Early Oral & Topical Anti-inflammatory Therapies for IBD

Treatment Options Overview: 5-ASA

PRODUCT DETAILS / COMPANY (APPROVED BY HEALTH CANADA FOR IBD INDICATIONS)

Sulfazine / Pharmascience Inc. (1984)

INDICATION

An adjunctive therapy in the treatment of severe ulcerative colitis, proctitis, or distal ulcerative colitis and Crohn’s disease.

           

Logistics and Monitoring: 5-ASA

METHOD OF ADMINISTRATION

Oral

LOCATION

Oral
Treatment of ulcerative colitis, proctitis, and distal colitis.

DOSING - ADULTS

Oral
Severe attacks: 2–4 500 mg tablets, 3–4 times daily

Moderate and mild attacks:
2 500 mg tablets, 3-4 times daily

Maintenance dose:
2 500 mg tablets, 2–3 times a day

DOSING - PEDIATRIC

Suggested dosing10:
40 to 70 mg/kg daily up to 4 g daily

*Practice point: also available as a liquid formulation.

ROUTINE MONITORING

CBC and LFTs should be performed at baseline and every second week during the first 3 months of therapy. During the second 3 months, the same tests should be done once monthly and thereafter every 3 months and as clinically indicated.

Renal function should be performed in all patients at baseline and at least monthly for the first 3 months of treatment.

For pediatric population10:
Gradual sulfasalazine dose augmentation over 7 to 14 days may mitigate against dose-dependent side-effects.

           

5-ASA: 5 -aminosalicylic acid, CBC: complete blood count, LTF: liver function test, eGFR: estimated glomerular filtration rate

Side Effects: 5-ASA

SIDE EFFECTS

For more detailed information regarding side effects, please refer to the appropriate product monograph.

Common Side Effects
• Nausea/Vomiting
• Paradoxical diarrhea
• Allergic hypersensitivity reactions causing rash and mild fever
• Possible decreased sperm count

Serious Side Effects
• Pericarditis
• Allergic interstitial nephritis
• Cytopenia
• Pancreatitis
• Hepatitis

           

Special Populations: 5-ASA

PEDIATRICS

Approved for use in pediatric patients. 

ELDERLY

According to the product monograph, no special dosage instructions are required for elderly patients.

Should be used with caution in patients with renal disease.

PREGNANCY

For access to the full guidelines click here

The Global Consensus Statement on the management of Pregnancy in Inflammatory Bowel Disease by Mahadevan, U. et al suggest13:

For women with IBD who are pregnant or attempting conception, the guidelines recommend continuing maintenance 5-ASA therapy. There is low risk in pregnancy.

Considerations to address regarding the use of 5ASA in pregnancy include:

  • Poor adherence during pregnancy. Maintenance of remission is key and it has been shown that nearly 25% of women who were previously adherent are not during pregnancy. Non-adherence was an independent risk factor than relapse.
  • Current available 5-ASA formulations do not contain DBP which had been associated with higher odds of preterm birth in humans.
  • Rectal 5-ASA formulations can be utilized in pregnant individuals with UC, especially those with predominant rectal symptoms including urgency and tenesmus. There is no evidence to support that rectal therapy increases miscarriage rates.


In women with IBD who are pregnant, the guidelines suggest the continuing maintenance sulfasalazine therapy.

  • Mesalamine is better tolerated than sulfasalazine with intolerance likely related to the sulfapyridine component.
  • There is low risk in pregnancy.
  • Supplementation with folate 2mg/d is recommended as sulfasalazine impair folic acid absorption and metabolism.

BREASTFEEDING

For access to the full guidelines click here

The Global Consensus Statement on the management of Pregnancy in Inflammatory Bowel Disease by Mahadevan, U. et al suggest13:

  • Literature supports breastfeeding as a generally safe and beneficial practice for mothers with IBD
  • Mothers with IBD currently on 5-ASA/sulfasalazine may breastfeed.
           

5-ASA: 5- aminosalicylic acid, DBP: dibutyl phthalate, UC: ulcerative colitis

Next: Corticosteroid Therapies
This tool is intended for Canadian Healthcare Professionals. Copyright © 2026 CANIBD Canadian IBD Nurses.

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CANIBD and Crohn's and Colitis Canada do not accept any responsibility or liability for the accuracy, content, completeness, legality, or reliability of the information contained in this Service. The content is not intended to diagnose, treat, cure or prevent disease. Content was developed in 2024 and is provided for informational purposes only.