Salazopyrin (Sulfasalazine)
Also sold as: Salazopyrin, Saaz, Azulfidine, Sulfazine, Ssz
Pregnancy
Cat B
Lactation
Caution
Schedule
H
Forms
Tablet 500mg +2
Indications
- Rheumatoid arthritis — DMARD (second-line or first-line in combination)
- Psoriatic arthritis
- Ankylosing spondylitis (peripheral arthritis component)
- Ulcerative colitis — induction and maintenance of remission
- Crohn's colitis (mild-moderate)
- Juvenile idiopathic arthritis (JIA)
Adult Dosing
Rheumatoid arthritis
Start 500 mg PO OD; increase by 500 mg/week to 2000-3000 mg/day in divided doses
Full effect at 6-12 weeks. EC tablets better tolerated.
Ulcerative colitis (active)
1-2 g PO QID (4-8 g/day); reduce to 2 g/day maintenance
Ongoing maintenance
Ankylosing spondylitis
2-3 g/day in divided doses
Pediatric Dosing
EC tablets for children ≥5 years. Suspension for younger children.
Renal Dose Adjustment
| CrCl / eGFR | Dose Adjustment |
|---|---|
| CrCl > 30 mL/min | No adjustment |
| CrCl < 30 mL/min | Use cautiously; reduce dose — sulfonamide component accumulates |
Hepatic Adjustment
Use cautiously in hepatic impairment — monitor LFTs
Pregnancy & Lactation
Pregnancy: Category B
Generally considered safe for RA and IBD in pregnancy. Causes folate antagonism — supplement folic acid 5 mg/day. Neonatal haemolysis and hyperbilirubinemia possible at delivery.
Lactation: Caution
Excreted in breast milk. Avoid in neonates with G6PD deficiency or jaundice. Generally acceptable.
Top Drug Interactions
| Interacting Drug | Effect | Severity |
|---|---|---|
| Methotrexate | Additive folate antagonism; myelosuppression risk | Moderate |
| Azathioprine | Risk of leukopenia (case reports of severe myelosuppression) | Major |
| Digoxin | Reduced digoxin absorption — monitor levels | Moderate |
| Folate supplements | Beneficial — reduces sulfonamide folate antagonism | Minor |
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Side Effects
Common
- Nausea and GI upset (very common — dose-related, improved with EC formulation)
- Headache
- Dizziness
- Orange-yellow urine/skin discolouration (harmless)
- Reversible male oligospermia
Serious / Discontinue If
- Agranulocytosis (rare but serious — fever, sore throat)
- Aplastic anaemia
- Stevens-Johnson syndrome / TEN
- Hepatotoxicity
- Pulmonary eosinophilia
- Haemolytic anaemia (G6PD deficiency)
Contraindications
- Sulfonamide or salicylate allergy
- G6PD deficiency (haemolysis)
- Intestinal and urinary obstruction
- Porphyria
Available Indian Brands
| Brand | Manufacturer | Price (approx) |
|---|---|---|
| Saaz 500mg | Sun Pharma | 100 tab ₹185 |
| Salazopyrin 500mg EC | Pfizer | 100 tab ₹350 |
| Sulfazine 500mg | Micro Labs | 100 tab ₹145 |
Monitoring Required
- CBC at baseline, 2-4 weeks for first 3 months, then 3-monthly
- LFTs (same schedule)
- Renal function (3-6 monthly)
- Semen analysis if male fertility concerns
Patient Counseling Points
- Take EC tablets whole — do not crush (enteric coating important)
- Take with food to reduce nausea
- Urine and skin may turn yellow-orange — harmless
- Men: may temporarily reduce sperm count — discuss family planning
- Takes 6-12 weeks to see benefit in arthritis
- Take folic acid supplement as prescribed
- Report: fever, rash, mouth ulcers, unusual bruising
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Clinically reviewed by: Dr. Suresh Pillai, MS (Orthopaedics), Pain Specialist
Last reviewed: 2026-04-01
References
- BNF — Sulfasalazine
- ACR RA Guidelines 2021
- ECCO UC Guidelines 2022
- BSR Sulfasalazine Monitoring Guidelines