Use of DIPENTUM, which is converted to mesalamine, may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection because of the similarity in the chromatograms of normetanephrine and the main metabolite of mesalamine, N‑acetyl‑5‑aminosalicylic acid (N‑Ac‑5‑ASA). Consider an alternative, selective assay for normetanephrine.
The following clinically significant adverse reactions are described elsewhere in the labeling:
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.
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.
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
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