sulfadoxine/pyrimethamine - oral, Fansidar (cont.)

SIDE EFFECTS: See also Warning section.Nausea, vomiting, or headache 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: swollen/painful tongue, mental/mood changes (such as depression, hallucinations, nervousness), unusually quick sunburn (photosensitivity).Tell your doctor immediately if any of these rare but very serious side effects occur: lower abdominal/back pain, bloody/pink urine, change in amount of urine, painful urination, chest pain, irregular heartbeat, signs of severe liver problems (such as severe tiredness, persistent nausea/vomiting, yellowing skin/eyes, abdominal pain, dark urine).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 sulfadoxine/pyrimethamine, tell your doctor or pharmacist if you are allergic to either sulfadoxine or pyrimethamine; or to other "sulfa" drugs (such as sulfamethoxazole, sulfisoxazole); 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: bleeding problems (such as low platelets), low red blood cell count (anemia), low white blood cell count, severe allergy or breathing problems (asthma), seizures, kidney problems, liver problems, low folic acid levels (such as problems with absorption of food, alcoholism), a certain enzyme problem (glucose-6-phosphate dehydrogenase deficiency-G6PD), a certain blood disorder (porphyria).This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details.This drug passes into breast milk. Due to the possibility of severe side effects in your nursing infant, avoid breast-feeding while taking sulfadoxine/pyrimethamine. 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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