Olsalazine has been evaluated in ulcerative colitis patients in remission as well as those with acute disease. Both sulfasalazine-tolerant and intolerant patients have been studied in controlled clinical trials. Overall, 10.4% of patients discontinued olsalazine because of an adverse experience compared with 6.7% of placebo patients. The most commonly reported adverse reactions leading to treatment withdrawal were diarrhea or loose stools (olsalazine 5.9%; placebo 4.8%), abdominal pain and rash or itching (slightly more than 1% of patients receiving olsalazine). Other adverse reactions to olsalazine leading to withdrawal occurred in fewer than 1% of patients (TABLE 1).

For those controlled studies, the comparative incidences of adverse reactions reported in 1% or more patients treated with olsalazine or placebo are provided in TABLE 2.

Digestive: Pancreatitis, diarrhea with dehydration, increased blood in stool, rectal bleeding, flare in symptoms, rectal discomfort, epigastric, discomfort, flatulence.

In a double-blind, placebo-controlled study, increased frequency and severity of diarrhea were reported in patients randomized to olsalazine 500 mg B.I.D. with concomitant pelvic radiation.

Rare cases of granulomatous hepatitis and nonspecific, reactive hepatitis have been reported in patients receiving olsalazine. Additionally; a patient developed mild cholestatic, hepatitis during treatment with sulfasalazine and experienced the same symptoms two weeks later after the treatment was changed to olsalazine. Withdrawal of olsalazine led to complete recovery in these cases.

Neurologic: Paresthesia, tremors, insomnia, mood swings, irritability, fever chills, rigors.

Dermatologic: Erythema nodosum, photosensitivity, erythema, hot flashes, alopecia.

Musculoskeletal: Muscle cramps.

Cardiovascular/Pulmonary: Pericarditis, second degree heart block, interstitial pulmonary disease hypertension, orthostatic hypotension, peripheral edema, chest pains, tachycardia, palpitations, bronchospasm, shortness of breath.

A patient who developed thyroid disease 9 days after starting DIPENTUM Capsules was given propranolol and radioactive iodine and subsequently developed shortness of breath and nausea. The patient died 5 days later with signs and symptoms of acute diffuse myocarditis.

Genitourinary: Frequency, dysuria, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, impotence, menorrhagia.

Hematologic: Leucopenia, neutropenia, lymphopenia, eosinophilia, thrombocytopenia, anemia, hemolytic anemia, reticulocytosis.

Laboratory: ALT (SGPT) or AST (SGOT) elevated beyond the normal range.

Special Senses: Tinnitus, dry mouth, dry eyes, watery eyes, blurred vision.

Postmarketing Reports
The following events have been identified during postapproval use of products which contain (or are metabolized to) mesalamine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine:

Gastrointestinal: 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. Some of these cases were fatal. One case of Kawasaki-like syndrome, which included hepatic function changes, was also reported.

DRUG ABUSE AND DEPENDENCE

Abuse: None reported.

Dependence: Drug dependence has not been reported with chronic administration of olsalazine.

Increased prothrombin time in patients taking concomitant warfarin has been reported.

Drug/Laboratory Test Interactions: None known.

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