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Dipentum Side Effects

Generic name: olsalazine

Medically reviewed by Philip Thornton, DipPharm. Last updated on Oct 16, 2023.

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

Applies to olsalazine: oral capsule.

Serious side effects of Dipentum

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 immediately if any of the following side effects occur while taking olsalazine:

More common

Less common

Rare

Incidence not know

Other side effects of Dipentum

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

Less common

Rare

For Healthcare Professionals

Applies to olsalazine: oral capsule.

General

The most commonly reported side effects included diarrhea, abdominal pain, cramps, nausea, and headaches.[Ref]

Gastrointestinal

Compared to patients given placebo, increased frequency and intensity of diarrhea was reported in patients given 500 mg orally 2 times a day who were also receiving pelvic radiation.[Ref]

Very common (10% or more): Diarrhea (up to 17%), abdominal pain (up to 10.1%), cramps (10.1%)

Common (1% to 10%): Bloating, heartburn, loose stools, nausea, rectal bleeding, stomatitis, upset stomach, vomiting

Uncommon (0.1% to 1%): Dyspepsia

Frequency not reported: Abdominal pain upper, diarrhea with dehydration, dry mouth, epigastric discomfort, exacerbation/flare in symptoms, flatulence, increased blood in stool, pancreatitis, rectal discomfort[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, lightheadedness, vertigo

Uncommon (0.1% to 1%): Paresthesia

Frequency not reported: Drowsiness, lethargy, peripheral neuropathy, tremors[Ref]

Dermatologic

Common (1% to 10%): Itching, rash

Uncommon (0.1% to 1%): Alopecia, photosensitivity/photosensitivity reaction, pruritus, urticaria

Frequency not reported: Erythema, erythema nodosum[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia

Frequency not reported: Irritability, mood swings[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, joint pain

Uncommon (0.1% to 1%): Myalgia

Frequency not reported: Muscle cramps[Ref]

Respiratory

Common (1% to 10%): Upper respiratory infection

Uncommon (0.1% to 1%): Dyspnea

Frequency not reported: Bronchospasm, interstitial lung/pulmonary disease, shortness of breath[Ref]

Metabolic

Common (1% to 10%): Anorexia

Postmarketing reports: Elevated lactate dehydrogenase (LDH)[Ref]

Hepatic

Uncommon (0.1% to 1%): Hepatic enzyme increased

Rare (0.01% to 0.1%): Granulomatous hepatitis, nonspecific, reactive hepatitis

Frequency not reported: ALT elevated beyond normal range, AST elevated beyond normal range, hepatitis, increased bilirubin, mild cholestatic hepatitis

Postmarketing reports: Cholestatic jaundice, cirrhosis, elevated alkaline phosphatase, elevated GGT, hepatic function changes, hepatocellular damage, hepatotoxicity, jaundice, liver failure, liver necrosis[Ref]

Patients who developed granulomatous hepatitis, nonspecific, reactive hepatitis, or mild cholestatic hepatitis had complete recovery after treatment was withdrawn.[Ref]

Hematologic

Uncommon (0.1% to 1%): Thrombocytopenia

Frequency not reported: Anemia, aplastic anemia, eosinophilia, granulocytopenia, hemolysis, hemolytic anemia, leukopenia, lymphopenia, neutropenia, pancytopenia, reticulocytosis[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Tachycardia

Frequency not reported: Chest pains, heart block second degree, hot flashes, hypertension, myocarditis, orthostatic hypotension, palpitations, pericarditis, peripheral edema[Ref]

A patient developed thyroid disease 9 days after starting treatment and was given propranolol radioactive iodine; the patient then developed nausea and shortness of breath and died 5 days later with signs/symptoms of acute diffuse myocarditis.[Ref]

Other

Uncommon (0.1% to 1%): Pyrexia

Frequency not reported: Chills, fatigue, fever, miscellaneous side effects, rigors, tinnitus[Ref]

Genitourinary

Frequency not reported: Dysuria, frequency/urinary frequency, hematuria, impotence, menorrhagia, proteinuria[Ref]

Ocular

Frequency not reported: Blurred vision, dry eyes, watery eyes[Ref]

Renal

Frequency not reported: Interstitial nephritis, nephrotic syndrome[Ref]

Hypersensitivity

Frequency not reported: Angioneurotic edema[Ref]

References

1. Product Information. Dipentum (olsalazine). Meda Pharmaceuticals. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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