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Olsalazine Side Effects

For the Consumer

Applies to olsalazine: oral capsule

As well as its needed effects, olsalazine may cause unwanted side effects that require medical attention.

Severity: Moderate

If any of the following side effects occur while taking olsalazine, check with your doctor or nurse as soon as possible:

Rare
  • Back or stomach pain (severe)
  • bloody diarrhea
  • fast heartbeat
  • fever
  • nausea or vomiting
  • skin rash
  • swelling of the stomach
  • yellow eyes or skin

Severity: Minor

Some olsalazine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Abdominal or stomach pain or upset
  • diarrhea
  • loss of appetite
Less common
  • Aching joints and muscles
  • acne
  • anxiety or depression
  • dizziness or drowsiness
  • headache
  • trouble in sleeping

For Healthcare Professionals

Applies to olsalazine: oral capsule

Gastrointestinal

Gastrointestinal side effects have included diarrhea (11.1% to 17%), abdominal pain/cramps (10.1%), nausea (5%), dyspepsia (4.0%), bloating (1.5%), vomiting (1%), and stomatitis (1.0%). Heartburn, upper abdominal pain, diarrhea with dehydration, dry mouth, epigastric discomfort, flare in symptoms, flatulence, pancreatitis, increased blood in stool, rectal bleeding, and rectal discomfort have been reported.[Ref]

Nervous system

Nervous system side effects have included headache (5%), vertigo/dizziness (1%), lightheadedness, insomnia, tinnitus, paresthesia, and tremors. Paresthesia and peripheral neuropathy have been reported during postmarketing experience of products containing or metabolized to mesalamine.[Ref]

Cardiovascular

Cardiovascular side effects have included chest pains, second degree heart block, myocarditis, palpitations, pericarditis, peripheral edema, shortness of breath, tachycardia, hypertension, and orthostatic hypotension.

Dermatologic

Dermatologic side effects have included rash (2.3%), itching (1.3%), alopecia, erythema, and photosensitivity reaction. Angioneurotic edema has been reported during postmarketing experience of products containing or metabolized to mesalamine.[Ref]

Other

Other side effects have included fatigue/drowsiness/lethargy (1.8%), fever chills, hot flashes, irritability, and rigors. Pyrexia has been reported during postmarketing experience of products containing or metabolized to mesalamine.

Respiratory

Respiratory side effects have included upper respiratory infection (1.5%). Dyspnea and interstitial lung disease have been reported during postmarketing experience of products containing or metabolized to mesalamine.

Hepatic

Cholestatic hepatitis has been reported in one patient. Olsalazine was confirmed as the causative agent by rechallenge. Liver function abnormalities returned to normal within 2 to 8 weeks after discontinuation of the drug.[Ref]

Hematologic

Hematologic side effects have included anemia, hemolysis, thrombocytopenia, eosinophilia, hemolytic anemia, interstitial pulmonary disease, leukopenia, lymphopenia, neutropenia, and reticulocytosis. Aplastic anemia and pancytopenia have been reported during postmarketing experience of products containing or metabolized to mesalamine.[Ref]

Renal

Renal toxicity findings due to mesalamine have been similar to NSAID-induced renal disease, and included proteinuria, elevated BUN and creatinine, oliguria, polyuria, polydipsia, and rarely ocular symptoms.[Ref]

Renal side effects have included nephrotic syndrome. Renal toxicity, elevated BUN, and elevated creatinine have been reported with mesalamine.[Ref]

Immunologic

Immunologic side effects have included bronchospasm and erythema nodosum.

Genitourinary

Renal toxicity findings due to mesalamine have been similar to NSAID-induced renal disease, and included proteinuria, elevated BUN and creatinine, oliguria, polyuria, polydipsia, and rarely ocular symptoms.

A 71-year-old man who had received olsalazine 250 mg orally two times a day for 8 months for treatment of colitis developed fever and transient blindness in the left eye. Percutaneous renal biopsy revealed severe interstitial nephritis. After discontinuation of the olsalazine, the fever and blindness resolved.

Genitourinary side effects have included dysuria, hematuria, interstitial nephritis, proteinuria, urinary frequency, impotence, and menorrhagia. Oliguria and polyuria have been reported with mesalamine. Interstitial nephritis has been reported during postmarketing experience of products containing or metabolized to mesalamine.

Psychiatric

Psychiatric side effects have included depression (1.5%) and mood swings.

Metabolic

Metabolic side effects have included anorexia (1.3%). Polydipsia has been reported with mesalamine.

Ocular

A case of blurred vision resolved with olsalazine discontinuation and recurred on rechallenge.[Ref]

Ocular side effects have included dry eyes, blurred vision, watery eyes, and transient blindness. Ocular symptoms have been reported with mesalamine.[Ref]

Hypersensitivity

Many patients who are allergic to or intolerant of sulfasalazine are able to tolerate olsalazine, although some cross-reactivity has been reported.[Ref]

Hypersensitivity side effects have included cross-reactivity to sulfasalazine.[Ref]

References

1. Kiilerich S, Ladefoged K, Rannem T, Ranlov PJ "Prophylactic effects of olsalazine v sulphasalazine during 12 months maintenance treatment of ulcerative colitis. The Danish Olsalazine Study Group." Gut 33 (1992): 252-5

2. Garau P, Orenstein SR, Neigut DA, Kocoshis SA "Pancreatitis associated with olsalazine and sulfasalazine in children with ulcerative colitis." J Pediatr Gastroenterol Nutr 18 (1994): 481-5

3. Wadworth AN, Fitton A "Olsalazine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in inflammatory bowel disease." Drugs 41 (1991): 647-64

4. Wright JP, O'Keefe EA, Cuming L, Jaskiewicz K "Olsalazine in maintenance of clinical remission in patients with ulcerative colitis." Dig Dis Sci 38 (1993): 1837-42

5. Eland IA, van Puijenbroek EP, Sturkenboom MJ, Wilson JH, Stricker BH "Drug-associated acute pancreatitis: twenty-one years of spontaneous reporting in The Netherlands." Am J Gastroenterol 94 (1999): 2417-22

6. Ireland A, Mason CH, Jewell DP "Controlled trial comparing olsalazine and sulphasalazine for the maintenance treatment of ulcerative colitis." Gut 29 (1988): 835-7

7. Jarnerot G "Clinical tolerance of olsalazine." Scand J Gastroenterol Suppl 148 (1988): 21-3

8. Loftus EV, Kane SV, Bjorkman D "Safety of 5-aminosalicylic acid agents in the treatment of ulcerative colitis: a systematic review." Am J Gastroenterol 98(9S) (2003): S249

9. Ewe K, Eckardt V, Kanzler G "Treatment of ulcerative colitis with olsalazine and sulphasalazine: efficacy and side-effects." Scand J Gastroenterol Suppl 148 (1988): 70-5

10. Feurle GE, Theuer D, Velasco S, Barry BA, Wordehoff D, Sommer A, Jantschek G, Kruis W "Olsalazine versus placebo in the treatment of mild to moderate ulcerative colitis: a randomised double blind trial." Gut 30 (1989): 1354-61

11. "Product Information. Dipentum (olsalazine)." Pharmacia and Upjohn, Kalamazoo, MI.

12. Meyers S, Sachar DB, Present DH, Janowitz HD "Olsalazine sodium in the treatment of ulcerative colitis among patients intolerant of sulfasalazine. A prospective, randomized, placebo-controlled, double-blind, dose-ranging clinical trial." Gastroenterology 93 (1987): 1255-62

13. Mulder H, Gratama S "Azodisalicylate (Dipentum)-induced hepatitis?" J Clin Gastroenterol 11 (1989): 708-11

14. Wilcox GM, Reynolds JR, Galvanek EG "Nephrotoxicity associated with olsalazine." Am J Med 100 (1996): 238-40

15. Doman DB, Baum MD "Olsalazine sodium can cause myopia that can be clinically confused with the uveitis of inflammatory bowel disease." Am J Gastroenterol 87 (1992): 1684-5

It is possible that some side effects of olsalazine may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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