Pancrease Side Effects

Generic name: pancrelipase

Medically reviewed by Drugs.com. Last updated on Dec 19, 2024.

Note: This document provides detailed information about Pancrease Side Effects associated with pancrelipase. Some dosage forms listed on this page may not apply specifically to the brand name Pancrease.

Applies to pancrelipase: oral capsule, oral capsule delayed release, oral powder, oral tablet, oral tablet chewable.

Other dosage forms:

• oral capsule, oral capsule delayed release, oral tablet, oral tablet enteric coated

Precautions

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.

Check with your doctor right away if you or your child have unusual or severe abdominal or stomach pain, trouble passing stool, nausea, or vomiting. These may be symptoms of a rare but serious bowel disorder called fibrosing colonopathy.

This medicine is made from the pancreas of pigs. The risk of getting a virus from medicines made of pig organs has been greatly reduced in recent years. This is the result of required testing for certain viruses, and testing during manufacture of these medicines. Although the risk of transmitting certain viruses to people who will use the medicine is low, talk with your doctor if you or your child have concerns.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you or your child are using this medicine.

Common side effects of Pancrease

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:

Serious side effects of Pancrease

Along with its needed effects, pancrelipase (the active ingredient contained in Pancrease) 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:

See also:

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.

General adverse events

The most commonly reported side effects included gastrointestinal complaints, abdominal pain, and headaches.^[Ref]

Gastrointestinal

• Very common (10% or more): Gastrointestinal complaints (up to 55%), abdominal pain (up to 18%), vomiting (up to 12%)
• Common (1% to 10%): Abdominal discomfort, abdominal distention, abdominal pain upper, abdominal tenderness, abnormal feces, anal pruritus, ascites, constipation, diarrhea, dyspepsia, early satiety, flatulence, frequent bowel movements, nausea
• Uncommon (0.1% to 1%): Bowel stricture formation
• Frequency not reported: Duodenitis, fibrosing colonopathy, gastritis, steatorrhea, strictures of the ileocecum
• Postmarketing reports: Distal intestinal obstruction syndrome (DIOS)^[Ref]

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.^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 15%)
• Common (1% to 10%): Dizziness
• Postmarketing reports: Dull headache^[Ref]

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

Metabolic

• Common (1% to 10%): Blood cholesterol decreased, blood glucose increased, decreased appetite, diabetes mellitus, diabetes mellitus including subtypes, hyperglycemia, hypoglycemia, weight decreased
• Frequency not reported: Hyperuricemia^[Ref]

Hepatic

• Common (1% to 10%): ALT increased, AST increased, biliary tract stones, blood alkaline phosphatase increased, cholangitis, GGT increased, hydrocholecystis
• Postmarketing reports: Asymptomatic liver enzyme elevations^[Ref]

Hematologic

• Common (1% to 10%): Anemia, hematocrit, hemoglobin, red blood cell count, increased white blood cell count
• Frequency not reported: Transient neutropenia with/without clinical sequelae^[Ref]

Respiratory

• Common (1% to 10%): Bronchitis, cough, nasopharyngitis, oropharyngeal pain, respiratory tract infection
• Postmarketing reports: Asthma^[Ref]

Other

• Common (1% to 10%): Asthenia, malaise, pain, pyrexia
• Frequency not reported: Fatigue^[Ref]

Dermatologic

• Common (1% to 10%): Pruritus, rash, skin reactions
• Frequency not reported: Itching, urticaria/hives
• Postmarketing reports: Blotchy/red facial rash^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, back pain, musculoskeletal pain
• Postmarketing reports: Muscle spasm, myalgia^[Ref]

Cardiovascular

• Common (1% to 10%): Contusion, hypertension, peripheral edema^[Ref]

Oncologic

• Common (1% to 10%): Metastases to specific sites, recurrent pancreatic carcinoma
• Postmarketing reports: Recurrence of preexisting carcinoma^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia, irritability^[Ref]

Renal

• Common (1% to 10%): Renal cyst^[Ref]

Immunologic

• Common (1% to 10%): Viral infection^[Ref]

Hypersensitivity

• Frequency not reported: Anaphylactic reactions, hypersensitivity
• Postmarketing reports: Anaphylaxis, mild allergic reactions, severe allergic reactions^[Ref]

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

Genitourinary

• Frequency not reported: Hyperuricosuria^[Ref]

Ocular

• Postmarketing reports: Blurred vision^[Ref]

Frequently asked questions

• What are enteric-coated tablets?

Further information

Pancrease side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer