Complete information including dosage, side effects, interactions and pregnancy & breast feeding warnings for patient and professional use

Overview and uses

Sulfasalazine is a sulfonamide used for the treatment of ulcerative colitis and rheumatoid arthritis.

Indication (uses)

  • Used for the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis.
  • Used for the prolongation of the remission period between acute attacks of ulcerative colitis.
  • Used for the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other NSAID (nonsteroidal anti-inflammatory drugs).
  • Used for the treatment of pediatric patients with polyarticular-course juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal antiinflammatory drugs.

Pharmacological classification

used for the treatment of ulcerative colitis and rheumatoid arthritis.

Brand names

Azulfidine EN (as delayed release tablets) and Azulfidine.

Dosage form

  • Available as delayed release (enteric coated) tablets in strength of sulfasalazine 500 mg.

Mechanism of action

The exact mechanism for sulfasalazine is not known. It is believed that inhibition of cytokine, platelet aggregation factor (PAF), TNF, nuclear factor generation plays an important role.


  • Initial therapy
    • Adults
      • 3 – 4 gm daily in evenly divided doses every 8 hours.
    • Children with 6 years or more of age
      • 40 – 60 mg/kg of body weight every 24 hours in 3 – 6 divided doses.
    • Maintenance therapy
      • Adults
        • 2 gm daily.
      • Children with 6 years or more of age
        • 30 mg/kg of body weight every 24 hours in 4 divided doses.
      • Adults (for rheumatoid arthritis)
        • 2 gm daily in 2 evenly divided doses.
          • 1st week – 1 tablet in evening.
          • 2nd week – 1 tablet in morning and 1 tablet in evening.
          • 3rd week – 1 tablet in morning and 2 tablets in evening.
          • 4th week – 2 tablets in morning and 2 tablets in evening.
        • Juvenile rheumatoid arthritis (Children with 6 years or more of age)
          • 30 – 50 mg/kg of body weight daily in 2 evenly divided doses.

Pediatric use

  • The safety and efficacy of Sulfasalazine has been established in children in age group of 6 years to 16 years.
  • Use in children with systemic-course juvenile rheumatoid arthritis has frequently resulted in a serum sickness-like reaction.


  • Symptoms of overdosage may include nausea, vomiting, gastric distress and abdominal pains.
  • In more advanced cases, central nervous system symptoms such as drowsiness, convulsions, etc., may be observed.
  • Serum sulfapyridine concentrations may be used to monitor the progress of recovery from overdosage.
  • Sulfasalazine and its metabolites can be removed by dialysis.
  • Gastric lavage or emesis plus catharsis as indicated. Alkalinize urine.
  • If kidney functions are normal, force fluids.
  • If anuria is present, restrict fluids and salt, and treat appropriately.

Side effects or adverse effects

  • Anorexia, headache, nausea, vomiting, gastric distress and oligospermia have been reported.
  • Pruritic, urticaria, rash, fever, Heinz body anemia, hemolytic anemia and cyanosis are less commonly reported.
  • Hypersensitivity reaction including urticarial rash (most common), allergic myocarditis, arthralgia, epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens – Johnson syndrome, urticaria, serum sickness, photo sensitization and generalized skin eruptions.
    • Consult your doctor as soon as possible if you observe skin rash, red or purple colored skin rash, facial swelling, swelling of the tongue, hives on the skin, joint pain, a painful red area on the skin that spreads quickly, peeling of the skin without blistering, fever, shortness of breath during exercise at first and then at night time while lying down, abnormal heart beat, light headedness, sharp or stabbing chest pain and fatigue are some of the symptoms. This may require immediate medical attention and discontinuation of the therapy.
  • Gastrointestinal side effects include nausea, vomiting, abdominal pain, diarrhea, anorexia, pancreatitis and stomatitis.
    • Ask your pharmacist to recommend a suitable medicine and consult your doctor.
  • Occurrence of hepatitis and jaundice, though rare cannot be ruled out.
    • Nausea, stomach pain, dark colored urine, yellowing of the skin and whites of the eye, light or clay colored stools, fever and unusual tiredness are some of the symptoms. Consult your doctor as soon as possible. This may require discontinuation of the treatment with sulfadiazine.
  • Aplastic anemia, hemolytic anemia, hypoprothrombinemia, leucopenia, purpura and agranulocytosis.
    • Purple colored spots under skin, sudden fever, chills, sore throat, weakness in limbs, mouth ulcers, bleeding gums, easy bruising and prolonged bleeding are some of the symptoms of the above mentioned condition. Consult your doctor as soon as possible as some of the above mentioned conditions are serious and life threatening.
  • Tremulousness, delirium and disorientation have been frequently reported
    • Shaking of a body part or even full body, anxiety, fear, hallucinations, irritability, rapid and unpredictable mood swings, difficulty in reading, writing, recalling or speaking of words are some of the symptoms of the above mentioned condition. Consult your doctor as soon as possible.
  • Occurrence of frank psychosis is rare.
  • Ataxia, convulsions, hallucinations, headache, insomnia, mental depression, peripheral neuritis, tinnitus and vertigo have also been reported.
  • Crystalluria, lupus periarteritis nodosa, toxic nephrosis with oliguria and anuria have also been reported.
  • Occurrence of hypoglycemia has also been reported with sulfadiazine use.
  • Kernicterus may be precipitated in new born, commonly observed with premature born babies.


  • Contra-indicated in patients with intestinal or urinary obstruction.
  • Contra-indicated in patients with porphyria.

Pregnancy & breast feeding warnings

Pregnancy: Category B, which means animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.


  • Sulfasalazine is excreted in human breast milk.
  • Sulfasalazine use is contraindicated in a mother nursing a G6PD deficient breast feeding infant.
  • Sulfasalazine use in mothers nursing a premature baby or a baby with jaundice should be avoided as safety profile for Sulfamethoxazole use in such cases is not established.
  • Sulfasalazine can be used in a mother nursing a healthy and full term baby.


Drug – drug interactions

  • Sulfasalazine interferes with folate absorption.
  • Folic acid supplementation should be given during its use.
  • Any drug that causes kidney problems should be administered under strict monitoring when co-administered with sulfasalazine.

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  • “Product information. Azulfidine EN tabs (Sulfasalazine delayed release tablets).” Pfizer pharmaceuticals.
  • Kaufman DW, editor. Birth defects and drugs during pregnancy. Littleton, MA: Publishing Sciences Group, Inc, 1977: 296–313.
  • Mogadam M, et al. Pregnancy in inflammatory bowel disease: effect of sulfasalazine and corticosteroids on fetal outcome. Gastroenterology 1981;80:72–6.
  • Jarnerot G. Fertility, sterility and pregnancy in chronic inflammatory bowel disease. Scand J Gastroenterol 1982;17:1–4.
  • Holdworth CG. Sulphasalazine desensitization. Br Med J 1981;282:110.
  • Korelitz B, et al. Desensitization to sulfasalazine in allergic patients with IBD: an important therapeutic modality. Gastroenterology 1982;82:1104.
  • Taffet SL, Das KM. Desensitization of patients with inflammatory bowel disease to sulfasalazine. Am J Med 1982;73:520–4
By |2018-12-29T06:37:14+00:00May 8th, 2017|medicines|Comments Off on sulfasalazine

About the Author:

B. Pharm (K.L.E. society's S.V.V. Patil College of Pharmacy, Bengaluru) M. Pharm (Maharishi Arvind Institute of Pharmacy, Jaipur)


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