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

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

Serious side effects of Ultresa

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

• 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

• Stuffy nose
• tightness in the chest
• trouble breathing

With tablets

• 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

Other side effects of Ultresa

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.

General

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

Gastrointestinal

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]

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]

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

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

Frequency not reported: Anaphylactic reactions, hypersensitivity

Postmarketing reports: Anaphylaxis, mild allergic reactions, severe allergic reactions^[Ref]

Genitourinary

Frequency not reported: Hyperuricosuria^[Ref]

Ocular

Postmarketing reports: Blurred vision^[Ref]