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What is the most important information I should know about sulfasalazine?

You should not use this medication if you have porphyria, a blockage in your bladder or intestines, or if you are allergic to sulfasalazine, sulfa drugs, aspirin, or salicylates (such as Disalcid, Doan’s Pills, Dolobid, Salflex, Tricosal, and others).

Before using sulfasalazine, tell your doctor if you have asthma, kidney or liver disease, or glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Also tell your doctor about all other medications you use, especially digoxin (digitalis, Lanoxin), folic acid (Folicin, FA-8), or vitamin or mineral supplements that contain folic acid.

Do not crush, break, or chew a sulfasalazine tablet. Swallow the pill whole. The enteric-coated tablet has a special coating to protect your stomach. Breaking the pill could damage this coating.

For best results, keep using the medication as directed. Sulfasalazine will not cure ulcerative colitis, but it can reduce the number of attacks you have.

If you are treating arthritis, do not stop using any of your other arthritis medications until your doctor tells you to.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is sulfasalazine?

Sulfasalazine affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Sulfasalazine is used to treat moderate to severe ulcerative colitis. It is also used to treat rheumatoid arthritis in children and adults who have received other arthritis medications without successful treatment of symptoms.

Sulfasalazine may also be used for other purposes not listed in this medication guide.

Precautions

You should not use this medication if you are allergic to sulfasalazine, or if you have:

  • a blockage in your bladder or intestines;
  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
  • if you are allergic to sulfa drugs (such as Bactrim, Septra, Cotrim, and others); or
  • if you are allergic to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).

Before using sulfasalazine, tell your doctor if you are allergic to any drugs, or if you have:

  • asthma;
  • glucose-6-phosphate dehydrogenase (G6PD) deficiency;
  • kidney disease; or
  • liver disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take sulfasalazine.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Sulfasalazine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using sulfasalazine.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, or seizure (convulsions).

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sulfasalazine and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, or other flu symptoms;
  • pale skin, easy bruising;
  • dark urine, jaundice (yellowing of the skin or eyes);
  • pain or burning when you urinate;
  • urinating less than usual or not at all;
  • the appearance of a whole tablet in your stool; or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, upset stomach;
  • loss of appetite;
  • headache, ringing in your ears;
  • dizziness, spinning sensation;
  • white patches or sores inside your mouth or on your lips;
  • sleep problems (insomnia); or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

Before taking sulfasalazine, tell your doctor if you are using any of the following drugs:

  • digoxin (digitalis, Lanoxin);
  • folic acid (Folicin, FA-8); or
  • vitamin or mineral supplements that contain folic acid.

This list is not complete and there may be other drugs that can interact with sulfasalazine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04