Side Effects and Safety
- Approximately 27.8 million Tamiflu prescriptions have been dispensed in the U.S. over the past 11 years.15
- Demonstrated safety profile 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
Adverse Events Reported in Treatment and Prophylaxis Studies in Children Aged 1 to 12 Years
Most Frequent Adverse Events Occurring in Children Aged 1 to 12 Years in Studies in Naturally Acquired Influenza1
twice daily n=515
once daily n=99
|Asthma (including aggravated)||3%||4%||1%||1%|
- Adverse events included are all events reported in the treatment studies with frequency ≥1% in the Tamiflu 75-mg twice daily group.
- The majority of subjects received placebo; 254 subjects from a randomized, open-label postexposure prophylaxis study in households did not receive placebo or prophylaxis therapy.
Prophylaxis Study in Immunocompromised Subjects
In a 12-week seasonal prophylaxis study in 475 immunocompromised subjects, including 18 pediatric subjects 1 to 12 years of age, the safety profile in the 238 subjects receiving Tamiflu was consistent with that previously observed in other Tamiflu prophylaxis clinical trials.1