TYLENOL Extra Strength: adverse event reports filed with FDA

7,851

reports as suspect product

0% of all reports · about 382 a year

205

reports, 12 months to June 2026

206 in the 12 months before

21%

marked serious by the reporter

57.4% across all reports

2.1%

record death among outcomes, as reported

162 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 TYLENOL Extra Strength reports recording the termall reports in the database

1. Incorrect dose administeredthe wrong dose was given19.6%1,536
2. Drug ineffectivethe medicine did not work as expected12%940
3. Foetal exposure during pregnancythe unborn baby was exposed to the medicine7.9%620
4. Autism spectrum disorder7.8%610
5. Product use in unapproved indicationused for a purpose not on the label7.7%602
6. Off label useused for a purpose or in a way not on the label7.5%585
7. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times7.3%572
8. Product use issuea problem in how the product was used5.9%467
9. Drug administration errora mistake in giving the medicine4.2%333
10. Overdosea dose above the recommended amount3.6%284
11. Therapeutic response unexpected3.4%266
12. Expired product administeredthe product was used past its expiry date3.1%245
13. Wrong technique in product usage processthe product was used in the wrong way3.1%241
14. Attention deficit hyperactivity disorder2.7%212
15. Nauseafeeling sick2.7%212
16. Product packaging issuea problem with the packaging2.6%206
17. Drug effect incomplete2.5%196
18. Intentional overdosea deliberate overdose2.2%175
19. Vomitingbeing sick2.2%175
20. Somnolencedrowsiness2.1%163
21. Drug ineffective for unapproved indication2%157
22. Acute hepatic failure1.9%153
23. Extra dose administered1.9%152
24. Dizzinesslight-headedness or unsteadiness1.9%151
25. Inappropriate schedule of product administrationthe product was taken at the wrong times1.9%149
26. Incorrect drug administration duration1.8%140
27. Underdoseless than the intended dose1.7%131
28. Product label issuea problem with the label1.6%129
29. Abdominal pain upperupper stomach pain1.6%128
30. Diarrhoealoose or frequent stools1.5%120

Top 30 of 488 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 share of all reports in the database; 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 20,646,523 reports. 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. 96.9% 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 7,851 reports.

Drugs most often listed in the same reports

Other products listed in reports where TYLENOL Extra Strength 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."

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 TYLENOL Extra Strength as a suspect or interacting product; reports listing it only as a concomitant medication (12,556) 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.