Dipentum Side Effects

Generic Name: olsalazine

Note: This document contains side effect information about olsalazine. Some of the dosage forms listed on this page may not apply to the brand name Dipentum.

Some side effects of Dipentum may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to olsalazine: oral capsule

Along with its needed effects, olsalazine (the active ingredient contained in Dipentum) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking olsalazine:

Rare
  • Back or stomach pain (severe)
  • bloody diarrhea
  • fast heartbeat
  • fever
  • nausea or vomiting
  • skin rash
  • swelling of the stomach
  • yellow eyes or skin

Some side effects of olsalazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach pain or upset
  • diarrhea
  • loss of appetite
Less common
  • Aching joints and muscles
  • acne
  • anxiety or depression
  • dizziness or drowsiness
  • headache
  • trouble in sleeping

For Healthcare Professionals

Applies to olsalazine: oral capsule

General

During clinical trials, olsalazine (the active ingredient contained in Dipentum) 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 (the active ingredient contained in Dipentum) 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 (the active ingredient contained in Dipentum) 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 (the active ingredient contained in Dipentum) 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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