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U.S. Department of Health and Human Services

Safety

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Levitra (vardenafil HCl) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


 

April 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.4 Effects on the Eye
  • Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including LEVITRA, and seek medical attention in the event of sudden loss of vision in one or both eyes. Such an event may be a sign of nonarteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision, including permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Based on published literature, the annual .....

17 PATIENT COUNSELING INFORMATION

Sudden Loss of Vision
  • Physicians should advise patients to stop use of all  PDE5 inhibitors, including LEVITRA, and seek medical attention in the event of sudden loss of vision in one or both eyes. Such an event may .....
     

 

March 2008

Summary View

Sections Modified

ADVERSE REACTIONS

  • Postmarketing Experience
    • Neurologic
      • Seizure and seizure recurrence have been reported postmarketing in temporal association with Levitra.