Omeprazole magnesium adverse event reports that FDA received

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

Name type: Generic name
Class: Proton pump inhibitor
Also reported as: Omeprazole Delayed Release Capsules 20 Mg, Omeprazole Tablet 10 Mg, Omeprazole Delayed Release Capsules 40 Mg

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 June 2005 to June 2026, FDA received 4,120 adverse event reports that name Omeprazole magnesium. In these reports the drug is a suspect or interacting product.

In the same period, 1,211 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 175 reports in the 12 months to June 2026 and 99 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, 175 (under 0.1%) name Omeprazole magnesium. Reports from lawyers were 28.7% of the reports that name Omeprazole magnesium 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 Omeprazole magnesium 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 63 reports that name Omeprazole magnesium.
In January to March 2026, FDA received 41.
In April to June 2025, FDA received 27.

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 276 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 4,018 of the 4,120 reports (97.5%).

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 276 terms.

Reaction terms in the reports that name Omeprazole magnesium, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,120 reports
Chronic kidney diseaselong-term kidney disease	1,809	43.9%
Acute kidney injurysudden loss of kidney function	919	22.3%
End stage renal diseasekidney failure needing dialysis or transplant	644	15.6%
Renal failurekidney failure	510	12.4%
Renal injury	385	9.3%
Gastrooesophageal reflux diseaseacid reflux	317	7.7%
Drug ineffectivethe medicine did not work as expected	252	6.1%
Tubulointerstitial nephritis	200	4.9%
Painpain, site not specified	144	3.5%
Constipation	127	3.1%
Diarrhoealoose or frequent stools	125	3%
Nauseafeeling sick	118	2.9%
Falla fall	117	2.8%
Toxicity to various agentspoisoning or toxic effect of one or more substances	114	2.8%
Drug interactionan interaction between medicines	112	2.7%
Deaththe patient died; cause not stated by this term	111	2.7%
Dyspnoeashortness of breath	110	2.7%
Hypotensionlow blood pressure	108	2.6%
Cognitive disorderproblems with thinking or memory	103	2.5%
Renal impairmentreduced kidney function	98	2.4%
Balance disorderproblems with balance	97	2.4%
Orthostatic hypotension	97	2.4%
Mobility decreasedreduced ability to move about	88	2.1%
Off label useused for a purpose or in a way not on the label	84	2%
Sedationdrowsiness	84	2%
Blood calcium decreased	80	1.9%
Depressed level of consciousness	80	1.9%
Creatinine renal clearance decreased	79	1.9%
Sedation complication	78	1.9%
Abdominal pain upperupper stomach pain	77	1.9%
Malaisegeneral feeling of being unwell	74	1.8%
Depressionlow mood	73	1.8%
Dizzinesslight-headedness or unsteadiness	73	1.8%
Product use in unapproved indicationused for a purpose not on the label	70	1.7%
Condition aggravatedthe condition being treated got worse	69	1.7%
Chest discomfort	67	1.6%
Vomitingbeing sick	65	1.6%
Anxiety	60	1.5%
Headachehead pain	60	1.5%
Dyspepsiaindigestion	59	1.4%
Overdosea dose above the recommended amount	58	1.4%
Rebound acid hypersecretion	57	1.4%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	54	1.3%
Hypertensionhigh blood pressure	52	1.3%
Rashskin rash	51	1.2%
Abdominal discomfortstomach discomfort	44	1.1%
Nephrogenic anaemia	43	1%
Product use issuea problem in how the product was used	42	1%
Hypersensitivityan allergic-type reaction	41	1%
Cerebrovascular accidentstroke	40	1%

Download all 276 terms of Omeprazole magnesium (CSV)

The counts add to more than 4,120 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.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Omeprazole with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Omeprazole	Generic name	61,176
Omeprazole magnesium (this page)	Generic name	4,120
Prilosec	Brand name	42,343
Prilosec OTC	Brand name	24,549

Sum of the separately reported names: 132,188. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

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

Outcomes in the reports that name Omeprazole magnesium, 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	0	0	0	0	0	0	0	0	0
2005	1	1	0	0	1	0	0	1	0
2006	1	1	0	0	1	0	0	0	0
2007	2	2	0	0	1	0	0	1	0
2008	1	1	0	0	1	0	0	0	0
2009	3	3	0	0	0	0	0	3	0
2010	6	1	0	0	1	0	0	0	5
2011	16	14	0	0	5	1	0	8	2
2012	19	18	0	0	8	1	0	11	1
2013	7	6	0	1	2	0	0	5	1
2014	31	19	6	0	16	0	0	3	12
2015	40	27	5	1	10	0	0	17	13
2016	43	16	2	0	8	0	0	8	27
2017	93	63	0	3	21	5	1	54	30
2018	314	111	5	3	42	4	3	91	203
2019	1,699	1,525	136	4	46	5	0	1,499	174
2020	596	418	61	13	89	10	4	365	178
2021	477	291	67	3	26	0	2	258	186
2022	303	280	52	5	61	3	1	264	23
2023	118	98	40	22	34	2	1	83	20
2024	81	70	4	19	39	0	0	56	11
2025	146	90	10	25	55	12	0	65	56
2026	123	29	3	12	18	5	2	25	94

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 Omeprazole magnesium, 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 Omeprazole magnesium, by the year in which FDA received them
Year	Reports
2005	1
2006	1
2007	2
2008	1
2009	3
2010	2
2011	20
2012	22
2013	7
2014	30
2015	43
2016	46
2017	98
2018	931
2019	1,470
2020	503
2021	406
2022	140
2023	83
2024	82
2025	125
2026	104

Reports that name Omeprazole magnesium, 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 Omeprazole magnesium
Age	Reports	Share
Under 2	14	0.3%
2 to 11	27	0.7%
12 to 17	12	0.3%
18 to 44	172	4.2%
45 to 64	554	13.4%
65 to 74	369	9%
75 and over	419	10.2%
Age not given	2,553	62%

Sex of the patient in the reports that name Omeprazole magnesium
Sex	Reports	Share
Female	1,446	35.1%
Male	858	20.8%
Unknown or not given	1,816	44.1%

Type of reporter in the reports that name Omeprazole magnesium
Reporter	Reports	Share
Physician	197	4.8%
Pharmacist	41	1%
Other health professional	733	17.8%
Lawyer	1,181	28.7%
Consumer or non-health professional	1,924	46.7%
Not given	44	1.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 84.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Omeprazole magnesium record
Indication as recorded (MedDRA)	Reports	Share
Gastrooesophageal reflux disease	1,043	25.3%
Dyspepsia	300	7.3%
Duodenal ulcer	68	1.7%
Gastrointestinal disorder	21	0.5%
Small intestine carcinoma	15	0.4%
Prophylaxis against gastrointestinal ulcer	14	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,120 reports.

Drugs in the same reports

Other drugs that the reports of Omeprazole magnesium name, in any role, in order of name
Drug	Reports that name the two
Dexilant	1,335
Lansoprazole	626
Nexium	2,053
Nexium 24HR	1,850
Omeprazole	1,525
Pantoprazole	1,018
Pantoprazole sodium	2,014
Prevacid	2,099
Prevacid 24 HR	1,778
Prilosec	2,022

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

Omeprazole same ingredient
Prilosec same ingredient
Prilosec OTC same ingredient
Omeprazole delayed release same class
Pantoprazole same class
Omeprazole and sodium bicarbonate same class
Pantoprazole sodium same class
Prevacid same class
Omeprazole Magnesium Delayed Release Otc next in the A to Z list
Omeprazole Sodium next in the A to Z list
Omnaris next in the A to Z list
Omeprazol next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Omeprazole magnesiumThe 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. Omeprazole magnesium: adverse event reports that FDA received. https://reportedreactions.com/drug/omeprazole-magnesium/ 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 Omeprazole magnesium as a suspect or interacting product. The 1,211 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 Omeprazole magnesium 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 Omeprazole magnesium?

No. It is a count of what people reported to FDA: 4,120 reports from June 2005 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 (46.7%), lawyer (28.7%) and other health professional (17.8%). 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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