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OVERVIEW — Sulfasalazine (brand name: Azulfidine) and the 5-aminosalicylate drugs (sample brand names: Delzicol, Asacol HD, Pentasa, Salofalk, Dipentum, Colazal, Apriso, Lialda) are used to treat inflammatory bowel disease. These drugs have anti-inflammatory actions, and they are effective for inducing and maintaining remission in mild to moderate ulcerative colitis. Their efficacy in Crohn disease is more controversial, and they are no longer routinely used to treat most people with Crohn disease. There is a little data that sulfasalazine may be effective in controlling mildly active Crohn colitis, but not for maintaining remission. (See "Patient education: Ulcerative colitis (Beyond the Basics)" and "Patient education: Crohn disease (Beyond the Basics)".)
Sulfasalazine is also used to treat rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and juvenile idiopathic arthritis. (See "Patient education: Rheumatoid arthritis treatment (Beyond the Basics)" and "Patient education: Axial spondyloarthritis, including ankylosing spondylitis (Beyond the Basics)" and "Patient education: Psoriatic arthritis (Beyond the Basics)" and "Patient education: Disease-modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis (Beyond the Basics)".)
In many cases, sulfasalazine or a 5-aminosalicylate must be taken for a long period of time. These medications can have side effects ranging from mild to serious. Side effects are much more common with sulfasalazine. 5-aminosalicylates are generally very well tolerated. Many of the mild side effects can be avoided by using lower doses of these drugs; the serious side effects are uncommon or rare, and usually resolve when the medication is stopped. In the vast majority of cases, the potential benefits of these drugs outweigh the potential risks. Nonetheless, it is important to be aware of the possible side effects before starting treatment.
How it works — Sulfasalazine acts locally in the colon to decrease inflammation. It also works throughout the body by inhibiting the formation of a chemical known as prostaglandins. Prostaglandins have several important functions in the body, one of which is control of pain and inflammation.
Sulfasalazine is a yellow/orange color; people who take it may notice that their urine, tears, and sweat develop an orange tinge, which can stain clothing and contact lenses. It's important to drink plenty of fluids while on therapy and avoid taking the drug on an empty stomach or with antacids. Sulfasalazine can affect folate absorption, so you should also take folic acid (1 mg per day) while taking the medication and if you are pregnant, you should take 2 mg of folic acid a day.
Side effects — The major side effects of sulfasalazine can be classified according to how frequently the side effect occurs: commonly, uncommonly, and rarely.
Common side effects — The most common side effects of sulfasalazine are headache, nausea, fever, rash, and reversible infertility in men.
Headache is one of the most common complaints, affecting up to one-third of people. Headaches are more likely with higher doses of the drug, and are less likely to occur if the dose is gradually increased. Loss of appetite, nausea, sensitivity to sunlight, and nervousness are also common when starting therapy. Sperm count may be reduced in men who take sulfasalazine, although this is reversible once the drug is stopped.
Uncommon side effect — Inflammation of the pancreas (pancreatitis) is an uncommon side effect of sulfasalazine.
Rare side effects — Rare and potentially serious side effects of sulfasalazine (affecting less than 1 percent of people who take this drug) include inflammation of the liver (hepatitis), inflammation of the lung (pneumonitis), a serious skin reaction called Stevens-Johnson syndrome, and destruction of red blood cells (hemolysis). Inflammation of the kidney can also occur. Routine blood tests to monitor kidney function are typically performed yearly while on sulfasalazine.
Rarely, there is a decrease in the number of infection-fighting white blood cells. In some cases, the bone marrow completely stops producing a specific type of white blood cells, a condition called agranulocytosis. Agranulocytosis usually occurs within two months of starting sulfasalazine and is usually accompanied by a fever and rash. In most people, agranulocytosis resolves within one or two weeks of stopping the medication. Testing to monitor the blood count is recommended in anyone taking sulfasalazine. Typically, this should be performed every one to two weeks for the first six to eight weeks, then once monthly for three months, and then every three months.
Sulfasalazine and sulfa allergies — People who are allergic to sulfa drugs may have a cross reaction to sulfasalazine and should therefore not take it. If sulfasalazine produces mild allergic symptoms but very effectively controls symptoms, desensitization, a method to reduce or eliminate the allergic reaction, may be attempted. Desensitization uses a very small dose of sulfasalazine initially, and gradually increases the dose over time. This strategy is not commonly done for people with inflammatory bowel disease since other treatments are available.
Sulfasalazine during pregnancy and breastfeeding — Women who wish to become pregnant can continue taking sulfasalazine during pregnancy and while breastfeeding. Sulfasalazine does not increase the risk of any complications of pregnancy or the risk of birth defects. Pregnant women taking sulfasalazine should increase their folic acid supplementation to 2 mg per day. If you have inflammatory bowel disease, you should speak with your health care provider before trying to get pregnant, as they will want to review all of your medications.
How they work — Sulfasalazine is a molecule that has two components: 5-aminosalicylate (5-ASA) and sulfapyridine. The sulfapyridine is responsible for many of the side effects of sulfasalazine, while the 5-ASA is responsible for many of its beneficial effects in people with inflammatory bowel disease. This discovery provided a rationale for the development of a drug that contains only the 5-ASA component. Unfortunately, the sulfapyridine component is necessary for the beneficial effects of sulfasalazine in people with rheumatoid arthritis; thus the 5-ASA drugs are not suitable for these people.
Several formulations of the 5-ASA drugs are available (sample brand names: Delzicol, Asacol HD, Pentasa, Dipentum, Colazal, Apriso, and Lialda). These differ in the specific formulation of 5-ASA, how many times per day they are taken, and the way the pills dissolve in particular parts of the bowel.
Overall, the 5-ASA drugs have fewer side effects than sulfasalazine.
Common side effects — The most common side effects of the 5-ASA drugs (occurring in more than 10 percent of people) include headache and malaise (a vague feeling of illness), cramps and gas. Watery diarrhea is fairly common with one of rarely used 5-ASA formulations (brand name: Dipentum), occurring in about 15 percent of people.
Uncommon side effects — Uncommon side effects include hair loss, skin rash, and a worsening of inflammation of the colon (colitis); these occur in 1 to 10 percent of people. Approximately 3 percent of people can have a reaction to 5-ASA drugs where their colitis symptoms get markedly worse. In this case, their physician should be notified and the drug should be stopped.
Rare side effects — Rare side effects affect less than 1 percent of people, but are potentially serious. They include inflammation of the lung (pneumonitis), inflammation of the tissue surrounding the heart (pericarditis), and inflammation of the pancreas (pancreatitis). Inflammation of the kidney (interstitial nephritis) can also occur. Routine blood tests to monitor kidney function are typically performed yearly.
5-aminosalicylates during pregnancy and breastfeeding — Studies suggest that the 5-ASA drugs are safe when taken during pregnancy and breastfeeding and that women should continue taking these drugs during this time. However, if you take a 5-ASA medication, you should speak with your health care provider before trying to get pregnant.
WHERE TO GET MORE INFORMATION — Your health care provider is the best source of information for questions and concerns related to your medical problem.
This article will be updated as needed on our website (www.uptodate.com/patients). Related topics for patients, as well as selected articles written for health care professionals, are also available. Some of the most relevant are listed below.
Patient level information — UpToDate offers two types of patient education materials.
The Basics — The Basics patient education pieces answer the four or five key questions a patient might have about a given condition. These articles are best for patients who want a general overview and who prefer short, easy-to-read materials.
Beyond the Basics — Beyond the Basics patient education pieces are longer, more sophisticated, and more detailed. These articles are best for patients who want in-depth information and are comfortable with some medical jargon.
Patient Level Information:
Patient education: Ulcerative colitis (Beyond the Basics)
Patient education: Crohn disease (Beyond the Basics)
Patient education: Rheumatoid arthritis treatment (Beyond the Basics)
Patient education: Axial spondyloarthritis, including ankylosing spondylitis (Beyond the Basics)
Patient education: Psoriatic arthritis (Beyond the Basics)
Patient education: Disease-modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis (Beyond the Basics)
Professional level information — Professional level articles are designed to keep doctors and other health professionals up-to-date on the latest medical findings. These articles are thorough, long, and complex, and they contain multiple references to the research on which they are based. Professional level articles are best for people who are comfortable with a lot of medical terminology and who want to read the same materials their doctors are reading.
Overview of dosing and monitoring of biologic agents and small molecules for treating ulcerative colitis in adults
Overview of azathioprine and mercaptopurine use in inflammatory bowel disease
Clinical manifestations, diagnosis, and prognosis of ulcerative colitis in adults
Fertility, pregnancy, and nursing in inflammatory bowel disease
Medical management of low-risk adult patients with mild to moderate ulcerative colitis
Overview of the medical management of mild (low risk) Crohn disease in adults
Management of the hospitalized adult patient with severe ulcerative colitis
Sulfasalazine and 5-aminosalicylates in the treatment of inflammatory bowel disease
The following organizations also provide reliable health information.
●National Library of Medicine
●US Food and Drug Administration
●The Crohn's and Colitis Foundation
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