85/100 · Critical
Manufactured by Amneal Pharmaceuticals LLC
Pantoprazole Adverse Events: High Seriousness and Diverse Reactions
652,999 FDA adverse event reports analyzed
Last updated: 2026-05-12
PANTOPRAZOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. Based on analysis of 652,999 FDA adverse event reports, PANTOPRAZOLE 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 include FATIGUE, OFF LABEL USE, NAUSEA, DIARRHOEA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PANTOPRAZOLE.
Pantoprazole 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 652,999 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Llc.
The most commonly reported adverse events include Fatigue, Off Label Use, Nausea. Of classified reports, 83.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Pantoprazole reports show a high percentage of serious adverse events, particularly respiratory and gastrointestinal issues.
The drug is frequently reported to cause fatigue, nausea, and diarrhea, indicating common gastrointestinal side effects. There is a notable increase in reports of renal and cardiovascular issues, suggesting potential organ-specific risks.
Patients taking Pantoprazole should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Pantoprazole can interact with other drugs, leading to adverse effects. Patients should inform their healthcare provider of all medications they are taking. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Pantoprazole received a safety concern score of 85/100 (high concern). This is based on a 83.6% serious event ratio across 240,714 classified reports. The score accounts for 652,999 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: 126,498, Male: 92,279, Unknown: 191. The most frequently reported age groups are age 69 (4,789 reports), age 65 (4,770 reports), age 71 (4,660 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 240,714 classified reports for PANTOPRAZOLE:
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 can interact with other drugs, leading to adverse effects. Patients should inform their healthcare provider of all medications they are taking.
If you are taking Pantoprazole, here are important things to know. The most commonly reported side effects include fatigue, off label use, nausea, diarrhoea, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Inform your healthcare provider about any pre-existing conditions or other medications you are taking. Report any unusual symptoms or side effects 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 continues to monitor Pantoprazole for safety, and updates will be issued based on new data.
The FDA has received approximately 652,999 adverse event reports associated with Pantoprazole. 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 include Fatigue, Off Label Use, Nausea, Diarrhoea, Dyspnoea. By volume, the top reported reactions are: Fatigue (19,878 reports), Off Label Use (17,589 reports), Nausea (16,993 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.
Out of 240,714 classified reports, 201,330 (83.6%) were classified as serious and 39,384 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 break down by patient sex as follows: Female: 126,498, Male: 92,279, Unknown: 191. 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 adverse events are: age 69: 4,789 reports, age 65: 4,770 reports, age 71: 4,660 reports, age 67: 4,549 reports, age 70: 4,527 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 adverse event reports is Amneal Pharmaceuticals Llc. 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 include: Drug Ineffective, Pain, Headache, Vomiting, Arthralgia. 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 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 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. Pantoprazole reports show a high percentage of serious adverse events, particularly respiratory and gastrointestinal issues.
Key safety signals identified in Pantoprazole's adverse event data include: High percentage of serious adverse events (83.6%). Frequent reports of respiratory issues like pneumonia and dyspnoea. Common gastrointestinal issues such as nausea, diarrhea, and abdominal pain. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Pantoprazole can interact with other drugs, leading to adverse effects. Patients should inform their healthcare provider of all medications they are taking. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Pantoprazole.
Inform your healthcare provider about any pre-existing conditions or other medications you are taking. Report any unusual symptoms or side effects to your healthcare provider promptly.
Pantoprazole has 652,999 adverse event reports on file with the FDA. The drug is frequently reported to cause fatigue, nausea, and diarrhea, indicating common gastrointestinal side effects. The volume of reports for Pantoprazole reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Pantoprazole for safety, and updates will be issued based on new data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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