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Tamiflu (Oseltamivir Phosphate) - Summary



TAMIFLU (oseltamivir phosphate) is available as capsules containing 30 mg, 45 mg, or 75 mg oseltamivir for oral use, in the form of oseltamivir phosphate, and as a powder for oral suspension, which when constituted with water as directed contains 6 mg/mL oseltamivir base. In addition to the active ingredient, each capsule contains pregelatinized starch, talc, povidone K30, croscarmellose sodium, and sodium stearyl fumarate. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide, and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide, and red iron oxide. Each capsule is printed with blue ink, which includes FD&C Blue No. 2 as the colorant. In addition to the active ingredient, the powder for oral suspension contains sorbitol, monosodium citrate, xanthan gum, titanium dioxide, tutti-frutti flavoring, sodium benzoate, and saccharin sodium.

Treatment of Influenza

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

Prophylaxis of Influenza

TAMIFLU is indicated for the prophylaxis of influenza in patients 1 year and older.

Limitations of Use

The following points should be considered before initiating treatment or prophylaxis with TAMIFLU:

  • Efficacy of TAMIFLU in patients who begin treatment after 48 hours of symptoms has not been established.
  • TAMIFLU is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
  • 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. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU.

See all Tamiflu indications & dosage >>


Published Studies Related to Tamiflu (Oseltamivir)

Oseltamivir treatment for influenza in adults: a meta-analysis of randomised controlled trials. [2015]
complications, and safety... INTERPRETATION: Our findings show that oseltamivir in adults with influenza

Efficacy of oseltamivir treatment started within 5 days of symptom onset to reduce influenza illness duration and virus shedding in an urban setting in Bangladesh: a randomised placebo-controlled trial. [2014]
urban setting in Bangladesh... INTERPRETATION: Oseltamivir treatment resulted in a modest reduction in the

Pharmacokinetic-pharmacodynamic determinants of oseltamivir efficacy using data from phase 2 inoculation studies. [2013]
Given the limited understanding about pharmacokinetic-pharmacodynamic (PK-PD) determinants of oseltamivir efficacy, data from two phase 2 influenza virus inoculation studies were evaluated. Healthy volunteers in studies 1 and 2 were experimentally infected with influenza A/Texas (the concentration of neuraminidase inhibitor which reduced neuraminidase activity by 50% [IC(50)] = 0.18 nM) or B/Yamagata (IC(50) = 16.76 nM), respectively.

Oseltamivir pharmacokinetics in morbid obesity (OPTIMO trial). [2011.09]
BACKGROUND: Detailed pharmacokinetics to guide oseltamivir (Tamiflu(R)) dosing in morbidly obese patients is lacking... CONCLUSIONS: With single and multiple dosing, the systemic exposure to oseltamivir is decreased but that of oseltamivir carboxylate is largely unchanged. Based on these pharmacokinetic data, an oseltamivir dose adjustment for body weight would not be needed in morbidly obese individuals.

Effect of milk on the pharmacokinetics of oseltamivir in healthy volunteers. [2011.09]
We previously showed that oseltamivir, a prodrug of the influenza virus neuraminidase inhibitor Ro 64-0802, is a substrate of proton-coupled oligopeptide transporter (PEPT1), and its intestinal absorption in rats is markedly inhibited by administration with milk...

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Clinical Trials Related to Tamiflu (Oseltamivir)

Pharmacokinetics of Tamiflu� (Oseltamivir) in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)and or Continuous Venovenous Hemodialysis (CVVHD) [Completed]
Critically ill patients with flu may receive a drug called oseltamivir. They may also receive medical therapies to support their lung function (extracorporeal membrane oxygenation; ECMO) and kidney function (continuous venovenous hemodialysis; CVVHD). CVVHD and ECMO may remove some oseltamivir from the bloodstream. The purpose of this study is to determine how much oseltamivir gets removed by CVVHD or ECMO in critically ill patients.

A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain [Terminated]
This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza strain or influenza A are eligible for this study. Patients will be randomized to one of four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body weight-adjusted for pediatric patients.

A Bioequivalence Study of Oseltamivir From Oseltamivir 75 mg Caps (Pharmacare PLC, Palestine) and Tamiflu� 75 mg Caps (Hoffmann-La Roche, Switzerland) [Completed]
Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Oseltamivir from Oseltamivir 75 mg capsules (Pharmacare PLC, Palestine) and Tamiflu 75 mg capsules (Hoffmann-La Roche, Switzerland under license Gilead Sciences ,California ,USA after a single oral dose administration of each to healthy adults under fasting conditions.

A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza [Completed]
This partially randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza. Adult and adolescent patients will be randomized to receive either 100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days, with an optional treatment extension of a further 5 days, if necessary. There will be a non-randomized, open-label treatment group for patients with moderate/severe renal impairment or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to their renal situation.

Observational Study on the Pharmacokinetics of Oseltamivir in the Treatment of Influenza During Lactation [Completed]
The main purpose of this study is to assess the potential exposure of neonates to oseltamivir during lactation by examining oseltamivir concentrations in maternal blood, urine, and breast milk in breastfeeding women who are treated with oseltamivir, an anti-flu medication.

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Reports of Suspected Tamiflu (Oseltamivir) Side Effects

Abnormal Behaviour (53)Overdose (49)Maternal Exposure During Pregnancy (33)Pneumonia (30)Influenza (29)Hallucination (22)Vomiting (20)Pregnancy (20)NO Adverse Event (19)Acute Respiratory Distress Syndrome (18)more >>


Based on a total of 10 ratings/reviews, Tamiflu has an overall score of 7.20. The effectiveness score is 7.60 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Tamiflu review by 52 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   family flu outbreak
Dosage & duration:   75mg taken twice x a day for the period of 5 days
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   My son came home from college with the flu. Student Health gave him a pack of Tamiflu and he felt better within 24 hours. When I started feeling sick 3 days later, I called my Dr and ask for Tamiflu. I felt almost back to norma lwithin 24 hours.
Side effects:   none
Comments:   Just took the pill and drank fluids


Tamiflu review by 40 year old female patient

Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   The flu
Dosage & duration:   75 mg capsules taken twice per day for the period of 5 days
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   This is an easy to take flu remedy that lasts only 5 days. It was good to know that as miserable as the flu was, I could finally take action to rid myself of it sooner, as compared to last year when there was no remedy available. By taking Tamiflu, I think the duration of the flu may have been shortened by 1-2 days
Side effects:   none
Comments:   I was hoping that I would feel my flu symptoms lessening on the first day of treatment. I didn't feel significantly better until the third day. This prescription cost close to $100. It makes me wonder if it was really worth it.


Tamiflu review by 25 year old female patient

Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   i was in a risk group - frontline pharmacist
Dosage & duration:   one jab (dosage frequency: once) for the period of once
Other conditions:   numbness in arm, cold, fever
Other drugs taken:   none
Reported Results
Benefits:   supposed prevention of catching swine flu
Side effects:   sickness for 4 days, numb arm for that period of time, couldn't dress, couldn't drive. then cold anf flu followed, with stomach problams because of lack of food because of associated problems
Comments:   no treatment was given except cold anf flu medication, just waited out the symptoms and side effects

See all Tamiflu reviews / ratings >>

Page last updated: 2015-08-10

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