Vardenafil hydrochloride (marketed as Levitra) Information

FDA SUMMARY [11/2007]:  FDA has received reports of cases of sudden decreases or loss of hearing following the use of PDE5 inhibitors, Viagra, Levitra, and Cialis for the treatment of erectile dysfunction and Revatio for the treatment of pulmonary arterial hypertension.  In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness.  Medical follow-up information was often limited for the cases reported postmarketing, which makes it difficult to determine whether these reports are directly related to the use of one of these drugs, an underlying medical condition, or other risk factors for hearing loss, a combination of these factors, or other factors. Sudden hearing loss was also reported in a few patients in clinical trials of these drugs.  In response to a request from FDA, the manufacturers of Viagra, Levitra and Cialis have revised the labeling for these products to address the potential risk of sudden hearing loss and to guide patients on what to do if they experience sudden problems with their hearing. FDA is currently working with the sponsor to revise the labeling for Revatio. The approved revised labeling for Viagra, Levitra and Cialis includes a new Precaution and updated Adverse Reactions sections.  The revised labeling is available at Drugs@FDA.

This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

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To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this sheet.