Rabeprazole sodium adverse event reports that FDA received

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

Name type: Generic name
Class: Proton pump inhibitor
Also reported as: Rabeprazole Na, Rabeprazole Sodium Delayed-Release Tablets, Rabeprazole Sodium Delayed-Release 20mg Tablets

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 2,214 adverse event reports that name Rabeprazole sodium. In these reports the drug is a suspect or interacting product.

In the same period, 9,215 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 127 reports in the 12 months to June 2026 and 171 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, 127 (under 0.1%) name Rabeprazole sodium. Reports from consumers or other non-health professionals were 16.2% of the reports that name Rabeprazole sodium and 45.8% 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 Rabeprazole sodium 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 26 reports that name Rabeprazole sodium.
In January to March 2026, FDA received 31.
In April to June 2025, FDA received 28.

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 351 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 2,175 of the 2,214 reports (98.2%).

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 351 terms.

Reaction terms in the reports that name Rabeprazole sodium, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,214 reports
Drug ineffectivethe medicine did not work as expected	338	15.3%
Dyspnoeashortness of breath	232	10.5%
Cough	227	10.3%
Headachehead pain	182	8.2%
Drug intolerancethe medicine was not tolerated	171	7.7%
Obstructive airways disorder	171	7.7%
Off label useused for a purpose or in a way not on the label	160	7.2%
Diarrhoealoose or frequent stools	155	7%
Hypersensitivityan allergic-type reaction	143	6.5%
Pneumonialung infection	137	6.2%
Nauseafeeling sick	136	6.1%
Rashskin rash	132	6%
Arthralgiajoint pain	128	5.8%
Eosinophil count increased	126	5.7%
Malaisegeneral feeling of being unwell	126	5.7%
Hypertensionhigh blood pressure	115	5.2%
Constipation	113	5.1%
Abdominal discomfortstomach discomfort	111	5%
Asthma	110	5%
Abdominal pain upperupper stomach pain	105	4.7%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	104	4.7%
Full blood count abnormal	104	4.7%
Dysphoniaa hoarse voice	99	4.5%
Gastrooesophageal reflux diseaseacid reflux	99	4.5%
Hepatic steatosisfatty liver	91	4.1%
Cardiac failure congestivecongestive heart failure	85	3.8%
Pulmonary mass	85	3.8%
Angioedemadeep swelling of skin or mucous membranes	84	3.8%
Painpain, site not specified	84	3.8%
Swelling facea swollen face	80	3.6%
Swollen tongue	80	3.6%
Therapeutic product effect decreased	79	3.6%
Pruritusitching	75	3.4%
Multiple allergies	74	3.3%
Bronchial secretion retention	73	3.3%
Respiratory tract infectiona respiratory infection	73	3.3%
Sputum culture positive	73	3.3%
Upper-airway cough syndrome	73	3.3%
Contraindicated product administered	72	3.3%
Vital capacity decreased	72	3.3%
Reversible airways obstruction	71	3.2%
Gait disturbancedifficulty walking	68	3.1%
Dizzinesslight-headedness or unsteadiness	67	3%
Hypotensionlow blood pressure	67	3%
Abdominal distensiona bloated abdomen	66	3%
Cardiac failureheart failure	66	3%
Gastrointestinal disorder	66	3%
Product use in unapproved indicationused for a purpose not on the label	66	3%
Myalgiamuscle pain	64	2.9%
Liver disorder	62	2.8%

Download all 351 terms of Rabeprazole sodium (CSV)

The counts add to more than 2,214 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 Rabeprazole with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Rabeprazole	Generic name	2,693
Rabeprazole sodium (this page)	Generic name	2,214
Aciphex	Brand name	7,246

Sum of the separately reported names: 12,153. 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 Rabeprazole sodium, 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	58	45	7	4	35	2	0	6	13
2005	78	62	19	8	38	7	0	7	16
2006	73	52	9	5	34	2	2	7	21
2007	84	77	3	2	54	2	0	21	7
2008	78	61	3	2	39	4	0	18	17
2009	27	23	1	1	14	2	0	9	4
2010	40	40	7	2	23	6	0	13	0
2011	139	137	12	17	72	1	0	64	2
2012	138	136	14	9	88	5	0	57	2
2013	14	12	1	1	9	0	0	4	2
2014	37	13	1	1	2	2	0	10	24
2015	50	24	1	3	14	1	0	11	26
2016	33	18	1	0	10	0	0	9	15
2017	31	22	1	2	9	2	0	14	9
2018	40	28	1	4	22	3	1	14	12
2019	78	67	6	2	29	6	0	43	11
2020	58	49	3	0	32	1	0	40	9
2021	90	88	2	1	26	3	0	69	2
2022	258	255	11	10	102	5	0	176	3
2023	275	268	9	13	102	13	5	185	7
2024	247	241	4	3	112	3	3	150	6
2025	180	180	6	7	89	2	2	125	0
2026	108	106	5	5	50	1	1	97	2

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 Rabeprazole sodium, 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 Rabeprazole sodium, by the year in which FDA received them
Year	Reports
2004	55
2005	76
2006	69
2007	84
2008	84
2009	30
2010	44
2011	132
2012	149
2013	14
2014	39
2015	51
2016	36
2017	34
2018	60
2019	107
2020	74
2021	136
2022	264
2023	252
2024	230
2025	137
2026	57

Reports that name Rabeprazole sodium, 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 Rabeprazole sodium
Age	Reports	Share
Under 2	1	under 0.1%
2 to 11	4	0.2%
12 to 17	9	0.4%
18 to 44	288	13%
45 to 64	584	26.4%
65 to 74	299	13.5%
75 and over	499	22.5%
Age not given	530	23.9%

Sex of the patient in the reports that name Rabeprazole sodium
Sex	Reports	Share
Female	1,326	59.9%
Male	751	33.9%
Unknown or not given	137	6.2%

Type of reporter in the reports that name Rabeprazole sodium
Reporter	Reports	Share
Physician	793	35.8%
Pharmacist	127	5.7%
Other health professional	853	38.5%
Lawyer	4	0.2%
Consumer or non-health professional	359	16.2%
Not given	78	3.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 9.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Rabeprazole sodium record
Indication as recorded (MedDRA)	Reports	Share
Gastrooesophageal reflux disease	220	9.9%
Helicobacter infection	88	4%
Migraine	59	2.7%
Gastric ulcer	45	2%
Prophylaxis against gastrointestinal ulcer	39	1.8%
Reflux oesophagitis	35	1.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,214 reports.

Drugs in the same reports

Other drugs that the reports of Rabeprazole sodium name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	232
Albuterol	198
Albuterol sulfate	155
Aspirin	173
Cephalexin	140
Clarithromycin	192
Codeine	138
Furosemide	194
Prednisone	365
Rabeprazole	160

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

Rabeprazole same ingredient
Aciphex same ingredient
Zegerid same class
Prilosec OTC same class
Zegerid OTC same class
Prilosec same class
Racecadotril next in the A to Z list
Qwo next in the A to Z list
Rad001 next in the A to Z list
Qvar Redihaler next in the A to Z list
Radiation next in the A to Z list
Qvar 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 Rabeprazole sodiumThe 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. Rabeprazole sodium: adverse event reports that FDA received. https://reportedreactions.com/drug/rabeprazole-sodium/ 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 Rabeprazole sodium as a suspect or interacting product. The 9,215 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 Rabeprazole sodium 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 Rabeprazole sodium?

No. It is a count of what people reported to FDA: 2,214 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?

Other health professional (38.5%), physician (35.8%) and consumer or non-health professional (16.2%). 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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