Olsalazine
Olsalazine is an aminosalicylate medication used to maintain remission of ulcerative colitis in adults who cannot tolerate sulfasalazine.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Olsalazine: Patient Information Guide
A plain-language walkthrough of Olsalazine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Olsalazine is an aminosalicylate used to treat ulcerative colitis. Its only currently supported use is through Dipentum capsules:
- Dipentum (oral capsule) is approved to maintain remission of ulcerative colitis in adult patients who cannot tolerate sulfasalazine.
⚙️How it works▾
When you take olsalazine by mouth, nearly all of it reaches the colon without being absorbed in the upper digestive tract. Once there, bacteria in the colon rapidly break it down into two molecules of mesalamine (5-aminosalicylic acid), the active compound. Mesalamine works directly on the inner lining of the colon to reduce inflammation — likely by blocking enzymes (cyclooxygenase) that produce inflammatory chemicals called prostaglandins, as well as other inflammatory pathways. This localized action means very high concentrations of the drug reach the colon while relatively little is absorbed into the bloodstream.
💊How it's taken▾
Dipentum capsules are taken by mouth twice daily. Before starting, your doctor will check your kidney function, and will continue to monitor it periodically during treatment. Drink plenty of fluids every day while on Dipentum to help protect your kidneys and reduce the risk of kidney stones. Always follow your prescriber's instructions for your specific dose and schedule.
🤒Side effects — in detail▾
The most commonly reported side effects with Dipentum include:
- Diarrhea or loose stools (the most frequent reason people stop the medication)
- Abdominal pain or cramping
- Nausea
- Joint pain
- Skin rash or itching
- Upper respiratory infection
- Depressed mood
- Vomiting
More serious reactions — including kidney problems, severe skin reactions, heart or liver inflammation, and blood cell disorders — are less common but require immediate medical attention if they occur. Contact your doctor right away if you develop worsening abdominal symptoms, bloody diarrhea, chest pain, shortness of breath, yellowing of the skin or eyes, or unusual bruising or bleeding.
⚠️Warnings & precautions▾
- Kidney damage: Mesalamine (what olsalazine converts to) can cause kidney inflammation or failure. Kidney function must be checked before starting and monitored regularly. Stop the medication if kidney function worsens.
- Acute intolerance syndrome: Some people develop a reaction that looks like a colitis flare but is actually caused by the drug — cramping, bloody diarrhea, fever, headache, and rash. If this is suspected, stop the medication and contact your doctor.
- Hypersensitivity reactions: Serious allergic reactions can involve the heart (myocarditis, pericarditis), lungs, liver, kidneys, or blood. Stop Dipentum and seek care if these are suspected.
- Liver failure: Rare but serious cases of liver failure have been reported, especially in people with pre-existing liver disease.
- Severe skin reactions: Rare, life-threatening reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. Stop the drug immediately at the first sign of blistering or widespread skin breakdown.
- Kidney stones (nephrolithiasis): Mesalamine-containing stones can form and are not detectable on standard X-rays or CT scans. Staying well-hydrated reduces this risk.
- Sun sensitivity: Especially in people with pre-existing skin conditions like eczema. Use sunscreen and protective clothing outdoors.
🔀What it interacts with▾
Tell your doctor and pharmacist about all medications you take, because Dipentum has several important interactions:
- NSAIDs (ibuprofen, naproxen, etc.): Taking these with Dipentum raises the risk of kidney damage — kidney function should be monitored closely.
- Azathioprine or 6-mercaptopurine: Combining these with Dipentum increases the risk of serious blood cell problems, including bone marrow failure. Blood counts need to be monitored.
- Low molecular weight heparins or heparinoids: Increased bleeding risk, particularly around the time of spinal or epidural anesthesia. Dipentum may need to be stopped beforehand.
- Varicella (chickenpox) vaccine: Avoid Dipentum for 6 weeks after receiving this vaccine to reduce the risk of Reye's syndrome, a rare but serious condition.
- Other kidney-toxic drugs: Any medication known to affect the kidneys can compound the risk when used alongside Dipentum.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy to salicylates or aminosalicylates: Do not take Dipentum if you are allergic to aspirin, sulfasalazine, mesalamine, or any ingredient in the capsule.
- Previous reaction to sulfasalazine: You may have a similar reaction to olsalazine — discuss this with your doctor.
- Kidney disease: Kidney function must be assessed before starting. Use with caution and close monitoring if you have impaired kidneys.
- Liver disease: People with pre-existing liver problems are at higher risk for liver failure; weigh the risks and benefits with your doctor.
- Pregnancy: Published human data have not clearly linked mesalamine to birth defects, but animal studies showed harm at high doses. Discuss with your doctor — uncontrolled ulcerative colitis in pregnancy also carries risks.
- Breastfeeding: Small amounts of mesalamine pass into breast milk. Watch your baby for diarrhea and discuss the decision to breastfeed with your doctor.
- Children: Safety and effectiveness have not been established in pediatric patients.
- Older adults (65+): Higher risk of blood cell disorders (such as low white blood cell or platelet counts). Blood counts should be monitored during treatment.
🚑If you take too much▾
Taking too much olsalazine can cause salicylate-type toxicity — symptoms include nausea, vomiting, abdominal pain, ringing in the ears, rapid breathing, dizziness, confusion, and in severe cases, seizures or electrolyte imbalances. There is no specific antidote. If an overdose is suspected, seek emergency medical care immediately; treatment focuses on supportive care, preventing further absorption, and maintaining fluid and electrolyte balance.
📡Pharmacodynamics — effects in the body▾
Olsalazine works by delivering high concentrations of mesalamine (5-aminosalicylic acid) directly to the lining of the colon, where it exerts a local anti-inflammatory effect. It appears to work by blocking enzymes involved in producing inflammatory chemicals such as prostaglandins and leukotrienes, which are elevated in people with ulcerative colitis. The precise relationship between mesalamine blood levels and its effectiveness or safety has not been fully characterized.
🔬Pharmacokinetics — how your body processes it▾
After you take olsalazine by mouth, 98–99% of it reaches the colon, where bacteria rapidly convert each molecule into two molecules of mesalamine — only about 2.4% is absorbed before it gets there. The drug has a very short half-life of roughly 0.9 hours in the bloodstream. Mesalamine is released slowly in the colon, creating high local concentrations, and is then partially absorbed and metabolized — mainly in the colon lining and liver — before being excreted in the urine and feces. Less than 1% of olsalazine itself is recovered in the urine.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F).
📄 Written from Olsalazine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Olsalazine
17 supplements and herbal products have documented interactions with Olsalazine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Olsalazine — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Dipentum for, and why was I prescribed it instead of another medication? ▾
How should I take these capsules — do I need to take them with food? ▾
What side effects should I expect, and which ones should make me call my doctor? ▾
Why does my doctor want to check my kidneys before I start this medication? ▾
Are there any medications I should avoid while taking Dipentum? ▾
Is it safe to take Dipentum if I'm pregnant or breastfeeding? ▾
Is Olsalazine available over the counter? ▾
When was Olsalazine first available? ▾
Who makes Olsalazine? ▾
💬 Answers drafted from Olsalazine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Olsalazine comes
Olsalazine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Dipentum capsules are used to maintain remission of ulcerative colitis in adults who are intolerant of sulfasalazine
- Dipentum capsules are taken by mouth twice daily
- Drink adequate fluids throughout the day while taking Dipentum
- Dipentum requires a kidney function check before starting and periodically during treatment
- Follow your prescriber's instructions for the exact dose and schedule of Dipentum
📊 Olsalazine across the U.S. market
How Olsalazine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Olsalazine products
A representative set of FDA-listed product records for Olsalazine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 250 mg | Oral | Meda Pharmaceuticals Inc. × 2 listings | NDA | View NDC → |
| 250 mg | Oral | Viatris Specialty LLC × 2 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Matrix Pharmacorp Private Limited | BULK INGREDIENT | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Olsalazine NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Olsalazine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Olsalazine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Olsalazine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 32385 2 dose forms · 2 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 373143In current FDA listingsClinical drug / strength (SCD) sodium 250 MGRxCUI 905162 -
Dose form (SCDF) Oral Tablet RxCUI 373144No current FDA listingClinical drug / strength (SCD) sodium 500 MGRxCUI 905166
Look up RxCUI 32385 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Olsalazine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Olsalazine belongs to the Aminosalicylate class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Meda Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.