Recommended Topic Related To:

Tamiflu

"There is still time to protect your children and yourself from the flu in what remains of a severe influenza season.

"Everyone seems to know that the elderly are particularly vulnerable, but so too are children," says William"...

Tamiflu

Tamiflu Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Tamiflu (oscltamivir phosphate) is 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. It is an antiviral medication. Common side effects include nausea and vomiting.

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]

The most common adverse reactions are nausea and vomiting.

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.

Treatment Studies in Adult and Adolescent Subjects (13 years of age and older)

A total of 1171 subjects who participated in adult controlled clinical trials for the treatment of influenza were treated with TAMIFLU. 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.

Adverse events that occurred with an incidence of 1% or greater in 1440 subjects taking placebo or TAMIFLU 75 mg twice daily in adult treatment studies are shown in Table 6. This summary includes 945 healthy young adults and 495 “at risk” subjects (elderly patients and patients with chronic cardiac or respiratory disease). Those events reported numerically more frequently in subjects taking TAMIFLU compared with placebo were nausea, vomiting, bronchitis, insomnia, and vertigo.

Prophylaxis Studies in Adult and Adolescent Subjects (13 years of age and older)

A total of 4187 subjects (adolescents, healthy adults, and elderly) participated in prophylaxis studies, of whom 1790 received the recommended dose of 75 mg once daily for up to 6 weeks. Adverse events were qualitatively very similar to those seen in the treatment studies, despite a longer duration of dosing (see Table 6). Events reported more frequently in subjects receiving TAMIFLU compared to subjects receiving placebo in prophylaxis studies, and more commonly than in treatment studies, were aches and pains, rhinorrhea, dyspepsia and upper respiratory tract infections. However, the difference in incidence between TAMIFLU and placebo for these events was less than 1%. There were no clinically relevant differences in the safety profile of the 942 elderly subjects who received TAMIFLU or placebo, compared with the younger population.

Table 6 : Most Frequent Adverse Events in Studies in Naturally Acquired Influenza in Subjects 13 Years of Age and Older

Adverse Event* Treatment Prophylaxis
Placebo
N=716
TAMIFLU 75 mg twice daily
N=724
Placebo/ No Prophylaxis†
N=1688
TAMIFLU 75 mg once daily
N=1790
Nausea (without vomiting) 40 (6%) 72 (10%) 56(3%) 129 (7%)
Vomiting 21 (3%) 68 (9%) 16 (1%) 39 (2%)
Diarrhea 70 (10%) 48 (7%) 40 (2%) 50 (3%)
Bronchitis 15 (2%) 17 (2%) 22 (1%) 15 (1%)
Abdominal pain 16 (2%) 16 (2%) 25 (1%) 37 (2%)
Dizziness 25 (3%) 15 (2%) 21 (1%) 24 (1%)
Headache 14 (2%) 13 (2%) 306 (18%) 326 (18%)
Cough 12 (2%) 9 (1%) 119 (7%) 94 (5%)
Insomnia 6 (1%) 8 (1%) 15 (1%) 22 (1%)
Vertigo 4 (1%) 7 (1%) 4 ( < 1%) 4 ( < 1%)
Fatigue 7 (1%) 7 (1%) 163 (10%) 139 (8%)
* 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.

Additional adverse events occurring in less than 1% of patients receiving TAMIFLU for treatment included unstable angina, anemia, pseudomembranous colitis, humerus fracture, pneumonia, pyrexia, and peritonsillar abscess.

Treatment Studies in Pediatric Subjects (1 to 12 years of age)

A total of 1032 pediatric subjects aged 1 to 12 years (including 698 otherwise healthy pediatric subjects aged 1 to 12 years and 334 asthmatic pediatric subjects aged 6 to 12 years) participated in controlled clinical trials of TAMIFLU given for the treatment of influenza. A total of 515 pediatric subjects received treatment with TAMIFLU for oral suspension.

Adverse events occurring in 1% or greater of pediatric subjects receiving TAMIFLU treatment are listed in Table 7. The most frequently reported adverse event was vomiting. Other events reported more frequently by pediatric subjects treated with TAMIFLU included abdominal pain, epistaxis, ear disorder, and conjunctivitis. These events generally occurred once and resolved despite continued dosing resulting in discontinuation of drug in 8 out of 515 (2%) cases.

The adverse event profile in adolescents is similar to that described for adult subjects and pediatric subjects aged 1 to 12 years.

Prophylaxis Studies in Pediatric Subjects (1 to 12 years of age)

Pediatric subjects aged 1 to 12 years participated in a postexposure prophylaxis study in households, both as index cases (n=134) and as contacts (n=222). Gastrointestinal events were the most frequent, particularly vomiting. In a separate 6-week, uncontrolled, pediatric seasonal prophylaxis study (n=49), the adverse events noted were consistent with those previously observed (see Table 7).

Table 7 : Most Frequent Adverse Events Occurring in Children Aged 1 to 12 Years in Studies in Naturally Acquired Influenza

Adverse Event1 Treatment Trials* Household Prophylaxis Trialf
Placebo
N=517
TAMIFLU 2 mg/kg twice daily
N=515
No Prophylaxis§
N=87
Prophylaxis with TAMIFLU once daily§
N=99
Vomiting 48(9%) 77(15%) 2(2%) 10(10%)
Diarrhea 55(11%) 49(10%) - 1(1%)
Otitis media 58(11%) 45(9%) 2(2%) 2(2%)
Abdominal pain 20(4%) 24(5%) - 3(3%)
Asthma (including aggravated) 19(4%) 18(3%) 1(1%) 1(1%)
Nausea 22(4%) 17(3%) 1(1%) 4(4%)
Epistaxis 13(3%) 16(3%) - 1(1%)
Pneumonia 17(3%) 10(2%) 2(2%) -
Ear disorder 6(1%) 9(2%) - -
Sinusitis 13(3%) 9(2%) - -
Bronchitis 11(2%) 8(2%) 2(2%) -
Conjunctivitis 2( < 1%) 5(1%) - -
Dermatitis 10(2%) 5(1%) - -
Lymphadenopathy 8(2%) 5(1%) - -
Tympanic membrane disorder 6(1%) 5(1%) - -
* 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

Treatment Studies in Pediatric Subjects (2 weeks to less than 1 year of age)

Assessment of adverse reactions is 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/kg twice daily for 5 days. The safety profile was similar across the age range studied, with vomiting, diarrhea and diaper rash being the most frequently reported adverse reactions. The safety profile observed in subjects 2 weeks to less than 1 year of age was consistent with the established safety profile of adults and pediatric subjects older than 1 year of age.

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.

Postmarketing Experience

The following adverse reactions have been identified during postapproval 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.

Body as a Whole: Swelling of the face or tongue, allergy, anaphylactic/anaphylactoid reactions, hypothermia

Dermatologic: Rash, dermatitis, urticaria, eczema, toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme [see WARNINGS AND PRECAUTIONS]

Digestive: Hepatitis, liver function tests abnormal

Cardiac: Arrhythmia

Gastrointestinal disorders: Gastrointestinal bleeding, hemorrhagic colitis

Neurologic: Seizure

Metabolic: Aggravation of diabetes

Psychiatric: 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) »

A A A

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.


Women's Health

Find out what women really need.