Dipentum Side Effects

Please note - some side effects for Dipentum may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Dipentum - for the Consumer

Dipentum

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Dipentum:

Diarrhea; joint pain; nausea; stomach pain or cramps.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine; chest pain; dark urine; fast or irregular heartbeat; pale stools; severe stomach pain; trouble urinating; unusual bruising or bleeding; yellowing of the eyes or skin.

Dipentum Side Effects - for the Professional

Dipentum

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.

Over 2,500 patients have been treated with olsalazine in various controlled and uncontrolled clinical studies. In these as well as in post-marketing experience, olsalazine was administered mainly to patients intolerant to sulfasalazine. There have been rare reports of the following adverse effects in patients receiving olsalazine. These were often difficult to distinguish from possible symptoms of the underlying disease or from the effects of prior and/or concomitant therapy. A causal relationship to the drug has not been demonstrated for some of these reactions.

Blood and Lymphatic System Disorders

Anemia, Eosinophilia, Hemolytic anemia, Interstitial pulmonary disease, Leukopenia, Lymphopenia, Neutropenia, 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

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.

General Disorders and Administration Site Conditions

Fever chills, Hot flashes, Irritability, Rigors

Immune System Disorders

Bronchospasm, Erythema nodosum

Laboratory

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

Musculoskeletal and Connective Tissue Disorders

Muscle cramps

Nervous System Disorders

Insomnia, Paraesthesia, Tremors

Psychiatric Disorders

Mood swings

Renal and Urinary Disorders

Dysuria, Hematuria, Interstitial nephritis, Nephrotic syndrome, Proteinuria, Urinary frequency

Reproductive System and Breast Disorders

Impotence, Menorrhagia

Skin and Subcutaneous Tissue Disorders

Alopecia, Erythema, Photosensitivity reaction

Vascular Disorders

Hypertension, Orthostatic hypotension

Postmarketing

The following events have been identified during post-approval use of products that 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:

Blood and Lymphatic System Disorders

Aplastic anemia, Pancytopenia

General Disorders and Administration Site Conditions

Pyrexia

Hepatobiliary Disorders

Hepatic enzyme increased, Hepatitis, 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.

Musculoskeletal and Connective Tissue Disorders

Myalgia

Respiratory, Thoracic and Mediastinal Disorders

Dyspnoea, Interstitial lung disease

Skin and Subcutaneous Tissue Disorders

Angioneurotic oedema

Nervous System Disorders

Paraesthesia

Renal and Urinary Disorders

Interstitial nephritis

Side Effects by Body System

Gastrointestinal

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.

Gastrointestinal (GI) side effects including GI intolerance have been reported commonly. Drug-induced watery diarrhea has been reported in approximately 17% of patients and resulted in drug withdrawal in 6%. Diarrhea (11.1%), abdominal cramps (10.1%), nausea (5% to 10%), vomiting (5% to 10%), abdominal pain (5% to 10%), dyspepsia (4.0%), bloating (1.5%), stomatitis (1.0%), heartburn (less than 1%), dry mouth, epigastric discomfort, flare in symptoms, flatulence, increased blood in stool, rectal bleeding, and rectal discomfort have been reported. Pancreatitis has also been reported in two pediatric patients.

Nervous system

Nervous system side effects including headache have been reported in approximately 5% of patients. Headache has resulted in drug withdrawal in 1% of patients. Lightheadedness, dizziness, and insomnia have been reported in 1% to 2% of patients. Vertigo has been reported in 1% of patients. Paraesthesia and tremors have also been reported.

Hypersensitivity

Many patients who are allergic to or intolerant of sulfasalazine are able to tolerate olsalazine, although some cross-reactivity has been reported.

Hypersensitivity side effects presented as rash (2.3%) or itching (1.3%) have been reported.

Musculoskeletal

Musculoskeletal side effects including muscle stiffness, weakness, myalgias, and arthralgias have been reported in up to 4% of treated patients. Muscle cramps have also been reported.

Dermatologic

Dermatologic side effects including hair loss or, rarely, alopecia, erythema, and photosensitivity reaction have been reported.

Hematologic

Hematologic side effects have been reported rarely. Anemia, hemolysis, thrombocytopenia, eosinophilia, hemolytic anemia, interstitial pulmonary disease, leucopenia, lymphopenia, neutropenia, and reticulocytosis have been reported. Aplastic anemia and pancytopenia have also been reported during postmarketing experience.

Ocular

A case of blurred vision resolved with olsalazine discontinuation and recurred on rechallenge.

Ocular side effects including dry eyes, blurred vision, and watery eyes have been reported.

Hepatic

Hepatic side effects have rarely included granulomatous hepatitis and nonspecific, reactive hepatitis. Elevated ALT (SGPT) and AST (SGOT) have been reported. At least one case of cholestatic hepatitis has been reported. Hepatic enzymes increased, increased bilirubin, elevated liver function tests (GGT, LDH, alkaline phosphatase), jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure have been reported during postmarketing experience. 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.

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.

Renal

Renal toxicity findings due to 5-ASA 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.

Renal side effects including nephritic syndrome have been reported. At least one case report of olsalazine-induced interstitial nephritis has also been reported.

Psychiatric

Psychiatric side effects including depression (1% to 2%) and mood swings have been reported.

Metabolic

Metabolic side effects have included anorexia (1.3%).

Respiratory

Respiratory side effects including upper respiratory infection have been reported in 1.5% of patients. Dyspnea and interstitial lung disease have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included chest pains, second degree heart block, myocarditis, palpitations, pericarditis, peripheral edema, shortness of breath, and tachycardia. Hypertension, orthostatic hypotension, and angioneurotic edema have also been reported during postmarketing experience.

Immunologic

Immunologic side effects have included bronchospasm and erythema nodosum.

Genitourinary

Genitourinary side effects including impotence and menorrhagia have been reported.

Other

Other side effects including fatigue, drowsiness, and lethargy have been reported in 1.8% of patients. Tinnitus, fever chills, hot flashes, irritability, and rigors have been reported. Pyrexia has also been reported during postmarketing experience.

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