Label Changes for:
Singulair (montelukast sodium) Tablet, Chewable
April 2008
Changes have been made to the ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 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 Experience
- Psychiatric Disorders
- Anxiousness
- Suicidal thinking and behavior (including suicide)
- Psychiatric Disorders
PATIENT PACKAGE INSERT
- Less common side effects that have happened with Singulair include:
- Behavior and Mood related changes
- Feeling anxious
- Suicidal thoughts and actions (including suicide)...
- Behavior and Mood related changes
