Acetaminophen and codeine: adverse event reports filed with FDA

7,248

reports as suspect product

0% of all reports · about 348 a year

493

reports, 12 months to June 2026

774 in the 12 months before

97.6%

marked serious by the reporter

91.7% across the class

35.1%

record death among outcomes, as reported

2,541 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 Acetaminophen and codeine reports recording the termmedian drug in opioid agonist

1. Dependence50.9%3,689
2. Overdosea dose above the recommended amount28.7%2,081
3. Painpain, site not specified11.7%845
4. Off label useused for a purpose or in a way not on the label11.3%816
5. Depressionlow mood10.8%783
6. Drug ineffectivethe medicine did not work as expected10.2%736
7. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease9.8%708
8. Fatiguetiredness9.8%707
9. Confusional stateconfusion9.6%698
10. Deaththe patient died; cause not stated by this term9.3%672
11. Arthropathy9.2%665
12. Rashskin rash9.2%665
13. Duodenal ulcer perforation9.2%664
14. Hypertensionhigh blood pressure9.1%663
15. Fibromyalgia9%654
16. Hepatic enzyme increasedraised liver enzymes9%651
17. Maternal exposure during pregnancythe mother took the medicine during pregnancy8.9%646
18. Infusion related reactiona reaction during or soon after an infusion8.9%645
19. Helicobacter infection8.9%644
20. Systemic lupus erythematosuslupus, an autoimmune disease8.9%643
21. Blistera blister8.8%639
22. Drug hypersensitivityan allergic-type reaction to a medicine8.7%632
23. Abdominal pain upperupper stomach pain8.7%628
24. Arthralgiajoint pain8.6%625
25. Stomatitissore mouth8.5%619
26. Hypoaesthesianumbness8.5%618
27. Pemphigus8.5%617
28. Joint swellinga swollen joint8.5%615
29. Headachehead pain8.5%614
30. Psoriatic arthropathy8.5%613

Top 30 of 755 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 42 drugs in the opioid agonist 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 965,051 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. 67.8% 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 7,248 reports.

Drugs most often listed in the same reports

Other products listed in reports where Acetaminophen and codeine 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 opioid agonist 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 Acetaminophen and codeine as a suspect or interacting product; reports listing it only as a concomitant medication (4,997) 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.