Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Central Nervous System Effects
- *Addition of the terms “hallucinations” and “confusion”
- *Addition of “hallucinations” and “confusion”
5 WARNINGS and PRECAUTIONS
5.5 Central Nervous System Effects
- Drugs containing oxybutynin are associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6.1)]. A variety of CNS anticholinergic effects have been reported, including headache, dizziness, and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly .....