sirolimus solution - oral, Rapamune (cont.)
SIDE EFFECTS: See also Warning section.Diarrhea, joint pain, shaking, acne, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor 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: muscle pain/cramps, bone pain, increased thirst/hunger, frequent urination, vision changes, hearing problems (e.g., hearing loss, ringing in the ears), unusual tiredness/weakness, fast/slow/irregular heartbeat, easy bruising/bleeding, mental/mood changes, swelling ankles/feet, severe headache, dizziness, stomach/abdominal pain, missed/heavy/painful periods.This drug increases the risk of a possibly fatal brain infection (PML - progressive multifocal leukoencephalopathy). Tell your doctor right away if you have any of these symptoms: clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving muscles, seizure, difficulty speaking.Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, frothy urine, chest pain, shortness of breath, pain/redness/swelling of arms or legs, swelling abdomen, dark urine, yellowing eyes/skin, persistent nausea/vomiting.Sirolimus may slow wound healing after surgery. Tell your doctor immediately if you have signs that your surgery wound is not healing well (e.g., redness, swelling, pain). The risk of poor wound healing is higher if you are obese.Sirolimus may cause your cholesterol/triglycerides to increase. You may be required to have your cholesterol/triglycerides checked periodically and/or take another medication to control your cholesterol/triglycerides.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.Sirolimus can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.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.
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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