in a general ED population of 762 North American men, aged 20 to 83 years (mean age 57 years), receiving placebo or 5-mg, 10-mg, or 20-mg doses of LEVITRA over 12 weeks. "scrollbars=yes, resizable=yes, width=400, height=400,top=100, left=100"[2]
§ International Index of Erectile Function-Erectile Function (IIEF-EF).

LEVITRA: Most Common Side Effects

The most frequently occurring side effects (≥2% with LEVITRA, and more frequent than placebo) include "scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"[1]:

In fixed- and flexible-dose,|| randomized, controlled trials of 5-mg, 10-mg, or 20-mg doses of vardenafil. LEVITRA
n=2203
Placebo
n=1199
Headache 15% 4%
Flushing 11% 1%
Rhinitis 9% 3%
Dyspepsia 4% 1%
Accidental Injury 3% 2%
Sinusitis 3% 1%
Flu Syndrome 3% 2%
Dizziness 2% 1%
Increased Creatine Kinase 2% 1%
Nausea 2% 1%
|| Flexible-dose studies started all patients at LEVITRA 10 mg and allowed decrease in dose to 5 mg or increase in dose to 20 mg based on side effects and efficacy. "scrollbars=yes, resizable=yes, width=400, height=400,top=100, left=100"[1]
All the events listed in this table were deemed to be adverse drug reactions with the exception of accidental injury.

Please see complete Prescribing Information, including Patient Information Leaflet, by clicking the ["Prescribing Information"] navigation above.