Along with its needed effects, budesonide may cause some unwanted or undesirable effects. Generally, budesonide is well tolerated and many people will not experience unwanted effects. The severity and duration of these effects are dependant on many factors including duration of therapy, dose, route of administration and individual response. Possible unwanted effects include:

• irritation and burning in the nose (nasal spray only)
• dry mouth, hoarsness, and loss of voice (oral inhalation only)
• localized infection of Candida Albicans (thrush) of the mouth and throat

Less common:

• sore throat
• cough
• headache
• dizziness
• nausea

Rare:

• immediate or delayed allergic reaction (e.g. rash, hives, and bronchospasm)
• flushing, itchiness, and swelling of the eyes, face, lips and throat

Budesonide is a corticosteroid that possesses potent anti-inflammatory activity. Whether inhaled through the nose or into the lungs, the effect of the drug is local (acting directly on the tissue it comes in contact with). The amount absorbed by the body is minimal and therefore the incidence of unwanted effects is low.

• Never use a higher dose than what you have been prescribed. Using higher than recommended doses will cause greater absorption by the body and possibly lead to greater occurrence of unwanted effects. Optimal relief of symptoms may require 1 to 2 weeks of continuous therapy of the inhaler or 2 to 3 days (in rare cases up to 2 weeks) of continuous therapy of the nasal spray.
• If symptoms do not improve or the condition worsens, the doctor should be contacted.
• Treatment with budesonide should never be stopped without first consulting your doctor.
• Discontinuation of budesonide requires gradual tapering or you may experience a flare-up of your condition.
• Inadequate response can often be a result of improper use of the delivery device. Your doctor or pharmacist should instruct you on the correct use of these preparations. Each product comes with a package insert that should be read and then kept as a reference.
• Children using any of these preparations should do so under the direct supervision of an adult who is familiar with its proper use.
• People who are using or who have used budesonide or any other corticosteroids should inform their doctor as this may change the treatment plan.
• When people have been treated with oral corticosteroids (e.g. prednisone) for prolonged periods and are being transferred to intranasally or orally inhaled budesonide, they may experience withdrawal symptoms (e.g. joint and/or muscular pain, depression). These symptoms should be reported to your doctor, especially if you have associated asthma or another condition in which too rapid a decrease in systemic steroids may cause a severe flare-up of symptoms.
• Budesonide may mask some signs of infection and new infections may appear. The body tends to have a decreased resistance to infections while on this therapy, so anything of this nature should be reported to the doctor.

Drug Interactions: Due to very low absorption at therapeutic doses it is unlikely that there would be any significant drug interactions. However, it is important to tell your doctor and pharmacist of any prescription or over-the-counter medications you are taking.

Use is not recommended in the following situations:

• allergy to beclomethasone dipropionate or any component of the preparation
• people with tuberculosis
• untreated fungal, bacterial and viral infections
• children under 6 years of age

Caution recommended in the following situations:

• people previously treated for prolonged periods with oral corticosteroids (e.g. prednisone)

Use in pregnancy: Inhaled budesonide would likely not result in significant absorption, and therefore, is generally considered compatible with pregnancy.  Consult your doctor or pharmacist before using.

Use while breast-feeding:  Levels in breast milk are very minimal - no untoward effects in infant are expected.