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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

PANCRELIPASE: 724 Adverse Event Reports & Safety Profile

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724
Total FAERS Reports
66 (9.1%)
Deaths Reported
281
Hospitalizations
724
As Primary/Secondary Suspect
32
Life-Threatening
13
Disabilities
Discontinued
Status

FDA Application: 020580 ·

First Report: 1993 · Latest Report: 20250908

What Are the Most Common PANCRELIPASE Side Effects?

#1 Most Reported
Diarrhoea
93 reports (12.8%)
#2 Most Reported
Drug ineffective
53 reports (7.3%)
#3 Most Reported
Abdominal pain upper
49 reports (6.8%)

All PANCRELIPASE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 93 12.9% 15 43
Drug ineffective 53 7.3% 1 20
Abdominal pain upper 49 6.8% 0 18
Maternal exposure during pregnancy 43 5.9% 0 4
Malaise 41 5.7% 1 20
Nausea 37 5.1% 11 20
Pain 36 5.0% 8 10
Vomiting 34 4.7% 4 31
Abdominal pain 31 4.3% 2 11
Cough 29 4.0% 8 10
Dyspnoea 27 3.7% 0 9
Abdominal distension 26 3.6% 10 11
Pyrexia 26 3.6% 1 22
Asthenia 25 3.5% 11 16
Blood pressure decreased 25 3.5% 7 21
Fatigue 25 3.5% 8 16
Foetal exposure during pregnancy 25 3.5% 4 6
Condition aggravated 24 3.3% 1 7
Decreased appetite 23 3.2% 3 16
Inappropriate schedule of product administration 23 3.2% 6 17

Who Reports PANCRELIPASE Side Effects? Age & Gender Data

Gender: 50.4% female, 49.6% male. Average age: 52.0 years. Most reports from: US. View detailed demographics →

Is PANCRELIPASE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 3 0 3
2003 2 0 2
2004 3 0 0
2007 2 0 2
2008 4 0 2
2009 2 0 1
2010 3 0 0
2011 4 0 3
2012 12 5 3
2013 39 11 13
2014 33 4 10
2015 30 3 8
2016 36 2 24
2017 29 3 15
2018 20 0 9
2019 15 2 11
2020 31 9 16
2021 25 0 9
2022 34 4 17
2023 20 1 7
2024 53 1 5
2025 5 0 1

View full timeline →

What Is PANCRELIPASE Used For?

IndicationReports
Product used for unknown indication 298
Pancreatic failure 64
Cystic fibrosis 60
Pancreatic insufficiency 42
Pancreatitis chronic 27
Pancreatitis 21
Tonsillitis 14
Diarrhoea 12
Pancreatic enzyme abnormality 8
Suicide attempt 7

PANCRELIPASE vs Alternatives: Which Is Safer?

PANCRELIPASE vs PANCRELIPASE AMYLASE\PANCRELIPASE LIPASE\PANCRELIPASE PROTEASE PANCRELIPASE vs PANCURONIUM PANCRELIPASE vs PANITUMUMAB PANCRELIPASE vs PANOBINOSTAT PANCRELIPASE vs PANTOPRAZOLE PANCRELIPASE vs PANTOPRAZOLE ANHYDROUS PANCRELIPASE vs PANTOTHENIC ACID PANCRELIPASE vs PAPAVERINE PANCRELIPASE vs PARACETAMOL PANCRELIPASE vs PARATHYROID HORMONE

Official FDA Label for PANCRELIPASE

Official prescribing information from the FDA-approved drug label.