Drug · FAERS side-effect profile with label screen
Pancrelipase, Pancrelipase and Pancrelipase side effects: what 5,822 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase (Zenpep)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
5,822 reports · 59% serious · 399 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ZENPEP ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. ZENPEP ® 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 pellets in ZENPEP 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) 4Likely indication confounding 3Reporting / coding artifact 4Not in label — unassessed 26
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.
- 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. 142 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Inability to afford medication | 38 | 14.0 10.2–19.2ROR 14.1 · χ² 443 / p 1e-98 | 13.6 EB05 10.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Tenderness | 37 | 12.8 9.3–17.7ROR 12.9 · χ² 390 / p 5e-87 | 12.4 EB05 9.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 100% (drug 56%) | no trial data cached |
| Haemoptysis | 70 | 9.0 7.2–11.4ROR 9.1 · χ² 492 / p 3e-109 | 8.7 EB05 7.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Lung infection | 39 | 8.9 6.5–12.2ROR 9.0 · χ² 266 / p 4e-60 | 8.4 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Intestinal obstruction | 84 | 8.1 6.5–10.0ROR 8.2 · χ² 515 / p 3e-114 | 7.8 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 | no trial data cached |
| Flatulence (gas) | 121 | 7.7 6.5–9.2ROR 7.9 · χ² 701 / p 1e-154 | 7.5 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 · 75% consumer | no trial data cached |
| Hospitalisation | 319 | 7.6 6.8–8.4ROR 7.9 · χ² 1,816 / p <1e-300 | 7.5 EB05 6.8 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 | no trial data cached |
| Photophobia (light sensitivity) | 39 | 7.5 5.5–10.3ROR 7.6 · χ² 214 / p 8e-49 | 7.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · ♀ 97% (drug 56%) | no trial data cached |
| Ear pain | 39 | 7.2 5.3–9.9ROR 7.3 · χ² 203 / p 2e-46 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.1 · ♀ 97% (drug 56%) | no trial data cached |
| Thinking abnormal | 36 | 6.9 5.0–9.6ROR 7.0 · χ² 177 / p 1e-40 | 6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 100% (drug 56%) | no trial data cached |
| Insurance issue | 27 | 6.6 4.5–9.6ROR 6.6 · χ² 121 / p 2e-28 | 6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Impaired gastric emptying | 23 | 6.5 4.3–9.8ROR 6.5 · χ² 102 / p 3e-24 | 5.8 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Oral pain | 39 | 6.3 4.6–8.6ROR 6.3 · χ² 167 / p 2e-38 | 5.9 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.7 · ♀ 100% (drug 56%) | no trial data cached |
| Sputum discoloured | 16 | 6.1 3.7–10.0ROR 6.1 · χ² 63 / p 9e-16 | 5.3 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Productive cough (cough with phlegm) | 80 | 6.1 4.9–7.6ROR 6.2 · χ² 336 / p 3e-75 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Pneumothorax | 26 | 5.9 4.0–8.7ROR 5.9 · χ² 101 / p 4e-24 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Therapy change | 15 | 5.6 3.4–9.3ROR 5.6 · χ² 52 / p 2e-13 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=8 | no trial data cached |
| Sneezing | 34 | 5.5 3.9–7.7ROR 5.5 · χ² 120 / p 3e-28 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · ♀ 94% (drug 56%) | no trial data cached |
| Pancreatitis (pancreas inflammation) | 73 | 5.0 4.0–6.2ROR 5.0 · χ² 228 / p 8e-52 | 4.8 EB05 4.0 · IC025 +1.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.8 | no trial data cached |
| Malnutrition | 15 | 4.9 2.9–8.1ROR 4.9 · χ² 42 / p 4e-11 | 4.3 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Sinus disorder | 26 | 4.7 3.2–6.9ROR 4.7 · χ² 73 / p 8e-18 | 4.4 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Pancreatic carcinoma | 38 | 4.7 3.4–6.5ROR 4.7 · χ² 107 / p 2e-25 | 4.5 EB05 3.4 · IC025 +1.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.5 | no trial data cached |
| Abdominal distension (bloating) | 135 | 4.7 4.0–5.5ROR 4.8 · χ² 388 / p 9e-87 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Infection | 184 | 4.6 4.0–5.3ROR 4.7 · χ² 518 / p 7e-115 | 4.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Product use complaint | 19 | 4.4 2.8–6.9ROR 4.4 · χ² 47 / p 4e-12 | 4.0 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious n=7 | no trial data cached |
| Wound | 34 | 4.4 3.2–6.2ROR 4.4 · χ² 86 / p 8e-21 | 4.2 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · ♀ 87% (drug 56%) | no trial data cached |
| Pancreatitis acute | 26 | 4.2 2.9–6.2ROR 4.2 · χ² 60 / p 4e-15 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.1 | no trial data cached |
| Lung disorder | 57 | 4.2 3.2–5.4ROR 4.2 · χ² 136 / p 1e-31 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 79% consumer | no trial data cached |
| Hospice care | 11 | 4.0 2.2–7.3ROR 4.0 · χ² 22 / p 1e-6 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Iron deficiency anaemia | 10 | 3.9 2.1–7.3ROR 3.9 · χ² 19 / p 7e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Frequent bowel movements | 29 | 3.9 2.7–5.6ROR 3.9 · χ² 59 / p 7e-15 | 3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 · 76% consumer | no trial data cached |
| Small intestinal obstruction | 13 | 3.8 2.2–6.6ROR 3.8 · χ² 24 / p 4e-7 | 3.4 EB05 2.2 · IC025 +0.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
| Feeding disorder | 21 | 3.8 2.5–5.8ROR 3.8 · χ² 40 / p 1e-10 | 3.5 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 80% consumer | no trial data cached |
| Wheezing | 61 | 3.7 2.9–4.8ROR 3.7 · χ² 119 / p 6e-28 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · ♀ 84% (drug 56%) | no trial data cached |
| Nephrolithiasis (kidney stones) | 47 | 3.7 2.8–4.9ROR 3.7 · χ² 90 / p 1e-21 | 3.6 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Viral infection | 33 | 3.6 2.5–5.0ROR 3.6 · χ² 59 / p 9e-15 | 3.4 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Skin disorder | 33 | 3.6 2.5–5.0ROR 3.6 · χ² 59 / p 9e-15 | 3.4 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 · ♀ 100% (drug 56%) | no trial data cached |
| Cholecystectomy | 11 | 3.5 1.9–6.3ROR 3.5 · χ² 17 / p 2e-5 | 3.1 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Intentional dose omission | 26 | 3.4 2.3–5.0ROR 3.4 · χ² 42 / p 4e-11 | 3.3 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 73% consumer | no trial data cached |
| Osteoarthritis | 40 | 3.4 2.5–4.6ROR 3.4 · χ² 65 / p 3e-16 | 3.3 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · ♀ 97% (drug 56%) | 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 |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 469 | 2.6 2.4–2.9ROR 2.8 · χ² 486 / p 7e-108 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Hospitalisation | 319 | 7.6 6.8–8.4ROR 7.9 · χ² 1,816 / p <1e-300 | 7.5 EB05 6.8 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 | no trial data cached |
| Death | 291 | 1.2 1.1–1.4ROR 1.2 · χ² 11 / p 3e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Outcome field, not a reaction | serious PRR 1.2 | no trial data cached |
| Pneumonia (lung infection) | 230 | 2.6 2.3–2.9ROR 2.6 · χ² 221 / p 3e-50 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Weight decreased (weight loss) | 214 | 2.8 2.4–3.2ROR 2.8 · χ² 242 / p 7e-55 | 2.7 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Cough | 196 | 2.5 2.2–2.9ROR 2.6 · χ² 181 / p 1e-41 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Abdominal pain | 196 | 3.0 2.6–3.5ROR 3.1 · χ² 269 / p 1e-60 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Constipation | 194 | 3.2 2.8–3.7ROR 3.3 · χ² 299 / p 2e-67 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Infection | 184 | 4.6 4.0–5.3ROR 4.7 · χ² 518 / p 7e-115 | 4.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Abdominal pain upper | 182 | 3.2 2.8–3.7ROR 3.3 · χ² 274 / p 7e-62 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.2 | no trial data cached |
| Abdominal distension (bloating) | 135 | 4.7 4.0–5.5ROR 4.8 · χ² 388 / p 9e-87 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Flatulence (gas) | 121 | 7.7 6.5–9.2ROR 7.9 · χ² 701 / p 1e-154 | 7.5 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 · 75% consumer | no trial data cached |
| Abdominal discomfort | 114 | 2.5 2.0–2.9ROR 2.5 · χ² 98 / p 2e-23 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Product dose omission issue | 105 | 1.3 1.1–1.6ROR 1.3 · χ² 8 / p 0.002 | 1.3 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 2.2 · 71% consumer | no trial data cached |
| Influenza | 93 | 3.0 2.4–3.7ROR 3.0 · χ² 122 / p 1e-28 | 3.0 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
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.
- Inability to afford medication — n=38, PRR 14.0
- Tenderness — n=37, PRR 12.8
- Haemoptysis — n=70, PRR 9.0
- Lung infection — n=39, PRR 8.9
- Photophobia — n=39, PRR 7.5
- Thinking abnormal — n=36, PRR 6.9
- Insurance issue — n=27, PRR 6.6
- Impaired gastric emptying — n=23, PRR 6.5
- Productive cough — n=80, PRR 6.1
- Pneumothorax — n=26, PRR 5.9
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 diarrhoea, pneumonia, weight decreased, cough, abdominal pain, constipation. 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 7f16f2d4-8df6-4bd7-ac10-56994fa257b0, effective 20251114; matched on
openfda.generic_name.exact:"PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE") - 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, 182 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.