82/100 · Critical
Manufactured by Takeda Pharmaceuticals America, Inc.
Lansoprazole Reports Show High Incidence of Renal and Gastrointestinal Issues
389,756 FDA adverse event reports analyzed
Last updated: 2026-05-12
LANSOPRAZOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. Based on analysis of 389,756 FDA adverse event reports, LANSOPRAZOLE has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for LANSOPRAZOLE include CHRONIC KIDNEY DISEASE, ACUTE KIDNEY INJURY, RENAL FAILURE, END STAGE RENAL DISEASE, RENAL INJURY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LANSOPRAZOLE.
Lansoprazole has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 389,756 adverse event reports for this medication, which is primarily manufactured by Takeda Pharmaceuticals America, Inc..
The most commonly reported adverse events include Chronic Kidney Disease, Acute Kidney Injury, Renal Failure. Of classified reports, 87.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Chronic kidney disease and acute kidney injury are among the most frequently reported serious adverse events.
Gastrointestinal issues such as nausea, diarrhea, and abdominal pain are also commonly reported. The majority of adverse events are serious, indicating a significant risk profile.
Patients taking Lansoprazole should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Lansoprazole may interact with other medications, and patients should be monitored for potential drug interactions, especially with those affecting renal function. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lansoprazole received a safety concern score of 82/100 (high concern). This is based on a 87.2% serious event ratio across 173,076 classified reports. The score accounts for 389,756 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 84,121, Male: 60,095, Unknown: 311. The most frequently reported age groups are age 72 (2,786 reports), age 69 (2,640 reports), age 65 (2,630 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 173,076 classified reports for LANSOPRAZOLE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Lansoprazole may interact with other medications, and patients should be monitored for potential drug interactions, especially with those affecting renal function.
If you are taking Lansoprazole, here are important things to know. The most commonly reported side effects include chronic kidney disease, acute kidney injury, renal failure, end stage renal disease, renal injury. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any signs of kidney issues, such as decreased urine output or swelling, to their healthcare provider immediately. Follow prescribed dosing instructions and inform healthcare providers of any other medications being taken to avoid potential drug interactions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA closely monitors adverse events for Lansoprazole, and healthcare providers should be aware of the potential for serious renal issues and gastrointestinal side effects.
The FDA has received approximately 389,756 adverse event reports associated with Lansoprazole. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Lansoprazole include Chronic Kidney Disease, Acute Kidney Injury, Renal Failure, End Stage Renal Disease, Renal Injury. By volume, the top reported reactions are: Chronic Kidney Disease (32,775 reports), Acute Kidney Injury (18,670 reports), Renal Failure (13,812 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Lansoprazole.
Out of 173,076 classified reports, 150,961 (87.2%) were classified as serious and 22,115 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Lansoprazole break down by patient sex as follows: Female: 84,121, Male: 60,095, Unknown: 311. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Lansoprazole adverse events are: age 72: 2,786 reports, age 69: 2,640 reports, age 65: 2,630 reports, age 68: 2,625 reports, age 70: 2,616 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Lansoprazole adverse event reports is Takeda Pharmaceuticals America, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Lansoprazole include: Nausea, Diarrhoea, Dyspnoea, Fatigue, Vomiting. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Lansoprazole to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Lansoprazole has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Chronic kidney disease and acute kidney injury are among the most frequently reported serious adverse events.
Key safety signals identified in Lansoprazole's adverse event data include: High frequency of renal-related issues (chronic kidney disease, acute kidney injury, renal failure). Common gastrointestinal issues (nausea, diarrhea, abdominal pain). Significant number of serious adverse events (87.2%). Reported in older age groups (65+). These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Lansoprazole may interact with other medications, and patients should be monitored for potential drug interactions, especially with those affecting renal function. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lansoprazole.
Patients should report any signs of kidney issues, such as decreased urine output or swelling, to their healthcare provider immediately. Follow prescribed dosing instructions and inform healthcare providers of any other medications being taken to avoid potential drug interactions.
Lansoprazole has 389,756 adverse event reports on file with the FDA. Gastrointestinal issues such as nausea, diarrhea, and abdominal pain are also commonly reported. The volume of reports for Lansoprazole reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors adverse events for Lansoprazole, and healthcare providers should be aware of the potential for serious renal issues and gastrointestinal side effects. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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