Label Changes for:
Uroxatral (alfuzosin HCl 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
- Postmarketing Adverse Event Reports
- Hepatobiliary Disorders
- Hepatocellular and cholestatic liver injury (including cases with jaundice leading to drug discontinuation)
- Hepatobiliary Disorders
Label approved 05/06/2008 is not available on Drugs@FDA
