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Pancreaze (pancrelipase) is used to treat exocrine pancreatic insufficiency. Includes Pancreaze side effects, interactions and indications.
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Drug Information:
The U.S. Food and Drug Administration has approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product (PEP). Pancreatic enzyme products improve food digestion in patients whose bodies do not produce enough pancreatic enzymes. This includes people who have conditions such as cystic fibrosis, chronic pancreatitis, pancreatic tumors, or removal of all or a part of the pancreas. Unapproved versions of pancreatic enzyme products have been available for many years. In October 2007, FDA established a date of April 28, 2010 for the makers of unapproved pancreatic enzyme products to stop manufacturing and distributing unapproved products. Learn more

Pancreaze Side Effects

Pancreaze Side Effects

Note: This document contains side effect information about pancrelipase. Some of the dosage forms listed on this page may not apply to the brand name Pancreaze.

In Summary

More frequent side effects include: headache. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to pancrelipase: oral capsule delayed release, oral tablet

Along with its needed effects, pancrelipase (the active ingredient contained in Pancreaze) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pancrelipase:


  • Skin rash or hives

With high doses

  • Bowel blockage
  • diarrhea
  • nausea
  • stomach cramps or pain

With very high doses

  • Blood in the urine
  • joint pain
  • swelling of the feet or lower legs

With powder dosage form or powder from opened capsules

- if breathed in
  • Stuffy nose
  • tightness in the chest
  • trouble breathing

With tablets

- if held in the mouth
  • Irritation of the mouth

Incidence not known

  • Cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • itching
  • noisy breathing
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • severe stomach pain
  • unusual tiredness or weakness

Some side effects of pancrelipase may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Blurred vision
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • sweating
  • unexplained weight loss
  • vomiting

Less common

  • Abnormal feces
  • anxiety
  • bloated feeling
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • depression
  • excess air or gas in the stomach or intestines
  • feeling of fullness
  • fever
  • frequent bowel movements
  • loss of consciousness
  • muscle aches
  • nightmares
  • passing gas
  • runny nose
  • seizures
  • shakiness
  • slurred speech
  • sore throat

Incidence not known

  • Difficulty having a bowel movement
  • difficulty with moving
  • muscle aching or cramping
  • muscle pains or stiffness
  • muscle spasm
  • swollen joints

For Healthcare Professionals

Applies to pancrelipase: oral capsule, oral capsule extended release, oral delayed release capsule, oral powder for reconstitution, oral tablet, oral tablet extended release


The most commonly reported side effects included gastrointestinal complaints, abdominal pain, and headaches.


Bowel stricture formation occasionally occurred in children with cystic fibrosis who received high doses.

Moderate duodenitis and gastritis occurred in a patient with exocrine pancreatic insufficiency due to cystic fibrosis 16 days after completing treatment with 4000 lipase units/gram fat ingested per day for 5 to 6 days, followed by placebo for an additional 5 to 6 days.

Very common (10% or more): Gastrointestinal complaints (up to 32%), abdominal pain (up to 18%)

Common (1% to 10%): Abdominal distention, abdominal pain upper, abnormal feces, anal pruritus, ascites, constipation, diarrhea, dyspepsia, early satiety, flatulence, frequent bowel movements, nausea, vomiting

Uncommon (0.1% to 1%): Abdominal discomfort, bowel stricture formation

Frequency not reported: Duodenitis, fibrosing colonopathy, gastritis, steatorrhea, strictures of the ileocecum

Postmarketing reports: Distal intestinal obstruction syndrome (DIOS)

Nervous system

Very common (10% or more): Headache (up to 15%)

Common (1% to 10%): Dizziness

Postmarketing reports: Dull headache

A dull headache was reported by a patient receiving treatment with ursodeoxycholic acid concomitantly. The event resolved without sequelae after discontinuation of this drug.


Common (1% to 10%): Decreased appetite, hyperglycemia, hypoglycemia, weight decreased

Frequency not reported: Hyperuricemia


Common (1% to 10%): Rash, skin reactions

Frequency not reported: Pruritus/itching, urticaria/hives

Postmarketing reports: Blotchy/red facial rash


Common (1% to 10%): Biliary tract stones, hydrocholecystis

Postmarketing reports: Asymptomatic liver enzyme elevations


Common (1% to 10%): Cough, nasopharyngitis

Postmarketing reports: Asthma


Common (1% to 10%): Contusion, peripheral edema


Common (1% to 10%): Anemia

Frequency not reported: Transient neutropenia with/without clinical sequelae


Common (1% to 10%): Renal cyst


Common (1% to 10%): Irritability


Common (1% to 10%): Viral infection


A patient with a known history of allergy to another pancrelipase (the active ingredient contained in Pancreaze) product developed a mild allergic reaction, including red, blotchy facial rash and itching. The event resolved without sequelae after discontinuation of this drug.

Frequency not reported: Anaphylactic reactions, hypersensitivity

Postmarketing reports: Anaphylaxis, mild allergic reactions, severe allergic reactions


Frequency not reported: Fatigue


Postmarketing reports: Muscle spasm, myalgia


Postmarketing reports: Recurrence of preexisting carcinoma


Postmarketing reports: Blurred vision

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Pancreaze