Label Changes for:
Seroquel XR (quetiapine fumarate) Extended-Release Tablets
May 2008
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) -- May 2008
| The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. |
Sections Modified
ADVERSE REACTIONS
- Extrapyramidal Symptoms
- Dystonia - Class Effect
Label approved 05/21/2008 is not available on Drugs@FDA
