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Pancrelipase

Pancrelipase replaces the digestive enzymes your pancreas isn't making enough of, so your body can properly absorb fats, proteins, and carbohydrates.

Brand names CreonPancreazePertzyeUltresaViokace +1 more
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 4, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Pancrelipase at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Pancrelipase, on the U.S. market since about 1994, is the standard treatment for exocrine pancreatic insufficiency (too few digestive enzymes from the pancreas, as in chronic pancreatitis, after pancreas surgery or with cystic fibrosis), supplying pig-derived enzymes that break down fats, proteins and starches. Very little reaches the bloodstream, so it is usually well tolerated; gas, belly pain and changed bowel habits are what people notice most. Report severe or unusual stomach pain, which can signal fibrosing colonopathy (scarring and narrowing of the colon), a rare risk tied to long-term high doses, especially in children with cystic fibrosis, so never raise the dose yourself.

Clinical pearls

  • Take it with every meal and snack, even small ones, since the enzymes only digest food eaten at the same time.
  • If capsules are hard to swallow, sprinkle the contents on applesauce and swallow unchewed; chewing irritates the mouth and weakens them.
  • The brands are not interchangeable, so a switch from Creon to Zenpep or another brand needs your prescriber's sign-off.
  • It is made from pig pancreas, so a pork allergy matters; hives, swelling or trouble breathing need urgent care.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asDelayed-release capsule
Earliest FDA record1994
FDA label last updatedFeb 28, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Pancrelipase, written from its FDA label.

What Pancrelipase is used for

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Pancrelipase treats exocrine pancreatic insufficiency (EPI) — when the pancreas doesn't make enough digestive enzymes. Approved conditions include:

  • Chronic pancreatitis (ongoing inflammation of the pancreas) in adults
  • Post-pancreatectomy (after surgical removal of all or part of the pancreas) in adults
  • Exocrine pancreatic insufficiency due to cystic fibrosis in adults and children

How Pancrelipase works

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The pancreas normally releases enzymes into the small intestine to digest food. When it can't, pancrelipase steps in as a direct replacement. It delivers lipases to break down fats, proteases to break down proteins, and amylases to break down starches — right where digestion happens, in the duodenum and upper small intestine. This allows the body to absorb nutrients it would otherwise lose.

The enzymes work locally in the gut and are not meaningfully absorbed into the bloodstream. They are also not broken down by the liver's CYP enzyme system, so drug interactions through that pathway are not expected.

Pancrelipase dosage

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Pancrelipase is taken by mouth with every meal and every snack. A typical daily schedule covers about three meals and two to three snacks; snack doses are generally about half a meal dose. Capsules must be swallowed whole — not crushed or chewed — and taken with plenty of liquid.

  • If you can't swallow capsules whole, the contents can be carefully sprinkled on soft acidic food like applesauce and swallowed immediately — do not save the mixture for later
  • Do not let the capsule contents linger in the mouth, as this can irritate the lining
  • Your prescriber sets your dose based on your weight, symptoms, and how much fat you eat — follow their guidance precisely
  • Do not switch to a different brand of pancreatic enzyme product without talking to your doctor first

Dosing details from the FDA-approved label

From the Pancrelipase prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

Pediatric Patients Birth to 12 Months : The recommended dosage is 3,000 lipase units (one capsule) per 120 mL of formula or per breastfeeding.

Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Important Dosing Information ( 2.1 ) CREON is a mixture of enzymes including lipases, proteases, and amylases, and dosing is based on lipase units. Dosing scheme based on actual body weight or fat ingestion. Individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Do not exceed 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in adult and pediatric patients greater than 12 months of age without further investigation. ( 5.1 ) The total daily dosage in adult and pediatric patients greater than 12 months of age should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed dose for a meal. Do not substitute other pancreatic enzyme products for CREON. When switching from another pancreatic enzyme product to CREON, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed. Recommended Dosage ( 2.2 ) Adult and Pediatric Patients Greater than 12 Months : The recommended initial starting dosage is: 500 lipase units/kg/meal for adult and pediatric patients 4 years and older. 500 to 1,000 lipase units/kg/meal for adult patients with chronic pancreatitis or pancreatectomy. 1,000 lipase units/kg/meal for pediatric patients greater than 12 months to less than 4 years. Titrate the dosage to either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day. Higher dosages may be administered if documented effective by fecal fat measures or improvement of malabsorption. Pediatric Patients Birth to 12 Months : The recommended dosage is 3,000 lipase units (one capsule) per 120 mL of formula or per breastfeeding. Preparation and Administration Instructions ( 2.3 ) Swallow capsules whole. For patients unable to swallow intact capsule(s), the capsule contents may be sprinkled on soft acidic food (e.g., applesauce, bananas, plain Greek yogurt). Do not crush or chew CREON capsules or capsule contents. Consume sufficient liquids to ensure complete swallowing of CREON. ( 5.2 ) See the full prescribing information for additional information on administering to pediatric patients birth to 12 months.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Pancrelipase side effects

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Most side effects are mild and digestive in nature. Common ones reported in clinical trials include:

Common side effects

  • Vomiting
  • Dizziness
  • Cough
  • Abdominal pain
  • Gas (flatulence)
  • Frequent or abnormal bowel movements
  • High or low blood sugar (hyperglycemia or hypoglycemia)
  • Stuffy or runny nose (nasopharyngitis)

When to get medical help

  • Call your doctor if you have severe or unusual stomach pain — this could signal fibrosing colonopathy (serious scarring of the colon), especially at high doses
  • Seek medical help for signs of an allergic reaction to pork proteins: rash, hives, difficulty breathing, or swelling
  • Tell your doctor if you have gout or kidney problems — high doses can raise uric acid levels in the blood
  • Watch for mouth soreness or irritation, which can happen if the capsule contents touch the mouth lining directly

Pancrelipase warnings and precautions

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  • Fibrosing colonopathy (colon scarring): High doses — especially in children under 12 with cystic fibrosis — have been linked to serious narrowing of the colon. Never exceed the prescribed dose without medical supervision.
  • Mouth irritation: If the capsule contents contact the mouth lining directly (from chewing or breaking capsules), irritation can occur. Always swallow intact or sprinkle carefully.
  • High uric acid (hyperuricemia): Elevated blood uric acid levels have been reported with high doses. People with gout or kidney problems should be monitored.
  • Porcine (pig-derived) origin: The medication comes from pig pancreas. Patients with known pork allergies should be monitored carefully. A very low theoretical risk of viral transmission exists.
  • Hypersensitivity reactions: Allergic reactions are possible. If you experience rash, breathing difficulty, or swelling, seek care immediately.

Pancrelipase interactions

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Based on available information, pancrelipase has a very low potential for drug interactions. Key points:

  • The enzymes in pancrelipase are not processed by the liver's CYP enzyme system, so interactions through that common drug-interaction pathway are not expected
  • The enzymes are not significantly absorbed into the bloodstream, further limiting systemic interaction risk

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿19 supplements and herbs with documented Pancrelipase interactions, ranked by severity Check Pancrelipase against a supplement or herb →

Before taking Pancrelipase

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  • Pork allergy: Pancrelipase is derived from pig pancreas — tell your doctor if you have any known sensitivity to pork or pork products
  • Gout or high uric acid: High doses may raise uric acid; your doctor may want to monitor your levels
  • Kidney problems: Elevated uric acid from high doses could be a concern; discuss with your prescriber
  • History of fibrosing colonopathy: Prior colon scarring from enzyme products puts you at higher risk — your doctor will monitor you closely
  • Pregnancy: Limited data exist, but the drug is minimally absorbed, so significant fetal exposure is not expected; discuss with your doctor
  • Breastfeeding: Minimal systemic absorption means the drug is unlikely to reach breast milk in meaningful amounts, but consult your prescriber
  • Children: Dosing in kids requires extra care, particularly in young children, due to the risk of colon complications at high doses

Pancrelipase overdose

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Taking too much pancrelipase over time has been linked to fibrosing colonopathy (scarring and narrowing of the colon) and to elevated uric acid levels in the blood (hyperuricosuria and hyperuricemia). If you think you or someone else has taken far more than prescribed, contact a poison control center or seek medical care promptly.

What Pancrelipase does in the body

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Pancrelipase works directly in the small intestine to improve the absorption of dietary fat. In clinical studies, patients taking pancrelipase absorbed significantly more fat from their diet compared to those taking a placebo — a meaningful result for people whose pancreas cannot produce enough enzymes on its own. Better fat absorption also means better absorption of fat-soluble nutrients overall.

How your body processes Pancrelipase

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After you swallow pancrelipase, the enzymes are released and go to work in the gut — but they are not meaningfully absorbed into the bloodstream. Because they stay in the digestive tract, they don't circulate through the body or get metabolized by the liver. This also means they don't interact with other medications through the liver's CYP enzyme pathways, keeping the interaction risk very low.

How to store Pancrelipase

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Store CREON at room temperature, 15°C to 25°C (59°F to 77°F), and protect from moisture. protect from moisture. Store and dispense CREON in the original container.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

19

Supplements & herbs that interact with Pancrelipase

19 supplements and herbal products have documented interactions with Pancrelipase in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 2
  • Moderate · 8
  • Minor · 9
ACTIVATED CHARCOAL Major ST. JOHN'S WORT Major COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate GARLIC Moderate GLUCOMANNAN Moderate GUAR GUM Moderate GUM ARABIC Moderate +11 more
Every supplement checked against Pancrelipase — ranked by severity The full interaction hub: 2 major · 8 moderate · 9 minor · every one linked to its full report. Check Pancrelipase against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

2

Nutrient depletion considerations

Pancrelipase has been associated with lower levels of 2 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

FOLIC ACID Moderate Depletion IRON Moderate Depletion
See the full Pancrelipase nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Pancrelipase: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Pancrelipase — the kind of thing our pharmacy team would talk through with you at the counter.

Why do I have to take this with every meal? Can I skip it if I'm not very hungry?

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The enzymes in pancrelipase only work when there's food for them to digest — so timing really does matter. Even a small snack needs about half your usual meal dose. Skipping doses means your body won't break down nutrients properly, which can lead to greasy, loose stools and gradual nutritional deficiencies. Try to make it a consistent habit: medication out whenever food comes out.

Can I open the capsule if I have trouble swallowing it?

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Yes, but carefully. You can sprinkle the contents onto a small amount of soft, acidic food like applesauce — just make sure to swallow it right away without chewing. What you absolutely want to avoid is chewing the capsule or letting the contents sit in your mouth, because the enzymes can irritate the lining of your mouth and throat. And don't save the mixture for later — take it immediately.

I've heard this medication comes from pigs. Is that a concern?

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Pancrelipase is indeed made from pig pancreas, so if you have a known allergy to pork, you should tell your doctor before starting it. There's also a very small theoretical risk related to porcine (pig) viruses, though this is considered extremely rare. Your prescriber weighs these risks against the real benefit of treating your condition — for most people, the benefit is clear.

What side effects should I actually watch out for?

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The most common ones — like vomiting, stomach discomfort, gas, or changes in bowel habits — are usually manageable. What's more important to call your doctor about is severe or unusual belly pain, which could be a sign of a rare but serious condition involving the colon, especially if you're taking high doses. Also watch for signs of an allergic reaction like hives, difficulty breathing, or swelling, and let your doctor know if your mouth feels irritated after taking it.

Is this safe to take during pregnancy or while breastfeeding?

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The good news is that pancrelipase is barely absorbed into your bloodstream — it works locally in your gut. That means very little to none of it is expected to reach your baby, whether through pregnancy or breast milk. That said, always let your OB and prescriber know you're taking it so they can keep the full picture and make the best recommendation for you.

Does pancrelipase interact with my other medications?

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Generally speaking, pancrelipase has a very low risk of interacting with other drugs. Because the enzymes stay in your gut and aren't absorbed into your bloodstream, they don't go through the liver pathways that most drug interactions involve. That said, always keep your pharmacist and doctor updated on everything you take — both prescription and over-the-counter — so nothing gets missed.

Is Pancrelipase available over the counter?

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No. Pancrelipase is a prescription medicine: every Pancrelipase product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Pancrelipase first available?

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The earliest FDA record we hold for Pancrelipase is from 1994: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Pancrelipase was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Pancrelipase on HelloPharmacist

📊Pancrelipase supplement interactions19 checked — ranked by severity 🌿Drug & Supplement CheckerPancrelipase vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Pancrelipase NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Pancrelipase Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Pancrelipase forms and strengths (how it comes)

Pancrelipase is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Delayed-release capsule

By mouth
Available strengths 1 strength
36000 [USP'U]
1 FDA-listed product record ⓘ

Pancrelipase on the U.S. market: products, makers and brands

How Pancrelipase appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

The FDA lists Pancrelipase products, mostly as delayed-release capsule; the earliest marketing or approval year on record is 1994. Brand names on the directory include Creon, Pancreaze, Pertzye and 3 more; the rest are generics.

1
Dose forms ⓘ
1994
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Pancrelipase recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Pancrelipase recalls since July 2021.

✅No Pancrelipase recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

Pancrelipase brand names

Pancrelipase is sold under 6 brand names in the FDA directory — Creon, Pancreaze, Pertzye, Ultresa and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Creon Pancreaze Pertzye Ultresa Viokace Zenpep

Sources for this Pancrelipase page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 28, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Pancrelipase.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Pancrelipase after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Linked representative label ⓘ
AbbVie Inc.
Linked label effective
Feb 28, 2024
Composite sections available
20
Linked SPL Set ID
073201aa-556d-4a70-918e-84e9616fd88d
Linked SPL Document ID
94463229-9296-4640-854f-41d76386d312
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 26
00032-0045-30 Creon Pancrelipase 15000 [USP'U]/1; 3000 [USP'U]/1; 9500 [USP'U]/1 CAPSULE, DELAYED RELEASE AbbVie 00032-0045-70 Creon Pancrelipase 15000 [USP'U]/1; 3000 [USP'U]/1; 9500 [USP'U]/1 CAPSULE, DELAYED RELEASE AbbVie 00032-0046-30 Creon Pancrelipase 30000 [USP'U]/1; 6000 [USP'U]/1; 19000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-0046-70 Creon Pancrelipase 30000 [USP'U]/1; 6000 [USP'U]/1; 19000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-0047-30 Creon Pancrelipase 60000 [USP'U]/1; 12000 [USP'U]/1; 38000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-0047-70 Creon Pancrelipase 60000 [USP'U]/1; 12000 [USP'U]/1; 38000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-1203-64 Creon Pancrelipase 15000 [USP'U]/1; 3000 [USP'U]/1; 9500 [USP'U]/1 CAPSULE, DELAYED RELEASE AbbVie 00032-1203-70 Creon Pancrelipase 15000 [USP'U]/1; 3000 [USP'U]/1; 9500 [USP'U]/1 CAPSULE, DELAYED RELEASE AbbVie 00032-1206-01 Creon Pancrelipase 30000 [USP'U]/1; 6000 [USP'U]/1; 19000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-1206-07 Creon Pancrelipase 30000 [USP'U]/1; 6000 [USP'U]/1; 19000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-1206-56 Creon Pancrelipase 30000 [USP'U]/1; 6000 [USP'U]/1; 19000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-1212-01 Creon Pancrelipase 60000 [USP'U]/1; 12000 [USP'U]/1; 38000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-1212-07 Creon Pancrelipase 60000 [USP'U]/1; 12000 [USP'U]/1; 38000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-1212-13 Creon Pancrelipase 60000 [USP'U]/1; 12000 [USP'U]/1; 38000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-1224-01 Creon Pancrelipase 24000 [USP'U]/1; 76000 [USP'U]/1; 120000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-1224-07 Creon Pancrelipase 24000 [USP'U]/1; 76000 [USP'U]/1; 120000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-1224-46 Creon Pancrelipase 24000 [USP'U]/1; 76000 [USP'U]/1; 120000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-2636-01 Creon Pancrelipase 24000 [USP'U]/1; 76000 [USP'U]/1; 120000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-2636-30 Creon Pancrelipase 24000 [USP'U]/1; 76000 [USP'U]/1; 120000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie 00032-2636-70 Creon Pancrelipase 24000 [USP'U]/1; 76000 [USP'U]/1; 120000 [USP'U]/1 CAPSULE, DELAYED RELEASE PELLETS AbbVie

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. AbbVie Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →