Azulfidine

Name: Azulfidine

What special precautions should I follow?

Before taking sulfasalazine,

  • tell your doctor if you are allergic to sulfasalazine, sulfapyridine, aspirin, choline magnesium trisalicylate (Triosal, Trilisate), choline salicylate (Arthropan), mesalamine (Asacol, Pentasa, Rowasa), salsalate (Argesic-SA, Disalcid, Salgesic, others), sulfa drugs, trisalicylate (Tricosal, Trilisate),or any other drugs.
  • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially digoxin (Lanoxin), folic acid, and vitamins.
  • tell your doctor if you have or have ever had asthma, kidney or liver disease, porphyria, blood problems, or blockage in your intestine or urinary tract.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking sulfasalazine, call your doctor.
  • plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Sulfasalazine may make your skin sensitive to sunlight.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Is Azulfidine safe to use during pregnancy or while breastfeeding?

In hundreds of pregnant women with ulcerative colitis or Crohn's disease treated with sulfasalazine, there has been no increase in the risk of fetal malformations relative to other women with these illnesses who have not been treated with sulfasalazine. Additionally, there have not been ill effects on pregnant animals given high doses of sulfasalazine. Thus, sulfasalazine may be used during pregnancy if the physician feels the benefit outweighs the possible risk.

It should also be noted, however, that sulfasalazine may reduce sperm count and sperm function in men. These effects are reversible upon stopping the drug.

Caution should be exercised by women who are nursing their infants. Sulfasalazine and its constituents are secreted into breast milk. There is a small risk that sulfapyridine (a byproduct of sulfasalazine) may displace bilirubin from albumen in the blood of infants and cause jaundice.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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Azulfidine Drug Class

Azulfidine is part of the drug class:

  • Aminosalicylic acid and similar agents

Azulfidine Overdose

If you take too much Azulfidine call your local Poison Control center or seek emergency medical attention right away.

Breastfeeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Azulfidine (sulfasalazine) 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.

Serious and sometimes fatal infections may occur during treatment with sulfasalazine. Stop using this medicine and call your doctor right away if you have signs of infection such as:

  • sudden weakness or ill feeling, fever, chills, cold or flu symptoms;

  • sore throat, cough, trouble breathing;

  • stabbing chest pain, cough with yellow or green mucus, wheezing;

  • pain when swallowing, painful mouth sores, red or swollen gums;

  • rapid heart rate, rapid and shallow breathing, fainting;

  • skin sores, pale skin, easy bruising, unusual bleeding; or

  • jaundice (yellowing of the skin or eyes).

Also call your doctor at once if you have:

  • severe nausea or vomiting when you first start taking sulfasalazine;

  • the first sign of any skin rash, no matter how mild;

  • signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • nausea, vomiting, upset stomach, loss of appetite;

  • headache; or

  • low sperm count in men.

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.

Interactions for Azulfidine

Specific Drugs

Drug

Interaction

Comments

Anticoagulants, oral (warfarin)

Possibility that sulfonamides may potentiate the effects of coumarin anticoagulants by displacing them from their protein-binding sites or by impairing anticoagulant metabolisma

If used concomitantly, monitor closelya

Antidiabetic agents, sulfonylureas

Sulfonamides may potentiate the hypoglycemic effects of tolbutamide and chlorpropamide by displacing the antidiabetic agents from their protein-binding sitesa

Use concomitantly with cautiona

Anti-infectives

Possibility that concomitant anti-infectives may alter the action of sulfasalazine by altering intestinal flora and consequently sulfasalazine metabolisma

Digoxin

Possible decreased GI absorption of digoxin145 146 b

If used concomitantly, monitor to ensure adequate digoxin concentrationsb

Folic acid

Sulfasalazine inhibits folic acid absorption,111 112 113 145 146 interferes with folic acid metabolism, and may result in decreased serum folic acid concentrations and possibly folic acid deficiency in some patients111 112 113

Folic acid deficiency may be prevented in patients receiving sulfasalazine by increased dietary intake of folic acid, taking the drug between meals, and/or by administration of folic acid supplements113

Iron

Sulfasalazine chelates iron, altering distribution of sulfasalazine in the intestinal lumen, interfering with its absorption and resulting in lower blood concentrations of sulfasalazinea

Methotrexate

No evidence of pharmacokinetic interaction in patients with rheumatoid arthritis;146 possible increased risk of GI effects (especially nausea)146

What are some things I need to know or do while I take Azulfidine?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have asthma, talk with your doctor. You may be more sensitive to Azulfidine.
  • Be careful if you have G6PD deficiency. Anemia may happen.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have your urine checked as you have been told by your doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
  • This medicine may change the color of urine or skin to a yellow or orange color. This is not harmful.
  • Very bad and sometimes deadly allergic reactions, infections, heart problems, kidney problems, liver problems, lung problems, and blood problems have happened with Azulfidine. Nerve or muscle problems that have not gone away have also happened with this medicine. Talk with the doctor.
  • Some males have had sperm problems while taking Azulfidine. This may affect being able to father a child. This may go back to normal after the drug is stopped. Talk with the doctor.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Use with care in children. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Azulfidine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Azulfidine Description

Azulfidine Tablets contain sulfasalazine, 500 mg, for oral administration.

Therapeutic Classification: Anti-inflammatory agent.

Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid.

Chemical Structure:

Molecular Formula: C18H14N4O5S

Contraindications

Azulfidine Tablets are contraindicated in:

  Patients with intestinal or urinary obstruction,   Patients with porphyria as sulfonamides have been reported to precipitate an acute attack,   Patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates.

Precautions

General

Azulfidine Tablets should be given with caution to patients with severe allergy or bronchial asthma. Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation. Patients with glucose-6 phosphate dehydrogenase deficiency should be observed closely for signs of hemolytic anemia. This reaction is frequently dose related. If toxic or hypersensitivity reactions occur, the drug should be discontinued immediately.

Information for Patients

Patients should be informed of the possibility of adverse reactions and of the need for careful medical supervision. The occurrence of sore throat, fever, pallor, purpura, or jaundice may indicate a serious blood disorder. Should any of these occur, the patient should seek medical advice. They should also be made aware that ulcerative colitis rarely remits completely, and that the risk of relapse can be reduced by continued administration of Azulfidine at a maintenance dosage. Patients should be instructed to take Azulfidine in evenly divided doses preferably after meals. Additionally, patients should be advised that sulfasalazine may produce an orange-yellow discoloration of the urine or skin.

Laboratory Tests

Complete blood counts, including differential white cell count and liver function tests, should be performed before starting Azulfidine and every second week during the first three months of therapy. During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated. Urinalysis and an assessment of renal function should also be done periodically during treatment with Azulfidine.

The determination of serum sulfapyridine levels may be useful since concentrations greater than 50 µg/mL appear to be associated with an increased incidence of adverse reactions.

Drug Interactions

Reduced absorption of folic acid and digoxin have been reported when those agents were administered concomitantly with sulfasalazine.

Drug/Laboratory Test Interactions

Several reports of possible interference with measurements, by liquid chromatography, of urinary normetanephrine causing a false-positive test result have been observed in patients exposed to sulfasalazine or its metabolite, mesalamine/mesalazine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year oral carcinogenicity studies were conducted in male and female F344/N rats and B6C3F1 mice. Sulfasalazine was tested at 84 (496 mg/m2), 168 (991 mg/m2), and 337.5 (1991 mg/m2) mg/kg/day doses in rats. A statistically significant increase in the incidence of urinary bladder transitional cell papillomas was observed in male rats. In female rats, two (4%) of the 337.5 mg/kg rats had transitional cell papilloma of the kidney. The increased incidence of neoplasms in the urinary bladder and kidney of rats was also associated with an increase in the renal calculi formation and hyperplasia of transitional cell epithelium. For the mouse study, sulfasalazine was tested at 675 (2025 mg/m2), 1350 (4050 mg/m2), and 2700 (8100 mg/m2) mg/kg/day. The incidence of hepatocellular adenoma or carcinoma in male and female mice was significantly greater than the control at all doses tested.

Sulfasalazine did not show mutagenicity in the bacterial reverse mutation assay (Ames test) and in L51784 mouse lymphoma cell assay at the HGPRT gene. However, sulfasalazine showed equivocal mutagenic response in the micronucleus assay of mouse and rat bone marrow and mouse peripheral RBC and in the sister chromatid exchange, chromosomal aberration, and micronucleus assays in lymphocytes obtained from humans.

Impairment of male fertility was observed in reproductive studies performed in rats at a dose of 800 mg/kg/day (4800 mg/m2). Oligospermia and infertility have been described in men treated with sulfasalazine. Withdrawal of the drug appears to reverse these effects.

Pregnancy

There are no adequate and well-controlled studies of sulfasalazine in pregnant women. Reproduction studies have been performed in rats and rabbits at doses up to 6 times the human maintenance dose of 2 g/day based on body surface area and have revealed no evidence of impaired female fertility or harm to the fetus due to sulfasalazine. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

There have been case reports of neural tube defects (NTDs) in infants born to mothers who were exposed to sulfasalazine during pregnancy, but the role of sulfasalazine in these defects has not been established. However, oral sulfasalazine inhibits the absorption and metabolism of folic acid which may interfere with folic acid supplementation (see Drug Interactions) and diminish the effect of periconceptional folic acid supplementation that has been shown to decrease the risk of NTDs.

A national survey evaluated the outcome of pregnancies associated with inflammatory bowel disease (IBD). In a group of 186 women treated with sulfasalazine alone or sulfasalazine and concomitant steroid therapy, the incidence of fetal morbidity and mortality was comparable to that for 245 untreated IBD pregnancies as well as to pregnancies in the general population.1 A study of 1,455 pregnancies associated with exposure to sulfonamides indicated that this group of drugs, including sulfasalazine, did not appear to be associated with fetal malformation.2 A review of the medical literature covering 1,155 pregnancies in women with ulcerative colitis suggested that the outcome was similar to that expected in the general population.3

No clinical studies have been performed to evaluate the effect of sulfasalazine on the growth development and functional maturation of children whose mothers received the drug during pregnancy.

Clinical Considerations

Sulfasalazine and its metabolite, sulfapyridine pass through the placenta. Sulfasalazine and its metabolite are also present in human milk. In the newborn, sulfonamides compete with bilirubin for binding sites on the plasma proteins and may cause kernicterus. Although sulfapyridine has been shown to have a poor bilirubin-displacing capacity, monitor the newborn for the potential for kernicterus.

A case of agranulocytosis has been reported in an infant whose mother was taking both sulfasalazine and prednisone throughout pregnancy.

Nursing Mothers

Sulfonamides, including sulfasalazine, are present in human milk (see Pregnancy, Clinical Considerations). Insignificant amounts of sulfasalazine have been found in milk, whereas levels of the active metabolite sulfapyridine in milk are about 30 to 60 percent of those in the maternal serum. Caution should be exercised when Azulfidine is administered to a nursing mother.

There are reports with limited data of bloody stools or diarrhea in human milk fed infants of mothers taking sulfasalazine. In cases where the outcome was reported, bloody stools or diarrhea resolved in the infant after discontinuation of sulfasalazine in the mother or discontinuation of breastfeeding. Due to limited data, a causal relationship between sulfasalazine exposure and bloody stools or diarrhea cannot be confirmed or denied. Monitor human milk fed infants of mothers taking sulfasalazine for signs and symptoms of diarrhea and/or bloody stools.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

For the Consumer

Applies to sulfasalazine: oral tablet, oral tablet enteric coated

Along with its needed effects, sulfasalazine (the active ingredient contained in Azulfidine) 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 while taking sulfasalazine:

More common
  • Aching of joints
  • fever
  • 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
  • fever
  • general body swelling
  • headache
  • loss of appetite
  • nausea
  • nosebleeds
  • pale skin
  • sore throat
  • 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
  • bloating
  • blood in the urine or stools
  • bloody diarrhea
  • bluish fingernails, lips, or skin
  • chest pain
  • constipation
  • cough
  • difficulty with swallowing
  • dizziness
  • fainting spells
  • fast heartbeat
  • general feeling of discomfort or illness
  • general tiredness and weakness
  • hives
  • 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 of sulfasalazine 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:

More common
  • Abdominal or stomach pain or upset
  • decreased weight
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

For Healthcare Professionals

Applies to sulfasalazine: compounding powder, oral delayed release tablet, oral tablet

General

The most common side effects reported were anorexia, headache, nausea, vomiting, gastric distress, elevated temperature, erythema, pruritus, rash, loss of appetite, and reversible oligospermia. Less common side effects included urticaria, fever, Heinz body anemia, hemolytic anemia, and cyanosis. Frequency of side effects increased with daily doses of 4 g or more, or total serum sulfapyridine levels above 50 mcg/mL.

The use of enteric-coated preparations may decrease gastrointestinal side effects.

Gastrointestinal

Very common (10% or more): Nausea (up to 33%), vomiting (up to 33%), gastric distress (about 33%), dyspepsia (13%)
Common (1% to 10%): Abdominal pain, diarrhea, stomatitis
Frequency not reported: Impaired folic acid absorption, impaired digoxin absorption, neutropenic enterocolitis, hemorrhagic colitis, bloody diarrhea, necrotizing pancreatitis
Postmarketing reports: Pseudomembranous colitis, pancreatitis, worsening ulcerative colitis, parotitis[Ref]

Nervous system

Transverse myelitis developed in 1 patient after receiving sulfasalazine (the active ingredient contained in Azulfidine) for 2 years. All symptoms resolved within 2 months after discontinuing sulfasalazine.[Ref]

Very common (10% or more): Headache (up to 33%)
Common (1% to 10%): Dizziness, taste disorders, tinnitus
Uncommon (0.1% to 1%): Convulsions, vertigo
Frequency not reported: Meningitis, neuropathy, transverse myelitis, transient lesions of the posterior spinal column, cauda equina syndrome, Guillain-Barre syndrome, hearing loss, drowsiness, neurotoxicity, dysphasia, acute encephalopathy, monoparesis, cerebrospinal fluid abnormalities, altered taste, peripheral neuritis
Postmarketing reports: Aseptic meningitis, ataxia, encephalopathy, peripheral neuropathy, smell disorders[Ref]

Metabolic

Hypoglycemia has been reported rarely in patients using sulfonamides.

Very common (10% or more): Anorexia (about 33%)
Rare (less than 0.1%): Hypoglycemia
Postmarketing reports: Folate deficiency, loss of appetite

Genitourinary

Diuresis has been reported rarely in patients using sulfonamides.

Infertility appeared to be reversible upon drug discontinuation.[Ref]

Very common (10% or more): Reversible oligospermia (about 33%)
Common (1% to 10%): Proteinuria
Rare (less than 0.1%): Impotence, diuresis
Frequency not reported: Decreased motility, abnormal sperm penetration (sometimes resulted in infertility), urinary tract infections, urine discoloration
Postmarketing reports: Hematuria, crystalluria[Ref]

Dermatologic

Angioedema was reported during postmarketing experience with the use of products containing or metabolized to mesalamine.

The risk of Stevens-Johnson syndrome or toxic epidermal necrolysis increased largely with the use of sulfonamides; however, these phenomena were rare as a whole.[Ref]

Very common (10% or more): Rash (up to 13%)
Common (1% to 10%): Pruritus, urticaria
Uncommon (0.1% to 1%): Alopecia
Frequency not reported: Toxic epidermal necrolysis (Lyell's syndrome), skin discoloration, erythema multiforme, parapsoriasis varioliformis acuta (Mucha-Haberman syndrome), generalized skin eruptions, petechiae
Postmarketing reports: Angioedema, purpura, epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), toxic pustuloderma, erythema, exanthema, exfoliative dermatitis, periorbital edema, lichen planus, photosensitivity[Ref]

Immunologic

Immunoglobulin suppression was slowly reversible and rarely accompanied by clinical findings.

In most cases of sulfasalazine-induced SLE, patients received the drug for greater than 1 year. Patients most commonly developed arthralgias and pleuritic chest pain. Generally, these patients had a positive ANA, anti-DNA antibody titer, and were slow acetylators of sulfonamides. Symptoms typically resolved over several weeks to several months.

At least 1 case of Kawasaki-like syndrome with hepatic function changes was reported during postmarketing experience with the use of products containing or metabolized to mesalamine.[Ref]

Very common (10% or more): Immunoglobulin suppression (10%)
Frequency not reported: Drug-induced systemic lupus erythematosus (SLE)
Postmarketing reports: Kawasaki-like syndrome with hepatic function changes, induction of autoantibodies[Ref]

Hepatic

Common (1% to 10%): Abnormal liver function tests
Uncommon (0.1% to 1%): Elevated liver enzymes
Frequency not reported: Hepatic necrosis
Postmarketing reports: Hepatotoxicity (some cases were fatal), including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, cholestatic hepatitis, cholestasis, possible hepatocellular damage (including liver necrosis and liver failure); Kawasaki-like syndrome with hepatic function changes; fulminant hepatitis; hepatitis; hepatic failure[Ref]

Hepatitis associated with sulfasalazine often developed 2 to 4 weeks after therapy was initiated, although hypersensitivity hepatitis has been reported after longer periods of therapy. Associated rash usually progressed to desquamation. Liver biopsy has shown necrosis and infiltration with moderate number of inflammatory cells. Noncaseating granulomas have also been seen. Hepatitis generally resolved over several weeks after therapy discontinuation, although some patients progressed to fulminant hepatic failure.

Hepatitis has been reported in patients with sulfasalazine hypersensitivity. Some of these cases were fatal.

Side effects listed as postmarketing reports were reported during postmarketing experience with the use of products containing or metabolized to mesalamine.[Ref]

Hematologic

Agranulocytosis has generally occurred during the first 1 to 3 months of therapy. Patients often presented with fever and sore throat. A few also presented with a rash. Bone marrow hypoplasia or aplasia was usually confined to the myeloid series, but may be accompanied by erythroid hypoplasia and marrow plasmacytosis. In one review of 62 cases of sulfasalazine-induced agranulocytosis, 6.5% of patients died. Recovery of granulocytes was generally seen within 1 to 2 weeks after drug discontinuation, and leukocyte counts and differential returned to normal in 1 to 3 weeks. Some cases of agranulocytosis were treated with colony stimulating factor, which appeared to increase the time to recovery.[Ref]

Common (1% to 10%): Hemolytic anemia, Heinz body anemia, leukopenia
Uncommon (0.1% to 1%): Thrombocytopenia
Frequency not reported: Red cell aplasia, congenital neutropenia, myelodysplastic syndrome
Postmarketing reports: Pseudomononucleosis, lymphadenopathy, macrocytosis, neutropenia, pancytopenia, agranulocytosis, aplastic anemia, hypoprothrombinemia, methemoglobinemia, megaloblastic (macrocytic) anemia[Ref]

Respiratory

Common (1% to 10%): Cough
Uncommon (0.1% to 1%): Dyspnea
Frequency not reported: Pulmonary infiltrates (frequently accompanied by eosinophilia), pneumonitis (with or without eosinophilia), pleuritis, bronchiolitis obliterans, lung toxicity (may mimic Wegener's granulomatosis)
Postmarketing reports: Oropharyngeal pain, fibrosing alveolitis, eosinophilic infiltration, interstitial lung disease[Ref]

Patients often presented after several weeks or months of therapy with fever, malaise, shortness of breath, and nonproductive cough. Eosinophilic infiltrates have been seen. Respiratory changes generally resolved over a few weeks, however, fatal reactions involving fibrosing alveolitis have been reported.[Ref]

Cardiovascular

Common (1% to 10%): Cyanosis
Uncommon (0.1% to 1%): Vasculitis
Frequency not reported: Tachycardia
Postmarketing reports: Myocarditis, allergic myocarditis, pallor, polyarteritis nodosa, pericarditis[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Depression
Frequency not reported: Confusion, vivid dreams
Postmarketing reports: Hallucinations[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia
Frequency not reported: Myopathy, rhabdomyolysis, Sjogren's syndrome
Postmarketing reports: Systemic lupus erythematosus

Other

Common (1% to 10%): Fever
Uncommon (0.1% to 1%): Facial edema
Frequency not reported: Malaise, false positive c-ANCAs, elevated temperature, petechiae and drug fever, LE phenomenon
Postmarketing reports: Yellow discoloration of skin and body fluids[Ref]

Ocular

Common (1% to 10%): Conjunctival and scleral injection
Frequency not reported: Diplopia, blurred vision, corneal damage[Ref]

Hypersensitivity

The following side effects have been reported as 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, 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, alopecia, and interstitial lung disease.

Anaphylaxis was reported during postmarketing experience with the use of products containing or metabolized to mesalamine.[Ref]

Frequency not reported: Hypersensitivity reactions, drug-induced rash, lupus erythematosus-like syndrome, anaphylactoid reactions
Postmarketing reports: Anaphylaxis, serum sickness[Ref]

Renal

Frequency not reported: Toxic nephrosis with oliguria and anuria, nephritis, hemolytic uremic syndrome, bilateral renal calculi composed of acetylsulfapyridine, proteinase 3-ANCA positive necrotizing glomerulonephritis
Postmarketing reports: Nephrolithiasis, nephrotic syndrome, interstitial nephritis[Ref]

At least 1 patient developed bilateral renal calculi composed of acetylsulfapyridine, a metabolite of sulfasalazine.[Ref]

Endocrine

Rare (less than 0.1%): Goiter production[Ref]

Goiter production has been reported rarely in patients using sulfonamides.[Ref]

Some side effects of Azulfidine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Precautions While Using Azulfidine

It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to check if the medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor right away if you or your child have a fever and sore throat, pale skin, unusual bruising or bleeding, or unusual tiredness or weakness. These may be symptoms of a blood problem.

This medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Call your doctor right away if you start to have a cough that won't go away, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Sulfasalazine may cause blood problems. These problems may result in a greater chance of certain infections, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.

Sulfasalazine may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

  • Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
  • Wear protective clothing, including a hat. Also, wear sunglasses.
  • Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
  • Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
  • Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Your skin or urine may turn an orange or yellow color while you or your child are using this medicine. This is normal and nothing to worry about.

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