• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail

Cialis (tadalafil) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2010


Summary View



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


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.