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This document outlines critical safety information and warnings regarding the use of Symbicort (budesonide / formoterol). Please read carefully and discuss any concerns with your healthcare provider.

• Worsening of Asthma or COPD: Symbicort may rarely cause paradoxical bronchospasm, a condition where symptoms of asthma or COPD worsen, potentially becoming life-threatening. Discontinue use and contact your healthcare provider immediately if you experience increased wheezing, shortness of breath, or coughing after using the medication.

• Overdose Risks: Exceeding the prescribed dose of Symbicort or using it with another long-acting beta-agonist (LABA) can lead to overdose. Symptoms include chest pain, rapid heartbeat, dizziness, headache, dry mouth, muscle cramps, nausea, and sleep disturbances. Seek emergency medical attention if you suspect an overdose.

• Oral Thrush: Not rinsing your mouth after using Symbicort increases the risk of fungal infections like oral thrush. Symptoms include white patches, redness, or soreness in the mouth, and pain while eating or swallowing. Contact your provider if symptoms develop, as antifungal treatment may be required.

• Infection Risk: Symbicort can weaken your immune response, making infections such as tuberculosis, chickenpox, and measles more severe. Avoid use if you have an active or recurrent infection without consulting your provider. Report any signs of infection, like fever or sore throat, to your healthcare provider promptly.

• Switching Steroid Forms: Transitioning from oral to inhaled steroids may cause withdrawal symptoms due to changes in cortisol levels. Notify your provider if you experience symptoms like tiredness, weakness, or nausea. Do not switch steroid forms without professional guidance.

• Adrenal Suppression: Long-term use of Symbicort may lead to adrenal gland suppression, reducing your body's ability to produce necessary hormones. Symptoms of withdrawal include fever, joint pain, and fatigue in adults, and stunted growth or headaches in children. Discuss your treatment plan with your provider to avoid sudden discontinuation.

• Cardiac Issues: Excessive use of Symbicort can lead to serious heart problems, including seizures and blood pressure changes. Consult your provider if you experience symptoms like chest pain, fast heart rate, or dizziness.

• Bone Loss and Growth Concerns: Long-term use may increase the risk of bone loss or stunted growth. If you have risk factors for osteoporosis or a history of fractures, discuss these with your provider.

• Eye Problems: Prolonged use can increase eye pressure and lead to glaucoma or cataracts. Report any vision changes to your healthcare provider, as an eye examination may be necessary.

• Allergic Reactions: Avoid using Symbicort if you have a known allergy to budesonide. Watch for signs of severe allergic reactions, such as rash, itching, or breathing difficulties, and seek immediate medical attention if they occur.

• Electrolyte Imbalances: The medication may cause low potassium levels, potentially affecting heart rhythm. Report symptoms like muscle pain or weakness to your provider.

Contraindications:

• Do not use Symbicort during asthma attacks or severe episodes of asthma or COPD without consulting your healthcare provider.

Common side effects:

• headache
• throat irritation
• stomach upset
• common cold symptoms
• sore throat
• cough
• stuffy nose
• upper respiratory tract infections
• sneezing
• throat pain

Less common but important to monitor:

• thrush
• bronchitis
• increased thirst
• increased urination
• muscle cramps
• shaking
• mental or mood changes
• trouble sleeping
• vision problems

Serious side effects:

• severe sudden worsening of breathing problems
• asthma
• chest pain
• irregular heartbeat
• severe dizziness
• fainting
• seizures
• rash
• itching
• swelling
• sudden trouble breathing

Interactions with high risk of serious adverse effects and should be avoided:

• Desmopressin
• Bepridil
• Cisapride
• Dronedarone
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Acebutolol
• Amiodarone
• Azithromycin
• Clarithromycin
• Ciprofloxacin
• Erythromycin
• Ketoconazole
• Mifepristone