What does Dipentum treat?

Dipentum (Olsalazine Sodium) may be used to treat ulcerative colitis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.

How does Dipentum work?

Dipentum is a aminosalicylate. Aminosalicylates (5-ASA drugs like mesalamine) act directly on the inflamed lining of the colon, where they are thought to calm the local inflammatory response by blocking several inflammation-driving chemicals and mopping up tissue-damaging free radicals, which helps the gut heal in ulcerative colitis.

Is there a coupon or discount for Dipentum?

pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Dipentum. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.

Dipentum is marketed by Mylan Spclt Viatris. You can see Mylan Spclt Viatris's full profile, rating, and other products on pharmaranks.

Is Dipentum a brand-name or generic drug?

Dipentum is a brand-name product with the active ingredient Olsalazine Sodium.

Is Dipentum available over the counter?

No. Dipentum is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.

What forms does Dipentum come in?

Dipentum is currently marketed as capsule, per the FDA's National Drug Code Directory.

What class of drug is Dipentum?

Dipentum is classified as aminosalicylate, per the FDA's Established Pharmacologic Class.

Is Dipentum FDA-registered?

Dipentum is on record with the U.S. FDA under application number NDA019715. You can verify this on its official FDA label.

There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Dipentum. Review its FDA-label side effects and warnings below, and always consult a licensed professional.

dipentum

Dipentum (Olsalazine Sodium) is an aminosalicylate used to treat Ulcerative Colitis.

Olsalazine Sodium · by Mylan Spclt Viatris

Not yet rated· sourced from the FDA label

Rated against independent regulatory sources·Last updated June 7, 2026·How we rate

Verified againstopenFDANIH DailyMedRxClass

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Key facts

Active ingredient: Olsalazine Sodium
Drug class: Aminosalicylate
Form: Capsule
Strength: Olsalazine Sodium 250MG
Type: Prescription (Rx)
Brand or generic: Brand-name
May treat: ulcerative colitis
Manufacturer: Mylan Spclt Viatris
FDA application: NDA019715

What is Dipentum?

From the FDA label:The active ingredient in DIPENTUM (olsalazine sodium) is the sodium salt of a salicylate, disodium 3,3'-azobis (6-hydroxybenzoate) a compound that is effectively bioconverted to mesalamine (5-aminosalicylic acid,5-ASA), an aminosalicylate. Its empirical formula is C14H8N2Na2O6 with a molecular weight of 346.21. The structural formula is: Olsalazine sodium is a yellow crystalline powder, which melts with decomposition at 240°C. It is the sodium salt of a weak acid, soluble in water and DMSO, and practically insoluble in ethanol, chloroform, and ether. Olsalazine sodium has acceptable stability under acidic or basic conditions. DIPENTUM is supplied in capsules for oral administration. Each DIPENTUM hard gelatin capsule contains 250 mg olsalazine sodium (equivalent to 233.4 mg of olsalazine). The inert ingredient in each capsule is magnesium stearate. The capsule shell contains the following inactive ingredients: black iron oxide, caramel, gelatin, and titanium dioxide. Olsalazine Sodium Structural Formula

How to use

Evaluate renal function before initiating therapy with DIPENTUM [see Warnings and Precautions (5.1) ]. The recommended dosage is 500 mg orally twice daily. Drink an adequate amount of fluids during treatment [see Warnings and Precautions (5.7) ] . • Evaluate renal function prior to initiation of DIPENTUM and periodically while on therapy. ( 2 , 5.1 ) • The recommended dosage is 500 mg orally twice daily. ( 2 ) • Drink an adequate amount of fluids. ( 2 , 5.7 )

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: • Renal impairment [see Warnings and Precautions (5.1) ] • Mesalamine-induced acute intolerance syndrome [see Warnings and Precautions (5.2) ] • Hypersensitivity reactions [see Warnings and Precautions (5.3) ] • Hepatic failure [see Warnings and Precautions (5.4) ] • Severe cutaneous adverse reactions [see Warnings and Precautions (5.5) ] • Photosensitivity [see Warnings and Precautions (5.6) ] • Nephrolithiasis [see Warnings and Precautions (5.7) ] The following adverse reactions have been identified from clinical studies or postmarketing reports of olsalazine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In double-blind, placebo- and active-controlled clinical trials of ulcerative colitis, discontinuations due to adverse reactions were reported in 10% of DIPENTUM-treated patients (N=441) and 7% of placebo-treated patients (N=208). Both sulfasalazine-tolerant and intolerant patients were included. The most common adverse reactions leading to discontinuation in DIPENTUM-treated patients were diarrhea/loose stools (6%), abdominal pain (1%), and rash/itching (1%). In these controlled trials, adverse reactions reported in 1% or…

Warnings

Important safety information

Renal Impairment : Assess renal function at the beginning of treatment and periodically during treatment. Discontinue DIPENTUM if renal function deteriorates while on therapy. ( 5.1 , 7.1 ) • Mesalamine-Induced Acute Intolerance Syndrome : Discontinue treatment if acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, sometimes fever, headache and rash) is suspected. ( 5.2 ) • Hypersensitivity Reactions, including myocarditis and pericarditis : Discontinue DIPENTUM if a hypersensitivity reaction is suspected. ( 5.3 ) • Hepatic Failure : Evaluate the risks and benefits of using DIPENTUM in patients with known liver impairment. ( 5.4 ) • Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.5 ) • Photosensitivity : Avoid sun exposure if pre-existing skin conditions. ( 5.6 ) • Nephrolithiasis : Cases of nephrolithiasis have been reported with the use of mesalamine. Mesalamine-containing stones are undetectable by standard radiography or computed tomography (CT). Ensure adequate hydration during treatment. ( 5.7 ) • Interference with Laboratory Tests : Mesalamine may lead to elevated urinary normetanephrine test results. ( 5.8 ) 5.1 Renal Impairment Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure have been reported in patients given DIPENTUM or other products that contain mesalamine or are converted to mesalamine. In animal studies, the kidney was the principal organ of mesalamine toxicity [see Nonclinical Toxicology (13.2) ] . Evaluate the risks and benefits of using DIPENTUM in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs. Evaluate renal function in all patients prior to initiation and periodically while on DIPENTUM therapy. Discontinue DIPENTUM if renal function deteriorates while on therapy [see Drug Interactions (7.1) , Use in Specific Populations (8.6) ] . 5.2 Mesalamine-Induced Acute Intolerance Syndrome Olsalazine is converted to mesalamine, which has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. Monitor patients for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with DIPENTUM. 5.3 Hypersensitivity Reactions Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to DIPENTUM or to other compounds that contain or are converted to mesalamine. Mesalamine‑induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and hematologic abnormalities. Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. Discontinue DIPENTUM if an alternative etiology for the signs and symptoms cannot be established. 5.4 Hepatic Failure There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Because olsalazine is converted to mesalamine, evaluate the risks and benefits of using DIPENTUM in patients with known liver impairment. 5.5 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of mesalamine, the active moiety in DIPENTUM [see Adverse Reactions (6.2) ] . Discontinue DIPENTUM at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. 5.6 Photosensitivity Patients with pre‑existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Advise patients to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. 5.7 Nephrolithiasis Cases of nephrolithiasis have been reported with the use of mesalamine, the active moiety in DIPENTUM, including stones with 100% mesalamine content. Mesalamine‑containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate fluid intake during treatment. 5.8 Interference with Laboratory Tests Use of DIPENTUM, which is converted to mesalamine, may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection because of the similarity in the chromatograms of normetanephrine and the main metabolite of mesalamine, N‑acetyl‑5‑aminosalicylic acid (N‑Ac‑5‑ASA). Consider an alternative, selective assay for normetanephrine.

Who should not take Dipentum

DIPENTUM is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the excipients in DIPENTUM [see Warnings and Precautions (5.3) , Description (11) ] . Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of DIPENTUM. ( 4 , 5.3 )

Overdose — what happens if you take too much

DIPENTUM is an aminosalicylate, and symptoms of salicylate toxicity include: nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Severe salicylate intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) damage. There is no specific antidote for olsalazine overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage and may include gastrointestinal tract decontamination to prevent of further absorption. Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Interactions

Nephrotoxic Agents including Non-Steroidal Anti-inflammatory Drugs (NSAIDs) : Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine-related adverse reactions. ( 7.1 ) • Azathioprine or 6-Mercaptopurine : Increased risk of blood dyscrasias; monitor complete blood cell counts and platelet counts. ( 7.2 ) • Low Molecular Weight Heparins or Heparinoids : Increased risk of bleeding following neuraxial anesthesia; if possible, discontinue DIPENTUM or closely monitor for bleeding. ( 7.1 ) • Varicella Vaccine : Avoid use for 6 weeks after vaccination. ( 7.4 ) 7.1 Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs The concurrent use of mesalamine with known nephrotoxic agents, including non‑steroidal anti‑inflammatory drugs (NSAIDs), may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions [see Warnings and Precautions (5.1) ] . 7.2 Azathioprine or 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6‑mercaptopurine and/or any other drugs known to cause myelotoxicity (e.g., thioguanine) may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of DIPENTUM and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts. 7.3 Low Molecular Weight Heparins or Heparinoids The co-administration of salicylates and low molecular weight heparins or heparinoids may result in an increased risk of bleeding (i.e., hematomas) following neuraxial anesthesia. Discontinue DIPENTUM prior to the initiation of a low molecular weight heparin or heparinoid. If this is not possible, it is recommended to monitor patients closely for bleeding. 7.4 Varicella Vaccine Avoid DIPENTUM, and other salicylates, for six weeks after the varicella vaccine to avoid a possible increased risk of developing Reye’s syndrome. 7.5 Interference With Urinary Normetanephrine Measurements Use of DIPENTUM, which is converted to mesalamine, may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see Warnings and Precautions (5.8) ] . Consider an alternative, selective assay for normetanephrine.

Drug class

Aminosalicylate

How this class works, per Mesalamine (USAN) - StatPearls - NCBI Bookshelf.

May treat (source: NIH RxClass)

ulcerative colitis

See how Dipentum ranks — best-rated aminosalicylate for:

ulcerative colitis

Dosage forms

Capsule

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

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Frequently asked questions

What does Dipentum treat?: Dipentum (Olsalazine Sodium) may be used to treat ulcerative colitis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
How does Dipentum work?: Dipentum is a aminosalicylate. Aminosalicylates (5-ASA drugs like mesalamine) act directly on the inflamed lining of the colon, where they are thought to calm the local inflammatory response by blocking several inflammation-driving chemicals and mopping up tissue-damaging free radicals, which helps the gut heal in ulcerative colitis.
Is there a coupon or discount for Dipentum?: pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Dipentum. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Dipentum?: Dipentum is marketed by Mylan Spclt Viatris. You can see Mylan Spclt Viatris's full profile, rating, and other products on pharmaranks.
Is Dipentum a brand-name or generic drug?: Dipentum is a brand-name product with the active ingredient Olsalazine Sodium.
Is Dipentum available over the counter?: No. Dipentum is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Dipentum come in?: Dipentum is currently marketed as capsule, per the FDA's National Drug Code Directory.
What class of drug is Dipentum?: Dipentum is classified as aminosalicylate, per the FDA's Established Pharmacologic Class.
Is Dipentum FDA-registered?: Dipentum is on record with the U.S. FDA under application number NDA019715. You can verify this on its official FDA label.
Is Dipentum safe?: There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Dipentum. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
What are the side effects of Dipentum?: Dipentum's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: • Renal impairment [see Warnings and Precautions (5.1) ] • Mesalamine-induced acute intolerance syndrome [see Warnings and Precautions (5.2) ] • Hypersensitivity reactions [see Warnings and Precautions (5… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.

Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.