SIDE EFFECTS: Stomach upset, nausea, vomiting, loss of appetite, headache, dizziness, or unusual tiredness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. 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 right away 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 right away if you have any serious side effects, including: hearing changes (e.g., ringing in the ears), mental/mood changes, signs of kidney problems (such as change in the amount of urine, painful urination, blood in the 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, nerve/muscle problems and infections. Get medical help right away if you have any very serious side effects, including: skin rash/blisters/peeling, mouth sores, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest pain, signs of infection (such as fever, chills, persistent sore throat, cough), swollen lymph nodes, 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking sulfasalazine, tell your doctor or pharmacist if you are allergic to it; or to sulfa drugs; or to aspirin and related drugs (salicylates, NSAIDs such as ibuprofen); or to mesalamine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: intestinal blockage, urinary blockage, kidney disease, liver disease, blood disorders (such as aplastic anemia, porphyria), a certain genetic condition (G6PD deficiency), asthma, severe allergies, current/recent/returning infections. This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Get medical help right away if you get sunburned or have skin blisters/redness. This medication is similar to aspirin. Children and teenagers should not take aspirin or aspirin-related medications (e.g., salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine (e.g., varicella vaccine), without first consulting a doctor about Reye's syndrome, a rare but serious illness. During pregnancy, this medication should be used only when clearly needed. Caution is advised if this medication is used near the expected delivery date because similar drugs may cause harm to a newborn. Discuss the risks and benefits with your doctor. If you become pregnant while taking this drug, contact your doctor right away. This medication may lower your folic acid levels, increasing the risk of spinal cord defects. Therefore, check with your doctor to make sure you are taking enough folic acid. Prenatal care should include tests for spinal cord defects. This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: digoxin, folic acid, methenamine, PABA taken by mouth. Sulfasalazine is very similar to mesalamine. Do not use mesalamine medications taken by mouth while using sulfasalazine. This medication may interfere with certain laboratory tests (including urine normetanephrine levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach/abdominal pain, persistent vomiting, extreme drowsiness, seizures.