Panadol: adverse event reports filed with FDA

712

reports as suspect product

0% of all reports · about 32 a year

44

reports, 12 months to June 2026

231 in the 12 months before

98%

marked serious by the reporter

45% across the class

38.1%

record death among outcomes, as reported

271 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 Panadol reports recording the termmedian drug in central nervous system stimulant

1. Off label useused for a purpose or in a way not on the label26.7%190
2. Confusional stateconfusion24.4%174
3. Fatiguetiredness22.3%159
4. Nauseafeeling sick22.3%159
5. Painpain, site not specified22.3%159
6. Systemic lupus erythematosuslupus, an autoimmune disease22.1%157
7. Rashskin rash21.9%156
8. Hypertensionhigh blood pressure21.3%152
9. General physical health deteriorationgeneral decline in health21.2%151
10. Hypersensitivityan allergic-type reaction20.9%149
11. Headachehead pain20.8%148
12. Drug ineffectivethe medicine did not work as expected20.2%144
13. Infusion related reactiona reaction during or soon after an infusion19.7%140
14. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease19.7%140
15. Condition aggravatedthe condition being treated got worse19.5%139
16. Joint swellinga swollen joint19.2%137
17. Swellingswelling19.1%136
18. Hepatic enzyme increasedraised liver enzymes18.1%129
19. Wound18.1%129
20. Abdominal discomfortstomach discomfort17.8%127
21. Pericarditisinflammation of the sac around the heart17.7%126
22. Synovitis17.7%126
23. Hand deformity17.6%125
24. Pyrexiafever17.6%125
25. Impaired healingslow healing17.4%124
26. Pemphigus17.3%123
27. Glossodynia17.1%122
28. Helicobacter infection17.1%122
29. Folliculitis17%121
30. Vomitingbeing sick16.9%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 median share across the 26 drugs in the central nervous system stimulant 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 109,804 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. 3.1% 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 712 reports.

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 central nervous system stimulant 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 Panadol as a suspect or interacting product; reports listing it only as a concomitant medication (2,718) 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.