85/100 · Critical
Manufactured by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
High Safety Concerns with PANTOPRAZOLE SODIUM, Particularly for Renal and Gastrointestinal Issues
411,823 FDA adverse event reports analyzed
Last updated: 2026-05-12
PANTOPRAZOLE SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. Based on analysis of 411,823 FDA adverse event reports, PANTOPRAZOLE SODIUM 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 PANTOPRAZOLE SODIUM include CHRONIC KIDNEY DISEASE, ACUTE KIDNEY INJURY, FATIGUE, RENAL FAILURE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PANTOPRAZOLE SODIUM.
Pantoprazole Sodium 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 411,823 adverse event reports for this medication, which is primarily manufactured by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc..
The most commonly reported adverse events include Chronic Kidney Disease, Acute Kidney Injury, Fatigue. Of classified reports, 78.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Chronic and acute kidney disease are among the most frequent and serious adverse reactions.
Renal failure and renal injury are also commonly reported, indicating potential nephrotoxicity. Gastrointestinal issues such as nausea, diarrhea, and abdominal pain are frequently reported.
Patients taking Pantoprazole Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Pantoprazole sodium may interact with other medications, and patients should be aware of 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.
Pantoprazole Sodium received a safety concern score of 85/100 (high concern). This is based on a 78.1% serious event ratio across 141,988 classified reports. The score accounts for 411,823 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: 76,310, Male: 45,507, Unknown: 164. The most frequently reported age groups are age 65 (2,264 reports), age 62 (2,139 reports), age 69 (2,074 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 141,988 classified reports for PANTOPRAZOLE SODIUM:
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.
Pantoprazole sodium may interact with other medications, and patients should be aware of potential drug interactions, especially with those affecting renal function.
If you are taking Pantoprazole Sodium, here are important things to know. The most commonly reported side effects include chronic kidney disease, acute kidney injury, fatigue, renal failure, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of kidney issues, such as changes in urine output or swelling, and report them to your healthcare provider. Inform your doctor about all medications you are taking, as Pantoprazole sodium may interact with them. 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 for Pantoprazole sodium, but patients should report any new or worsening symptoms to their healthcare provider.
The FDA has received approximately 411,823 adverse event reports associated with Pantoprazole Sodium. 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 Pantoprazole Sodium include Chronic Kidney Disease, Acute Kidney Injury, Fatigue, Renal Failure, Nausea. By volume, the top reported reactions are: Chronic Kidney Disease (24,452 reports), Acute Kidney Injury (13,735 reports), Fatigue (10,851 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Pantoprazole Sodium.
Out of 141,988 classified reports, 110,929 (78.1%) were classified as serious and 31,059 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 Pantoprazole Sodium break down by patient sex as follows: Female: 76,310, Male: 45,507, Unknown: 164. 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 Pantoprazole Sodium adverse events are: age 65: 2,264 reports, age 62: 2,139 reports, age 69: 2,074 reports, age 63: 2,032 reports, age 70: 2,006 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 Pantoprazole Sodium adverse event reports is Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer 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 Pantoprazole Sodium include: Pain, Dyspnoea, Diarrhoea, Drug Ineffective, Headache. 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 Pantoprazole Sodium 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.
Pantoprazole Sodium 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 and acute kidney disease are among the most frequent and serious adverse reactions.
Key safety signals identified in Pantoprazole Sodium's adverse event data include: Chronic kidney disease and acute kidney injury are the most serious safety signals.. Renal failure and renal injury are also significant safety signals.. Gastrointestinal disorders are frequently reported, suggesting potential adverse effects on the digestive system.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Pantoprazole sodium may interact with other medications, and patients should be aware of 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 Pantoprazole Sodium.
Monitor for signs of kidney issues, such as changes in urine output or swelling, and report them to your healthcare provider. Inform your doctor about all medications you are taking, as Pantoprazole sodium may interact with them.
Pantoprazole Sodium has 411,823 adverse event reports on file with the FDA. Renal failure and renal injury are also commonly reported, indicating potential nephrotoxicity. The volume of reports for Pantoprazole Sodium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has not issued specific warnings for Pantoprazole sodium, but 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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