Side Effects of Tamiflu (oseltamivir)

Tamiflu (oseltamivir) is an antiviral medication used to treat and prevent influenza (the "flu"). It suppresses and decreases the spread of influenza A and B viruses, which are responsible for the flu. Tamiflu blocks the action of neuraminidase, an enzyme produced by the viruses that enables them to spread from infected cells to healthy cells.

By preventing the spread of the virus from cell to cell, Tamiflu reduces the symptoms and duration of influenza infection. On average, it reduces the duration of symptoms by one and a half days if treatment is started within forty-eight hours of the beginning of symptoms.

The common side effects of Tamiflu include:

The serious side effects of Tamiflu include:

• allergic reactions
• skin reactions
• seizures
• behavioral disturbances
• aggravation of diabetes

Tamiflu interacts with the live attenuated flu vaccine given by injection. Administration of the live attenuated flu vaccine should not occur within two weeks before or 48 hours after administration of Tamiflu.

The Centers for Disease Control (CDC) recommends the use of Tamiflu for treating flu in pregnant women. It also recommends that women with flu who have recently given birth may be treated with Tamiflu. Tamiflu passes into breast milk. Consult your doctor before breastfeeding.

What are the important side effects of Tamiflu (oseltamivir)?

The most frequent side effects of oseltamivir are:

Administering oseltamivir after meals helps reduce nausea.

Other reported adverse events include:

• Allergic reactions
• Skin reactions
• Seizures
• Behavioral disturbances
• Aggravation of diabetes

Tamiflu (oseltamivir) side effects list for healthcare professionals

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

• Serious skin and hypersensitivity reactions
• Neuropsychiatric events

Clinical Trials Experience

Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the trials of one drug cannot be directly compared to rates in the 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 adult and adolescent subjects that received the recommended dosage for treatment and prophylaxis of influenza in clinical trials.

The most common adverse reactions in the treatment and prophylaxis trials in adults and adolescents are displayed in Table 5:

Adverse Reactions From Treatment And Prophylaxis Trials In Pediatric Subjects (1 Year To 12 Years Of Age)

A total of 1,481 pediatric subjects participated in clinical trials of Tamiflu for the treatment of influenza.

A total of 859 pediatric subjects received treatment with Tamiflu for oral suspension. The only adverse reaction reported at a frequency of ≥1% in subjects receiving Tamiflu compared to placebo was vomiting.

Amongst the 148 pediatric subjects who received Tamiflu in a post-exposure prophylaxis study in household contacts and in a separate 6-week seasonal influenza prophylaxis safety study, vomiting was the most frequent adverse reaction.

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 open-label studies that included safety data on influenza-infected subjects exposed to Tamiflu at various doses. Vomiting, diarrhea, and diaper rash were the most frequently reported adverse reactions.

Adverse Reactions From The Prophylaxis Trial In Immunocompromised Subjects

In a 12-week seasonal prophylaxis study in immunocompromised subjects, the safety profile in the subjects receiving Tamiflu was consistent with that observed in other Tamiflu prophylaxis clinical trials.

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
• 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

What drugs interact with Tamiflu (oseltamivir)?

Influenza Vaccines

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 Tamiflu to inhibit replication of live vaccine virus and possibly reduce the efficacy of LAIV, avoid administration of LAIV within 2 weeks before or 48 hours after Tamiflu administration, unless medically indicated.

Inactivated Influenza Vaccine

Inactivated influenza vaccine can be administered at any time relative to use of Tamiflu.

Drugs Without Clinically Significant Drug Interaction With Tamiflu

No dose adjustments are needed when coadministering oseltamivir with certain drugs.

Summary

Tamiflu (oseltamivir) is an antiviral medication used to treat and prevent influenza (the "flu"). It suppresses and decreases the spread of influenza A and B viruses, which are responsible for the flu. Common side effects of Tamiflu include nausea, vomiting, diarrhea, bronchitis, abdominal pain, headache, and dizziness. Serious side effects of Tamiflu include allergic reactions, skin reactions, seizures, behavioral disturbances, and aggravation of diabetes. Consult your doctor before taking Tamiflu if pregnant or breastfeeding.

Tamiflu (oseltamivir) is an antiviral medication used to treat and prevent influenza (the "flu"). It suppresses and decreases the spread of influenza A and B viruses, which are responsible for the flu. Common side effects of Tamiflu include nausea, vomiting, diarrhea, bronchitis, abdominal pain, headache, and dizziness. Serious side effects of Tamiflu include allergic reactions, skin reactions, seizures, behavioral disturbances, and aggravation of diabetes. Consult your doctor before taking Tamiflu if pregnant or breastfeeding.