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Sulfasalazine, Oral Tablet

Highlights for sulfasalazine

  1. Sulfasalazine oral tablet is available as both a generic and brand-name drug. Brand name: Azulfidine.
  2. The tablets come in immediate-release and extended-release forms.
  3. Sulfasalazine is used to treat rheumatoid arthritis, juvenile rheumatoid arthritis, and ulcerative colitis.
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Important warnings

Important warnings

  • Allergies warning: Tell your doctor if you have an allergy to sulfasalazine, sulfa drugs, or salicylates. If you’re allergic to these drugs, you may have a very serious reaction that could be deadly.
  • Infections warning: Sulfasalazine may increase your risk of infections by lowering your body’s immunity. Call your doctor right away if you have signs of an infection, such as a fever, sore throat, or paleness. Your doctor will check your blood regularly for infections.
  • Blood disorder or liver damage warning: This drug may cause blood disorder or liver damage. Symptoms include:
    • sore throat
    • fever
    • paleness
    • purple spots on your skin
    • yellowing of your skin or the whites of your eyes

About

What is sulfasalazine?

Sulfasalazine oral tablet is a prescription drug that’s available as the brand-name drug Azulfidine. It’s also available as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand.

Why it's used

Sulfasalazine is used to reduce inflammation and pain in rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), and ulcerative colitis (UC).

In RA and JRA, the medication is used to treat people who haven’t responded to other therapies. It’s used to decrease pain and swelling in the joints.

The medication is used to treat inflammation in the gut and stomach that occur with UC. It also helps to increase the time between your UC flare-ups or attacks. It can be used alone to treat mild-to-moderate pain. It can also be used in combination with other drugs to treat severe UC when other therapies don’t work.

This drug may be used as part of a combination therapy. That means you may need to take it with other drugs.

How it works

Sulfasalazine is an anti-inflammatory drug. It isn’t fully understood how it works. It’s believed that it affects your immune system and decreases inflammation.

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Side effects

Sulfasalazine side effects

Sulfasalazine oral tablet may cause drowsiness. It may also cause other side effects.

Most common side effects

The most common side effects that occur with sulfasalazine include:

  • decreased appetite
  • headache
  • nausea
  • vomiting
  • stomach upset and pain
  • rash
  • itching
  • decreased sperm count (only while taking the medication)
  • dizziness

Mild side effects may go away within a few days or a couple of weeks. Talk to your doctor or pharmacist if they’re more severe or don’t go away.

Serious side effects

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life threatening or if you think you’re experiencing a medical emergency, call 911.

  • blood disorder or liver damage. Symptoms include:
    • sore throat
    • fever
    • paleness
    • purple spots on your skin
    • yellowing of your skin or the whites of your eyes
  • serious skin disorder. Symptoms include:
    • flu-like symptoms
    • painful red or purple rash
    • blistering
    • peeling skin
  • kidney damage. Symptoms include:
    • difficulty urinating, making less urine, or not urinating at all

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Interactions

Sulfasalazine may interact with other medications

Sulfasalazine oral tablet may interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Examples of drugs that can cause interactions with sulfasalazine are listed below.

Folic acid

Folic acid (vitamin B9) is absorbed less by your body when you take sulfasalazine. Your doctor may recommend a folic acid supplement or a higher dose if you’re already taking one.

Heart drug

  • digoxin

This drug is absorbed less when you take it while taking sulfasalazine. Your doctor will monitor the amount of digoxin you get and may increase your dose.

Disease-modifying antirheumatic drug

This drug interaction is possible if you’re taking sulfasalazine for rheumatoid or juvenile rheumatoid arthritis:

  • methotrexate

Taking this drug while taking sulfasalazine may increase side effects in your gut and stomach, especially nausea.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

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Other warnings

Sulfasalazine warnings

Sulfasalazine oral tablet comes with several warnings.

Allergy warning

Sulfasalazine can cause a severe allergic reaction, especially to people with a known allergy to sulfonamides (“sulfa” drugs). Symptoms may include:

  • trouble breathing
  • swelling of your throat or tongue
  • hives

Don’t take this drug again if you’ve ever had an allergic reaction to sulfasalazine, sulfonamides, or salicylates like aspirin. Taking it again could be fatal.

Warnings for people with certain health conditions

For people with asthma or severe allergies: Tell your doctor if you have asthma. You may be more sensitive to sulfasalazine and have more side effects.

For people with bowel obstructions: Tell your doctor if you have problems with obstruction in your bowel or when urinating. You shouldn’t take sulfasalazine because it could make these problems worse.

For people with porphyria: Tell your doctor if you have porphyria. In this disease, your body doesn’t process certain chemicals (called porphyrins) normally. If you take sulfasalazine, you may have an acute attack or flare-up of porphyria.

Warnings for other groups

For pregnant women: Sulfasalazine is a pregnancy category B drug. That means two things:

  1. Studies of the drug in pregnant animals have not shown risk to the fetus.
  2. There aren’t enough studies done in pregnant women to show if the drug poses a risk to the fetus.

Sulfasalazine decreases the amount of folic acid that your body absorbs. Folic acid is important for an unborn baby’s development. If you take sulfasalazine while you’re pregnant, it’s important that you also take a folic acid supplement. Talk to your doctor about how much folic acid you should be getting each day.

Speak with your doctor if you’re pregnant or plan to become pregnant. Sulfasalazine should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

For women who are breastfeeding: Sulfasalazine may be passed through breast milk. This could cause side effects in your child. In a few cases, infants had bloody stools or diarrhea that went away once the mother stopped using sulfasalazine or stopped breastfeeding. If you breastfeed or plan to breastfeed, talk to your doctor about the safety of breastfeeding while taking sulfasalazine.

For children: The safety and effectiveness of this medication haven’t been established in children who are younger than 6 years.

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Dosage

How to take sulfasalazine

This dosage information is for sulfasalazine oral tablet. All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

Forms and strengths

Generic: sulfasalazine

  • Form: Oral tablet (immediate-release)
  • Strength: 500 mg
  • Form: Oral tablet (extended-release)
  • Strength: 500 mg

Brand: Azulfidine

  • Form: Oral tablet (immediate-release)
  • Strength: 500 mg

Brand: Azulfidine EN

  • Form: Oral tablet (extended-release)
  • Strength: 500 mg

Dosage for ulcerative colitis

Adult dosage (ages 18 years and older)

  • For initial therapy, the dose is 3,000–4,000 mg per day taken in evenly divided doses no more than 8 hours apart.
  • For maintenance therapy, the dose is 2,000 mg per day.

Child dosage (ages 6-17 years)

  • For initial therapy, the dose is 40–60 mg/kg of body weight per day, evenly divided in 3–6 evenly spaced doses.
  • For maintenance therapy, the dose is 30 mg/kg, per day taken in 4 evenly divided and evenly spaced doses.

Child dosage (ages 0-5 years)

Dosage for people younger than 6 years hasn’t been established.

Warnings

Your doctor may choose to start you at a lower dose to decrease the risk of any stomach side effects.

Dosage for rheumatoid arthritis

Adult dosage (ages 18 years and older)

  • The extended-release tablets are used to treat this condition.
  • For initial therapy, the dose is 500–1,000 mg per day. This is increased slowly to the maintenance dose.
  • For maintenance therapy, the dose is 2,000 mg per day taken in 2 evenly divided and evenly spaced doses.

Warnings

Your doctor may choose to start you at a lower dose to decrease the risk of any stomach side effects.

Dosage for juvenile rheumatoid arthritis

Child dosage (ages 6 years and older)

  • The extended-release tablets are used to treat this condition.
  • The starting dose may be only one quarter to one third of the maintenance dose.
  • The maintenance dose is 30–50 mg/kg of body weight per day taken in two evenly divided and evenly spaced doses.

Child dosage (ages 0-5 years)

Dosage for people younger than 6 years hasn’t been established.

Warnings

Your doctor may choose to start you at a lower dose to decrease the risk of any stomach side effects.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.

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Take as directed

Take as directed

Sulfasalazine oral tablet is used for long-term treatment. It comes with risks if you don’t take it as prescribed by your doctor.

If you don’t take it at all: If you don’t take this medication, you may experience more flare-ups of your symptoms.

If you miss doses or don’t take it on schedule: If you miss doses or don’t take it on schedule, you may experience more symptoms, such as pain and inflammation.

If you take too much: Too much sulfasalazine may be harmful and cause:

  • vomiting
  • nausea
  • stomach pain
  • drowsiness
  • seizures

If you take too much sulfasalazine, call your doctor or get emergency medical help immediately.

What to do if you miss a dose: Take the missed dose as soon as you remember. Skip the missed dose if it’s almost time for your next scheduled dose. Don’t take extra medicine to make up the missed dose.

How can if tell if the drug is working?: You may be able to tell that this medication is working for arthritis if it reduces your joint pain and makes it easier to perform daily tasks.

When treating ulcerative colitis, you may be able to tell this drug is working if you have less stomach pain and the time between your flare-ups or attacks becomes longer.

Important considerations

Important considerations for taking sulfasalazine

Keep these considerations in mind if your doctor prescribes sulfasalazine oral tablets for you.

General

Take this medication with food or shortly after you eat so you don’t get an upset stomach.

Space your doses of this medication evenly throughout the day. Don’t cut or crush the extended-release tablet. Swallow it whole.

You can cut or crush the immediate-release tablet.

Storage

  • Store sulfasalazine at room temperature: 68–77°F (20–25°C).
  • Keep your medications away from areas where they could get wet, such as bathrooms.  

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

  • Always carry it with you or in your carry-on bag.
  • Don’t worry about airport X-ray machines. They can’t hurt this medication.
  • You may need to show your pharmacy’s preprinted label to identify the medication. Keep the original prescription-labeled box with you when traveling.

Clinical monitoring

Your doctor may regularly do the following tests:

  • blood tests. Sulfasalazine can decrease some of your blood cell counts, putting you at risk for infections. Your doctor will perform these tests frequently for the first 3 months you take this drug, then less often.
  • liver tests. Sulfasalazine can cause damage to your liver.
  • kidney tests. Sulfasalazine is cleared from your body through your kidneys. If your kidneys aren’t working well, they won’t be able to get rid of the drug. This will increase your risk of side effects.

Your diet

This drug may decrease how well your body can absorb folic acid, so you may need to take folic acid supplements. Ask your doctor if this is necessary for you.

Sun sensitivity

You may be more sensitive to the sun while taking sulfasalazine. Apply sunscreen before going outside and wear protective clothing and eyewear. Don’t spend long periods in the sun or near sunlamps. Avoid going to tanning salons as well.

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Alternatives

Are there any alternatives?

There are several drugs that can treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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