Label Changes for:
Tamiflu (Oseltamivir Phosphate) Capsules and Oral Suspension
December 2012
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2012
WARNINGS AND PRECAUTIONS
Limitations of Populations Studied
- Safety and efficacy of TAMIFLU for treatment of influenza in pediatric patients less than 2 weeks of age have not been established. Safety and efficacy of TAMIFLU for prophylaxis of influenza have not been established for pediatric patients less than 1 year of age.
December 2010
DRUG INTERACTIONS
- Proposed update on Aspirin/Tamiflu Drug-Drug Interaction
November 2010
ADVERSE REACTIONS
Postmarketing Experience
- Hypothermia
