Protilase Side Effects

Generic name: pancrelipase

Medically reviewed by Drugs.com. Last updated on Nov 20, 2024.

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

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

Common side effects of Protilase

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 side effects

• 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 side effects

• 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

Serious side effects of Protilase

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

Rare side effects

• 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

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 Protilase) 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

Protilase 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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer