Side Effects and Safety

Side Effects and Safety for Children Aged 1-12 Years

Adverse events reported in treatment and prophylaxis studies in children aged 1 to 12 years

The most frequently reported adverse events in these studies were nausea and vomiting. These events were generally of mild to moderate severity and usually occurred on the first 2 days of administration. Less than 1% of subjects discontinued prematurely from clinical trials due to nausea and vomiting.1 (See table below.)

Learn about clinical data regarding susceptibility and resistance >

Most Frequent Adverse Events Occurring in Children Aged 1 to 12 Years in Studies in Naturally Acquired Influenza1

  • Pooled data from trials of Tamiflu treatment of naturally acquired influenza.
  • A randomized, open-label study of household transmission in which household contacts received either prophylaxis or no prophylaxis but treatment if they became ill. Only contacts who received prophylaxis or who remained on no prophylaxis are included in this table.
  • Adverse events included in Table 7 are all events reported in the treatment studies with frequency ≥1% in the Tamiflu 75 mg twice daily group.
  • Unit dose = age-based dosing of 30 mg, 45 mg, or 60 mg.

Read Prescribing Information >

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

Side Effects and Safety for Adults and Adolescents

Adverse events reported in adult and adolescent studies

In treatment studies in adults and adolescents aged 13 years and older, the most frequently reported adverse events (incidence ≥1%) were nausea and vomiting. In prophylaxis studies in adult and adolescent patients, adverse events were similar.1 (See Table Below.)

Most Frequent Adverse Events in Studies in Naturally Acquired Influenza in Subjects 13 Years of Age and Older (≥1% with Tamiflu)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.

Did You Know?

During the 2014-2015 flu season, the flu-related hospitalization rate among people 65 and older was the highest rate recorded since the CDC began tracking these data in 2005.3

Learn more >

Links to cdc.gov and references to CDC are provided for informational purposes only. CDC does not endorse private products, services or enterprises.


References

  1. Tamiflu® (oseltamivir phosphate) Prescribing Information. South San Francisco, CA: Genentech USA, Inc.; November 2014.
  2. Data on file, Genentech USA, Inc.
  3. Centers for Disease Control and Prevention. What you should know about the 2014-2015 Influenza Season. http://www.cdc.gov/flu/about/season/flu-season-2014-2015.htm. Updated March 12, 2015. Accessed October 8, 2015.

Indications

Tamiflu is indicated for the treatment of acute, uncomplicated illness due to influenza infection in patients 2 weeks of age and older who have been symptomatic for no more than 2 days. Tamiflu is also indicated for the prophylaxis of influenza in patients 1 year and older

  • Efficacy of Tamiflu in patients who begin treatment after 48 hours of symptoms has not been established
  • Tamiflu is not a substitute for early and annual influenza vaccination
  • There is no evidence for efficacy of Tamiflu in any illness caused by agents other than influenza viruses types A and B
  • Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Tamiflu

Important Safety Information

Serious Skin/Hypersensitivity Reactions

  • Tamiflu is contraindicated in patients who have had severe allergic reactions such as anaphylaxis or serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme to any component of Tamiflu
  • In postmarketing experience, cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with Tamiflu. Tamiflu should be stopped and appropriate treatment instituted if an allergic-like reaction occurs or is suspected

Neuropsychiatric Events

  • Influenza can be associated with a variety of neurologic and behavioral symptoms, which can include events such as hallucinations, delirium and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease
  • Closely monitor patients with influenza for signs of abnormal behavior. If neuropsychiatric symptoms occur, evaluate the risks and benefits of continuing treatment for each patient

Bacterial Infections

  • Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Tamiflu has not been shown to prevent such complications

Limitations of Populations Studied

  • Efficacy of Tamiflu in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease has not been established. No information is available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalization
  • Efficacy of Tamiflu for treatment or prophylaxis of influenza has not been established in immunocompromised patients

Concurrent Use with Live Attenuated Influenza Vaccine

  • The concurrent use of Tamiflu with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of Tamiflu, unless medically indicated

Most Common Adverse Reactions

  • Adverse events that occurred more frequently in patients treated with Tamiflu than in patients taking placebo (frequency ≥ 2%) across clinical trials were nausea, vomiting, abdominal pain, ear disorder, and diarrhea
  • The safety profile observed in pediatric patients 2 weeks to less than 1 year of age was consistent with the established safety profile of subjects aged 1 year and above, with vomiting, diarrhea and diaper rash being the most frequently reported adverse reactions

For additional important safety information, please see Tamiflu full prescribing information at www.tamiflu.com.

You are encouraged to report side effects to Genentech by calling 1-888-835-2555 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Indications and Important Safety Information

Indications

Tamiflu is indicated for the treatment of acute, uncomplicated illness due to influenza infection in patients 2 weeks of age and older who have been symptomatic for no more than 2 days. Tamiflu is also indicated for the prophylaxis of influenza in patients 1 year and older

  • Efficacy of Tamiflu in patients who begin treatment after 48 hours of symptoms has not been established
  • Tamiflu is not a substitute for early and annual influenza vaccination
  • There is no evidence for efficacy of Tamiflu in any illness caused by agents other than influenza viruses types A and B
  • Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Tamiflu

Important Safety Information

Serious Skin/Hypersensitivity Reactions

  • Tamiflu is contraindicated in patients who have had severe allergic reactions such as anaphylaxis or serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme to any component of Tamiflu
  • In postmarketing experience, cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with Tamiflu. Tamiflu should be stopped and appropriate treatment instituted if an allergic-like reaction occurs or is suspected

Neuropsychiatric Events

  • Influenza can be associated with a variety of neurologic and behavioral symptoms, which can include events such as hallucinations, delirium and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease
  • Closely monitor patients with influenza for signs of abnormal behavior. If neuropsychiatric symptoms occur, evaluate the risks and benefits of continuing treatment for each patient

Bacterial Infections

  • Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Tamiflu has not been shown to prevent such complications

Limitations of Populations Studied

  • Efficacy of Tamiflu in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease has not been established. No information is available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalization
  • Efficacy of Tamiflu for treatment or prophylaxis of influenza has not been established in immunocompromised patients

Concurrent Use with Live Attenuated Influenza Vaccine

  • The concurrent use of Tamiflu with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of Tamiflu, unless medically indicated

Most Common Adverse Reactions

  • Adverse events that occurred more frequently in patients treated with Tamiflu than in patients taking placebo (frequency ≥ 2%) across clinical trials were nausea, vomiting, abdominal pain, ear disorder, and diarrhea
  • The safety profile observed in pediatric patients 2 weeks to less than 1 year of age was consistent with the established safety profile of subjects aged 1 year and above, with vomiting, diarrhea and diaper rash being the most frequently reported adverse reactions

For additional important safety information, please see Tamiflu full prescribing information at www.tamiflu.com.

You are encouraged to report side effects to Genentech by calling 1-888-835-2555 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

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