Label Changes for:

Tamiflu (oseltamivir phosphate) Capsules and For Oral Suspension

January 2008

Changes have been made to the PRECAUTIONS, 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) -- 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.


Summary View

Sections Modified

PRECAUTIONS

  • Hepatic Impairment
  • Neuropsychiatric Events
  • Drug Interactions
    • ...No pharmacokinetic interactions have been observed when coadministering oseltamivir with amoxicillin, acetaminophen, cimetidine or with antacids (magnesium and aluminum hydroxides and calcium carbonates).

ADVERSE REACTIONS

  • Observed During Clinical Practice
    • Gastrointestinal Disorders
      • Gastrointestinal Bleeding
      • Hemorrhagic Colitis
    • Psychiatric
      • Delirium, including symptoms such as altered level of consciousness, confusion, abnormal behavior, delusions, hallucinations, agitation, anxiety, nightmares...

PATIENT PACKAGE INSERT

  • What are the possible side effects of Tamiflu?
    • People with the flu, particularly children and adolescents, may be at an increased risk of seizures, confusion, or abnormal behavior early during their illness. These events may occur shortly after beginning Tamiflu or may occur when flu is not treated. These events are uncommon but may result in accidental injury to the patient. Therefore, patients should be observed for signs of unusual behavior and a healthcare professional should be contacted immediately if the patient shows any signs of unusual behavior.
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