"The U.S. Food and Drug Administration today approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections.
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Sporanox Consumer (continued)
Nausea/vomiting, diarrhea, gas, headache, dizziness, or stomach upset may occur. If any of these effects persist or worsen, notify 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: signs of infection (e.g., fever, persistent sore throat), trouble breathing, unusual tiredness, swelling ankles/feet, burning/painful/frequent urination, decreased sexual interest/ability, hair loss, muscle cramps/pain, weakness, fast/irregular heartbeat, mental/mood changes (e.g., depression), enlarged breasts in men, ringing in the ears, temporary or permanent hearing loss.
Tell your doctor immediately if any of these rare but very serious side effects occur: numbness/tingling of the hands/feet.
Itraconazole has rarely caused very serious (possibly fatal) liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking itraconazole and tell your doctor immediately: yellowing eyes/skin, dark urine, persistent nausea/vomiting, stomach/abdominal pain.
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.
Itraconazole 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.
Read the Sporanox (itraconazole capsules) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Warning section.
Before taking itraconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals (e.g., ketoconazole); 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: liver disease (or history of liver disease with other drugs), kidney disease, heart disease (e.g., coronary artery disease, heart valve disease, congestive heart failure), severe lung disease (e.g., chronic obstructive pulmonary disease-COPD), high blood pressure, decreased or no stomach acid (e.g., achlorhydria), cystic fibrosis.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages since they can increase the effects of dizziness and also increase the risk of serious liver problems.
Older adults may be at greater risk for hearing loss while using this drug.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. This medication should not be used to treat fungal nail infections if you are pregnant or could become pregnant during treatment. Women of childbearing age should start this medication 2 to 3 days after the start of their periods to make sure that they are not pregnant. Discuss the use of reliable forms of birth control (such as condoms and birth control pills) while taking this medication and for 2 months after stopping it.
Itraconazole passes into breast milk. Consult 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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