Olsalazine Side Effects
For the Consumer
Applies to olsalazine: oral capsule
Along with its needed effects, olsalazine 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 as soon as possible if any of the following side effects occur while taking olsalazine:Rare
- Back or stomach pain (severe)
- bloody diarrhea
- fast heartbeat
- nausea or vomiting
- skin rash
- swelling of the stomach
- yellow eyes or skin
Some side effects of olsalazine 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
- Abdominal or stomach pain or upset
- loss of appetite
- Aching joints and muscles
- anxiety or depression
- dizziness or drowsiness
- trouble in sleeping
For Healthcare Professionals
Applies to olsalazine: oral capsule
During clinical trials, olsalazine was discontinued due to side effects in 10.4% of patients compared to 6.7% of patients receiving placebo. The side effects leading to treatment withdrawal included diarrhea/loose stools (5.9%), abdominal pain (1.1%), and rash/itching (1.1%). Side effects leading to olsalazine withdrawal in less than 1% of patients included nausea, headache, heartburn, rectal bleeding, insomnia, dizziness, anorexia, lightheadedness, and depression.
Diarrhea may be minimized by initiating therapy with lower doses and gradually increasing therapy as tolerated. Administration of smaller doses more frequently may also minimize diarrhea. Diarrhea induced by olsalazine differs from diarrhea due to colitis because of the absence of blood.[Ref]
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 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]
A patient who developed thyroid disease 9 days after starting olsalazine was given propranolol and radioactive iodine and subsequently developed shortness of breath and nausea. Five days later, the patient died with signs and symptoms of acute diffuse myocarditis.
Cardiovascular side effects have included chest pains, second degree heart block, myocarditis, palpitations, pericarditis, peripheral edema, shortness of breath, tachycardia, hypertension, and orthostatic hypotension.
Musculoskeletal side effects have included arthralgia/joint pain (4%), muscle cramps, muscle stiffness, and weakness. Myalgia has been reported during postmarketing experience of products containing or metabolized to mesalamine.[Ref]
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 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 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 side effects have included granulomatous hepatitis (rare), nonspecific reactive hepatitis (rare), elevated ALT (SGPT) and AST (SGOT), and at least one case of cholestatic hepatitis. Increased hepatic enzymes, increased bilirubin, hepatitis, reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure have been reported during postmarketing experience of products containing or metabolized to mesalamine. Some of these cases were fatal. At least one case of Kawasaki-like syndrome, which included hepatic function changes, was also reported during postmarketing experience of products containing or metabolized to mesalamine.[Ref]
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 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 side effects have included nephrotic syndrome. Renal toxicity, elevated BUN, and elevated creatinine have been reported with mesalamine.[Ref]
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]
Immunologic side effects have included bronchospasm and erythema nodosum.
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.
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.
Psychiatric side effects have included depression (1.5%) and mood swings.
Metabolic side effects have included anorexia (1.3%). Polydipsia has been reported with mesalamine.
Ocular side effects have included dry eyes, blurred vision, watery eyes, and transient blindness. Ocular symptoms have been reported with mesalamine.[Ref]
A case of blurred vision resolved with olsalazine discontinuation and recurred on rechallenge.[Ref]
Hypersensitivity side effects have included cross-reactivity to sulfasalazine.[Ref]
Many patients who are allergic to or intolerant of sulfasalazine are able to tolerate olsalazine, although some cross-reactivity has been reported.[Ref]
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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
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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
Some side effects of olsalazine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
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- Drug class: 5-aminosalicylates
Other brands: Dipentum
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