Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Renal impairment [see Warnings and Precautions (5.1) ] • Mesalamine-induced acute intolerance syndrome [see Warnings and Precautions (5.2) ] • Hypersensitivity reactions [see Warnings and Precautions (5.3) ] • Hepatic failure [see Warnings and Precautions (5.4) ] • Severe cutaneous adverse reactions [see Warnings and Precautions (5.5) ] • Photosensitivity [see Warnings and Precautions (5.6) ] • Nephrolithiasis [see Warnings and Precautions (5.7) ] 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
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.
5 WARNINGS AND PRECAUTIONS • Renal Impairment : Assess renal function at the beginning of treatment and periodically during treatment.
Discontinue DIPENTUM if renal function deteriorates while on therapy.
( 5.1 , 7.1 ) • Mesalamine-Induced Acute Intolerance Syndrome : Discontinue treatment if acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, sometimes fever, headache and rash) is suspected.
( 5.2 ) • Hypersensitivity Reactions, including myocarditis and pericarditis : Discontinue DIPENTUM if a hypersensitivity reaction is suspected.
( 5.3 ) • Hepatic Failure : Evaluate the risks and benefits of using DIPENTUM in patients with known liver impairment.
Like all medications, Dipentum can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: