July 27, 2016
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Tamiflu

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Tamiflu




Tamiflu Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/29/2015

Tamiflu (oscltamivir phosphate) is an antiviral medication used to treat flu symptoms caused by influenza virus in patients who have had symptoms for less than 2 days. Tamiflu may also be given to prevent influenza in people who may be exposed but do not yet have symptoms. Tamiflu will not treat the common cold. Common side effects of Tamiflu include nausea, vomiting, diarrhea, dizziness, headache, nosebleed, eye redness or discomfort, sleep problems (insomnia), or cough or other respiratory problems.

The recommended oral dose of Tamiflu for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily for 5 days. Pediatric dose is determined by the child's weight. Tamiflu is not indicated for treatment in pediatric patients less than 1 year of age. Treatment should begin within 2 days of onset of symptoms of influenza. There may be other drugs that can interact with Tamiflu. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. During pregnancy, Tamiflu should be used only when prescribed. This medication passes into breast milk. Consult your doctor before breast-feeding.

Our Tamiflu (oscltamivir phosphate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Tamiflu in Detail - Patient Information: Side Effects

Stop using oseltamivir and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat; a red and blistering or peeling skin rash.

Some people using oseltamivir have had rare side effects of sudden confusion, delirium, hallucinations, unusual behavior, or self-injury. These symptoms have occurred most often in children. It is not known whether oseltamivir was the exact cause of these symptoms. However, anyone using oseltamivir should be watched closely for signs of confusion or unusual behavior. Call a doctor at once if you or the child using oseltamivir has any of these symptoms.

Less serious side effects may include:

  • nausea, vomiting, diarrhea;
  • dizziness, headache;
  • nosebleed;
  • eye redness or discomfort;
  • sleep problems (insomnia); or
  • cough or other respiratory symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tamiflu (Oseltamivir Phosphate)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Tamiflu Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea and vomiting may occur. If either of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

The flu itself or oseltamivir may rarely cause serious mental/mood changes. This may be more likely in children. Tell your doctor right away of any signs of unusual behavior, including: confusion, agitation, self-injury.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Tamiflu (Oseltamivir Phosphate)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Tamiflu FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed below and elsewhere in the labeling:

  • Serious skin and hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
  • Neuropsychiatric events [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse Reactions From Treatment And Prophylaxis Trials In Adult And Adolescent Subjects (13 years of age and older)

The overall safety profile of TAMIFLU is based on data from 2,646 adult and adolescent subjects that received the recommended dosage of 75 mg orally twice daily for 5 days for treatment of influenza and 1,943 adult and adolescent subjects that received the recommended dosage of 75 mg orally once daily for up to 6 weeks for prophylaxis of influenza in clinical trials.

The most common adverse reactions in the pooled treatment and pooled prophylaxis trials in adults and adolescents are displayed in Table 5. The majority of these adverse reactions were reported on a single occasion, occurred on either the first or second treatment day and resolved spontaneously within 1-2 days. This summary includes otherwise healthy adults/adolescents and subjects “at risk” (subjects at higher risk of developing complications associated with influenza, e.g., elderly patients and patients with chronic cardiac or respiratory disease). In general, the safety profile in the subjects “at risk” was qualitatively similar to that in otherwise healthy adults/adolescents.

Table 5 : Adverse Reactions Occurring in ≥ 1% of Adults and Adolescents (13 years of age and older) in Treatment and Prophylaxis Trials*

System Organ Class Treatment Trials Prophylaxis Trials
Adverse Reaction TAMIFLU 75 mg twice daily
(n = 2646)
Placebo
(n =1977)
TAMIFLU 75 mg once daily
(n =1943)
Placebo
(n =1586)
Gastrointestinal Disorders
  Nausea 10% 6% 8% 4%
  Vomiting 8% 3% 2% 1%
Nervous System Disorders
  Headache 2% 1% 17% 16%
General Disorders
  Pain < 1% < 1% 4% 3%
* Adverse reactions that occurred in ≥ 1% of TAMIFLU-treated adults and adolescents and ≥ 1% greater in TAMIFLU-treated subjects compared to placebo-treated subjects in either the treatment or prophylaxis trials.

Adverse Reactions From Treatment And Prophylaxis Trials In Pediatric Subjects (1 year to 12 years of age)

A total of 1,481 pediatric subjects (including otherwise healthy pediatric subjects aged 1 year to 12 years and asthmatic pediatric subjects aged 6 to 12 years) participated in clinical trials of TAMIFLU for the treatment of influenza. A total of 859 pediatric subjects received treatment with TAMIFLU for oral suspension either at a 2 mg per kg twice daily for 5 days or weight-band dosing. Vomiting was the only adverse reaction reported at a frequency of > 1% in subjects receiving TAMIFLU (16%) compared to placebo (8%).

Amongst the 148 pediatric subjects aged 1 year to 12 years who received TAMIFLU at doses of 30 to 60 mg once daily for 10 days in a post-exposure prophylaxis study in household contacts (n = 99), and in a separate 6- week seasonal influenza prophylaxis safety study (n = 49), vomiting was the most frequent adverse reaction (8% on TAMIFLU versus 2% in the no prophylaxis group).

Adverse Reactions From Treatment Trials In Pediatric Subjects (2 weeks to less than 1 year of age)

Assessment of adverse reactions in pediatric subjects 2 weeks to less than 1 year of age was based on two open-label studies that included safety data on 135 influenza-infected subjects 2 weeks to less than 1 year of age (including premature infants at least 36 weeks post conceptional age) exposed to TAMIFLU at doses ranging from 2 to 3.5 mg per kg of the formulation for oral suspension twice daily orally for 5 days. The safety profile of TAMIFLU was similar across the age range studied, with vomiting (9%), diarrhea (7%) and diaper rash (7%) being the most frequently reported adverse reactions, and was generally comparable to that observed in older pediatric and adult subjects.

Adverse Reactions From The Prophylaxis Trial In Immunocompromised Subjects

In a 12-week seasonal prophylaxis study in 475 immunocompromised subjects, including 18 pediatric subjects 1 year to 12 years of age, the safety profile in the 238 subjects receiving TAMIFLU 75 mg once daily was consistent with that previously observed in other TAMIFLU prophylaxis clinical trials [see Clinical Studies].

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of TAMIFLU. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to TAMIFLU exposure.

General disorders and administration site conditions: Swelling of the face or tongue, allergy, anaphylactic/anaphylactoid reactions, hypothermia

Skin and subcutaneous tissue disorders: Rash, dermatitis, urticaria, eczema, toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme [see WARNINGS AND PRECAUTIONS]

Gastrointestinal Disorders: Gastrointestinal bleeding, hemorrhagic colitis

Cardiac Disorders: Arrhythmia

Hepatobiliary Disorders: Hepatitis, abnormal liver function tests

Nervous System Disorders: Seizure

Metabolism and Nutrition Disorders: Aggravation of diabetes

Psychiatric Disorders: Abnormal behavior, delirium, including symptoms such as hallucinations, agitation, anxiety, altered level of consciousness, confusion, nightmares, delusions [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Tamiflu (Oseltamivir Phosphate)

Tamiflu - User Reviews

Tamiflu User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Tamiflu sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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