Tamiflu: adverse event reports filed with FDA

13,223

reports as suspect product

0.1% of all reports · about 588 a year

190

reports, 12 months to June 2026

1,019 in the 12 months before

57.2%

marked serious by the reporter

60.6% across the class

9%

record death among outcomes, as reported

1,188 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Tamiflu reports recording the termmedian drug in neuraminidase inhibitor

1. Vomitingbeing sick11.3%1,498
2. No adverse eventno adverse event was reported7.4%984
3. Nauseafeeling sick6.9%907
4. Abnormal behaviourunusual behaviour6.8%900
5. Hallucinationseeing or hearing things that are not there5.6%739
6. Diarrhoealoose or frequent stools4.3%562
7. Dyspnoeashortness of breath4%531
8. Influenzaflu3.7%493
9. Drug exposure during pregnancythe medicine was taken during pregnancy3.6%482
10. Drug ineffectivethe medicine did not work as expected3.4%448
11. Pyrexiafever3.4%443
12. Rashskin rash3.3%433
13. Coughcough3.1%412
14. Urticariahives3%403
15. Headachehead pain2.6%346
16. Deaththe patient died; cause not stated by this term2.5%324
17. Dizzinesslight-headedness or unsteadiness2.4%320
18. Malaisegeneral feeling of being unwell2.4%319
19. Confusional stateconfusion2.4%316
20. Pneumonialung infection2.4%315
21. Insomniadifficulty sleeping2.2%295
22. Overdosea dose above the recommended amount2.2%287
23. Deliriumsudden confusion2%267
24. Chest discomfortchest discomfort2%259
25. Pregnancypregnancy1.8%237
26. Abdominal painstomach or belly pain1.8%236
27. Anxietyanxiety1.6%215
28. Asthmaasthma1.6%215
29. Wheezingwheezing1.6%215
30. Nasal congestiona blocked nose1.6%213

Top 30 of 986 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the neuraminidase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,262 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 43.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 13,223 reports.

Drugs most often listed in the same reports

Other products listed in reports where Tamiflu is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the neuraminidase inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Tamiflu as a suspect or interacting product; reports listing it only as a concomitant medication (3,212) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.