Olsalazineside effects

The following clinically significant adverse reactions are described elsewhere in the labeling:

Renal impairment

Mesalamine-induced acute intolerance syndrome

Hypersensitivity reactions

Hepatic failure

Severe cutaneous adverse reactions

Photosensitivity

Nephrolithiasis The following adverse reactions have been identified from clinical studies or postmarketing reports of olsalazine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In double-blind, placebo- and active-controlled clinical trials of ulcerative colitis, discontinuations due to adverse reactions were reported in 10% of DIPENTUM-treated patients (N=441) and 7% of placebo-treated patients (N=208). Both sulfasalazine-tolerant and intolerant patients were included. The most common adverse reactions leading to discontinuation in DIPENTUM-treated patients were diarrhea/loose stools (6%), abdominal pain (1%), and rash/itching (1%). In these controlled trials, adverse reactions reported in 1% or more of patients treated with DIPENTUM and greater than placebo are provided in Table 1. Table 1 Adverse Reactions reported in at least 1% of patients in the DIPENTUM group and greater than placebo in Patients with Ulcerative Colitis in Double-Blind, Controlled Clinical Trials Adverse Reaction DIPENTUM (N=441) % Placebo (N=208) % Diarrhea 11 7 Abdominal pain/cramps 10 7 Nausea 5 4 Arthralgia/Joint Pain 4 3 Rash 2 1 Upper Respiratory Infection 2 0 Depression 2 0 Vomiting 1 0 Stomatitis 1 0 Vertigo/Dizziness 1 0 Itching 1 0 Other adverse reactions reported in clinical trials or post-marketing experience: Blood and Lymphatic System Disorders aplastic anemia, anemia, eosinophilia, hemolytic anemia, leukopenia, lymphopenia, neutropenia, pancytopenia, reticulocytosis, thrombocytopenia Cardiac Disorders chest pains, heart block second degree, myocarditis, palpitations, pericarditis, peripheral edema, shortness of breath, tachycardia A patient who developed thyroid disease 9 days after starting DIPENTUM 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. Ear and Labyrinth Disorders tinnitus Eye Disorders dry eyes, vision blurred, watery eyes Gastrointestinal Disorders abdominal pain (upper), diarrhea with dehydration, dry mouth, epigastric discomfort, flare in symptoms, flatulence, increased blood in stool, pancreatitis, rectal bleeding, rectal discomfort General Disorders and Administration Site Conditions fever chills, hot flashes, irritability, pyrexia, rigors Hepatobiliary Disorders hepatic enzyme increased, hepatitis (including cholestasis, granulomatous, and non-specific, reactive), increased bilirubin 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. Immune System Disorders bronchospasm, erythema nodosum Musculoskeletal and Connective Tissue Disorders myalgia, muscle cramps Nervous System Disorders insomnia, paraesthesia, peripheral neuropathy, tremors Psychiatric Disorders mood swings Renal and Urinary Disorders dysuria, hematuria, interstitial nephritis, nephrolithiasis, nephrotic syndrome, proteinuria, urinary frequency

Urine discoloration occurring ex-vivo caused by contact of mesalamine, including inactive metabolite, with surfaces or water treated with hypochlorite-containing bleach. Reproductive System and Breast Disorders impotence, menorrhagia, reversible oligospermia Respiratory, Thoracic and Mediastinal Disorders dyspnea, interstitial lung disease, pleurisy/pleuritis Skin and Subcutaneous Tissue Disorders AGEP, alopecia, angioneurotic edema, DRESS, erythema, photosensitivity reaction, SJS/TEN Vascular Disorders hypertension, orthostatic hypotension Most common adverse reactions (≥2%) are: diarrhea, abdominal pain/cramps, nausea, arthralgia/joint pain, rash, upper respiratory infection and depression. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-888-380-3276 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.