Pangestyme EC Side Effects

Generic name: pancrelipase

Medically reviewed by Drugs.com. Last updated on Dec 10, 2024.

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

Applies to pancrelipase: oral capsule, oral capsule delayed release, oral tablet, oral tablet enteric coated.

Other dosage forms:

• oral capsule, oral capsule delayed release, oral powder, oral tablet, oral tablet chewable

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.

For patients taking the capsules containing the powder:

• If the capsules are opened to mix with food, be careful not to breathe in the powder. To do so may cause harmful effects, such as stuffy nose, shortness of breath, troubled breathing, or tightness in the chest.

For patients taking the powder form of this medicine:

• Avoid breathing in the powder. To do so may cause harmful effects such as stuffy nose, shortness of breath, troubled breathing, or tightness in the chest.

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 may cause irritation of the inside of your or your child's mouth if it is not swallowed completely, is crushed or chewed, or is mixed into foods that are not recommended. Follow your doctor's instructions carefully to prevent this.

Pancrelipase may increase uric acid levels in the blood. Check with your doctor if you or your child have joint pain, stiffness, or swelling, lower back, side, or stomach pain, or swelling of the feet or lower legs.

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, which 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.

Tell your doctor if you have a history of abnormal blood glucose levels before taking Zenpep®.

Common side effects of Pangestyme EC

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 Pangestyme EC

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

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

• stuffy nose
• tightness in the chest
• trouble breathing

With tablets

• Irritation of the mouth

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 Pangestyme EC) 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]

See also:

Frequently asked questions

• What are enteric-coated tablets?

Further information

Pangestyme EC 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