85/100 · Critical
Manufactured by Ajanta Pharma USA Inc.
Pantoprazole Sodium in 0.9% Sodium Chloride: High Serious Adverse Event Rate
247,942 FDA adverse event reports analyzed
Last updated: 2026-05-12
PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Ajanta Pharma USA Inc.. Based on analysis of 247,942 FDA adverse event reports, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE.
Pantoprazole Sodium In 0.9% Sodium Chloride 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 247,942 adverse event reports for this medication, which is primarily manufactured by Ajanta Pharma Usa 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%) among reported reactions.
A wide range of reactions, including respiratory, gastrointestinal, and neurological issues. Significant number of reports involving drug ineffectiveness and drug intolerance. Common reactions include fatigue, dyspnea, and pain, indicating potential systemic effects. Age distribution shows a concentration of reports among older adults.
Patients taking Pantoprazole Sodium In 0.9% Sodium Chloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other drugs may cause adverse effects, and patients should be monitored for signs of drug intolerance or ineffectiveness. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Pantoprazole Sodium In 0.9% Sodium Chloride received a safety concern score of 85/100 (high concern). This is based on a 80.7% serious event ratio across 58,018 classified reports. The score accounts for 247,942 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: 32,994, 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 58,018 classified reports for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE:
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.
Interactions with other drugs may cause adverse effects, and patients should be monitored for signs of drug intolerance or ineffectiveness.
If you are taking Pantoprazole Sodium In 0.9% Sodium Chloride, 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 adverse reactions to their healthcare provider immediately. Follow prescribed dosing instructions and do not alter the treatment without medical advice. 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 the safety of Pantoprazole Sodium in 0.9% Sodium Chloride, and updates will be provided as necessary.
The FDA has received approximately 247,942 adverse event reports associated with Pantoprazole Sodium In 0.9% Sodium Chloride. 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 In 0.9% Sodium Chloride include Fatigue, Off Label Use, Dyspnoea, Pain, Drug Ineffective. By volume, the top reported reactions are: Fatigue (6,905 reports), Off Label Use (5,859 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 In 0.9% Sodium Chloride.
Out of 58,018 classified reports, 46,818 (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 In 0.9% Sodium Chloride break down by patient sex as follows: Female: 32,994, 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 In 0.9% Sodium Chloride 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 In 0.9% Sodium Chloride adverse event reports is Ajanta Pharma Usa 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 In 0.9% Sodium Chloride 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 In 0.9% Sodium Chloride 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 In 0.9% Sodium Chloride 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%) among reported reactions.
Key safety signals identified in Pantoprazole Sodium In 0.9% Sodium Chloride's adverse event data include: High rate of serious adverse events (46,818 out of 58,018 total outcomes).. A significant number of reports involving drug ineffectiveness and drug intolerance.. Multiple reports of respiratory issues such as pneumonia and asthma.. A high frequency of gastrointestinal issues including diarrhea, nausea, and abdominal pain.. Reports of neurological symptoms such as confusion and dizziness.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other drugs may cause adverse effects, and patients should be monitored for signs of drug intolerance or ineffectiveness. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Pantoprazole Sodium In 0.9% Sodium Chloride.
Patients should report any adverse reactions to their healthcare provider immediately. Follow prescribed dosing instructions and do not alter the treatment without medical advice.
Pantoprazole Sodium In 0.9% Sodium Chloride has 247,942 adverse event reports on file with the FDA. A wide range of reactions, including respiratory, gastrointestinal, and neurological issues. The volume of reports for Pantoprazole Sodium In 0.9% Sodium Chloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Pantoprazole Sodium in 0.9% Sodium Chloride, and updates will be provided as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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