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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Dipentum:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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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).

Table 1 Adverse Reactions Resulting In Withdrawal From Controlled Studies Total

	Olsalazine (N = 441)	Placebo (N = 208)
Diarrhea/Loose Stools	26 (5.9%)	10 (4.8 %)
Nausea	3	2
Abdominal Pain	5 (1.1%)	0
Rash/Itching	5 (1.1%)	0
Headache	3	0
Heartburn	2	0
Rectal Bleeding	1	0
Insomnia	1	0
Dizziness	1	0
Anorexia	1	0
Light Headedness	1	0
Depression	1	0
Miscellaneous	4 (0.9%)	3 (1.4%)
Total Number of Patients Withdrawn	46 (10.4%)	14 (6.7 %)

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.

Table 2 Comparative Incidence (%) of Adverse Effects Reported By One Percent Or More of Ulcerative Colitis Patients Treated With Olsalazine Or Placebo in Double Blind Controlled Studies

Adverse Event	Olsalazine (N = 441) %	Placebo (N = 208) %
Gastrointestinal Disorders
Diarrhea	11.1	6.7
Abdominal Pain/Cramps	10.1	7.2
Nausea	5.0	3.9
Dyspepsia	4.0	4.3
Bloating	1.5	1.4
Vomiting	1.0	-
Stomatitis	1.0	-
Increased Blood in Stool	-	3.4
Metabolism and Nutrition Disorders
Anorexia	1.3	1.9
Nervous System Disorders
Headache	5.0	4.8
Insomnia	-	2.4
General Disorders and Administration Site Conditions
Fatigue/Drowsiness/Lethargy	1.8	2.9
Psychiatric Disorders
Depression	1.5	-
Ear and Labyrinth Disorders
Vertigo/Dizziness	1.0	-
Skin and Subcutaneous Tissue Disorders
Rash	2.3	1.4
Itching	1.3	-
Musculoskeletal and Connective Tissue Disorders
Arthralgia/Joint Pain	4.0	2.9
Infections and Infestations
Upper Respiratory Infection	1.5	-

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, Peripheral neuropathy

Renal and Urinary Disorders: Interstitial nephritis

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Side Effects by Body System - for Healthcare Professionals

General

During clinical trials, olsalazine was discontinued due to side effects in 10.4% of patients compared to 6.7% of patients receiving placebo. The side effects leading to treatment withdrawal included diarrhea/loose stools (5.9%), abdominal pain (1.1%), and rash/itching (1.1%). Side effects leading to olsalazine withdrawal in less than 1% of patients included nausea, headache, heartburn, rectal bleeding, insomnia, dizziness, anorexia, lightheadedness, and depression.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (11.1% to 17%), abdominal pain/cramps (10.1%), nausea (5%), dyspepsia (4.0%), bloating (1.5%), vomiting (1%), and stomatitis (1.0%). Heartburn, upper abdominal pain, diarrhea with dehydration, dry mouth, epigastric discomfort, flare in symptoms, flatulence, pancreatitis, increased blood in stool, rectal bleeding, and rectal discomfort have been reported.

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.

Nervous system

Nervous system side effects have included headache (5%), vertigo/dizziness (1%), lightheadedness, insomnia, tinnitus, paresthesia, and tremors. Paresthesia and peripheral neuropathy have been reported during postmarketing experience of products containing or metabolized to mesalamine.

Cardiovascular

Cardiovascular side effects have included chest pains, second degree heart block, myocarditis, palpitations, pericarditis, peripheral edema, shortness of breath, tachycardia, hypertension, and orthostatic hypotension.

A patient who developed thyroid disease 9 days after starting olsalazine was given propranolol and radioactive iodine and subsequently developed shortness of breath and nausea. Five days later, the patient died with signs and symptoms of acute diffuse myocarditis.

Musculoskeletal

Musculoskeletal side effects have included arthralgia/joint pain (4%), muscle cramps, muscle stiffness, and weakness. Myalgia has been reported during postmarketing experience of products containing or metabolized to mesalamine.

Dermatologic

Dermatologic side effects have included rash (2.3%), itching (1.3%), alopecia, erythema, and photosensitivity reaction. Angioneurotic edema has been reported during postmarketing experience of products containing or metabolized to mesalamine.

Other

Other side effects have included fatigue/drowsiness/lethargy (1.8%), fever chills, hot flashes, irritability, and rigors. Pyrexia has been reported during postmarketing experience of products containing or metabolized to mesalamine.

Respiratory

Respiratory side effects have included upper respiratory infection (1.5%). Dyspnea and interstitial lung disease have been reported during postmarketing experience of products containing or metabolized to mesalamine.

Hepatic

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.

Hepatic side effects have included granulomatous hepatitis (rare), nonspecific reactive hepatitis (rare), elevated ALT (SGPT) and AST (SGOT), and at least one case of cholestatic hepatitis. Increased hepatic enzymes, increased bilirubin, hepatitis, 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 have been reported during postmarketing experience of products containing or metabolized to mesalamine. 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 of products containing or metabolized to mesalamine.

Hematologic

Hematologic side effects have included anemia, hemolysis, thrombocytopenia, eosinophilia, hemolytic anemia, interstitial pulmonary disease, leukopenia, lymphopenia, neutropenia, and reticulocytosis. Aplastic anemia and pancytopenia have been reported during postmarketing experience of products containing or metabolized to mesalamine.

Renal

Renal side effects have included nephrotic syndrome. Renal toxicity, elevated BUN, and elevated creatinine have been reported with mesalamine.

Renal toxicity findings due to mesalamine have been similar to NSAID-induced renal disease, and included proteinuria, elevated BUN and creatinine, oliguria, polyuria, polydipsia, and rarely ocular symptoms.

Immunologic

Immunologic side effects have included bronchospasm and erythema nodosum.

Genitourinary

Renal toxicity findings due to mesalamine 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.

Genitourinary side effects have included dysuria, hematuria, interstitial nephritis, proteinuria, urinary frequency, impotence, and menorrhagia. Oliguria and polyuria have been reported with mesalamine. Interstitial nephritis has been reported during postmarketing experience of products containing or metabolized to mesalamine.

Psychiatric

Psychiatric side effects have included depression (1.5%) and mood swings.

Metabolic

Metabolic side effects have included anorexia (1.3%). Polydipsia has been reported with mesalamine.

Ocular

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

Ocular side effects have included dry eyes, blurred vision, watery eyes, and transient blindness. Ocular symptoms have been reported with mesalamine.

Hypersensitivity

Hypersensitivity side effects have included cross-reactivity to sulfasalazine.

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

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