Drug · FAERS side-effect profile with label screen

Pancrelipase Lipase side effects: what 675 FDA adverse event reports show

Pancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease · 7 reaction terms · 91 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Pancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease (Pancreaze)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

675 reports · 54% serious · 49 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. PANCREAZE ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. ( 1 )

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 microtablets in PANCREAZE 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 7 strongest signals

Likely indication confounding 1Reporting / coding artifact 6

What the badges mean

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.
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 0 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Incorrect product storage	12	28.0 16.0–49.1ROR 28.5 · χ² 286 / p 2e-64	26.9 EB05 16.3 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Drug dispensing error	13	26.1 15.2–44.8ROR 26.6 · χ² 289 / p 3e-65	25.2 EB05 15.5 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product packaging issue	5	16.8 7.0–40.2ROR 16.9 · χ² 59 / p 7e-15	12.3 EB05 4.1 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Expired product administered	13	12.2 7.1–20.9ROR 12.4 · χ² 123 / p 8e-29	10.7 EB05 6.0 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug dose omission	36	6.7 4.9–9.2ROR 7.0 · χ² 170 / p 5e-39	6.2 EB05 4.7 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 6.8 · ♀ 38% (drug 60%)	no trial data cached
Pancreatic carcinoma	6	6.4 2.9–14.3ROR 6.5 · χ² 22 / p 1e-6	4.6 EB05 2.3 · IC025 +0.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 5.7	no trial data cached
Wrong technique in drug usage process	6	5.1 2.3–11.2ROR 5.1 · χ² 16 / p 4e-5	3.8 EB05 1.9 · IC025 +0.5	Reporting / coding artifact	serious PRR 3.0	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Drug dose omission	36	6.7 4.9–9.2ROR 7.0 · χ² 170 / p 5e-39	6.2 EB05 4.7 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 6.8 · ♀ 38% (drug 60%)	no trial data cached
Expired product administered	13	12.2 7.1–20.9ROR 12.4 · χ² 123 / p 8e-29	10.7 EB05 6.0 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug dispensing error	13	26.1 15.2–44.8ROR 26.6 · χ² 289 / p 3e-65	25.2 EB05 15.5 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Incorrect product storage	12	28.0 16.0–49.1ROR 28.5 · χ² 286 / p 2e-64	26.9 EB05 16.3 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Wrong technique in drug usage process	6	5.1 2.3–11.2ROR 5.1 · χ² 16 / p 4e-5	3.8 EB05 1.9 · IC025 +0.5	Reporting / coding artifact	serious PRR 3.0	no trial data cached
Pancreatic carcinoma	6	6.4 2.9–14.3ROR 6.5 · χ² 22 / p 1e-6	4.6 EB05 2.3 · IC025 +0.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 5.7	no trial data cached
Product packaging issue	5	16.8 7.0–40.2ROR 16.9 · χ² 59 / p 7e-15	12.3 EB05 4.1 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Lipase?

In FDA FAERS, the most frequently co-reported reaction terms for Pancrelipase Lipase are pancreatic carcinoma. 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 Lipase have an FDA boxed warning?

No. The FDA label retrieved for Pancrelipase Lipase has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Pancrelipase Lipase 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 e8f5d2fe-728d-42af-99a6-83dddc6539c5, effective 20250606; matched on openfda.generic_name.exact:"PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, AND PANCRELIPASE PROTEASE")
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, field patient.drug.openfda.generic_name.exact, 7 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

Page generated 2026-10-08. 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.