Cotazym-S Side Effects

Generic Name: pancrelipase

Note: This page contains information about the side effects of pancrelipase. Some of the dosage forms included on this document may not apply to the brand name Cotazym-S.

Not all side effects for Cotazym-S may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to pancrelipase: oral capsule, oral capsule delayed release, oral powder, oral tablet, oral tablet chewable

In addition to its needed effects, some unwanted effects may be caused by pancrelipase (the active ingredient contained in Cotazym-S). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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 - if breathed in
  • Shortness of breath
  • stuffy nose
  • tightness in the chest
  • trouble breathing
With tablets - if held in 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

Some of the side effects that can occur with pancrelipase may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • depression
  • excess air or gas in the stomach or intestines
  • fever
  • frequent bowel movements
  • full feeling
  • muscle aches
  • nightmares
  • passing gas
  • runny nose
  • seizures
  • shakiness
  • slurred speech
  • sore throat
Incidence not known
  • Difficulty having a bowel movement (stool)
  • 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

In general, pancreatic enzymes are well tolerated at recommended therapeutic doses. Gastrointestinal symptoms appear to be the primary, and most common adverse effect.[Ref]

Gastrointestinal

Fibrosing colonopathy should be suspected in patients who present with obstruction, bloody diarrhea, chylous ascites, or a combination of abdominal pain with chronic diarrhea, inadequate weight gain, or both. Patients with fibrosing colonopathy should have their enzyme dosage reduced to the recommended range of 500 to 2500 units/kg per meal. Surgical intervention is often needed in patients who cannot maintain their nutritional status.[Ref]

Gastrointestinal side effects have included cramping, nausea, abnormal feces, flatulence, abdominal pain, upper abdominal pain, and diarrhea, particularly with high doses. Fibrosing colonopathy has been reported. Animal studies suggest that the fibrosing colonopathy seen in some patients receiving high doses of pancreatic enzymes may be due to a plasticizer (methacrylic acid copolymer) found in some of the enteric coatings. Postmarketing reports have included abdominal distention, abdominal pain, diarrhea, flatulence, constipation, nausea, fibrosing colonopathy, and distal intestinal obstruction syndrome (DIOS).[Ref]

Metabolic

Metabolic side effects reported with high doses of pancreatic enzymes have included hyperuricosuria and hyperuricemia. It appears that both the enzyme product and some undefined aspect of the disease may lead to increased uric acid levels. Postmarketing reports of inadequate control of diabetes mellitus have been reported.[Ref]

Krasinger and colleagues suggest that it may be reasonable to add allopurinol to the pancreatic enzyme treatment regimen in CF patients that have a urine pH of less than 6 and also excrete large amounts of uric acid. The addition of allopurinol may help to protect the renal tubules from long-term damage due to uric acid crystallization.[Ref]

Hypersensitivity

Hypersensitivity side effects have included reversible bronchial asthma and nasal rhinitis due to exposure to pancreatic enzyme powder. Postmarketing severe allergic reactions including anaphylaxis, asthma, hives and pruritus have been reported.[Ref]

Local

Local side effects have included ulcerations and stomatitis after a prolonged retention of pancreatic enzyme formulations in the mouth.[Ref]

Nervous system

Nervous system side effects have included several case reports of elevation in intracranial pressure (leading to a bulging cranial fontanelle) in cystic fibrosis children receiving pancreatic enzymes. The adverse effect has been self-limiting without interruption of cystic fibrosis therapy in most cases.[Ref]

Dermatologic

Postmarketing side effects include pruritus, urticaria and rash

Oncologic

Postmarketing side effects include recurrence of pre-existing carcinoma.

References

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. "Product Information. Zymase (pancrelipase)." Organon, West Orange, NJ.

6. "Product Information. Pancrease (pancrelipase)." McNeil Pharmaceutical, Raritan, NJ.

7. "Product Information. Creon 20 (pancrelipase)." Solvay Pharmaceuticals Inc, Marietta, GA.

8. "Product Information. Ultrase MT (pancrelipase)." Scandipharm Inc, Birmingham, AL.

9. Cho YW, Aviado DM "Clinical pharmacology for pediatricians. I. Pancreatic enzyme preparations, with special reference to enterically coated microspheres of pancrelipase." J Clin Pharmacol 21 (1981): 224-37

10. "Product Information. Pancrease MT (pancrelipase)." McNeil Pharmaceutical, Raritan, NJ.

11. "Product Information. Cotazym (pancrelipase)." Organon, West Orange, NJ.

12. "Product Information. Viokase (pancrelipase)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

13. "Product Information. Creon 5 (pancrelipase)." Solvay Pharmaceuticals Inc, Marietta, GA.

14. McHugh K, Thomson A, Tam P "Case report: colonic stricture and fibrosis associated with high- strength pancreatic enzymes in a child with cystic fibrosis." Br J Radiol 67 (1994): 900-1

15. Croft NM, Marshall TG, Ferguson A "Gut inflammation in children with cystic fibrosis on high-dose enzyme supplements." Lancet 346 (1995): 1265-7

16. Smyth RL, van Velzen D, Smyth AR, Lloyd DA, Heaf DP "Strictures of ascending colon in cystic fibrosis and high-strength pancreatic enzymes." Lancet 343 (1994): 85-6

17. Kraisinger M, Hochhaus G, Stecenko A, Bowser E, Hendeles L "Clinical pharmacology of pancreatic enzymes in patients with cystic fibrosis and in vitro performance of microencapsulated formulations." J Clin Pharmacol 34 (1994): 158-66

18. Lankisch PG, Creutzfeldt W "Therapy of exocrine and endocrine pancreatic insufficiency." Clin Gastroenterol 13 (1984): 985-99

19. Nassif EG, Younoszai MK, Weinberger MW, Nassif CM, "Comparative effects of antacids, enteric coating, and bile salts on the efficacy of oral pancreatic enzyme therapy in cystic fibrosis." J Pediatr 98 (1981): 320-3

20. Stapleton FB, Kennedy J, Nousia-Arvanitakis S, Linshaw MA "Hyperuricosuria due to high-dose pancreatic extract therapy in cystic fibrosis." N Engl J Med 295 (1976): 246-8

21. Bergner A, Bergner RK "Pulmonary hypersensitivity associated with pancreatin powder exposure." Pediatrics 55 (1975): 814-7

22. Sakula A "Bronchial asthma due to allergy to pancreatic extract." Lancet 2 (1977): 193

23. Sakula A "Bronchial asthma due to allergy to pancreatic extract: a hazard in the treatment of cystic fibrosis." Br J Dis Chest 71 (1977): 295-9

24. Nasr SZ, Schaffert D "Symptomatic increase in intracranial pressure following pancreatic enzyme replacement therapy for cystic fibrosis." Pediatr Pulmonol 19 (1995): 396-7

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