
sulfasalazine
Sulfasalazine (Azulfidine) is an anti-inflammatory medication that comes in immediate-release and delayed-release tablets. Both formulations are used to treat ulcerative colitis (UC). The delayed-release tablets can also be used for rheumatoid arthritis (RA). Adults and children 6 years and older can take sulfasalazine (Azulfidine). It's best to split your total daily dose into a few smaller doses throughout the day. This medication can commonly cause stomach problems, such as nausea and indigestion, as side effects.
What is Sulfasalazine (Azulfidine)?
What is Sulfasalazine (Azulfidine) used for?
- Ulcerative colitis (UC) - immediate-release and delayed release tablets
- Rheumatoid arthritis (RA) - delayed-release tablets only
- Polyarticular juvenile rheumatoid arthritis - delayed-release tablets only
How Sulfasalazine (Azulfidine) works
Sulfasalazine (Azulfidine) is an anti-inflammatory medication. It's also considered a disease-modifying antirheumatic drug (DMARD) for treating rheumatoid arthritis.
It's not completely clear how sulfasalazine (Azulfidine) works. But it's thought to break down in the body into chemicals called sulfapyridine and 5-aminosalicylic acid. These chemicals help block certain processes in the immune system, which lessen inflammation and pain.
Drug facts
| Common Brands | Azulfidine, Azulfidine EN-tabs |
|---|---|
| Drug Class | Anti-inflammatory |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | Lower-cost generic available |
| Availability | Prescription only |
Side effects of Sulfasalazine (Azulfidine)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
For UC:
- Nausea (33%)
- Vomiting (33%)
- Stomach upset (belly pain and cramping; 33%)
- Low appetite (33%)
- Headache (33%)
For RA (delayed-release tablets only):
- Nausea (19%)
- Indigestion (13%)
- Headache (9%)
- Belly pain (8%)
- Vomiting (8%)
- Fever (5%)
Less Common Side Effects
- Urine or skin turning orange or yellow
- Nerve pain
- Depression
- Hair loss
- Hearing loss
- Ringing in the ear
- Dizziness
- Drowsiness
- Trouble sleeping
Sulfasalazine (Azulfidine) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infections: fever, cough, chills, sore throat, runny or stuffy nose, body aches
- Severe allergic or skin reaction: itching, rash, blistering or peeling of skin, hives, painful sores in your mouth or around your eyes, fever, trouble breathing, swollen lymph nodes
- Serious bleeds: bleeding that's difficult to stop, vomiting blood, blood in the urine or stool, "coffee-ground" stool
- Kidney problems: feeling sick, weak, or confused; dehydration; urinating less than usual; blood in urine; swelling in the legs, ankles, or feet
- Liver problems: nausea, vomiting, not feeling hungry, pain in the right side of the stomach, yellowing of the whites of the eyes or skin, dark-colored urine, light-colored stool
The following Sulfasalazine (Azulfidine) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Aching of joints
headache (continuing)
increased sensitivity of the skin to sunlight
skin rash or itching
vomiting
Less common
Back, leg, or stomach pains
bleeding gums
bluish color of the fingernails, lips, skin, palms, or nail beds
chills
dark urine
difficulty breathing
general body swelling
headache
loss of appetite
nosebleeds
pale skin
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
yellowing of the eyes or skin
Less common or rare
Aching of muscles
black, tarry stools
blistering, peeling, or loosening of the skin
blood in the urine or stools
bloody diarrhea
bluish fingernails, lips, or skin
difficulty with swallowing
dizziness
fainting spells
fast heartbeat
general feeling of discomfort or illness
general tiredness and weakness
indigestion
inflammation of the joints
irregular heartbeat
light-colored stools
muscle aches
muscle cramps or spasms
muscle pain or stiffness
painful or difficult urination
pains in the stomach, side, or abdomen, possibly radiating to the back
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rash
red skin lesions, often with a purple center
red, irritated eyes
redness, blistering, peeling, or loosening of the skin
sores, ulcers, or white spots in the mouth or on the lips
swollen or painful glands
tightness in the chest
upper right abdominal or stomach pain
Incidence not known
Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Welts
Less common or rare
Discoloration of the skin or urine
hair loss or thinning of the hair
swelling or inflammation of the mouth
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Sulfasalazine (Azulfidine)
Pros
- Available as a lower-cost generic medication
- Safe to take for children 6 years and older
- Available as immediate-release and delayed-release tablets
- Delayed-release tablets helpful for people with bothersome stomach upset from the medication
Cons
- Can cause side effects like nausea, vomiting, and stomach upset
- Might cause low sperm count
- Might require regular blood work and lab tests to make sure your liver, kidneys, and blood counts are healthy and normal
- Might not be safe for people with allergies to sulfa drugs, aspirin, or other salicylates
Pharmacist tips for Sulfasalazine (Azulfidine)
- Swallow sulfasalazine (Azulfidine) whole, particularly delayed-release tablets. Delayed-release tablets are coated to prevent stomach upset from the medication. Don't chew, crush, or split the tablets.
- Take sulfasalazine (Azulfidine) with food (after a meal) to lower the risk of vomiting, nausea, or stomach problems.
- Let your provider know if you experience nausea and vomiting while you're taking sulfasalazine (Azulfidine). Your provider might ask you to stop this medication for 5 to 7 days, then restart it at a lower dose.
- Drink plenty of fluids or water to stay hydrated while you're taking sulfasalazine (Azulfidine). Doing so can lower your risk of getting a kidney stone or crystals in your urine.
- Sulfasalazine (Azulfidine) might cause your urine or skin to turn orange. This side effect is harmless and typically goes away after you stop taking the medication.
- Sulfasalazine (Azulfidine) can interact with some medications. Let your provider or pharmacist know what medications you're taking, including over-the-counter products and supplements, before you start sulfasalazine (Azulfidine). Talk with your provider or pharmacist if you have any questions about whether sulfasalazine (Azulfidine) is safe to take with your other medications.
- Make sure to get any routine blood and urine tests done on time before and while you’re taking sulfasalazine (Azulfidine). This helps your provider make sure the medication is working for you and not causing side effects.
Risks and warnings for Sulfasalazine (Azulfidine)
Sulfasalazine (Azulfidine) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk of liver, kidney, and blood problems
- Risk factors: History of liver, kidney, or blood problems | Genetic problem called glucose-6 phosphate dehydrogenase deficiency (G6PD deficiency)
Some people taking sulfasalazine (Azulfidine) have had liver, kidney, or blood problems. In rare cases, these problems can even be fatal. To prevent serious injury to your body, it's recommended that you let your provider know if you have a history of liver damage, kidney injury, or different blood conditions.
Before starting and during treatment with sulfasalazine (Azulfidine), your provider will order blood work or urine tests to make sure this medication is safe for you. Tell your provider right away if you have bone or muscle pain, pain in your arms or legs, or general weakness that doesn't go away. These might be signs of kidney problems. Also call your provider right away if you have sore throat, fever, pale skin, abnormal bruising, or yellowing of the whites of the eyes or skin. These might be signs of liver or blood problems.
Low sperm count
In some cases, some people who take sulfasalazine (Azulfidine) can have lower sperm counts, which might affect your ability to have children. But this side effect generally goes away once you stop the medication. Make sure to discuss family planning with your provider to find the best anti-inflammatory treatment for you if you're concerned about this side effect.
Serious infections
- Risk factors: History of recurring or long-term infections | Taking immunosuppressants | Having a medical condition that weakens your immune system
Some people who've taken sulfasalazine (Azulfidine) reported serious infections, including pneumonia and blood infections. Your provider will check for signs and symptoms of infection before and during treatment to make sure this medication is safe for you. Let your provider know if you have an infection while you're taking this medication. Watch out for symptoms of fever, chills, sweating, trouble breathing, nausea, vomiting, or general weakness.
Severe skin and allergic reactions
- Risk factors: History of allergies to sulfasalazine (Azulfidine), sulfa drugs, or salicylates
Sulfasalazine (Azulfidine) can sometimes cause rash and other severe skin reactions. In rare cases, these skin reactions can lead to hospitalization and other complications. The risk is higher if you have a history of allergies to sulfasalazine (Azulfidine), sulfa drugs or salicylates (e.g., aspirin). Get medical care immediately if you have a rash, blistering or peeling skin, painful sores on your face, swelling, or trouble breathing.
Note that severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS), can sometimes happen with or without a rash. Although these reactions are rare, they can cause organ failure or blood problems. Get medical help right away if you have signs like sudden rash, mouth sores, fever, chills, body aches, or swollen lymph nodes.
Sulfasalazine (Azulfidine) dosage
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 500mg | 120 tablets | $9.81 | $0.08 |
Typical dosage for Sulfasalazine (Azulfidine)
Ulcerative colitis — immediate-release and delayed-release tablets
- Adults: The typical starting dose is 3 to 4 grams by mouth daily, split evenly into doses that are taken up to 8 hours apart. Your provider will then lower your dose to prevent stomach problems. The usual maintenance dose is 2 grams by mouth daily.
- Children age 6 years and older: Dosing for children will depend on weight. The dosage starts from a total of 40 mg/kg to 60 mg/kg of body weight by mouth daily, split evenly into 3 or 6 doses throughout the day. The usual maintenance dose is 30 mg/kg of body weight by mouth daily, split evenly into 4 doses in the day.
Rheumatoid arthritis — delayed-release tablets only
- Adults: The typical dose is 1 gram by mouth twice daily.
- Children age 6 years and older: Dosing for children will depend on weight. The dosage starts from a total of 30 mg/kg to 50 mg/kg of body weight by mouth daily, split evenly into 2 doses throughout the day. The maximum total dose is 2 grams daily.
Your provider might lower your dose if you have bothersome side effects like stomach upset.
Interactions between Sulfasalazine (Azulfidine) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Ketorolac
- Methenamine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aceclofenac
- Acemetacin
- Amoxicillin
- Amtolmetin Guacil
- Azathioprine
- Balsalazide
- Bismuth Subsalicylate
- Bromfenac
- Bufexamac
- Capmatinib
- Celecoxib
- Choline Magnesium Trisalicylate
- Choline Salicylate
- Clonixin
- Darolutamide
- Dexibuprofen
- Dexketoprofen
- Diclofenac
- Diflunisal
- Dipyrone
- Droxicam
- Enasidenib
- Etodolac
- Etofenamate
- Etoricoxib
- Felbinac
- Fenoprofen
- Fepradinol
- Feprazone
- Floctafenine
- Flufenamic Acid
- Flurbiprofen
- Ibuprofen
- Indomethacin
- Ketoprofen
- Lasmiditan
- Leflunomide
- Lornoxicam
- Loxoprofen
- Lumiracoxib
- Magnesium Salicylate
- Meclofenamate
- Mefenamic Acid
- Meloxicam
- Mercaptopurine
- Mesalamine
- Morniflumate
- Nabumetone
- Naproxen
- Nepafenac
- Niflumic Acid
- Nimesulide
- Nimesulide Beta Cyclodextrin
- Olsalazine
- Oxaprozin
- Oxyphenbutazone
- Parecoxib
- Phenylbutazone
- Phenyl Salicylate
- Piketoprofen
- Piroxicam
- Porfimer
- Proglumetacin
- Propyphenazone
- Proquazone
- Rofecoxib
- Salicylamide
- Salicylic Acid
- Salsalate
- Sodium Salicylate
- Sulindac
- Tenoxicam
- Teriflunomide
- Tiaprofenic Acid
- Tolfenamic Acid
- Tolmetin
- Trolamine Salicylate
- Valdecoxib
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aminolevulinic Acid
- Cyclosporine
- Digoxin
- Eltrombopag
- Warfarin
How much does Sulfasalazine (Azulfidine) cost?
Sulfasalazine (Azulfidine) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Sulfasalazine (Azulfidine) will not be safe for you to take.
- Gut or bladder blockage
- Porphyria (liver disease that causes buildup of porphyrins)
- Allergic to sulfasalazine (Azulfidine), sulfa drugs, or salicylates (e.g., aspirin)
What are alternatives to Sulfasalazine (Azulfidine)?
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