85/100 · Critical
Manufactured by AbbVie Inc.
Pancrelipase Adverse Events: High Seriousness and Diverse Reactions
56,891 FDA adverse event reports analyzed
Last updated: 2026-05-12
PANCRELIPASE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AbbVie Inc.. Based on analysis of 56,891 FDA adverse event reports, PANCRELIPASE 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 PANCRELIPASE include DIARRHOEA, DEATH, NAUSEA, WEIGHT DECREASED, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PANCRELIPASE.
Pancrelipase 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 56,891 adverse event reports for this medication, which is primarily manufactured by Abbvie Inc..
The most commonly reported adverse events include Diarrhoea, Death, Nausea. Of classified reports, 73.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Pancrelipase reports show a high percentage of serious adverse events, particularly deaths and respiratory issues.
The most common reactions include diarrhea, nausea, and abdominal pain, indicating gastrointestinal side effects. There is a significant number of reports related to pancreatic disorders and cancer, suggesting potential risks.
Patients taking Pancrelipase should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Pancrelipase may interact with other drugs, and off-label use has been reported, which could lead to adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Pancrelipase received a safety concern score of 85/100 (high concern). This is based on a 73.6% serious event ratio across 35,334 classified reports. The score accounts for 56,891 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: 18,640, Male: 14,655, Unknown: 61. The most frequently reported age groups are age 70 (533 reports), age 71 (515 reports), age 72 (486 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 35,334 classified reports for PANCRELIPASE:
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.
Pancrelipase may interact with other drugs, and off-label use has been reported, which could lead to adverse effects.
If you are taking Pancrelipase, here are important things to know. The most commonly reported side effects include diarrhoea, death, nausea, weight decreased, fatigue. 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 serious adverse events such as respiratory issues and gastrointestinal problems. Follow prescribed dosages and consult healthcare providers for off-label use. 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.
Regulatory oversight is ongoing, with frequent updates on safety concerns. Patients should report any adverse reactions promptly.
The FDA has received approximately 56,891 adverse event reports associated with Pancrelipase. 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 Pancrelipase include Diarrhoea, Death, Nausea, Weight Decreased, Fatigue. By volume, the top reported reactions are: Diarrhoea (3,314 reports), Death (1,819 reports), Nausea (1,718 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Pancrelipase.
Out of 35,334 classified reports, 25,993 (73.6%) were classified as serious and 9,341 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 Pancrelipase break down by patient sex as follows: Female: 18,640, Male: 14,655, Unknown: 61. 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 Pancrelipase adverse events are: age 70: 533 reports, age 71: 515 reports, age 72: 486 reports, age 69: 485 reports, age 73: 471 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 Pancrelipase adverse event reports is Abbvie 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 Pancrelipase include: Abdominal Pain, Vomiting, Infective Pulmonary Exacerbation Of Cystic Fibrosis, Pain, Abdominal Pain Upper. 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 Pancrelipase 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.
Pancrelipase 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. Pancrelipase reports show a high percentage of serious adverse events, particularly deaths and respiratory issues.
Key safety signals identified in Pancrelipase's adverse event data include: High percentage of serious adverse events (73.6%). Multiple reports of death and respiratory issues. Pancreatic disorders and cancer are frequently reported. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Pancrelipase may interact with other drugs, and off-label use has been reported, which could lead to adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Pancrelipase.
Monitor for signs of serious adverse events such as respiratory issues and gastrointestinal problems. Follow prescribed dosages and consult healthcare providers for off-label use.
Pancrelipase has 56,891 adverse event reports on file with the FDA. The most common reactions include diarrhea, nausea, and abdominal pain, indicating gastrointestinal side effects. The volume of reports for Pancrelipase reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with frequent updates on safety concerns. Patients should report any adverse reactions promptly. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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