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Label Changes for:

Casodex (bicalutamide) Tablets

February 2015

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

February 2015

ADVERSE REACTIONS

Post-Marketing Experience
  • Respiratory disorders: Interstitial lung disease (some fatal) including interstitial pneumonitis and pulmonary fibrosis, most often at doses greater than 50 mg
  • Skin and subcutaneous tissue disorders: Photosensitivity 

 

September 2010

WARNINGS AND PRECAUTIONS

Hepatitis
  • Cases of death or hospitalization due to severe liver injury (hepatic failure) have been reported postmarketing in association with the use of Casodex.

 

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