Prevacid 24 HR (lansoprazole) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Prevacid 24 HR
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Lansoprazole
Class: Proton pump inhibitor

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 November 2009 to June 2026, FDA received 20,136 adverse event reports that name Prevacid 24 HR. In these reports the drug is a suspect or interacting product.

In the same period, 61 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 13 reports in the 12 months to June 2026 and 21 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, 13 (under 0.1%) name Prevacid 24 HR. Reports from lawyers were 41.2% of the reports that name Prevacid 24 HR 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 Prevacid 24 HR 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 12 reports that name Prevacid 24 HR.
In January to March 2026, FDA received 0.
In April to June 2025, FDA received 21.

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 325 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 20,123 of the 20,136 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 325 terms.

Reaction terms in the reports that name Prevacid 24 HR, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 20,136 reports
Chronic kidney diseaselong-term kidney disease	15,688	77.9%
Acute kidney injurysudden loss of kidney function	7,839	38.9%
Renal failurekidney failure	6,039	30%
Renal injury	5,649	28.1%
End stage renal diseasekidney failure needing dialysis or transplant	5,048	25.1%
Tubulointerstitial nephritis	1,756	8.7%
Nephrogenic anaemia	1,172	5.8%
Gastrooesophageal reflux diseaseacid reflux	1,143	5.7%
Renal impairmentreduced kidney function	1,045	5.2%
Deaththe patient died; cause not stated by this term	1,035	5.1%
Rebound acid hypersecretion	1,016	5%
Hyperchlorhydria	725	3.6%
Off label useused for a purpose or in a way not on the label	634	3.1%
Nephropathy	583	2.9%
Rebound effect	574	2.9%
Hyperparathyroidism secondary	491	2.4%
Incorrect product administration duration	422	2.1%
Dialysis	386	1.9%
Renal haemangioma	349	1.7%
Painpain, site not specified	347	1.7%
Drug dependencedependence on a medicine	319	1.6%
Proteinuriaprotein in the urine	310	1.5%
Hypertensive nephropathy	300	1.5%
Chronic kidney disease-mineral and bone disorder	285	1.4%
Nephrolithiasiskidney stones	274	1.4%
Renal disorder	272	1.4%
Incorrect drug administration duration	269	1.3%
Diabetic nephropathy	263	1.3%
Product use in unapproved indicationused for a purpose not on the label	256	1.3%
Dyspepsiaindigestion	253	1.3%
Dysuriapain on passing urine	244	1.2%
Renal cyst	227	1.1%
Depressionlow mood	212	1.1%
Haematuriablood in the urine	209	1%
Overdosea dose above the recommended amount	209	1%
Hypertensionhigh blood pressure	185	0.9%
Pollakiuriapassing urine more often	181	0.9%
Drug ineffectivethe medicine did not work as expected	175	0.9%
Anxiety	161	0.8%
Nocturia	155	0.8%
Product use issuea problem in how the product was used	155	0.8%
Renal tubular necrosis	146	0.7%
Gastric cancer	132	0.7%
Haemodialysis	129	0.6%
Therapeutic response unexpected	122	0.6%
Condition aggravatedthe condition being treated got worse	116	0.6%
Nephrosclerosis	116	0.6%
Urinary incontinenceleaking urine	93	0.5%
Renal atrophy	90	0.4%
Essential hypertension	88	0.4%

Download all 325 terms of Prevacid 24 HR (CSV)

The counts add to more than 20,136 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 Lansoprazole with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Lansoprazole	Generic name	26,570
Prevacid	Brand name	40,151
Prevacid 24 HR (this page)	Brand name	20,136
Prevacid SoluTab	Brand name	239

Sum of the separately reported names: 87,096. 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 Prevacid 24 HR, 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
2009	4	4	0	0	0	0	0	4	0
2010	59	57	0	1	12	0	0	47	2
2011	60	59	0	0	11	0	0	52	1
2012	129	124	4	4	15	2	0	109	5
2013	6	6	0	1	2	0	0	3	0
2015	3	3	0	0	1	1	0	1	0
2016	495	2	0	0	1	0	0	1	493
2017	103	5	2	0	0	0	0	5	98
2018	3,205	2,747	379	3	39	11	2	2,725	458
2019	10,288	10,107	817	3	616	76	8	10,098	181
2020	2,069	1,983	260	0	269	41	0	1,972	86
2021	2,087	2,041	284	1	263	39	1	2,030	46
2022	1,165	1,121	158	0	116	20	2	1,118	44
2023	381	359	197	0	65	10	0	357	22
2024	46	14	2	0	1	0	0	14	32
2025	21	1	0	0	0	0	0	1	20
2026	15	3	1	0	0	0	0	3	12

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 Prevacid 24 HR, 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 Prevacid 24 HR, by the year in which FDA received them
Year	Reports
2009	3
2010	59
2011	61
2012	131
2013	8
2015	3
2016	500
2017	148
2018	7,777
2019	8,330
2020	1,314
2021	1,258
2022	372
2023	99
2024	39
2025	22
2026	12

Reports that name Prevacid 24 HR, 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 Prevacid 24 HR
Age	Reports	Share
Under 2	20	0.1%
2 to 11	32	0.2%
12 to 17	12	0.1%
18 to 44	1,016	5%
45 to 64	4,229	21%
65 to 74	1,694	8.4%
75 and over	831	4.1%
Age not given	12,302	61.1%

Sex of the patient in the reports that name Prevacid 24 HR
Sex	Reports	Share
Female	7,205	35.8%
Male	5,150	25.6%
Unknown or not given	7,781	38.6%

Type of reporter in the reports that name Prevacid 24 HR
Reporter	Reports	Share
Physician	524	2.6%
Pharmacist	34	0.2%
Other health professional	1,710	8.5%
Lawyer	8,303	41.2%
Consumer or non-health professional	4,164	20.7%
Not given	5,401	26.8%

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 Prevacid 24 HR record
Indication as recorded (MedDRA)	Reports	Share
Gastrooesophageal reflux disease	4,759	23.6%
Dyspepsia	643	3.2%
Gastrointestinal disorder	332	1.6%
Abdominal discomfort	39	0.2%
Gastric ph decreased	36	0.2%
Barrett's oesophagus	18	0.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 20,136 reports.

Drugs in the same reports

Other drugs that the reports of Prevacid 24 HR name, in any role, in order of name
Drug	Reports that name the two
Dexilant	11,364
Lisinopril	2,954
Nexium	16,938
Nexium 24HR	16,007
Omeprazole	7,343
Pantoprazole	4,222
Pantoprazole sodium	14,682
Prevacid	17,112
Prilosec	16,841
Prilosec OTC	10,616

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

Lansoprazole same ingredient
Prevacid same ingredient
Prevacid SoluTab same ingredient
Pantoprazole sodium same class
Prilosec same class
Pantoprazole same class
Prilosec OTC same class
Pretomanid next in the A to Z list
Prevalite next in the A to Z list
Prepopik next in the A to Z list
Previscan next in the A to Z list
Preparation H 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 Prevacid 24 HRThe 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. Prevacid 24 HR: adverse event reports that FDA received. https://reportedreactions.com/drug/prevacid-24-hr/ 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 Prevacid 24 HR as a suspect or interacting product. The 61 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 Prevacid 24 HR 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 Prevacid 24 HR?

No. It is a count of what people reported to FDA: 20,136 reports from November 2009 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 (41.2%), consumer or non-health professional (20.7%) and other health professional (8.5%). 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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