Levitra Tablets (Luh-VEE-Trah) (vardenafil HCl)

Adverse Reactions

Levitra was administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% other) during controlled and uncontrolled clinical trials worldwide. Over 2200 patients were treated for 6 months or longer, 880 patients were treated for at least 1 year.

In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for Levitra compared to 1.1% for placebo.

When Levitra was taken as recommended in placebo-controlled clinical trials, the following adverse events were reported (see Table 2).

Table 2: Adverse Events Reported by = 2% of Patients Treated with Levitra and More Frequent on Drug than Placebo in Fixed and Flexible** Dose Randomised, Controlled Trials of 5 mg, 10 mg, or 20 mg Vardenafil


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

** 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

 

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 events (headache, flushing, dyspepsia, nausea, rhinitis) over the 5 mg, 10 mg, and 20 mg doses of Levitra. The following section identifies additional, less frequent events (<2%) reported during clinical development of Levitra. Excluded from this list are those events 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: anaphylactic reaction (including laryngeal edema), asthenia, face edema, pain

Auditory: tinnitus

Cardiovascular: angina pectoris, chest pain, hypertension, hypotension, myocardial ischemia, myocardial infarction, palpitation, postural hypotension, syncope, tachycardia

Digestive: abdominal pain, abnormal liver function tests, diarrhea, dry mouth, dysphagia, esophagitis, gastritis, gastroesophageal reflux, GGTP increases, vomiting

Musculoskeletal: arthralgia, back pain, myalgia, neck pain
Nervous: hypertonia, hypesthesia, insomnia, parasthesia, somnolence, vertigo

Respiratory: dyspnea, epistaxis, pharyngitis

Skin and Appendages: photosensitivity reaction, pruritus, rash, sweating

Ophthalmologic: abnormal vision, blurred vision, chromatopsia, changes in color vision, conjunctivitis (increased redness of the eye), dim vision, eye pain, glaucoma, photophobia, watery eyes

Urogenital: abnormal ejaculation, priapism (including prolonged or painful erections)

© 2004 - 2008 PSP Global Ltd. All Rights reserved.
The health information contained on this site is for educational purposes only and is not intended to replace individualized medical advice and discussions with your healthcare provider.
All decisions regarding patient care must be made by a healthcare provider, who will consider the unique characteristics of each patient.
All trademarks and registered marks are the properties of their respective companies.
Viagra® is a registered trademark of Pfizer® Inc.
Levitra ® is a registered trademark of Bayer and GlaxoSmithKline
Cialis® is a registered trademark of Lilly ICOS LLC