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Azulfidine (sulfasalazine) Uses, Side Effects & Dosage

What is Azulfidine?

Sulfasalazine is a drug that is used primarily for treating ulcerative colitis.

Why is Azulfidine prescribed to patients?

Sulfasalazine is used for the treatment of mild to severe
ulcerative colitis, and treatment of
arthritis. It has also been used “off label” (unapproved by the FDA) for
Crohn’s disease
and ankylosing spondylitis.

Is Azulfidine available as a generic drug?


Do I need a prescription for Azulfidine?


What are the side effects of Azulfidine?

Gastrointestinal disturbances frequently occur in patients
taking sulfasalazine that may include:

Headache, allergic reactions, and
photosensitivity (development of a rash when exposed to
sunlight) may develop during sulfasalazine therapy and require medical
attention. Some of the allergic reactions may progress from a rash to difficulty
in swallowing, blistering, peeling, or loosening of the skin, aching joints and
muscles, and unusual tiredness or weakness. It may
be accompanied by fever. The
more severe allergic reactions are rare.

Sulfasalazine may cause the skin or the urine to change color.

Development of an orange-yellow discoloration of the urine is no cause for concern.

Several potentially dangerous side effects have been reported rarely with sulfasalazine. A drop in white blood cell count or a type of anemia in which red
blood cells are disrupted (hemolyzed) may occur. These effects are characterized
by fever, pale skin,
sore throat, fatigue, and unusual bleeding and bruising, and require
discontinuation of the drug. Liver failure,
and kidney failure also have been associated with sulfasalazine.

What is the dosage for Azulfidine?

  • For treating ulcerative colitis, adult doses range from 3000 mg to 4000 mg daily. Treatment may be started at 1000 to 2000 mg daily to reduce stomach upset.
  • Rheumatoid arthritis is treated with 2000 to 3000 mg daily. Treatment may be started with 500 to 1000 mg daily.
  • Sulfasalazine is administered 3 to 4 times daily. It should be taken with a full glass of water after meals or with food to minimize upset stomach.

Patients with kidney diseases may need to use lower doses of sulfasalazine.

Which drugs or supplements interact with Azulfidine?

Sulfasalazine may cause reduced absorption of folic acid
and digoxin
(Lanoxin). Reduced folic acid absorption may cause folic acid deficiency and
result in anemia.
Reduced digoxin absorption may reduce the effectiveness of digoxin.
Sulfapyridine (a byproduct of sulfasalazine) is a sulfonamide, and sulfonamides
increase blood levels of
(Rheumatrex, Trexall), resulting in increased methotrexate toxicity. Conversely,
methotrexate can increase the occurrence of the anemia caused by sulfonamides
because methotrexate also causes folic acid deficiency. Sulfonamides can
increase the risk of kidney damage from cyclosporine by an unknown mechanism.
They also may increase the blood glucose lowering effect of oral anti-diabetic
drugs and potentially cause excessive reductions in blood sugar (hypoglycemia)
by decreasing elimination of anti-diabetic drugs by the liver and elevating the
levels of the anti-diabetic drugs in the blood.

Combining 5-ASA with drugs that affect kidney function such as nonsteroidal
antiinflammatory drugs, for example,
(Advil) may increase the likelihood of kidney dysfunction. Concurrent use of
5-ASA and 6-mercaptopurine or
(Imuran) may increase the likelihood of blood disorders. 5-ASA may increase the
blood thinning effect of

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Is Azulfidine safe to use during pregnancy or while breastfeeding?

In hundreds of pregnant women with ulcerative colitis or Crohn’s
disease treated with sulfasalazine, there has been no increase in the risk of
fetal malformations relative to other women with these illnesses who have not
been treated with sulfasalazine. Additionally, there have not been ill effects
on pregnant animals given high doses of sulfasalazine. Thus, sulfasalazine may
be used during
pregnancy if the physician feels the benefit outweighs the possible risk.

It should also be noted, however, that sulfasalazine may reduce sperm count
and sperm function in men. These effects are reversible upon stopping the drug.

Caution should be exercised by women who are nursing their
infants. Sulfasalazine and its constituents are secreted into
breast milk.
There is a small risk that sulfapyridine (a byproduct of sulfasalazine) may
displace bilirubin from albumen in the blood of infants and cause


Ulcerative colitis affects the colon. The colon is also referred to as the…
See Answer

What else should I know about Azulfidine?

What preparations of Azulfidine are available?

Tablets: 500 mg. Suspension: 250 mg/5 ml.

How should I keep Azulfidine stored?

The tablets should be stored at room temperature, 15 C -30 C (59 F- 86 F).

How does Azulfidine work?

Sulfasalazine is a prodrug, that is, it is not active in its
ingested form. It is broken down by bacteria in the colon into its two
components, 5-aminosalicylic acid (5-ASA), and sulfapyridine. (5-ASA also is
marketed as
mesalamine (Lialda, Rowasa, Pentasa, Canasa Apriso, and Asacol.) The 5-ASA
has a therapeutic benefit, but it is not clear if sulfapyridine adds any
additional therapeutic benefit. The inflammation of ulcerative colitis and other
inflammatory diseases is caused, in part, by excessive production of chemicals
(for example, prostaglandins) that produce inflammation. Prostaglandins are
produced by two enzymes, cyclooxygenase and lipoxygenase, and these enzymes are
over-active in individuals with ulcerative colitis. 5-ASA may reduce
inflammation by blocking the activity of cyclooxygenase and lipoxygenase thereby
reducing the production of prostaglandins.

When was Azulfidine approved by the FDA?

Sulfasalazine was approved by the FDA in 1950.


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