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Pancrelipase side effects: what 38,364 FDA adverse event reports show

Pancrelipase · Creon · 1,215 reaction terms · 117,213 drug–reaction co-reports · data 2026-09-14
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Drug class

Not stated in label

Brand names

Creon

openFDA label

Who reports

38,364 reports · 74% serious · 3,830 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

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.

FDA label, Indications and Usage

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.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 3Labeled (related wording) 3Likely indication confounding 16Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 14
What the badges mean

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.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Pancreaticoduodenectomy352657.9
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% consumernot reported in cached trials
Pancreatic stent placement48461.4
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% consumernot reported in cached trials
Pancreatectomy239440.6
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% consumernot reported in cached trials
Pancreatic operation89395.9
301.2–520.5ROR 396.8 · calibrated p 2e-12 ✓
217.9 EB05 182.5 · IC025 +6.3
3/3 methods agree
Reporting / coding artifactserious n=88 · 100% consumernot reported in cached trials
Pancreatic failure635324.9
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% consumernot reported in cached trials
Pancreatic carcinoma recurrent64202.6
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% consumerNCT01427725: 5/553 (0.9%) on Pancrelipase (serious AE)
Cystic fibrosis related diabetes35174.4
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 — unassessedserious n=23not reported in cached trials
Infective pulmonary exacerbation of cystic fibrosis1,317173.1
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 — unassessedserious n=1,181not reported in cached trials
Cystic fibrosis lung31170.3
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 — unassessedserious n=31 · 100% cliniciannot reported in cached trials
Pancreatic enzymes decreased28160.3
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 markerserious n=21 · ♀ 100% (drug 56%)not reported in cached trials
Pancreatic enzyme abnormality23158.7
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=20not reported in cached trials
Pancreatolithiasis83144.1
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% consumernot reported in cached trials
Cystic fibrosis respiratory infection suppression177134.0
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 — unassessedserious n=176 · 79% consumernot reported in cached trials
Enzyme level decreased24125.4
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 markerserious n=19 · 100% consumernot reported in cached trials
Distal intestinal obstruction syndrome58112.3
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=55not reported in cached trials
Cystic fibrosis78790.1
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=759not reported in cached trials
Dehiscence2479.3
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 — unassessedserious n=24 · ♀ 0% (drug 56%)NCT01427725: 1/553 (0.2%) on Pancrelipase (serious AE)
Chemotherapy43572.7
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 — unassessedserious n=431 · 100% consumernot reported in cached trials
Steatorrhoea31472.6
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 — unassessedserious n=187not reported in cached trials
Pancreatic atrophy4766.1
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% consumernot reported in cached trials
Pancreatic insufficiency3863.5
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=36not reported in cached trials
Bile duct stent insertion3555.6
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 — unassessedserious n=35 · 100% consumernot reported in cached trials
Gastrointestinal microorganism overgrowth2752.1
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 — unassessedserious n=23 · 100% consumernot reported in cached trials
Liver operation2651.1
34.2–76.4ROR 51.1 · calibrated p 2e-5 ✓
45.3 EB05 32.5 · IC025 +4.0
3/3 methods agree
Reporting / coding artifactserious n=26 · 100% consumernot reported in cached trials
Pancreatic disorder38446.2
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% consumerNCT01427725: 17/553 (3.1%) on Pancrelipase (serious AE)
Pancreatic neoplasm9646.0
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% consumernot reported in cached trials
Pancreatic injury2242.8
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% consumernot reported in cached trials
Pancreatic carcinoma metastatic20041.1
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=200not reported in cached trials
Pulmonary function test decreased30540.7
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 — unassessedserious n=258not reported in cached trials
Pancreatic duct dilatation1940.6
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=17not reported in cached trials
Splenectomy7738.7
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 — unassessedserious n=77 · 86% consumernot reported in cached trials
Biliary obstruction8137.8
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 — unassessedserious n=81 · 86% consumernot reported in cached trials
Pseudocyst2035.9
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 — unassessedserious n=18not reported in cached trials
Pancreatic mass6334.5
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% consumernot reported in cached trials
Weight gain poor13233.0
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 — unassessedserious n=81 · 77% consumernot reported in cached trials
Pancreatitis relapsing4632.8
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=46not reported in cached trials
Pancreas infection2130.3
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=21not 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).

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.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Diarrhoea (diarrhea)3,6983.2
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 2.9NCT01427725: 1/553 (0.2%) on Pancrelipase (serious AE)
Death1,9931.3
1.2–1.3ROR 1.3 · calibrated p 0.494
1.3 EB05 1.2 · IC025 +0.3Outcome field, not a reactionserious PRR 1.0 · 70% consumernot reported in cached trials
Nausea1,8641.3
1.2–1.4ROR 1.3 · calibrated p 0.513
1.3 EB05 1.2 · IC025 +0.3Labeled adverse reaction
exact term
serious PRR 1.3not reported in cached trials
Weight decreased (weight loss)1,8003.5
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 — unassessedserious PRR 3.2 · 73% consumerNCT01427725: 3/553 (0.5%) on Pancrelipase (serious AE)
Fatigue (tiredness)1,6261.1
1.1–1.2ROR 1.2 · calibrated p 0.407
1.1 EB05 1.1 · IC025 +0.1Not in label — unassessedserious PRR 1.2not reported in cached trials
Abdominal pain1,5493.7
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 2.7NCT01427725: 2/553 (0.4%) on Pancrelipase (serious AE)
Vomiting1,4541.7
1.6–1.8ROR 1.7 · calibrated p 0.784
1.7 EB05 1.6 · IC025 +0.7Labeled adverse reaction
exact term
serious PRR 1.6NCT01427725: 2/553 (0.4%) on Pancrelipase (serious AE)
Infective pulmonary exacerbation of cystic fibrosis1,317173.1
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 — unassessedserious n=1,181not reported in cached trials
Pain1,2981.2
1.1–1.2ROR 1.2 · calibrated p 0.412
1.2 EB05 1.1 · IC025 +0.1Labeled adverse reaction
exact term
serious PRR 1.1 · 80% consumerNCT01427725: 4/553 (0.7%) on Pancrelipase (serious AE)
Pancreatic carcinoma1,23224.2
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% consumerNCT01427725: 17/553 (3.1%) on Pancrelipase (serious AE)
Dyspnoea (shortness of breath)1,1821.1
1.1–1.2ROR 1.1 · calibrated p 0.404
1.1 EB05 1.1 · IC025 +0.1Not in label — unassessedserious PRR 1.0not reported in cached trials
Malaise (feeling unwell)1,1701.5
1.4–1.5ROR 1.5 · calibrated p 0.622
1.5 EB05 1.4 · IC025 +0.4Not in label — unassessedserious PRR 1.4NCT01427725: 1/553 (0.2%) on Pancrelipase (serious AE)
Drug ineffective (drug did not work)1,1650.5
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 artifactserious PRR 0.6 · 71% consumernot reported in cached trials
Off label use (used outside approved label)1,1620.7
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 artifactserious PRR 0.6not 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.

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

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.