85/100 · Critical
Manufactured by Takeda Pharmaceuticals America, Inc.
High Concern for Renal Issues with DEXLANSOPRAZOLE
112,812 FDA adverse event reports analyzed
Last updated: 2026-05-12
DEXLANSOPRAZOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. Based on analysis of 112,812 FDA adverse event reports, DEXLANSOPRAZOLE has a safety score of 85 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 DEXLANSOPRAZOLE 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 DEXLANSOPRAZOLE.
Dexlansoprazole has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 112,812 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, 81.0% 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 the most serious and frequent adverse reactions.
Renal failure and end-stage renal disease are also significant concerns. The majority of reactions are non-serious, but the high volume of reports indicates a notable safety profile.
Patients taking Dexlansoprazole should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. DEXLANSOPRAZOLE may exacerbate pre-existing renal conditions and should be used with caution in patients with renal impairment. Regular monitoring of renal function is advised. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dexlansoprazole received a safety concern score of 85/100 (high concern). This is based on a 81.0% serious event ratio across 40,786 classified reports. The score accounts for 112,812 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: 19,177, Male: 8,895, Unknown: 40. The most frequently reported age groups are age 56 (535 reports), age 64 (491 reports), age 65 (490 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 40,786 classified reports for DEXLANSOPRAZOLE:
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.
DEXLANSOPRAZOLE may exacerbate pre-existing renal conditions and should be used with caution in patients with renal impairment. Regular monitoring of renal function is advised.
If you are taking Dexlansoprazole, 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. Monitor renal function regularly, especially in patients with pre-existing renal conditions. Report any new or worsening symptoms to your healthcare provider promptly. 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 has not issued specific warnings regarding DEXLANSOPRAZOLE, but the high volume of adverse event reports suggests a need for vigilance. Patients should report any new or worsening symptoms to their healthcare provider.
The FDA has received approximately 112,812 adverse event reports associated with Dexlansoprazole. 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 Dexlansoprazole 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 (16,100 reports), Acute Kidney Injury (7,791 reports), Renal Failure (6,721 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Dexlansoprazole.
Out of 40,786 classified reports, 33,024 (81.0%) were classified as serious and 7,762 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 Dexlansoprazole break down by patient sex as follows: Female: 19,177, Male: 8,895, Unknown: 40. 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 Dexlansoprazole adverse events are: age 56: 535 reports, age 64: 491 reports, age 65: 490 reports, age 53: 489 reports, age 62: 474 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 Dexlansoprazole 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 Dexlansoprazole include: Drug Ineffective, Fatigue, Off Label Use, Tubulointerstitial Nephritis, Nausea. 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 Dexlansoprazole 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.
Dexlansoprazole has a safety concern score of 85 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 the most serious and frequent adverse reactions.
Key safety signals identified in Dexlansoprazole's adverse event data include: Chronic kidney disease. Acute kidney injury. Renal failure. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
DEXLANSOPRAZOLE may exacerbate pre-existing renal conditions and should be used with caution in patients with renal impairment. Regular monitoring of renal function is advised. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dexlansoprazole.
Monitor renal function regularly, especially in patients with pre-existing renal conditions. Report any new or worsening symptoms to your healthcare provider promptly.
Dexlansoprazole has 112,812 adverse event reports on file with the FDA. Renal failure and end-stage renal disease are also significant concerns. The volume of reports for Dexlansoprazole reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has not issued specific warnings regarding DEXLANSOPRAZOLE, but the high volume of adverse event reports suggests a need for vigilance. Patients should report any new or worsening symptoms to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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