Advil: adverse event reports filed with FDA

19,649

reports as suspect product

0.1% of all reports · about 874 a year

522

reports, 12 months to June 2026

571 in the 12 months before

27.6%

marked serious by the reporter

71.8% across the class

2.3%

record death among outcomes, as reported

459 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 Advil reports recording the termmedian drug in nonsteroidal anti-inflammatory drug

1. Drug ineffectivethe medicine did not work as expected24%4,719
2. Product use in unapproved indicationused for a purpose not on the label7.5%1,469
3. Drug effective for unapproved indication4.7%926
4. Abdominal discomfortstomach discomfort4.3%852
5. Nauseafeeling sick4%779
6. Drug hypersensitivityan allergic-type reaction to a medicine3.8%746
7. Abdominal pain upperupper stomach pain3.2%627
8. Headachehead pain3%592
9. Malaisegeneral feeling of being unwell2.9%568
10. Painpain, site not specified2.8%544
11. Off label useused for a purpose or in a way not on the label2.7%527
12. Dizzinesslight-headedness or unsteadiness2.7%522
13. Hypersensitivityan allergic-type reaction2.5%492
14. Vomitingbeing sick2.5%485
15. Intentional product misusedeliberate use not as intended2.5%483
16. Dyspepsiaindigestion2.3%461
17. Condition aggravatedthe condition being treated got worse2.3%445
18. Diarrhoealoose or frequent stools2.2%442
19. Drug effect incomplete2.2%441
20. Rashskin rash2.2%433
21. Urticariahives2.1%421
22. Overdosea dose above the recommended amount2.1%408
23. Dyspnoeashortness of breath2.1%405
24. Pruritusitching2%399
25. Product use issuea problem in how the product was used1.9%383
26. Feeling abnormalfeeling odd or not right1.8%362
27. Fatiguetiredness1.8%361
28. Insomniadifficulty sleeping1.8%353
29. Poor quality drug administered1.8%348
30. Somnolencedrowsiness1.7%329

Top 30 of 1,374 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 47 drugs in the nonsteroidal anti-inflammatory drug 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 548,672 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. 86.4% 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 19,649 reports.

Drugs most often listed in the same reports

Other products listed in reports where Advil 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 nonsteroidal anti-inflammatory drug 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 Advil as a suspect or interacting product; reports listing it only as a concomitant medication (24,463) 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.