Olsalazine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 15, 2026🚩 Report this page

Olsalazine

Aminosalicylic Acid and Similar Agents

GB MHRA

Drug class: Aminosalicylic Acid and Similar Agents
Availability: See label
Markets covered: 1
Products on record: 25

A07ECAminosalicylic Acid and Similar Agents

Overview

Olsalazine is an active pharmaceutical ingredient in the Aminosalicylic Acid and Similar Agents group (A07EC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	25	May 15, 2026

GBUnited Kingdom· MHRA

25 products

Uses

GBOfficial regulatory label· revised August 15, 2025[1]

Oral treatment of mild active ulcerative colitis and maintenance of remission.

How to take

GBOfficial regulatory label

Drug interactions

Known interactions involving Olsalazine. Select one for details. This list is informational and not a complete interaction checker.

Cidofovir Deferasirox Diatrizoate Inotersen Iodipamide Iodixanol Iohexol Iopamidol Iopromide Iothalamic Acid Ioversol Ioxilan Sirolimus Tacrolimus Acetohexamide Acyclovir Amikacin Amphotericin B Azathioprine Bacitracin Bromfenac Capreomycin Celecoxib Chlorpropamide Cisplatin Clofarabine Cyclosporine Diclofenac Diflunisal Entecavir Etodolac Exenatide Fenoprofen Flucytosine Flurbiprofen Foscarnet Gentamicin Givosiran Glimepiride Glipizide Glyburide Ibandronate Ibuprofen Indomethacin Kanamycin Ketoprofen Ketorolac Lithium Carbonate Meclofenamic Acid Mefenamate Meloxicam Mercaptopurine Methotrexate Methoxyflurane Moxetumomab Pasudotox Nabumetone Naproxen Nateglinide Neomycin Netilmicin Oxaliplatin Oxaprozin Pamidronate Pemetrexed Pentamidine Phenylbutazone Piroxicam Plazomicin Polymyxin B Remdesivir Repaglinide Rofecoxib Salsalate Streptomycin Sulindac Telavancin Telbivudine Temsirolimus Thioguanine Tobramycin Tolazamide Tolbutamide Tolmetin Valacyclovir Valdecoxib Vancomycin Zoledronic Acid Anisindione Dicumarol Warfarin

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PL432520001 · revised August 15, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised August 15, 2025[1]

Frequency estimate: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). The most common side effect is diarrhoea which is usually transient.
Where it doesnot, taking the drug at the end of a more substantial meal, dose titration or dose reduction are usually effective. Withdrawal in clinical studies when the drug was taken at the end of meals was around 3%. Where diarrhoea persists, the drug shouldbe stopped.
In addition, the following undesirable effects have been reported:General disorders and administration site conditions: Common: headache Uncommon: pyrexia Blood and lymphatic system disorders: Uncommon: thrombocytopenia Not known: aplastic anaemia, eosinophilia, haemolytic anemia, leukopenia,neutropenia, pancytopenia Gastrointestinal disorders: Common: diarrhoea, nausea Uncommon: vomiting, dyspepsia Not known: abdominal pain upper, pancreatitis Hepatobiliary disorders: Uncommon: hepatic enzyme increased Not known: hepatitis, increased bilirubin Skin and subcutaneous tissue disorders: Common: rash Uncommon: pruritus, alopecia, photosensitivity reaction, urticaria Not known: angioneurotic oedema Cardiac disorders: Uncommon: tachycardia Not known: myocarditis, palpitations, pericarditis Renal and urinary disorders: Not known: interstitial nephritis Respiratory, thoracic and mediastinal disorders: Uncommon: dyspnoea Not known: interstitial lung disease Musculoskeletal and connective tissue disorders: Common: arthralgia Uncommon: myalgia Nervous system disorders: Uncommon: dizziness, paraesthesia Not known: peripheral neuropathy Psychiatric disorders Uncommon: depression Eye disorders: Not known: vision blurred Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinalproduct. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised August 15, 2025[1]

It is recommended to monitor patients with impaired kidney or liver function. Patients suffering from severe allergy or asthma should be observed for signs of worsening of these conditions. Baseline renal function measurement is required in all patients initiating treatment with olsalazine.
For patients with baseline renal impairment, treatment with olsalazine should only be initiated if the benefits are considered to outweigh risk. In addition, periodic renal function monitoring, especially in the early months of treatment, should be conducted based on clinical judgment taking baseline renal function into account.
It is recommended to monitor renal function in patients receiving olsalazine, by estimating serum creatinine before treatment, every 3 months for the first year, every6 months for the next 4 years, and annually after 5 years of treatment.
Treatment should be discontinued if renal function deteriorates. Serious blood dyscrasias have been reported very rarely with olsalazine. Treatment should be stopped if there is a suspicion or evidence of a blood dyscrasia. Patients or their carers should be instructed how to recognise the signs of haematotoxicity and should be advised to contact their physicians immediately if thesymptoms develop.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

Drug interactions

Drugs in the same class

Sources & citations