Intestinal aminosalicylate and disease-modifying antirheumatic drug (DMARD)
Brand names: Salazopyrin, Azulfidine, Sulazine
Updated · Methodology
Second line
Second-line DMARD in rheumatoid arthritis per 2022 after methotrexate. Dose 2–3 g daily in 2–3 doses after titration from 500 mg. The 2014 Cochrane meta-analysis showed efficacy comparable to methotrexate and leflunomide. Often used in combination (methotrexate + sulfasalazine + hydroxychloroquine – triple therapy) when monotherapy is insufficient. Effect develops over 2–3 months.
Sources
ICD-10: M06.9 · ICD-11: FA20
First line
First-line for mild-to-moderate ulcerative colitis to induce and maintain remission per 2022 and the Spanish GETECCU 2023 consensus. Dose 2–4 g daily for induction; 2 g daily for maintenance. In patients intolerant to sulfonamides, pure 5-ASA agents (mesalazine, olsalazine) are preferred. Mostly used in mild colitis with distal involvement; severe disease requires systemic steroids and immunosuppressants.
Sources
ICD-10: K51 · ICD-11: DD71
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Sulfasalazine is a disease-modifying antirheumatic drug and an anti-inflammatory for bowel diseases. It is prescribed for rheumatoid arthritis, psoriatic arthritis, Crohn's disease, and ulcerative colitis ( 2023, 2024 guidelines). In anti-aging circles, sulfasalazine is prescribed to suppress chronic inflammation in healthy people. In healthy adults, no clinical studies of such use exist. The drug has specific risks: myelosuppression (leukopenia, agranulocytosis, aplastic anemia), severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome), hepatotoxicity, hemolytic anemia in G6PD-deficient patients, and reversible male infertility. If sulfasalazine was recommended to a healthy person to suppress inflammation, consider seeking a second opinion.
The molecule combines sulfapyridine and 5-aminosalicylic acid (5-ASA) via an azo bond. Colonic bacterial azoreductases split the bond, releasing active 5-ASA (anti-inflammatory effect on intestinal mucosa) and sulfapyridine (systemically absorbed). In rheumatoid arthritis, action is attributed to cytokine inhibition, folate-dependent lymphocyte effects, and NF-κB inhibition. In Spain widely prescribed for IBD and RA under the brand Salazopyrina.
Use in pregnancy is acceptable when indicated. Sulfasalazine reduces folate absorption – mandatory 5 mg folic acid daily supplementation in pregnant patients. T3 use needs caution due to neonatal kernicterus risk.
Compatible with breastfeeding in healthy term infants. In preterm infants or G6PD deficiency, hemolysis is possible – use caution.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Verbatim lines from the interaction sections, in the language of the label
«Ciclosporina: La combinación de sulfasalazina y ciclosporina, puede reducir las concentraciones de ciclosporina posiblemente por una interacción con el citocromo P450. Por este motivo, será necesario…»AEMPS, section 4.5 · Open on CIMA
«Anticoagulantes: Su administración concomitante con sulfasalazina puede producir cambios en el metabolismo hepático de los anticoagulantes orales (tales como fenprocumon y dicumarol). Se debe tener…»AEMPS, section 4.5 · Open on CIMA
«Diuréticos/AEMPS, section 4.5 · Open on CIMA
«Diuréticos/AEMPS, section 4.5 · Open on CIMA
«Tiopurinas: 6-mercaptopurina/AEMPS, section 4.5 · Open on CIMA
«Digoxina: Se han descrito casos de reducción en la absorción de digoxina y la consecuente obtención de niveles terapéuticos séricos deficientes cuando se administró de forma concomitante con la…»AEMPS, section 4.5 · Open on CIMA
«Drug Interactions:: Reduced absorption of folic acid and digoxin have been reported when those agents were administered concomitantly with sulfasalazine.»FDA, section 7 · Open on DailyMed
«Diuréticos/AEMPS, section 4.5 · Open on CIMA
«Medicamentos hepatotóxicos: En pacientes expuestos a la sulfasalazina y/AEMPS, section 4.5 · Open on CIMA
«Medicamentos con elevada unión a proteínas: Su administración concomitante con fármacos que presenten una elevada unión a proteínas plasmáticas como metotrexato, fenilbutazona o sulfinpirazona pueden…»AEMPS, section 4.5 · Open on CIMA
«Drug Interactions:: When daily doses of sulfasalazine 2 g and weekly doses of methotrexate 7.5 mg were coadministered to 15 rheumatoid arthritis patients in a drug-drug interaction study, the…»FDA, section 7 · Open on DailyMed
«Antibióticos: La administración conjunta con antibióticos (tales como ampicilina, neomicina, rifamicina y etambutol) pueden reducir el efecto de sulfasalazina por inhibición parcial del metabolismo…»AEMPS, section 4.5 · Open on CIMA
«Diuréticos/AEMPS, section 4.5 · Open on CIMA
«Existe evidencia in vitro e in vivo de que los derivados de aminosalicilatos (por ejemplo, olsalazina, mesalazina o sulfasalazina) inhiben la enzima TPMT. Por consiguiente, puede ser necesario…»AEMPS, section 4.5 · Open on CIMA
«Pharmacokinetic Drug Interactions: Acarbose, activated charcoal, albuterol, antacids, certain cancer chemotherapy or radiation therapy, cholestyramine, colestipol, exenatide, kaolin-pectin, meals…»FDA, section 7 · Open on DailyMed
«Transporters: Use caution when concomitantly administering eltrombopag and drugs that are substrates of OATP1B1 (e.g., atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan…»FDA, section 7 · Open on DailyMed
«antiácidos, algunos laxantes, caolin-pectina, neomicina, penicilamina, rifampicina, algunos citostáticos, metoclopramida, sulfasalazina, adrenalina, salbutamol, colestiramina, fenitoína.»AEMPS, section 4.5 · Open on CIMA
«Medicamentos afectados por la administración concomitante de ácido fólico: Agentes antibacterianos del subgrupo terapéutico sulfonamidas y sulfasalazina.»AEMPS, section 4.5 · Open on CIMA
«Alcohol, medicamentos hepatotóxicos y medicamentos hematotóxicos: La probabilidad de que el metotrexato produzca un efecto hepatotóxico aumenta con el consumo regular de alcohol y con la…»AEMPS, section 4.5 · Open on CIMA
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Sulfasalazine is evaluated for the following indications with varying evidence strength: Rheumatoid arthritis (evidence tier A), Ulcerative colitis (evidence tier A), Anti-aging and longevity (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Sulfasalazine (≥ 1 in 100): Nausea, vomiting, appetite loss, Headache, Rash and pruritus, Yellow discoloration of urine, sweat, tears, and contact lenses, Reversible oligospermia in men, Mild anemia. See the Safety section for uncommon and serious reactions.
Use in pregnancy is acceptable when indicated. Sulfasalazine reduces folate absorption – mandatory 5 mg folic acid daily supplementation in pregnant patients. T3 use needs caution due to neonatal kernicterus risk.
Compatible with breastfeeding in healthy term infants. In preterm infants or G6PD deficiency, hemolysis is possible – use caution.
Sulfasalazine is contraindicated in: Hypersensitivity to sulfonamides or salicylates; G6PD deficiency (hemolytic anemia risk); Severe hepatic or renal impairment; Porphyria; Intestinal or urinary obstruction. Full list in the Safety section.
Direct links to regulator labels. Open in a new tab.
Berberine, Bifidobacterium longum, Curcumin (Curcuma longa extract), Diosmectite, Mesalazine, Nystatin, Lactobacillus rhamnosus GG (LGG), Loperamide