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Dipentum

Last reviewed on RxList: 10/15/2020
Dipentum Side Effects Center

What Is Dipentum?

Dipentum (olsalazine sodium) is a salicylate anti-inflammatory drug used to treat ulcerative colitis.

What Are Side Effects of Dipentum?

Common side effects of Dipentum include:

Dosage for Dipentum

The usual dosage of Dipentum in adults for maintenance of remission is 1.0 g/day in two divided doses.

What Drugs, Substances, or Supplements Interact with Dipentum?

Dipentum may interact with blood thinners, thioguanine, or mercaptopurine. Tell your doctor all medications and supplements you use.

Dipentum During Pregnancy and Breastfeeding

During pregnancy, Dipentum should be used only when prescribed. This drug may pass into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Dipentum (olsalazine sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Ulcerative colitis affects the colon. The colon is also referred to as the... See Answer
Dipentum Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using olsalazine and call your doctor at once if you have:

  • severe or ongoing diarrhea;
  • worsening colitis (fever, stomach pain, cramping, or bloody diarrhea);
  • chest pain, shortness of breath, fast or pounding heartbeats;
  • liver problems--loss of appetite, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • symptoms of kidney stones--sudden and severe pain in your lower back or side, blood in your urine, pain or burning when you urinate.

Older adults may be more likely to have low white blood cell counts while taking olsalazine. Symptoms include fever, mouth sores, skin sores, sore throat, cough, and trouble breathing.

Common side effects may include:

  • diarrhea, stomach pain;
  • upset stomach;
  • rash, itching;
  • headache; or
  • joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Dipentum (Olsalazine Sodium Capsules)

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Dipentum Professional Information

SIDE EFFECTS

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 Stools26 (5.9%)10 (4.8%)
Nausea32
Abdominal Pain5 (1.1%)0
Rash/Itching5 (1.1%)0
Headache30
Heartburn20
Rectal Bleeding10
Insomina10
Dizziness10
Anorexia10
Light Headedness10
Depression10
Miscellaneous4 (0.9%)3 (1.4%)
Total Number of Patients Withdrawn46 (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 EventOlsalazine
(N = 441) %
Placebo
(N = 208) %
Gastrointestinal Disorders
Diarrhea11.16.7
Abdominal Pain/Cramps10.17.2
Nausea5.03.9
Dyspepsia4.04.3
Bloating1.51.4
Vomiting1.0-
Stomatitis1.0-
Increased Blood in Stool-3.4
Metabolism and Nutrition Disorders
Anorexia1.31.9
Nervous System Disorders
Headache5.04.8
Insomnia-2.4
General Disorders and Administration Site Conditions
Fatigue/Drowsiness/Lethargy1.82.9
Psychiatric Disorders
Depression1.5-
Ear and Labyrinth Disorders
Vertigo/Dizziness1.0-
Skin and Subcutaneous Tissue Disorders
Rash2.31.4
Itching1.3-
Musculoskeletal and Connective Tissue Disorders
Arthralgia/Joint Pain4.02.9
Infections and Infestations
Upper Respiratory Infection1.5-

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

Drug Abuse And Dependency

Abuse: None reported.

Dependence: Drug dependence has not been reported with chronic administration of olsalazine.

Read the entire FDA prescribing information for Dipentum (Olsalazine Sodium Capsules)

Related Resources for Dipentum

Read the Dipentum User Reviews »

© Dipentum Patient Information is supplied by Cerner Multum, Inc. and Dipentum Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

Ulcerative colitis affects the colon. The colon is also referred to as the... See Answer

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