Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Addition to listing of adverse reactions...arthralgia
- Replacement of “events” with “reactions” throughout section.
- movement disorders (including dystonia and oculogyric crisis
- tic, myoclonus, extrapyramidal symptoms
5 WARNINGS AND PRECAUTIONS
5.2 Urinary Retention
- Urinary retention has been reported post-marketing....
6 ADVERSE REACTIONS
6.2 Postmarketing Experience
- added ..... urinary retention
17 PATIENT COUNSELING INFORMATION
- vomiting, dysuria, blurred vision, angioedema, paraesthesia, dizziness