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Dipentum

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Dipentum

Dipentum

Dipentum Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Dipentum (olsalazine sodium) is used to treat ulcerative colitis. It is a salicylate anti-inflammatory drug. Common side effects include headache, nausea, vomiting, or loss of appetite.

The usual dosage of Dipentum in adults for maintenance of remission is 1.0 g/day in two divided doses. Dipentum may interact with blood thinners, thioguanine, or mercaptopurine. Tell your doctor all medications and supplements you use. 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Dipentum in Detail - Patient Information: Side Effects

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

Stop using olsalazine and call your doctor at once if you have any of these serious side effects:

  • worsening colitis (fever, stomach pain, cramping, or bloody diarrhea);
  • chest pain, shortness of breath, fast or pounding heartbeats; or
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild stomach discomfort;
  • nausea, heartburn;
  • skin rash, itching;
  • headache;
  • muscle or joint pain; or
  • urinating more often than usual.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Dipentum Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, nausea, vomiting, or loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if diarrhea occurs. Your doctor may need to lower your dose or prescribe another medication to treat the diarrhea.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, pale stools, unusual tiredness, persistent nausea/vomiting, change in the amount of urine, dark urine, yellowing eyes/skin, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Dipentum (Olsalazine Sodium Capsules)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Dipentum FDA Prescribing Information: Side Effects
(Adverse Reactions)

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).

Table1: 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.

Table2: 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 (olsalazine sodium capsules) 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) »

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Dipentum - User Reviews

Dipentum User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Dipentum sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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