Hydrocodone adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Hydrocodone
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Product name as reported
Also reported as: Hydrocodone /00060002/

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 15,163 adverse event reports that name Hydrocodone. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 35,447 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 225 reports in the 12 months to June 2026 and 238 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 225 (under 0.1%) name Hydrocodone. Reports for female patients were 29.5% of the reports that name Hydrocodone and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Hydrocodone is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 32 reports that name Hydrocodone.
In January to March 2026, FDA received 46.
In April to June 2025, FDA received 57.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 475 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 15,136 of the 15,163 reports (99.8%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 475 terms.

Reaction terms in the reports that name Hydrocodone, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 15,163 reports
Deaththe patient died; cause not stated by this term	4,260	28.1%
Toxicity to various agentspoisoning or toxic effect of one or more substances	3,424	22.6%
Overdosea dose above the recommended amount	3,155	20.8%
Drug dependencedependence on a medicine	1,292	8.5%
Completed suicidedeath by suicide	1,128	7.4%
Drug withdrawal syndrome neonatal	1,004	6.6%
Drug abusemisuse of a medicine	942	6.2%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	896	5.9%
Accidental overdosean accidental overdose	710	4.7%
Painpain, site not specified	620	4.1%
Drug ineffectivethe medicine did not work as expected	403	2.7%
Anxiety	361	2.4%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	359	2.4%
Drug diversion	321	2.1%
Cardiac arrestthe heart stopped	309	2%
Emotional distress	298	2%
Cardio-respiratory arrestthe heart and breathing stopped	295	1.9%
Dependence	292	1.9%
Nauseafeeling sick	283	1.9%
Respiratory arrestbreathing stopped	275	1.8%
Developmental delayslower development in a child	263	1.7%
Injurya physical injury	250	1.6%
Drug use disorder	249	1.6%
Learning disability	244	1.6%
Drug withdrawal syndromesymptoms on stopping a medicine	206	1.4%
Drug interactionan interaction between medicines	198	1.3%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	195	1.3%
Vomitingbeing sick	188	1.2%
Somnolencedrowsiness	175	1.2%
Constipation	164	1.1%
Depressionlow mood	159	1%
Dizzinesslight-headedness or unsteadiness	156	1%
Pruritusitching	147	1%
Back pain	144	0.9%
Falla fall	143	0.9%
Fatiguetiredness	141	0.9%
Headachehead pain	138	0.9%
Feeling abnormalfeeling odd or not right	134	0.9%
Arthralgiajoint pain	131	0.9%
Intentional product misusedeliberate use not as intended	119	0.8%
Hypotensionlow blood pressure	114	0.8%
Dyspnoeashortness of breath	113	0.7%
Insomniadifficulty sleeping	112	0.7%
Drug toxicity	109	0.7%
Intentional overdosea deliberate overdose	107	0.7%
Malaisegeneral feeling of being unwell	106	0.7%
Off label useused for a purpose or in a way not on the label	99	0.7%
Pain in extremitypain in an arm or leg	96	0.6%
Condition aggravatedthe condition being treated got worse	95	0.6%
Confusional stateconfusion	95	0.6%

Download all 475 terms of Hydrocodone (CSV)

The counts add to more than 15,163 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Hydrocodone, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	64	60	37	1	17	1	0	19	4
2005	29	29	14	1	7	0	1	13	0
2006	80	78	63	2	12	0	0	12	2
2007	33	31	23	0	6	0	0	10	2
2008	56	51	45	0	3	0	0	12	5
2009	86	71	49	3	14	0	0	13	15
2010	171	169	145	0	14	1	0	30	2
2011	104	100	81	1	8	1	0	18	4
2012	149	111	53	1	22	1	0	59	38
2013	448	341	202	2	48	6	5	145	107
2014	578	433	306	9	49	7	3	140	145
2015	730	544	437	11	64	6	1	139	186
2016	494	270	165	4	58	4	0	103	224
2017	2,260	2,119	741	18	1,069	10	351	559	141
2018	5,604	5,455	4,574	33	388	8	346	935	149
2019	786	483	381	13	69	10	2	179	303
2020	725	600	370	15	137	14	2	375	125
2021	831	693	149	7	71	107	44	606	138
2022	764	630	203	36	83	11	2	516	134
2023	489	418	155	5	81	2	0	322	71
2024	258	201	65	4	44	5	0	162	57
2025	331	269	91	11	66	6	2	211	62
2026	93	72	37	2	30	1	0	56	21

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Hydrocodone, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Hydrocodone, by the year in which FDA received them
Year	Reports
2004	51
2005	39
2006	81
2007	31
2008	55
2009	81
2010	181
2011	105
2012	202
2013	453
2014	599
2015	748
2016	515
2017	2,287
2018	5,634
2019	723
2020	744
2021	802
2022	746
2023	486
2024	232
2025	289
2026	78

Reports that name Hydrocodone, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Hydrocodone
Age	Reports	Share
Under 2	48	0.3%
2 to 11	30	0.2%
12 to 17	83	0.5%
18 to 44	1,784	11.8%
45 to 64	2,178	14.4%
65 to 74	653	4.3%
75 and over	388	2.6%
Age not given	9,999	65.9%

Sex of the patient in the reports that name Hydrocodone
Sex	Reports	Share
Female	4,473	29.5%
Male	2,850	18.8%
Unknown or not given	7,840	51.7%

Type of reporter in the reports that name Hydrocodone
Reporter	Reports	Share
Physician	2,374	15.7%
Pharmacist	722	4.8%
Other health professional	1,728	11.4%
Lawyer	3,902	25.7%
Consumer or non-health professional	6,174	40.7%
Not given	263	1.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 98.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Hydrocodone record
Indication as recorded (MedDRA)	Reports	Share
Pain	6,648	43.8%
Back pain	107	0.7%
Suicide attempt	80	0.5%
Drug abuse	54	0.4%
Breakthrough pain	27	0.2%
Completed suicide	27	0.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 15,163 reports.

Drugs in the same reports

Other drugs that the reports of Hydrocodone name, in any role, in order of name
Drug	Reports that name the two
Dilaudid	6,640
Duragesic	6,379
Hydromorphone	7,006
MS Contin	6,471
Opana	6,948
Opana Er	6,876
Oxycodone hydrochloride	7,603
OxyContin	7,513
Percocet	7,291
Percodan	6,883

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Hydrochlorothiazide/Lisinopril next in the A to Z list
Hydrocodone and Acetaminophen next in the A to Z list
Hydrochlorothiazide/Irbesartan next in the A to Z list
Hydrocodone bitartrate next in the A to Z list
Hydrochlorothiazide Valsartan next in the A to Z list
Hydrocodone Bitartrate + Acetaminophen next in the A to Z list
Hydrochlorothiazide Unk next in the A to Z list
Hydrocodone Bitartrate Acetaminophen Unk next in the A to Z list
Hydrochlorothiazide Triamterene next in the A to Z list
Hydrocodone bitartrate and acetaminophen next in the A to Z list
Hydrochlorothiazide Telmisartan next in the A to Z list
Hydrocodone bitartrate and ibuprofen next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for HydrocodoneThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

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Reported Reactions. Hydrocodone: adverse event reports that FDA received. https://reportedreactions.com/drug/hydrocodone/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Hydrocodone as a suspect or interacting product. The 35,447 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Hydrocodone was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Hydrocodone?

No. It is a count of what people reported to FDA: 15,163 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (40.7%), lawyer (25.7%) and physician (15.7%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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