85/100 · Critical
Manufactured by Alembic Pharmaceuticals Inc.
Pantoprazole Sodium Injection Reports Show High Serious Reaction Rate
247,950 FDA adverse event reports analyzed
Last updated: 2026-05-12
PANTOPRAZOLE SODIUM INJECTION is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alembic Pharmaceuticals Inc.. Based on analysis of 247,950 FDA adverse event reports, PANTOPRAZOLE SODIUM INJECTION 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 INJECTION include FATIGUE, OFF LABEL USE, DYSPNOEA, PAIN, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PANTOPRAZOLE SODIUM INJECTION.
Pantoprazole Sodium Injection 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 247,950 adverse event reports for this medication, which is primarily manufactured by Alembic Pharmaceuticals Inc..
The most commonly reported adverse events include Fatigue, Off Label Use, Dyspnoea. Of classified reports, 80.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (80.7%) indicates significant safety concerns.
A wide range of reactions, including respiratory and gastrointestinal issues, suggest diverse safety risks. The majority of reports (58,024) are serious, highlighting the severity of adverse events. Age distribution shows a concentration of reports among older adults, aged 65-75.
Patients taking Pantoprazole Sodium Injection should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Pantoprazole Sodium Injection may interact with other medications, and warnings include potential for drug ineffectiveness and hypersensitivity reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Pantoprazole Sodium Injection received a safety concern score of 85/100 (high concern). This is based on a 80.7% serious event ratio across 58,024 classified reports. The score accounts for 247,950 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: 33,000, Male: 20,405, Unknown: 28. The most frequently reported age groups are age 44 (1,464 reports), age 65 (1,136 reports), age 43 (1,077 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 58,024 classified reports for PANTOPRAZOLE SODIUM INJECTION:
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 Injection may interact with other medications, and warnings include potential for drug ineffectiveness and hypersensitivity reactions.
If you are taking Pantoprazole Sodium Injection, here are important things to know. The most commonly reported side effects include fatigue, off label use, dyspnoea, pain, drug ineffective. 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 serious adverse events to their healthcare provider immediately. Follow prescribed dosages and administration instructions carefully to minimize risk. 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 Sodium Injection for safety, and healthcare providers should be vigilant about serious adverse events and patient monitoring.
The FDA has received approximately 247,950 adverse event reports associated with Pantoprazole Sodium Injection. 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 Injection include Fatigue, Off Label Use, Dyspnoea, Pain, Drug Ineffective. By volume, the top reported reactions are: Fatigue (6,905 reports), Off Label Use (5,860 reports), Dyspnoea (5,677 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 Injection.
Out of 58,024 classified reports, 46,824 (80.7%) were classified as serious and 11,200 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 Injection break down by patient sex as follows: Female: 33,000, Male: 20,405, Unknown: 28. 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 Injection adverse events are: age 44: 1,464 reports, age 65: 1,136 reports, age 43: 1,077 reports, age 69: 1,029 reports, age 73: 1,012 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 Injection adverse event reports is Alembic Pharmaceuticals 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 Injection include: Diarrhoea, Nausea, Headache, Arthralgia, Pyrexia. 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 Injection 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 Injection 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. High percentage of serious adverse events (80.7%) indicates significant safety concerns.
Key safety signals identified in Pantoprazole Sodium Injection's adverse event data include: High rate of serious adverse events (46,824 out of 58,024, 80.7%). Respiratory issues like dyspnoea and pneumonia are frequently reported. Gastrointestinal issues such as nausea, vomiting, and abdominal pain are common. Drug ineffectiveness and hyper-sensitivity reactions are also significant safety signals. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Pantoprazole Sodium Injection may interact with other medications, and warnings include potential for drug ineffectiveness and hypersensitivity reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Pantoprazole Sodium Injection.
Patients should report any serious adverse events to their healthcare provider immediately. Follow prescribed dosages and administration instructions carefully to minimize risk.
Pantoprazole Sodium Injection has 247,950 adverse event reports on file with the FDA. A wide range of reactions, including respiratory and gastrointestinal issues, suggest diverse safety risks. The volume of reports for Pantoprazole Sodium Injection reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Pantoprazole Sodium Injection for safety, and healthcare providers should be vigilant about serious adverse events and patient monitoring. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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