Opana Er adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Opana Er
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.

Reports on file

From October 2006 to June 2026, FDA received 30,627 adverse event reports that name Opana Er. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 395 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 10 reports in the 12 months to June 2026 and 93 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Opana Er 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 1 report that names Opana Er.
In January to March 2026, FDA received 1.
In April to June 2025, FDA received 0.

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 237 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 30,607 of the 30,627 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 237 terms.

Reaction terms in the reports that name Opana Er, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 30,627 reports
Deaththe patient died; cause not stated by this term	12,563	41%
Toxicity to various agentspoisoning or toxic effect of one or more substances	9,113	29.8%
Overdosea dose above the recommended amount	7,732	25.2%
Dependence	3,987	13%
Drug abusemisuse of a medicine	1,872	6.1%
Drug dependencedependence on a medicine	1,698	5.5%
Drug withdrawal syndrome neonatal	1,455	4.8%
Ill-defined disordera condition that was not clearly described	1,348	4.4%
Accidental overdosean accidental overdose	639	2.1%
Withdrawal syndrome	564	1.8%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	533	1.7%
Drug diversion	498	1.6%
Drug ineffectivethe medicine did not work as expected	437	1.4%
Intentional product misusedeliberate use not as intended	431	1.4%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	347	1.1%
Drug effect decreasedthe medicine had less effect	229	0.7%
Painpain, site not specified	217	0.7%
Medication residue present	215	0.7%
Depressionlow mood	169	0.6%
Developmental delayslower development in a child	167	0.5%
Wrong technique in drug usage processthe medicine was used in the wrong way	165	0.5%
Hepatitis Chepatitis C infection	160	0.5%
Tremorshaking	151	0.5%
Drug withdrawal syndromesymptoms on stopping a medicine	145	0.5%
Nauseafeeling sick	137	0.4%
Incorrect route of drug administrationthe medicine was given by the wrong route	133	0.4%
Crying	128	0.4%
Poor feeding infant	126	0.4%
Live birth	124	0.4%
Opisthotonus	122	0.4%
Intentional drug misuse	120	0.4%
Exposure during pregnancythe medicine was taken during pregnancy	107	0.3%
Intentional product use issuedeliberate use not as intended	107	0.3%
Vomitingbeing sick	107	0.3%
Constipation	92	0.3%
Malaisegeneral feeling of being unwell	89	0.3%
Dysphagiadifficulty swallowing	84	0.3%
Anxiety	82	0.3%
Drug screen positive	78	0.3%
Gastrointestinal disorder	78	0.3%
Feeling abnormalfeeling odd or not right	76	0.2%
Inappropriate schedule of drug administrationthe medicine was taken at the wrong times	70	0.2%
Diarrhoealoose or frequent stools	67	0.2%
Infectionan infection, type not specified	67	0.2%
Abdominal pain upperupper stomach pain	63	0.2%
Abdominal discomfortstomach discomfort	60	0.2%
Headachehead pain	59	0.2%
Acute kidney injurysudden loss of kidney function	57	0.2%
Asthma	55	0.2%
Speech disorder developmental	55	0.2%

Download all 237 terms of Opana Er (CSV)

The counts add to more than 30,627 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 Opana Er, 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
2006	7	7	1	0	1	0	0	6	0
2007	79	78	9	4	18	3	0	54	1
2008	110	104	35	5	18	0	0	63	6
2009	80	77	38	1	13	0	0	34	3
2010	67	64	18	0	18	0	0	34	3
2011	139	135	40	2	14	0	0	88	4
2012	354	235	16	3	48	1	0	190	119
2013	889	195	26	9	56	0	0	152	694
2014	124	73	3	0	33	3	0	61	51
2015	52	45	7	0	20	2	0	28	7
2016	262	66	12	2	17	1	0	56	196
2017	1,779	1,774	453	2	943	2	371	442	5
2018	21,717	21,659	19,634	0	992	0	536	4,025	58
2019	21	11	2	1	2	0	1	11	10
2020	441	436	3	0	220	0	0	311	5
2021	259	258	0	0	105	0	0	257	1
2022	8	8	2	0	2	0	2	6	0
2023	3,902	3,899	458	0	3	2	0	3,853	3
2024	273	263	16	2	12	0	1	255	10
2025	59	57	3	1	1	0	0	56	2
2026	5	5	0	0	0	0	0	5	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 Opana Er, 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 Opana Er, by the year in which FDA received them
Year	Reports
2006	7
2007	74
2008	99
2009	93
2010	68
2011	134
2012	383
2013	881
2014	153
2015	51
2016	228
2017	1,776
2018	21,725
2019	17
2020	647
2021	51
2022	3
2023	3,972
2024	252
2025	11
2026	2

Reports that name Opana Er, 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 Opana Er
Age	Reports	Share
Under 2	101	0.3%
2 to 11	0	0%
12 to 17	15	under 0.1%
18 to 44	381	1.2%
45 to 64	327	1.1%
65 to 74	45	0.1%
75 and over	16	0.1%
Age not given	29,742	97.1%

Sex of the patient in the reports that name Opana Er
Sex	Reports	Share
Female	2,436	8%
Male	2,653	8.7%
Unknown or not given	25,538	83.4%

Type of reporter in the reports that name Opana Er
Reporter	Reports	Share
Physician	601	2%
Pharmacist	193	0.6%
Other health professional	178	0.6%
Lawyer	20,423	66.7%
Consumer or non-health professional	9,054	29.6%
Not given	178	0.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 100% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Opana Er record
Indication as recorded (MedDRA)	Reports	Share
Pain	22,240	72.6%
Back pain	216	0.7%
Drug abuse	184	0.6%
Drug diversion	41	0.1%
Arthralgia	14	under 0.1%
Pain in extremity	10	under 0.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 30,627 reports.

Drugs in the same reports

Other drugs that the reports of Opana Er name, in any role, in order of name
Drug	Reports that name the two
Actiq	22,813
Duragesic	23,096
Fentora	22,814
Hydromorphone	23,086
MS Contin	22,920
Opana	27,058
Oxycodone hydrochloride	23,333
OxyContin	23,627
Percocet	26,655
Percodan	23,622

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

Opana next in the A to Z list
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These links are for navigation. No count selected them.

Official pages

DailyMed labels for Opana ErThe 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. Opana Er: adverse event reports that FDA received. https://reportedreactions.com/drug/opana-er/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Opana Er as a suspect or interacting product. The 395 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 Opana Er 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 Opana Er?

No. It is a count of what people reported to FDA: 30,627 reports from October 2006 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 (66.7%), consumer or non-health professional (29.6%) and physician (2%). 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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