"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...
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Shaking, headache, diarrhea, nausea/vomiting, upset stomach, loss of appetite, trouble sleeping, or tingling of the hands/feet 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: mental/mood changes, seizures, dizziness, change in the amount of urine, tiredness/weakness, fast/pounding heartbeat, hearing problems (e.g., hearing loss, ringing in the ears), pain/redness/swelling of arms or legs, easy bruising/bleeding, muscle pain/cramp, yellowing skin/eyes, dark urine, persistent nausea/vomiting, stomach/abdominal pain, swelling ankles/feet.
Seek immediate medical attention if any of these rare but very serious side effects occur: fainting, irregular heartbeat, vision changes, chest/jaw/left arm pain, black stools, vomit that looks like coffee grounds.
Tacrolimus may cause your blood pressure to increase. You may be required to check your blood pressure periodically and/or take another medication to control your blood pressure.
Tacrolimus may cause diabetes. Tell your doctor or pharmacist if you experience any of the following symptoms of high blood sugar: increased thirst/hunger, frequent urination.
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.
Read the Prograf (tacrolimus) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking tacrolimus, tell your doctor or pharmacist if you are allergic to it; or to other macrolide medications (e.g., sirolimus, erythromycin); 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: mineral imbalances (e.g., high potassium), kidney disease, any recent/current infections, cancer, liver disease, high blood pressure, diabetes.
Tacrolimus may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using tacrolimus, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using tacrolimus safely.
This medication may increase your risk of developing skin cancer. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen with a high protection factor and wear protective clothing when outdoors.
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.
Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).
This drug may increase your potassium levels. Before using potassium supplements or salt substitutes containing potassium, consult your doctor or pharmacist.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This drug passes into breast milk and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.
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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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