Side Effects and Safety

PULMICORT RESPULES was created especially for children as young as 12 months and up to 8 years of age. Its effectiveness has been studied through extensive clinical trials.


PULMICORT RESPULES is a type of corticosteroid. Sometimes when parents hear the word "steroid" they think about the anabolic steroids that some athletes abuse. But PULMICORT RESPULES is a corticosteroid, which is different than an anabolic steroid. Corticosteroids are similar to a hormone called cortisol, which occurs naturally in the body.


In studies, the most common side effects for PULMICORT RESPULES were:

  • Respiratory infections. Symptoms may include stuffy nose, sore nose and throat
  • Runny nose
  • Cough
  • Viral infections
  • Viral irritation and inflammation of the stomach and intestine (gastroenteritis). Gastroenteritis symptoms may include: stomach area pain, diarrhea, nausea and vomiting, and loss of appetite
  • Ear infections
  • Nosebleed
  • Pink eye (conjunctivitis)
  • Rash

Inhaled corticosteroids like PULMICORT RESPULES may cause a reduction in your child’s growth rate, or how quickly his or her height increases. The long-term effect on final adult height is not known.


When switching to PULMICORT RESPULES from an oral (syrup or pill) corticosteroid, follow the doctor's instructions to help avoid health risks.


Tell the doctor if your child is exposed to chicken pox or measles.


Once your child’s asthma stabilizes and remains consistently controlled, your child's doctor will make sure your child receives the lowest possible dose of inhaled corticosteroid to help minimize risk. Your child's doctor should also regularly check growth and will consider this risk along with the benefits of taking a daily preventive asthma medication.


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IMPORTANT INFORMATION ABOUT PULMICORT RESPULES

Important Safety Information

PULMICORT RESPULES is not a bronchodilator and should NOT be used to treat an acute asthma attack. If your child is switching to PULMICORT RESPULES from an oral corticosteroid, follow the doctor's instructions to avoid serious health risks when your child stops using oral corticosteroids.

Only use PULMICORT RESPULES with a jet nebulizer machine that is connected to an air compressor. Do not use an ultrasonic nebulizer.

Thrush infection of the mouth and throat may occur with PULMICORT RESPULES.

Avoid exposure of your child to infections such as chicken pox and measles. Tell your doctor immediately if your child is exposed.

Inhaled corticosteroids may cause a reduction in growth rate. The long-term effect on final adult height is unknown.

PULMICORT RESPULES should not be used if your child is allergic to budesonide or any of the ingredients.

Be sure to tell the healthcare provider about all your child's health conditions and all medicines he or she may be taking.

As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with PULMICORT RESPULES, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with PULMICORT RESPULES should be stopped and your physician consulted.

The most common side effects include respiratory infection, runny nose, coughing, ear infection, viral infection, thrush in the mouth and throat, inflammation of the stomach including vomiting, diarrhea, abdominal pain and loss of appetite, nose bleed, pink eye, and rash.

Approved Use

PULMICORT RESPULES (budesonide inhalation suspension) is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.

Please click here for full Prescribing Information for PULMICORT RESPULES.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

PULMICORT RESPULES® Asthma Medication

Doctor
Discussion Guide

Learn how to talk to your doctor and help improve your child's asthma symptoms with the Doctor Discussion Guide.