Label Changes for:
Casodex (bicalutamide) Tablets
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)
- 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
WARNINGS AND PRECAUTIONS
- Cases of death or hospitalization due to severe liver injury (hepatic failure) have been reported postmarketing in association with the use of Casodex.