Label Changes for:
Seroquel (quetiapine fumarate) Tablets
Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 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.|
- Leukopenia, Neutropenia and Agranulocytosis
- Information for Patients
- Laboratory Tests
- Vital Signs and Laboratory Studies
- In postmarketing clinical trials, elevations in total cholesterol (predominantly LDL cholesterol) have been observed.
- Postmarketing Experience
January 2008 Label not available at this site.