Ultresa Side Effects
Generic Name: pancrelipase
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 Ultresa.
For the Consumer
Applies to pancrelipase: oral capsule, oral capsule delayed release, oral tablet
Side effects requiring immediate medical attention
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:
With high doses
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
- difficulty with swallowing
- fast heartbeat
- 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
Side effects not requiring immediate medical attention
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:
- Blurred vision
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- unexplained weight loss
- Abnormal feces
- bloated feeling
- cold sweats
- cool, pale skin
- excess air or gas in the stomach or intestines
- feeling of fullness
- frequent bowel movements
- loss of consciousness
- muscle aches
- passing gas
- runny nose
- 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
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 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
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]
Common (1% to 10%): Decreased appetite, hyperglycemia, hypoglycemia, weight decreased
Frequency not reported: Hyperuricemia[Ref]
Common (1% to 10%): Rash, skin reactions
Frequency not reported: Pruritus/itching, urticaria/hives
Postmarketing reports: Blotchy/red facial rash[Ref]
Common (1% to 10%): Biliary tract stones, hydrocholecystis
Postmarketing reports: Asymptomatic liver enzyme elevations[Ref]
Common (1% to 10%): Cough, nasopharyngitis
Common (1% to 10%): Anemia
Common (1% to 10%): Renal cyst[Ref]
Common (1% to 10%): Irritability[Ref]
Common (1% to 10%): Viral infection[Ref]
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
Frequency not reported: Fatigue[Ref]
Postmarketing reports: Muscle spasm, myalgia[Ref]
Postmarketing reports: Recurrence of preexisting carcinoma[Ref]
Postmarketing reports: Blurred vision[Ref]
1. "Product Information. Ku-zyme (pancrelipase)." Schwarz Pharma, Mequon, WI.
2. "Product Information. Ultrase (pancrelipase)." Scandipharm Inc, Birmingham, AL.
3. "Product Information. Cotazym-S (pancrelipase)." Organon, West Orange, NJ.
4. "Product Information. Creon 10 (pancrelipase)." Solvay Pharmaceuticals Inc, Marietta, GA.
5. Cerner Multum, Inc. "Australian Product Information." O 0
6. "Product Information. Zymase (pancrelipase)." Organon, West Orange, NJ.
7. "Product Information. Creon 20 (pancrelipase)." Solvay Pharmaceuticals Inc, Marietta, GA.
8. "Product Information. Pancrease (pancrelipase)." McNeil Pharmaceutical, Raritan, NJ.
9. "Product Information. Ultrase MT (pancrelipase)." Scandipharm Inc, Birmingham, AL.
10. "Product Information. Cotazym (pancrelipase)." Organon, West Orange, NJ.
11. "Product Information. Viokase (pancrelipase)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
12. "Product Information. Pancrease MT (pancrelipase)." McNeil Pharmaceutical, Raritan, NJ.
13. "Product Information. Creon 5 (pancrelipase)." Solvay Pharmaceuticals Inc, Marietta, GA.
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.
More about Ultresa (pancrelipase)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Images
- Drug Interactions
- Drug class: digestive enzymes
- FDA Approval History