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 Viokace.
Applies to pancrelipase: oral capsule delayed release, oral tablet
Along with its needed effects, pancrelipase (the active ingredient contained in Viokace) 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
With very high doses
With powder dosage form or powder from opened capsules- if breathed in
With tablets- if held in the mouth
Incidence not known
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:
Incidence not known
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)
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 Viokace) 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
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Viokace