Side Effects and Safety

Side Effects and Safety

  • Millions of patients in the U.S. have been prescribed TAMIFLU 12
  • Generally well tolerated in children (≥1 year of age), adults and the elderly (>65 years of age) 1
  • In vitro studies showed no interference with the cytochrome P450 pathway 1
  • Co-administration with amoxicillin does not alter plasma levels of either drug 1

Indications

TAMIFLU is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients 1 year and older who have had flu symptoms for no more than 2 days.

TAMIFLU is also indicated for the prevention of influenza in patients 1 year and older.

TAMIFLU is not a substitute for annual early vaccination as recommended by the Centers for Disease Control and Prevention.1

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Safety Information

  • TAMIFLU has not been shown to be effective against any illness other than that caused by influenza types A and B. Efficacy of treatment in patients with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was seen between the treatment and placebo groups in this population. No information is available regarding treatment of influenza in patients at imminent risk of requiring hospitalization. Efficacy of TAMIFLU has not been established in immunocompromised patients. 1
  • Patients who are allergic to oseltamivir phosphate or any other ingredients in TAMIFLU should not take TAMIFLU. 1
  • TAMIFLU is normally not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. 1
  • Please see special dosing instructions for patients with kidney disease and creatinine clearance between 10 mL/min and 30 mL/min. 1
  • Safety and efficacy of repeated courses of TAMIFLU for treatment or prevention have not been studied. In postmarketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported. 1
  • There have been postmarketing reports (mostly from Japan) of self-injury and delirium with the use of TAMIFLU in patients with influenza. The reports were primarily among children. The relative contribution of the drug to these events is not known. Patients with influenza should be closely monitored for signs of abnormal behavior throughout the treatment period. 1
  • The concurrent use of TAMIFLU and live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, due to the possibility for interference between these products, LAIV should not be given within 2 weeks before or 48 hours after taking TAMIFLU, unless it is deemed appropriate by your doctor. Trivalent inactivated influenza vaccine can be administered at any time relative to use of TAMIFLU. 1

Adverse Events Reported in Treatment and Prophylaxis Studies in Adults

In treatment studies in adult patients, the most frequently reported adverse events (incidence ≥1%) were nausea and vomiting. In prophylaxis studies in adult patients, adverse events were similar. 1

Most Frequent Adverse Events in Studies in Naturally Acquired Influenza in Patients 13 Years of Age and Older 1

 
    Treatment Postexposure Prophylaxis  
  Adverse Event TAMIFLU
2 mg/kg
bid
n=515 		Placebo


n=517 		TAMIFLU
qd

n=99 		No
prophylaxis

n=87 		 
     
  Vomiting 15% 9% 10% 2%  
  Diarrhea 10% 11% 1% –  
  Otitis media 9% 11% 2% 2%  
  Abdominal pain 5% 4% 3% –  
  Asthma (including aggravated) 3% 4% 1% 1%  
  Nausea 3% 4% 4% 1%  

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Adverse Events Reported in Treatment and Prophylaxis Studies in Children Aged 1 to 12 Years

In treatment studies in patients 1 to 12 years old, the most frequently reported adverse event (incidence ≥1%) was vomiting (15%). In a household prevention trial that included patients 1 to 12 years old, adverse events were similar to those observed in pediatric treatment studies, with GI events being the most common. 1

Most Frequent Adverse Events Occurring in Children Aged 1 to 12 Years in Clinical Trials 1

     
    Treatment Prophylaxis  
  Adverse Event TAMIFLU
75 mg bid
n=724 		Placebo

n=716 		TAMIFLU
75 mg bid
n=1790 		Placebo

n=1688 		 
     
  Nausea (w/out vomiting) 10% 6% 7% 3%  
  Vomiting 9% 3% 2% 1%  
  Diarrhea 7% 10% 3% 2%  
  Bronchitis 2% 2% 1% 1%  
  Abdominal pain 2% 2% 2% 1%  
  Dizziness 2% 3% 1% 1%  
  Headache 2% 2% 18% 18%  
  Cough 1% 2% 5% 7%  
  Insomnia 1% 1% 1% 1%  
  Vertigo 1% 1% ≤1% ≤1%  
  Fatigue 1% 1% 8% 10%  

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Learn more about dosing, administration and storage of TAMIFLU.

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