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U.S. Department of Health and Human Services

Safety

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Cialis (tadalafil) tablets

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

 

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

17.6 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 .....
     

 

February 2010

Summary View 

CONTRAINDICATIONS

Hypersensitivity Reactions
  • Cialis is contraindicated in patients with a known serious hypersensitivity to tadalafil (Cialis or Adcirca).  Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis

WARNINGS AND PRECAUTIONS

Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies
  • The safety and efficacy of combinations of Cialis and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to take Cialis with other PDE5 inhibitors, including Adcirca.