Hydrocodone Bitartrate And Acetaminophen
According to the FDA label: Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
55,870 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Hydrocodone Bitartrate And Acetaminophen in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
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Drug Dependence 33,279 reports
A report that the body or mind has come to rely on a medication, so that stopping it causes difficulty. The term describes a physical or psychological state, not a judgment about the person.
Full definition in the glossary →Overdose 14,496 reports
Taking more of a medication than intended or recommended. This can be accidental.
Full definition in the glossary →Pain 12,028 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Emotional Distress 10,823 reports
A report of emotional suffering such as upset, worry, or anguish. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Drug Withdrawal Syndrome 5,338 reports
The set of symptoms that can occur when a medication the body has gotten used to is stopped or reduced.
Full definition in the glossary →Anxiety 4,199 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Death 3,163 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Depression 2,726 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →- Learning Disability 2,404 reports
Foetal Exposure During Pregnancy 2,312 reports
A report noting that a developing baby was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself. Also spelled fetal in American English.
Full definition in the glossary →Drug Abuse 2,247 reports
A report that a medication was used in a way other than prescribed, or for non-medical reasons. The term describes a pattern of use, not a judgment about the person.
Full definition in the glossary →- Developmental Delay 2,240 reports
Drug Withdrawal Syndrome Neonatal 2,213 reports
Withdrawal symptoms in a newborn whose mother took certain medications during pregnancy.
Full definition in the glossary →- Disability 1,764 reports
Completed Suicide 1,750 reports
A report that a person died by suicide. This is recorded in adverse event data when it occurs during medication use, and its presence does not establish that the drug was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 27,244 |
| Female | 26,277 |
| Unknown | 4 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 254 |
| 18-34 | 1,731 |
| 35-49 | 2,756 |
| 50-64 | 4,747 |
| 65-74 | 2,579 |
| 75+ | 1,783 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Hydrocodone Bitartrate And Acetaminophen. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 42,576 |
| Death | 8,198 |
| Non-Serious | 7,627 |
| Hospitalization | 7,164 |
| Disability | 6,189 |
| Life-Threatening | 423 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Hydrocodone Bitartrate And Acetaminophen. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 50 |
| 2005 | 30 |
| 2006 | 12 |
| 2007 | 42 |
| 2008 | 75 |
| 2009 | 348 |
| 2010 | 466 |
| 2011 | 950 |
| 2012 | 1,189 |
| 2013 | 129 |
| 2014 | 254 |
| 2015 | 2,000 |
| 2016 | 2,443 |
| 2017 | 1,939 |
| 2018 | 2,249 |
| 2019 | 2,148 |
| 2020 | 10,263 |
| 2021 | 19,948 |
| 2022 | 8,270 |
| 2023 | 1,424 |
| 2024 | 856 |
| 2025 | 637 |
| 2026 (partial) | 148 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Hydrocodone Bitartrate And Acetaminophen
In FDA adverse event reports that mention Hydrocodone Bitartrate And Acetaminophen, these medications appeared most often in the same report.
- Oxycodone (27,115 reports)
- Hydromorphone (11,978 reports)
- Morphine (11,431 reports)
- Gabapentin (4,104 reports)
- Buprenorphine (3,879 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026