sulfinpyrazone - oral (cont.)

SIDE EFFECTS: Nausea, heartburn, dizziness, and ringing in the ears may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.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.Tell your doctor immediately if any of these unlikely but serious side effects occur: lower back pain, swelling of the arms/legs/feet, difficult/painful urination, change in amount/color of urine.Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, bloody/black/tarry stools, fast/irregular heartbeat, signs of infection (e.g., fever, sore throat), severe stomach/abdominal pain, vomit that looks like coffee grounds, unusual tiredness.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.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.

PRECAUTIONS: Before taking sulfinpyrazone, tell your doctor or pharmacist if you are allergic to it; or to phenylbutazone or other pyrazoles; 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.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: bleeding/inflammation in the stomach or intestines (e.g., active peptic ulcer disease), severe kidney disease, a certain type of kidney stone (urate/uric acid).Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (e.g., low platelets, blood clotting problems), low blood counts (e.g., anemia, low white blood cells), cancer of the blood (e.g., leukemia), radiation treatment for cancer, diabetes, kidney disease, history of peptic ulcer disease.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

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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