BUDESONIDE-ORAL BREATH ACTIVATED INHALER (cont.)
SIDE EFFECTS: Dry or irritated throat, hoarseness or coughing may occur as your body adjusts to the medication. A bad taste in the mouth, headache, nausea, diarrhea, thirst and tiredness have also been reported. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you develop: rash, sore throat, mouth sores, swelling of the face, wheezing, breathing trouble, behavioral changes (especially in children), vision changes. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Before you use this drug, tell your doctor your medical history including: all illnesses or infections, recent exposures to contagious diseases (e.g., chickenpox), glaucoma, cataracts, any allergies (especially drug allergies). If you have switched from an oral corticosteroid (e.g., prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses and suddenly stop using it, your body may not produce enough natural steroids. You may need to start taking additional corticosteroids, especially if your body is stressed due to a major infection, surgery, or injury. Deaths have sometimes occurred during such stresses, due to low steroid levels. Tell your doctor immediately if any of the following side effects occur: unusual weakness, sudden weight loss, dizziness. Consult your doctor or pharmacist for more details, and inform them that you use (or have used) any type of corticosteroid. Carry a warning card or medical ID bracelet that identifies your need for oral corticosteroids during times of stress as noted. Consult your doctor or pharmacist now for specific advice regarding stress situations; you may need to carry a supply of corticosteroid tablets as a precaution. If you cough up mucus that has thickened or changed color from clear white to yellow, green, or gray, contact your doctor; these changes may be signs of an infection. Caution is advised when using this drug in children. Though it is unlikely to occur with inhaled steroids (budesonide), this medication may temporarily slow down a child's rate of growth, but it will probably not affect final adult height. Monitor your child's height periodically. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Based on information for similar drugs, budesonide may pass into breast milk. Therefore, 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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