Azulfidine Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Azulfidine EN-tabs (sulfasalazine delayed release tablets) 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. Azulfidine is an anti-inflammatory agent and immunomodulatory agent. This medication is available in generic form. Common side effects include stomach upset, nausea, vomiting, loss of appetite, mouth sores, headache, dizziness, or unusual tiredness.
Adult doses of Azulfidine range from 1000 mg to 4000 mg daily, taken 2 to 4 times daily depending on the condition being treated. Pediatric doses are determined by weight. Azulfidine EN-tabs may interact with digoxin, folic acid, or vitamin or mineral supplements that contain folic acid. There may be other drugs that can interact with Azulfidine. Tell your doctor about all the prescription and over-the-counter medications and supplements you use. During pregnancy, Azulfidine EN-tabs should be used only when prescribed. Caution is advised if this medication is used near the expected delivery date because similar drugs may cause harm to a newborn. This medication may lower folic acid levels, increasing the risk of spinal cord defects. Consult your doctor about taking enough folic acid. This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Our Azulfidine EN-tabs (sulfasalazine delayed release tablets) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Azulfidine in Detail - Patient Information: 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.
Read the entire detailed patient monograph for Azulfidine (Sulfasalazine Delayed Release Tablets) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Azulfidine Overview - Patient Information: Side Effects
This medication may cause your skin and urine to turn orange-yellow. This effect is harmless and will disappear when the medication is stopped.
Rarely, delayed-release tablets of sulfasalazine may appear whole or only partly dissolved in your stool. If this occurs, tell your doctor immediately so your treatment can be changed.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may cause temporary male infertility. This effect is reversible when the medication is stopped.
Tell your doctor immediately if any of these unlikely but serious side effects occur: sun sensitivity, hearing changes (e.g., ringing in the ears), mental/mood changes, painful urination, blood in the urine, change in the amount of urine, new lump/growth in the neck (goiter), numbness/tingling of the hands/feet, signs of low blood sugar (e.g., hunger, cold sweat, blurred vision, weakness, fast heartbeat).
This medication may rarely cause very serious allergic reactions (e.g., Stevens-Johnson syndrome), blood disorders (e.g., agranulocytosis, aplastic anemia), liver damage, and nerve/muscle problems. Seek immediate medical attention if you notice any of the following symptoms: skin rash/blisters/peeling, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest pain, signs of infection (e.g., fever, chills, persistent sore throat), easy bruising/bleeding, severe tiredness, muscle pain/weakness (especially with fever and unusual tiredness), pale or blue skin/lips/nails, new/worsening joint pain, confusion, persistent/severe headache, unexplained neck stiffness, seizures, signs of liver problems (e.g., persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, dark urine).
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Azulfidine (Sulfasalazine Delayed Release Tablets)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Azulfidine FDA Prescribing Information: Side Effects
The most common adverse reactions associated with sulfasalazine in ulcerative colitis are anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia. These occur in about one-third of the patients. Less frequent adverse reactions are pruritus, urticaria, rash, fever, Heinz body anemia, hemolytic anemia and cyanosis, which may occur at a frequency of 1 in 30 patients or less. Experience suggests that with a daily dose of 4 g or more, or total serum sulfapyridine levels above 50 μg/mL, the incidence of adverse reactions tends to increase.
Similar adverse reactions are associated with sulfasalazine use in adult rheumatoid arthritis, although there was a greater incidence of some reactions. In rheumatoid arthritis studies, the following common adverse reactions were noted: nausea (19%), dyspepsia (13%), rash (13%), headache (9%), abdominal pain (8%), vomiting (8%), fever (5%), dizziness (4%), stomatitis (4%), pruritis (4%), abnormal liver function tests (4%), leukopenia (3%), and thrombocytopenia (1%). One report7 showed a 10% rate of immunoglobulin suppression, which was slowly reversible and rarely accompanied by clinical findings.
In general, the adverse reactions in juvenile rheumatoid arthritis patients are similar to those seen in patients with adult rheumatoid arthritis except for a high frequency of serum sickness-like syndrome in systemic-course juvenile rheumatoid arthritis (see PRECAUTIONS, Pediatric Use). One clinical trial showed an approximate 10% rate of immunoglobulin suppression.1
Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the sulfonamides require that each of these reactions be considered when AZULFIDINE EN-tabs (sulfasalazine delayed release tablets) is administered.
Less common or rare adverse reactions include:
Hypersensitivity reactions: erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, epidermal necrolysis (Lyell's syndrome) with corneal damage, drug rash with eosinophilia and systemic symptoms (DRESS), anaphylaxis, serum sickness syndrome, interstitial lung disease, pneumonitis with or without eosinophilia, vasculitis, fibrosing alveolitis, pleuritis, pericarditis with or without tamponade, allergic myocarditis, polyarteritis nodosa, lupus erythematosus-like syndrome, hepatitis and hepatic necrosis with or without immune complexes, fulminant hepatitis, sometimes leading to liver transplantation, parapsoriasis varioliformis acuta (Mucha-Haberman syndrome), rhabdomyolysis, photosensitization, arthralgia, periorbital edema, conjunctival and scleral injection and alopecia.
Gastrointestinal reactions: hepatitis, hepatic failure, pancreatitis, bloody diarrhea, impaired folic acid absorption, impaired digoxin absorption, stomatitis, diarrhea, abdominal pains, and neutropenic enterocolitis.
Central Nervous System reactions: transverse myelitis, convulsions, meningitis, transient lesions of the posterior spinal column, cauda equina syndrome, Guillain-Barre syndrome, peripheral neuropathy, mental depression, vertigo, hearing loss, insomnia, ataxia, hallucinations, tinnitus and drowsiness.
Other reactions: urine discoloration and skin discoloration.
The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides), and oral hypoglycemic agents. Goiter production, diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.
Cross-sensitivity may exist with these agents. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides and long-term administration has produced thyroid malignancies in this species.
The following events have been identified during post-approval use of products which contain (or are metabolized to) mesalamine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine:
Reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. One case of Kawasaki-like syndrome, which included hepatic function changes, was also reported.
Drug Abuse And Dependence
Read the entire FDA prescribing information for Azulfidine (Sulfasalazine Delayed Release Tablets) »
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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