Tamifluoseltamivir
According to the FDA label: Oseltamivir phosphate capsule is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2) Limitations of Use : Not a substitute for annual influenza vaccination.
17,902 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Tamiflu in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Vomiting 1,836 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Nausea 1,318 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →No Adverse Event 1,053 reports
A report that was filed but did not actually describe any adverse event. This is a record-keeping category.
Full definition in the glossary →Influenza 938 reports
The flu, a viral infection of the respiratory system.
Full definition in the glossary →Abnormal Behaviour 929 reports
A report of behavior that is unusual for the person. The term records what was reported and does not establish that a medication was the cause. Also spelled behavior in American English.
Full definition in the glossary →Diarrhoea 857 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 824 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Hallucination 823 reports
Seeing, hearing, or sensing things that are not actually there. The term records what was reported and does not establish that a medication was the cause.
Full definition in the glossary →Pyrexia 730 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Headache 651 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 621 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Drug Ineffective 617 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Rash 601 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Cough 589 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 565 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 9,210 |
| Male | 6,708 |
| Unknown | 91 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 3,457 |
| 18-34 | 1,669 |
| 35-49 | 1,751 |
| 50-64 | 1,970 |
| 65-74 | 1,199 |
| 75+ | 1,428 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Tamiflu. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 6,878 |
| Other Serious | 6,547 |
| Hospitalization | 4,385 |
| Death | 1,774 |
| Life-Threatening | 818 |
| Disability | 479 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Tamiflu. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2003 | 1 |
| 2004 | 153 |
| 2005 | 393 |
| 2006 | 278 |
| 2007 | 546 |
| 2008 | 351 |
| 2009 | 1,569 |
| 2010 | 1,310 |
| 2011 | 477 |
| 2012 | 518 |
| 2013 | 550 |
| 2014 | 475 |
| 2015 | 1,361 |
| 2016 | 1,136 |
| 2017 | 1,867 |
| 2018 | 1,599 |
| 2019 | 1,157 |
| 2020 | 1,013 |
| 2021 | 404 |
| 2022 | 378 |
| 2023 | 525 |
| 2024 | 1,172 |
| 2025 | 548 |
| 2026 (partial) | 121 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Tamiflu
In FDA adverse event reports that mention Tamiflu, these medications appeared most often in the same report.
- Oseltamivir Acid (1,591 reports)
- Acetaminophen (1,486 reports)
- Albuterol (1,088 reports)
- Prednisone (1,063 reports)
- Ergocalciferol (787 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026