TAMIFLU FDA MedWatch Voluntary U.S. Reports Summary
These tables and charts are created from 888 U.S. reports for TAMIFLU (OSELTAMIVIR PHOSPHATE) voluntarily reported by individuals directly to the FDA via the MedWatch Reporting System from 2004 through July 30, 2026. Events listed on this page represent serious and often rare adverse events
reported to the FDA, and often do not represent typical side effects for the medication. Find common side effects on the most recent
official drug label.
For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS TAMIFLU Report.
Top Adverse Events Reported with TAMIFLU (from U.S. FDA Medwatch Reports)
Side Effect # of FDA Reports 1 HALLUCINATION 136 2 VOMITING 103 3 ABNORMAL BEHAVIOUR 79 4 NAUSEA 74 5 CONFUSIONAL STATE 70 6 INSOMNIA 58 7 DIARRHEA 53 8 DIZZINESS 45 9 ANXIETY 44 10 NIGHTMARE 44 11 SCREAMING 44 12 RASH 43 13 CRYING 42 14 FEAR 39 15 FEELING ABNORMAL 39 16 ABDOMINAL PAIN UPPER 35 17 SHORTNESS OF BREATH 34 18 HEADACHE 34 19 AGGRESSION 32 20 INFLUENZA 29 21 DELIRIUM 27 22 SLEEP TERROR 27 23 PAIN 26 24 FEVER 26 25 HIVES 26
TAMIFLU Total Medwatch Safety Reports by Patient Sex
| Male | Female | Unknown | Total |
|---|---|---|---|
| 377 | 471 | 40 | 888 |
| Medwatch Reporter Type | Count |
| Consumer | 392 |
| Physician | 31 |
| Pharmacist | 90 |
| Other Health Professional | 66 |
| Lawyer | 1 |
| Top Indications | |
| Product used for unknown indication | |
| Influenza | |
| Pneumonia | |
| Influenza A virus test positive | |
| Infection | |
Type of Outcome Reported
Serious: 607
Not Serious: 281
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.
Suspected Role
Primary Suspect: 887
Concomitant Drugs: 390
Note: A single MedWatch report can list more than one drug. This summary includes TAMIFLU identified as the suspect drug or as a concomitantly taken drug.
FDA Safety-Related Labeling Changes
TAMIFLU (OSELTAMIVIR PHOSPHATE) Rx Drug:
FDA Safety-related Labeling Changes
Have experience (good or bad) with TAMIFLU? Rate TAMIFLU at Ask a Patient.
For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.
NOTES
This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.
After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"
The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.
Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."
FDA uses the "MedDRA" classification system to describe reported adverse
reactions. MedDRA is a standardized medical terminology that facilitates
sharing of regulatory information internationally. In some cases, "patient
friendly" terms for the layman designated by MedDRA have been substituted
for medical jargon. Please
contact us
with questions about this report.
