Product name as reported
Acetaminophen Hydrocodone Bitartrate: adverse event reports filed with FDA
28,904 reports list it as a suspect or interacting product, 2011–2026.
- 28,904
- reports as suspect product
- 0.1% of all reports · about 1,866 a year
- 133
- reports, 12 months to June 2026
- 121 in the 12 months before
- 98.8%
- marked serious by the reporter
- 57.4% across all reports
- 8.2%
- record death among outcomes, as reported
- 2,384 reports · not verified by FDA
Between January 2011 and June 2026, 28,904 adverse event reports received by FDA list the product name "Acetaminophen Hydrocodone Bitartrate" as reporters wrote it as a suspect or interacting product. Reports that mention it only as a concomitant medication (1,653) are left out of every figure here.
In the 12 months to June 2026, 133 reports listed it, up 10% from 121 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 1,866 reports a year and 0.1% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded dependence (93.5%), overdose (29.3%) and ill-defined disorder (20.3%). A report can list several reactions, so shares add to more than 100%; 414 different terms appear across these reports. Dependence is recorded in 93.5% of these reports, against 0.3% of all reports in the database.
98.8% of the reports are marked serious by the reporter; 8.2% record death among the outcomes and 0.3% record hospitalisation, as reported. 96.7% of the reports came from consumers, and the largest patient age group is 45 to 64 (0.9%). 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
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 Hydrocodone Bitartrate reports recording the termall reports in the database
- Dependence93.5%27,015
- Overdosea dose above the recommended amount29.3%8,482
- Ill-defined disordera condition that was not clearly described20.3%5,881
- Drug withdrawal syndrome neonatal6.8%1,952
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine6.7%1,947
- Deaththe patient died; cause not stated by this term6.7%1,936
- Withdrawal syndrome5%1,455
- Dysphagiadifficulty swallowing3.2%931
- Depressionlow mood3%877
- Learning disorder2.9%838
- Developmental delayslower development in a child2.8%802
- Speech disorder developmental2.7%782
- Asthmaasthma2.5%719
- Gastrointestinal disorder2.1%607
- Attention deficit hyperactivity disorder1.9%560
- Gastrooesophageal reflux diseaseacid reflux1.9%559
- Drug dependencedependence on a medicine1.9%557
- Visual impairmentreduced vision1.5%443
- Premature babya baby born early1.5%422
- Disturbance in attentiondifficulty concentrating1.3%365
- Cardiac disorder1.1%324
- Gait disturbancedifficulty walking1.1%323
- Hypoacusisreduced hearing1.1%310
- Painpain, site not specified1%289
- Anxietyanxiety0.9%253
- Emotional distressemotional distress0.8%224
- Gait inability0.8%221
- Autism spectrum disorder0.7%207
- Completed suicidedeath by suicide0.6%183
- Exposure via breast milk0.5%144
Top 30 of 414 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
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. 99.3% 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 | 186 | 0.6% |
| Back pain | 40 | 0.1% |
| Pain management | 17 | 0.1% |
| Arthritis | 8 | 0% |
| Arthralgia | 7 | 0% |
| Injury | 6 | 0% |
The indication field is filled in by the reporter and is often blank; shares are of all 28,904 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Acetaminophen Hydrocodone Bitartrate reports |
|---|---|---|
| Acetaminophen Oxycodone Hydrochloride | 7,583 | 26.2% |
| Percocet | 7,028 | 24.3% |
| Endocet | 4,049 | 14% |
| Tramadol hydrochloride | 3,410 | 11.8% |
| Morphine sulfate | 2,950 | 10.2% |
| Acetaminophen and codeine | 2,465 | 8.5% |
| Fentanyl citrate | 2,292 | 7.9% |
| Opana | 2,084 | 7.2% |
| Opana Er | 1,731 | 6% |
| Oxymorphone hydrochloride | 1,527 | 5.3% |
Other products listed in reports where Acetaminophen Hydrocodone Bitartrate 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
| Measure | Acetaminophen Hydrocodone Bitartrate | All reports |
|---|---|---|
| Reports as suspect product | 28,904 | 20,646,523 |
| Share of that pool | — | 0.1% |
| Reports, latest 12 months | 133 | 1,332,454 |
| Marked serious | 98.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 82 | 91 |
| Hospitalisation recorded, per 1,000 reports | 3 | 213 |
| Consumer-filed share | 96.7% | 45.8% |
| Top term, share of reports | Dependence 93.5% | 0.3% |
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."
Questions about Acetaminophen Hydrocodone Bitartrate reports
How many adverse event reports has FDA received for Acetaminophen Hydrocodone Bitartrate?
28,904 reports list Acetaminophen Hydrocodone Bitartrate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 133 of them arrived in the latest 12 months. Another 1,653 list it only as a concomitant medication.
What reactions are recorded in Acetaminophen Hydrocodone Bitartrate reports?
dependence (93.5%), overdose (29.3%), ill-defined disorder (20.3%), drug withdrawal syndrome neonatal (6.8%) and foetal exposure during pregnancy (6.7%). 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 Hydrocodone Bitartrate was responsible.
How serious are the reports?
98.8% are marked serious by the reporter. Among the outcomes recorded, 8.2% of reports include death and 0.3% 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?
consumer or non-health professional (96.7%), physician (1.4%) and lawyer (1.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Acetaminophen Hydrocodone Bitartrate rising?
133 reports in the 12 months to June 2026, up 10% from 121 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 Hydrocodone Bitartrate 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 Hydrocodone Bitartrate?
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 Hydrocodone Bitartrate as a suspect or interacting product; reports listing it only as a concomitant medication (1,653) 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.