Budesonide and Formoterol (Inhalation Route)

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Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Body aches or pain
• Chills
• Cough, fever, sneezing, or sore throat
• Difficulty with breathing
• Ear congestion
• Fever
• Headache
• Loss of voice
• Muscle aches
• Pain or tenderness around the eyes and cheekbones
• Shortness of breath or troubled breathing
• Stuffy or runny nose
• Tightness of the chest or wheezing
• Unusual tiredness or weakness

• Abdominal or stomach pain
• Bladder pain
• Bloody or cloudy urine
• Congestion
• Cough producing mucus
• Diarrhea
• Difficult, burning, or painful urination
• Dryness of the throat
• Fast, irregular, pounding, or racing heartbeat or pulse
• Frequent urge to urinate
• General feeling of discomfort or illness
• Hoarseness
• Joint pain
• Loss of appetite
• Lower back or side pain
• Nausea
• Noisy breathing
• Shakiness in the legs, arms, hands, or feet
• Shivering
• Sore mouth or tongue
• Sweating
• Tender, swollen glands in the neck
• Trembling or shaking of the hands or feet
• Trouble with swallowing
• Trouble with sleeping
• Voice changes
• Vomiting
• White patches in the mouth or on the tongue

• Blurred vision
• Confusion
• Decreased urine
• Dizziness or lightheadedness when getting up from a lying or sitting position suddenly
• Dry mouth
• Enlarged pupils
• Fainting
• Flushed, dry skin
• Fruit-like breath odor
• Increased hunger
• Increased sensitivity of the eyes to light
• Increased sweating, possibly with fever or cold, clammy skin
• Increased thirst
• Increased urination
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Mood changes
• Muscle cramps
• Nervousness
• Numbness or tingling in the hands, feet, or lips
• Pounding in the ears
• Seizures
• Severe chest pain
• Severe headache
• Slow, fast, pounding, or irregular heartbeat or pulse
• Stiff or sore neck
• Unexplained weight loss

• Blindness
• Decreased vision
• Eye pain
• Puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• Tearing

Get emergency help immediately if any of the following symptoms of overdose occur:

• Arm, back, or jaw pain
• Chest pain or discomfort
• Darkening of the skin
• Drowsiness
• Mental depression
• Rapid, deep breathing
• Restlessness
• Skin rash
• Sleeplessness
• Stomach cramps
• Unable to sleep

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Stomach discomfort

• Acid or sour stomach
• Belching
• Difficulty with moving
• Heartburn
• Indigestion
• Muscle spasms or stiffness
• Pain in the arms or legs
• Stomach upset
• Swollen joints

• Bad, unusual, or unpleasant (after) taste
• Change in taste
• Deep or fast breathing with dizziness, numbness to feet, hands, and around the mouth
• Fear
• Hives or welts
• Irritability
• Itching skin
• Large, flat, blue, or purplish patches in the skin
• Redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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