Kadian adverse event reports that FDA received

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

Name type: Product name as reported

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 February 2004 to June 2026, FDA received 20,205 adverse event reports that name Kadian. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 966 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 17 reports in the 12 months to June 2026 and 1 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, 17 (under 0.1%) name Kadian. Reports from lawyers were 84.8% of the reports that name Kadian and 2.6% 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 Kadian 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 6 reports that name Kadian.
In January to March 2026, FDA received 8.
In April to June 2025, FDA received 1.

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 190 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 20,191 of the 20,205 reports (99.9%).

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 190 terms.

Reaction terms in the reports that name Kadian, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 20,205 reports
Deaththe patient died; cause not stated by this term	9,460	46.8%
Toxicity to various agentspoisoning or toxic effect of one or more substances	8,036	39.8%
Overdosea dose above the recommended amount	4,020	19.9%
Drug abusemisuse of a medicine	1,649	8.2%
Drug dependencedependence on a medicine	1,520	7.5%
Drug withdrawal syndrome neonatal	740	3.7%
Accidental overdosean accidental overdose	596	2.9%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	369	1.8%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	332	1.6%
Intentional product misusedeliberate use not as intended	292	1.4%
Drug diversion	255	1.3%
Painpain, site not specified	201	1%
Tremorshaking	138	0.7%
Crying	128	0.6%
Poor feeding infant	128	0.6%
Hepatitis Chepatitis C infection	126	0.6%
Live birth	126	0.6%
Opisthotonus	125	0.6%
Developmental delayslower development in a child	121	0.6%
Drug withdrawal syndromesymptoms on stopping a medicine	77	0.4%
Exposure during pregnancythe medicine was taken during pregnancy	70	0.3%
Completed suicidedeath by suicide	69	0.3%
Substance abuse	56	0.3%
Unresponsive to stimuli	45	0.2%
Vomitingbeing sick	36	0.2%
Nauseafeeling sick	35	0.2%
Somnolencedrowsiness	34	0.2%
Drug ineffectivethe medicine did not work as expected	33	0.2%
Depressionlow mood	32	0.2%
Drug toxicity	28	0.1%
Hypotensionlow blood pressure	27	0.1%
Emotional distress	26	0.1%
Pulmonary oedemafluid in the lungs	25	0.1%
Anxiety	23	0.1%
Cardio-respiratory arrestthe heart and breathing stopped	23	0.1%
Fatiguetiredness	23	0.1%
Pulmonary congestion	22	0.1%
Weight decreasedweight loss	22	0.1%
Tooth loss	21	0.1%
Coma	20	0.1%
Multiple drug overdose	20	0.1%
Cardiac arrestthe heart stopped	19	0.1%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	19	0.1%
Respiratory depressionslow or shallow breathing	19	0.1%
Accidental death	18	0.1%
Drug screen positive	18	0.1%
Headachehead pain	18	0.1%
Constipation	17	0.1%
Falla fall	17	0.1%
Drug abuser	16	0.1%

Download all 190 terms of Kadian (CSV)

The counts add to more than 20,205 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 Kadian, 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	28	27	17	1	9	0	0	5	1
2005	48	45	28	4	22	0	0	3	3
2006	28	28	12	2	10	1	0	11	0
2007	40	38	16	2	16	0	0	12	2
2008	92	92	14	3	25	1	0	61	0
2009	133	133	2	4	13	4	0	122	0
2010	183	181	6	1	8	0	0	170	2
2011	94	94	1	0	2	1	0	90	0
2012	86	84	68	5	36	1	0	66	2
2013	162	161	131	1	4	0	0	132	1
2014	15	9	2	0	3	0	0	8	6
2015	17	8	0	0	5	0	0	6	9
2016	15	7	0	0	5	0	0	4	8
2017	435	426	356	1	25	0	44	76	9
2018	17,939	17,929	16,851	1	657	0	300	2,841	10
2019	30	15	2	0	8	0	2	12	15
2020	469	464	6	0	236	6	1	337	5
2021	305	304	2	0	115	7	1	302	1
2022	28	27	0	2	8	2	2	25	1
2023	30	15	1	0	3	3	0	15	15
2024	6	6	1	1	1	4	0	6	0
2025	8	8	1	1	3	2	0	8	0
2026	14	14	1	0	0	0	0	13	0

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 Kadian, 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 Kadian, by the year in which FDA received them
Year	Reports
2004	25
2005	50
2006	28
2007	35
2008	84
2009	52
2010	198
2011	176
2012	85
2013	162
2014	14
2015	19
2016	16
2017	436
2018	17,944
2019	31
2020	689
2021	91
2022	20
2023	29
2024	3
2025	4
2026	14

Reports that name Kadian, 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 Kadian
Age	Reports	Share
Under 2	102	0.5%
2 to 11	5	under 0.1%
12 to 17	12	0.1%
18 to 44	184	0.9%
45 to 64	221	1.1%
65 to 74	35	0.2%
75 and over	24	0.1%
Age not given	19,622	97.1%

Sex of the patient in the reports that name Kadian
Sex	Reports	Share
Female	971	4.8%
Male	564	2.8%
Unknown or not given	18,670	92.4%

Type of reporter in the reports that name Kadian
Reporter	Reports	Share
Physician	302	1.5%
Pharmacist	22	0.1%
Other health professional	89	0.4%
Lawyer	17,133	84.8%
Consumer or non-health professional	2,196	10.9%
Not given	463	2.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 99.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Kadian record
Indication as recorded (MedDRA)	Reports	Share
Pain	17,992	89%
Back pain	55	0.3%
Intentional drug misuse	12	0.1%
Completed suicide	9	under 0.1%
Maternal exposure timing unspecified	7	under 0.1%
Eye pain	5	under 0.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 20,205 reports.

Drugs in the same reports

Other drugs that the reports of Kadian name, in any role, in order of name
Drug	Reports that name the two
Actiq	18,992
Duragesic	18,978
Fentora	18,979
Norco	18,698
Opana	19,009
Opana Er	19,018
Oxycodone hydrochloride	18,625
OxyContin	18,703
Percocet	19,087
Percodan	18,788

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.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for KadianThe 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.

Cite this page

Reported Reactions. Kadian: adverse event reports that FDA received. https://reportedreactions.com/drug/kadian/ 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 Kadian as a suspect or interacting product. The 966 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 Kadian 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 Kadian?

No. It is a count of what people reported to FDA: 20,205 reports from February 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?

Lawyer (84.8%), consumer or non-health professional (10.9%) and physician (1.5%). 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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