Generic name
Acetaminophen and codeine phosphate: adverse event reports filed with FDA
531 reports list it as a suspect or interacting product, 2004–2016. Class: Opioid agonist. Also reported as Acetaminophen And Codeine Phosphate 3, Acetaminophen And Codeine Phosphate Oral Solution Usp, Acetaminophen / Codeine Phosphate.
- 531
- reports as suspect product
- 0% of all reports · about 24 a year
- 0
- reports, 12 months to June 2026
- 0 in the 12 months before
- 96%
- marked serious by the reporter
- 91.7% across the class
- 33.3%
- record death among outcomes, as reported
- 177 reports · not verified by FDA
531 adverse event reports received by FDA list acetaminophen and codeine phosphate, a generic name as a suspect or interacting product, from February 2004 to November 2016. A further 1,354 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 0 reports listed it, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 24 reports a year and 0% of the 20,646,523 reports in the database, and 0.1% of the reports for the opioid agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded completed suicide (18.3%), drug interaction (5.3%) and vomiting (5.3%). A report can list several reactions, so shares add to more than 100%; 228 different terms appear across these reports. Completed suicide is recorded in 18.3% of these reports, a larger share than in the median opioid agonist drug (1.5%).
96% of the reports are marked serious by the reporter (91.7% across the class); 33.3% record death among the outcomes and 32.6% record hospitalisation, as reported. 39.5% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (30.5%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
No report listing Acetaminophen and codeine phosphate was received in the five years to June 2026; the latest was received in November 2016.
By year received
Reactions recorded in the reports
share of Acetaminophen and codeine phosphate reports recording the termmedian drug in opioid agonist
- Completed suicidedeath by suicide18.3%97
- Drug interactionan interaction between medicines5.3%28
- Vomitingbeing sick5.3%28
- Dyspnoeashortness of breath4.3%23
- Multiple drug overdose intentional4.3%23
- Overdosea dose above the recommended amount4.1%22
- Drug toxicity4%21
- Cardio-respiratory arrestthe heart and breathing stopped3.8%20
- Medication errora mistake in prescribing, dispensing or taking a medicine3.6%19
- Cardiac arrestthe heart stopped3.4%18
- Drug abusemisuse of a medicine3.4%18
- Loss of consciousnesspassing out3%16
- Intentional drug misuse2.6%14
- Nauseafeeling sick2.6%14
- Confusional stateconfusion2.4%13
- Poisoning2.4%13
- Respiratory arrestbreathing stopped2.4%13
- Back painback pain2.3%12
- Drug exposure during pregnancythe medicine was taken during pregnancy2.3%12
- Macrocytosis2.3%12
- Metabolic acidosistoo much acid in the body fluids2.3%12
- Multiple drug overdose2.3%12
- Renal failurekidney failure2.3%12
- Somnolencedrowsiness2.3%12
- Constipationconstipation2.1%11
- Dizzinesslight-headedness or unsteadiness2.1%11
- Maternal exposure during pregnancythe mother took the medicine during pregnancy2.1%11
- Pyrexiafever2.1%11
- Dehydrationdehydration1.9%10
- Headachehead pain1.9%10
Top 30 of 228 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 39.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Pain | 52 | 9.8% |
| Back pain | 33 | 6.2% |
| Arthralgia | 16 | 3% |
| Analgesic therapy | 7 | 1.3% |
| Drug exposure during pregnancy | 5 | 0.9% |
| Migraine | 5 | 0.9% |
The indication field is filled in by the reporter and is often blank; shares are of all 531 reports.
In context
| Measure | Acetaminophen and codeine phosphate | Opioid agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 531 | 965,051 | 20,646,523 |
| Share of that pool | — | 0.1% | 0% |
| Reports, latest 12 months | 0 | — | 1,332,454 |
| Marked serious | 96% | 91.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 333 | 357 | 91 |
| Hospitalisation recorded, per 1,000 reports | 326 | 126 | 213 |
| Consumer-filed share | 8.9% | 32.5% | 45.8% |
| Top term, share of reports | Completed suicide 18.3% | median 1.5% | 0.4% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| OxyContin | brand | 146,263 | 584 | 94.6% |
| Oxycodone hydrochloride | generic | 113,220 | 2,598 | 94.7% |
| Dilaudid | brand | 64,191 | 173 | 95.7% |
| Morphine sulfate | generic | 60,092 | 1,577 | 79.8% |
| Hydrocodone bitartrate and acetaminophen | generic | 59,052 | 170 | 96.2% |
| Percocet | brand | 57,793 | 198 | 95.4% |
| Fentanyl | generic | 53,656 | 3,292 | 86.2% |
| MS Contin | brand | 52,128 | 55 | 98.7% |
| Oxycodone | generic | 35,671 | 2,853 | 91.8% |
| Hysingla ER | brand | 30,703 | 6 | 92.1% |
| Morphine | generic | 28,421 | 1,421 | 90.5% |
| Nucynta | brand | 27,575 | 127 | 90.4% |
| Tramadol hydrochloride | generic | 27,447 | 1,952 | 92.4% |
| Oxycodone and acetaminophen | generic | 24,919 | 112 | 94% |
| Norco | brand | 24,661 | 42 | 93.1% |
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.
Questions about Acetaminophen and codeine phosphate reports
How many adverse event reports has FDA received for Acetaminophen and codeine phosphate?
531 reports list Acetaminophen and codeine phosphate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 1,354 list it only as a concomitant medication.
What reactions are recorded in Acetaminophen and codeine phosphate reports?
completed suicide (18.3%), drug interaction (5.3%), vomiting (5.3%), dyspnoea (4.3%) and multiple drug overdose intentional (4.3%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Acetaminophen and codeine phosphate was responsible.
How serious are the reports?
96% are marked serious by the reporter. Among the outcomes recorded, 33.3% of reports include death and 32.6% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (39.5%), physician (31.3%) and not given (12.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Acetaminophen and codeine phosphate rising?
0 reports in the 12 months to June 2026, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Acetaminophen and codeine phosphate was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Acetaminophen and codeine phosphate?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 phosphate as a suspect or interacting product; reports listing it only as a concomitant medication (1,354) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.