Pharmacologic class (EPC) · 22 drug pages

Proton pump inhibitor: adverse event reports filed with FDA

484,090 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

484,090
reports across the class: 2.3% of all reports; 12,604
reports, 12 months to June 2026: 13,869 in the 12 months before; 86.4%
marked serious by the reporter: 57.4% across all reports; 22
drugs with a page: brand and generic names counted separately

Proton pump inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 22 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 484,090 adverse event reports received by FDA, 2.3% of the database, from January 2004 to June 2026.

12,604 reports arrived in the 12 months to June 2026, close to the 13,869 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 86.4% of the class's reports are marked serious, 10.5% record death among the outcomes and 19.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are chronic kidney disease (46.4%), acute kidney injury (24.1%) and renal failure (18.4%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
NexiumEsomeprazole magnesium	brand	85,367	576	68.6%	Chronic kidney disease
Omeprazole	generic	61,176	2,506	89.4%	Chronic kidney disease
Pantoprazole	generic	44,980	2,710	95.2%	Chronic kidney disease
Pantoprazole sodium	generic	44,098	1,629	90.9%	Chronic kidney disease
PrilosecOmeprazole magnesium	brand	42,343	115	88.3%	Chronic kidney disease
PrevacidLansoprazole	brand	40,151	273	95.8%	Chronic kidney disease
Nexium 24HREsomeprazole magnesium	brand	27,753	300	85.1%	Chronic kidney disease
Lansoprazole	generic	26,570	1,749	94.8%	Chronic kidney disease
Prilosec OTCOmeprazole magnesium	brand	24,549	119	78.4%	Chronic kidney disease
DexilantDexlansoprazole	brand	23,621	233	91.5%	Chronic kidney disease
Prevacid 24 HRLansoprazole	brand	20,136	13	92.6%	Chronic kidney disease
Esomeprazole	generic	17,193	1,293	96.8%	Chronic kidney disease
AciphexRabeprazole sodium	brand	7,246	3	92.1%	Chronic kidney disease
Esomeprazole magnesium	generic	5,014	368	82.5%	Drug ineffective
Omeprazole magnesium	generic	4,120	175	74.9%	Chronic kidney disease
Rabeprazole	generic	2,693	180	90.8%	Drug ineffective
Rabeprazole sodium	generic	2,214	127	90.5%	Drug ineffective
Dexlansoprazole	generic	1,460	188	85.2%	Chronic kidney disease
ZegeridOmeprazole and sodium bicarbonate	brand	1,117	0	88%	Chronic kidney disease
Zegerid OTCOmeprazole sodium bicarbonate	brand	943	0	29.4%	Chronic kidney disease
Omeprazole delayed releaseOmeprazole 20mg	brand	712	0	18%	Drug ineffective
Esomeprazole sodium	generic	634	47	97.6%	Nausea

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Chronic kidney diseaselong-term kidney disease46.4%224,638
Acute kidney injurysudden loss of kidney function24.1%116,683
Renal failurekidney failure18.4%89,299
End stage renal diseasekidney failure needing dialysis or transplant13.8%66,939
Renal injury12.6%60,995
Gastrooesophageal reflux diseaseacid reflux6.3%30,453
Tubulointerstitial nephritis5.8%27,912
Drug ineffectivethe medicine did not work as expected5.5%26,726
Painpain, site not specified3.8%18,317
Off label useused for a purpose or in a way not on the label3.7%17,910
Deaththe patient died; cause not stated by this term3.7%17,793
Nephrogenic anaemia3.2%15,531
Nauseafeeling sick3%14,533
Diarrhoealoose or frequent stools2.9%13,945
Dyspnoeashortness of breath2.8%13,438
Malaisegeneral feeling of being unwell2.8%13,417
Rebound acid hypersecretion2.7%13,223
Drug dose omissiona dose was missed2.6%12,602
Renal impairmentreduced kidney function2.6%12,379
Vomitingbeing sick2.5%12,294
Dyspepsiaindigestion2.5%12,244
Headachehead pain2.5%12,150
Hyperchlorhydria2.4%11,830
Fatiguetiredness2.4%11,754
Abdominal pain upperupper stomach pain2.2%10,479

Solid bar: share of all class reports. Hollow bar: the median share across the 22 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death10.5%50,627

Life-threatening3.4%16,473

Hospitalisation (initial or prolonged)19.9%96,231

Disability3.1%14,844

Congenital anomaly0.7%3,348

Other serious75.6%365,982

Not serious13.6%65,605

Patient age

Under 20.2%1,165

2 to 110.3%1,570

12 to 170.4%1,740

18 to 447.6%37,022

45 to 6422.7%109,907

65 to 7411%53,196

75 and over9.2%44,489

Age not given48.5%235,001

Who reported

Physician10.5%50,754

Pharmacist3.2%15,456

Other health professional15.9%76,756

Lawyer23%111,504

Consumer or non-health professional26.2%126,912

Not given21.2%102,708

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Proton pump inhibitor reports

Which drugs are in the Proton pump inhibitor class on this site?

Nexium, Omeprazole, Pantoprazole, Pantoprazole sodium, Prilosec and Prevacid and 16 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

484,090 reports through June 2026, 12,604 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

chronic kidney disease (46.4%), acute kidney injury (24.1%), renal failure (18.4%), end stage renal disease (13.8%) and renal injury (12.6%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.