Pancrelipase side effects: what 38,364 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Creon
Who reports
38,364 reports · 74% serious · 3,830 with death outcome · 56% female
Used for
CREON ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. CREON is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
What it is
Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,175 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Pancreaticoduodenectomy | 352 | 657.9 563.2–768.5ROR 664.0 · calibrated p 4e-15 ✓ | 291.9 EB05 267.2 · IC025 +7.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=351 · 87% consumer | not reported in cached trials |
| Pancreatic stent placement | 48 | 461.4 313.8–678.3ROR 462.0 · calibrated p 8e-13 ✓ | 226.5 EB05 177.7 · IC025 +5.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=48 · 100% consumer | not reported in cached trials |
| Pancreatectomy | 239 | 440.6 371.4–522.6ROR 443.3 · calibrated p 3e-13 ✓ | 238.1 EB05 213.8 · IC025 +7.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=239 · 90% consumer | not reported in cached trials |
| Pancreatic operation | 89 | 395.9 301.2–520.5ROR 396.8 · calibrated p 2e-12 ✓ | 217.9 EB05 182.5 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious n=88 · 100% consumer | not reported in cached trials |
| Pancreatic failure | 635 | 324.9 294.6–358.4ROR 330.4 · calibrated p 4e-12 ✓ | 201.8 EB05 188.9 · IC025 +7.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=627 · 83% consumer | not reported in cached trials |
| Pancreatic carcinoma recurrent | 64 | 202.6 152.0–270.1ROR 203.0 · calibrated p 7e-10 ✓ | 141.4 EB05 114.6 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=64 · 100% consumer | NCT01427725: 5/553 (0.9%) on Pancrelipase (serious AE) |
| Cystic fibrosis related diabetes | 35 | 174.4 119.2–255.4ROR 174.6 · calibrated p 4e-9 ✓ | 123.3 EB05 92.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Infective pulmonary exacerbation of cystic fibrosis | 1,317 | 173.1 162.8–184.0ROR 179.2 · calibrated p 1e-9 ✓ | 131.0 EB05 125.1 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=1,181 | not reported in cached trials |
| Cystic fibrosis lung | 31 | 170.3 113.7–255.0ROR 170.4 · calibrated p 6e-9 ✓ | 120.2 EB05 88.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=31 · 100% clinician | not reported in cached trials |
| Pancreatic enzymes decreased | 28 | 160.3 105.2–244.5ROR 160.5 · calibrated p 1e-8 ✓ | 114.3 EB05 83.0 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=21 · ♀ 100% (drug 56%) | not reported in cached trials |
| Pancreatic enzyme abnormality | 23 | 158.7 99.7–252.7ROR 158.8 · calibrated p 2e-8 ✓ | 111.7 EB05 78.4 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=20 | not reported in cached trials |
| Pancreatolithiasis | 83 | 144.1 113.1–183.6ROR 144.4 · calibrated p 1e-8 ✓ | 111.0 EB05 92.4 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=81 · 86% consumer | not reported in cached trials |
| Cystic fibrosis respiratory infection suppression | 177 | 134.0 113.7–157.9ROR 134.6 · calibrated p 1e-8 ✓ | 106.3 EB05 93.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=176 · 79% consumer | not reported in cached trials |
| Enzyme level decreased | 24 | 125.4 80.4–195.6ROR 125.5 · calibrated p 8e-8 ✓ | 94.5 EB05 66.8 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=19 · 100% consumer | not reported in cached trials |
| Distal intestinal obstruction syndrome | 58 | 112.3 84.6–149.0ROR 112.5 · calibrated p 8e-8 ✓ | 90.4 EB05 72.5 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=55 | not reported in cached trials |
| Pancreatic duct obstruction | 26 | 93.9 61.9–142.4ROR 94.0 · calibrated p 5e-7 ✓ | 75.8 EB05 54.4 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=26 · 100% consumer | not reported in cached trials |
| Cystic fibrosis | 787 | 90.1 83.6–97.1ROR 91.9 · calibrated p 2e-7 ✓ | 77.2 EB05 72.7 · IC025 +6.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=759 | not reported in cached trials |
| Dehiscence | 24 | 79.3 51.6–121.6ROR 79.3 · calibrated p 2e-6 ✓ | 65.8 EB05 46.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 0% (drug 56%) | NCT01427725: 1/553 (0.2%) on Pancrelipase (serious AE) |
| Pancreatitis chronic | 293 | 77.8 68.8–87.9ROR 78.4 · calibrated p 7e-7 ✓ | 67.8 EB05 61.5 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious n=282 | NCT01427725: 1/553 (0.2%) on Pancrelipase (serious AE) |
| Chemotherapy | 435 | 72.7 65.8–80.3ROR 73.5 · calibrated p 1e-6 ✓ | 64.0 EB05 59.1 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=431 · 100% consumer | not reported in cached trials |
| Steatorrhoea | 314 | 72.6 64.6–81.6ROR 73.2 · calibrated p 1e-6 ✓ | 63.9 EB05 58.1 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=187 | not reported in cached trials |
| Pancreatic atrophy | 47 | 66.1 48.8–89.4ROR 66.1 · calibrated p 4e-6 ✓ | 57.6 EB05 45.1 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=42 · 78% consumer | not reported in cached trials |
| Pancreatic insufficiency | 38 | 63.5 45.4–88.9ROR 63.6 · calibrated p 5e-6 ✓ | 55.4 EB05 42.2 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=36 | not reported in cached trials |
| Bile duct stent insertion | 35 | 55.6 39.2–78.7ROR 55.6 · calibrated p 1e-5 ✓ | 49.2 EB05 37.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=35 · 100% consumer | not reported in cached trials |
| Gastrointestinal microorganism overgrowth | 27 | 52.1 35.1–77.3ROR 52.1 · calibrated p 2e-5 ✓ | 46.1 EB05 33.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% consumer | not reported in cached trials |
| Liver operation | 26 | 51.1 34.2–76.4ROR 51.1 · calibrated p 2e-5 ✓ | 45.3 EB05 32.5 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=26 · 100% consumer | not reported in cached trials |
| Pancreatic disorder | 384 | 46.2 41.7–51.3ROR 46.7 · calibrated p 2e-5 ✓ | 42.6 EB05 39.1 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=340 · 86% consumer | NCT01427725: 17/553 (3.1%) on Pancrelipase (serious AE) |
| Pancreatic neoplasm | 96 | 46.0 37.3–56.6ROR 46.1 · calibrated p 3e-5 ✓ | 42.1 EB05 35.5 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=96 · 86% consumer | not reported in cached trials |
| Pancreatic cyst | 138 | 42.8 36.0–50.9ROR 42.9 · calibrated p 4e-5 ✓ | 39.5 EB05 34.3 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=133 · 84% consumer | not reported in cached trials |
| Pancreatic injury | 22 | 42.8 27.7–66.0ROR 42.8 · calibrated p 7e-5 ✓ | 38.5 EB05 26.8 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=19 · 100% consumer | not reported in cached trials |
| Pancreatic carcinoma metastatic | 200 | 41.1 35.6–47.4ROR 41.3 · calibrated p 5e-5 ✓ | 38.1 EB05 33.9 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=200 | not reported in cached trials |
| Pulmonary function test decreased | 305 | 40.7 36.2–45.7ROR 41.0 · calibrated p 5e-5 ✓ | 37.8 EB05 34.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=258 | not reported in cached trials |
| Pancreatic duct dilatation | 19 | 40.6 25.5–64.7ROR 40.6 · calibrated p 1e-4 ✓ | 36.5 EB05 24.7 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | not reported in cached trials |
| Splenectomy | 77 | 38.7 30.7–48.8ROR 38.8 · calibrated p 8e-5 ✓ | 35.9 EB05 29.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=77 · 86% consumer | not reported in cached trials |
| Biliary obstruction | 81 | 37.8 30.2–47.3ROR 37.9 · calibrated p 9e-5 ✓ | 35.1 EB05 29.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=81 · 86% consumer | not reported in cached trials |
| Pseudocyst | 20 | 35.9 22.8–56.4ROR 35.9 · calibrated p 2e-4 ✓ | 32.8 EB05 22.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Pancreatic mass | 63 | 34.5 26.7–44.5ROR 34.6 · calibrated p 2e-4 ✓ | 32.2 EB05 26.1 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=61 · 74% consumer | not reported in cached trials |
| Weight gain poor | 132 | 33.0 27.7–39.4ROR 33.1 · calibrated p 2e-4 ✓ | 31.1 EB05 26.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=81 · 77% consumer | not reported in cached trials |
| Pancreatitis relapsing | 46 | 32.8 24.4–44.2ROR 32.8 · calibrated p 2e-4 ✓ | 30.6 EB05 23.9 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=46 | not reported in cached trials |
| Pancreas infection | 21 | 30.3 19.5–47.0ROR 30.3 · calibrated p 5e-4 ✓ | 28.1 EB05 19.4 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Pancrelipase as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (4 of 40 signal terms matched).
- NCT01427725 — Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency (N=579, phase n/a; 84 AE terms posted; arms: LipaCreon)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 3,698 | 3.2 3.1–3.3ROR 3.4 · calibrated p 0.514 | 3.1 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | NCT01427725: 1/553 (0.2%) on Pancrelipase (serious AE) |
| Death | 1,993 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.494 | 1.3 EB05 1.2 · IC025 +0.3 | Outcome field, not a reaction | serious PRR 1.0 · 70% consumer | not reported in cached trials |
| Nausea | 1,864 | 1.3 1.2–1.4ROR 1.3 · calibrated p 0.513 | 1.3 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.3 | not reported in cached trials |
| Weight decreased (weight loss) | 1,800 | 3.5 3.4–3.7ROR 3.7 · calibrated p 0.446 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 73% consumer | NCT01427725: 3/553 (0.5%) on Pancrelipase (serious AE) |
| Fatigue (tiredness) | 1,626 | 1.1 1.1–1.2ROR 1.2 · calibrated p 0.407 | 1.1 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.2 | not reported in cached trials |
| Abdominal pain | 1,549 | 3.7 3.5–3.8ROR 3.8 · calibrated p 0.423 | 3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | NCT01427725: 2/553 (0.4%) on Pancrelipase (serious AE) |
| Vomiting | 1,454 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.784 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | NCT01427725: 2/553 (0.4%) on Pancrelipase (serious AE) |
| Infective pulmonary exacerbation of cystic fibrosis | 1,317 | 173.1 162.8–184.0ROR 179.2 · calibrated p 1e-9 ✓ | 131.0 EB05 125.1 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=1,181 | not reported in cached trials |
| Pain | 1,298 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.412 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.1 · 80% consumer | NCT01427725: 4/553 (0.7%) on Pancrelipase (serious AE) |
| Abdominal pain upper | 1,283 | 3.4 3.2–3.6ROR 3.5 · calibrated p 0.482 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 · 75% consumer | NCT01427725: 2/553 (0.4%) on Pancrelipase (serious AE) |
| Pancreatic carcinoma | 1,232 | 24.2 22.8–25.6ROR 24.9 · calibrated p 7e-4 ✓ | 23.2 EB05 22.1 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 17.9 · 86% consumer | NCT01427725: 17/553 (3.1%) on Pancrelipase (serious AE) |
| Dyspnoea (shortness of breath) | 1,182 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.404 | 1.1 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.0 | not reported in cached trials |
| Malaise (feeling unwell) | 1,170 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.622 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.4 | NCT01427725: 1/553 (0.2%) on Pancrelipase (serious AE) |
| Drug ineffective (drug did not work) | 1,165 | 0.5 0.5–0.5ROR 0.5 · calibrated p 0.039 ✓ | 0.5 EB05 0.5 · IC025 -1.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.6 · 71% consumer | not reported in cached trials |
| Off label use (used outside approved label) | 1,162 | 0.7 0.7–0.8ROR 0.7 · calibrated p 0.142 | 0.7 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.6 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Cystic fibrosis related diabetes — n=35, PRR 174.4
- Infective pulmonary exacerbation of cystic fibrosis — n=1,317, PRR 173.1
- Cystic fibrosis lung — n=31, PRR 170.3
- Cystic fibrosis respiratory infection suppression — n=177, PRR 134.0
- Dehiscence — n=24, PRR 79.3 (also seen in trial arm)
- Chemotherapy — n=435, PRR 72.7
- Steatorrhoea — n=314, PRR 72.6
- Bile duct stent insertion — n=35, PRR 55.6
- Gastrointestinal microorganism overgrowth — n=27, PRR 52.1
- Pulmonary function test decreased — n=305, PRR 40.7
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Pancrelipase?
In FDA FAERS, the most frequently co-reported reaction terms for Pancrelipase are diarrhoea, nausea, weight decreased, fatigue, abdominal pain, vomiting. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Pancrelipase have an FDA boxed warning?
No. The FDA label retrieved for Pancrelipase has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pancrelipase causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 073201aa-556d-4a70-918e-84e9616fd88d, effective 20240228; matched on
openfda.generic_name.exact:"PANCRELIPASE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,215 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
PANCRELIPASE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.