When LEVITRA was taken as recommended in placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1).

Table 1: Adverse Reactions Reported By ≥2% of Patients Treated with LEVITRA and More Frequent on Drug than Placebo in Fixed and Flexible* Dose Randomized, Controlled Trials of 5 mg, 10 mg, or 20 mg Vardenafil 

Adverse Reaction

Percentage of Patients Reporting Reactions

Placebo 

N = 1199

 

LEVITRA 

N = 2203

* 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. † All the events listed in the above table were deemed to be adverse drug reactions with the exception of accidental injury.  

Headache

 

4%

 

15%

 

 

Flushing

 

1%

 

11%

 

 

Rhinitis

 

3%

 

9%

 

Dyspepsia

 

1%

 

4%

 

Accidental Injury† 

 

2%

 

3%

 

 

Sinusitis

 

1%

 

3%

Flu Syndrome

 

2%

 

3%

 

Dizziness

 

1%

 

2%

 

Increased Creatine Kinase

 

1%

 

2%

Nausea

 

1%

 

2%

Back pain was reported in 2.0% of patients treated with LEVITRA and 1.7% of patients on placebo. 

 

Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (headache, flushing, dyspepsia, nausea, and rhinitis) over the 5 mg, 10 mg, and 20 mg doses of LEVITRA. 

 

All Vardenafil Studies: LEVITRA film-coated tablets and vardenafil orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18–89 years; 70% White, 5% Black, 13% Asian, 4% Hispanic and 8% Other) during controlled and uncontrolled clinical trials worldwide. The number of patients treated for 6 months or longer was 3357, and 1350 patients were treated for at least 1 year. 

 

In the placebo-controlled clinical trials for LEVITRA film-coated tablets and vardenafil orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo. 

 

The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of LEVITRA film-coated tablets and vardenafil orally disintegrating tablets. Excluded from this list are those adverse reactions that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug:

 

Body as a whole: allergic edema and angioedema, feeling unwell, allergic reactions, chest pain

 

Auditory: tinnitus, vertigo

 

Cardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension