Safety

Indications
TAMIFLU is indicated for the treatment of uncomplicated influenza caused by viruses (virus) 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.

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.

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.

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. In treatment studies in adult patients, the most frequently reported adverse events (incidence ≥ 1%) were nausea and vomiting. Other events reported numerically more frequently in patients taking TAMIFLU compared with placebo were bronchitis, insomnia and vertigo. In treatment studies in patients 1 to 12 years old, the most frequently reported adverse event (incidence ≥ 1%) was vomiting (15%). Other events reported more frequently in patients taking TAMIFLU compared with placebo included abdominal pain (5% vs 4%), nosebleed (3% vs 3%), ear disorder (2% vs 1%) and pinkeye (1% vs < 1%).

In prophylaxis studies in adult patients, adverse events were similar to those seen in the treatment studies. Events reported more frequently in patients taking TAMIFLU compared with placebo (incidence ≥ 1%) were nausea (7% vs 3%), vomiting (2% vs 1%), diarrhea (3% vs 2%), abdominal pain (2% vs 1%), dizziness (1% vs 1%), headache (18% vs 18%) and insomnia (1% vs 1%). 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.

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.

Next: Compare Flu Treatment

Side effects

Rare but serious skin reactions and allergic reactions have been reported. Stop taking TAMIFLU and call your doctor if you experience any of these reactions, as they could be potentially life threatening.

Some instances of self–injury and delirium with the use of TAMIFLU in patients with the flu have been reported

The reports were primarily among children (mostly in Japan)
The relationship of these reported events to TAMIFLU is not known.
Pediatric patients with the flu should be closely monitored for signs of abnormal behavior throughout the treatment period

The most common side effects of TAMIFLU are mild to moderate nausea and vomiting. TAMIFLU is generally well tolerated.

In addition, take the following precautions when using TAMIFLU:

You should not take TAMIFLU if you are allergic to oseltamivir phosphate or any other ingredients of TAMIFLU.
TAMIFLU is normally not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. If you are pregnant, planning to become pregnant or breastfeeding while taking TAMIFLU, talk to your doctor before taking TAMIFLU.
If you have any type of kidney disease, talk to your doctor before starting TAMIFLU therapy.
The use of TAMIFLU along with an intranasal flu vaccine like FluMist®* has not been evaluated. However, due to the possibility for interference between these products, an intranasal flu vaccine should not be given within 2 weeks before or 48 hours after taking TAMIFLU, unless it is deemed appropriate by your doctor. The type of flu vaccine administered as a shot through the skin can be given at any time relative to use of TAMIFLU.

As with any medication, be sure to discuss with your doctor any over–the–counter or prescription medicines you are currently taking before beginning TAMIFLU therapy.