Pulmicort Flexhaler (budesonide) - Uses, Side Effects, and More

What are the most common side effects of Pulmicort Flexhaler?

The most common side effects of Pulmicort Flexhaler are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

• Infection in the nose or throat, sore throat, or common cold symptoms
• Runny or stuffy nose, flu-like symptoms
• Nausea, stomach flu
• Ear infection
• Oral thrush (see below)

There may be other side effects of Pulmicort Flexhaler that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Pulmicort Flexhaler?

While less common, the most serious side effects of Pulmicort Flexhaler are described below, along with what to do if they happen.

Severe Allergic Reactions. Pulmicort Flexhaler may cause allergic reactions, which can be serious. Stop using Pulmicort Flexhaler and get help right away if you have any of the following symptoms of a serious allergic reaction.

• Breathing problems or wheezing
• Racing heart
• Fever or general ill feeling
• Swollen lymph nodes
• Swelling of the face, lips, mouth, tongue, or throat
• Trouble swallowing or throat tightness
• Itching, skin rash, or pale red bumps on the skin called hives
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Stomach cramps
• Joint pain

Oral Thrush. Pulmicort Flexhaler can cause a fungal infection in your mouth and throat, a condition known as oral thrush or oral candidiasis. To help prevent the risk of thrush, rinse your mouth with water and spit out the water (do not swallow it) after each dose of Pulmicort Flexhaler. Contact your healthcare provider if you notice any of the following symptoms of oral thrush. 

• Cracking in the corners of the mouth
• Loss of taste
• Red or white patches in the mouth or throat
• Raised white spots in the mouth or throat
• Pain in the throat
• Hoarseness

Sudden Breathing Problems. Pulmicort Flexhaler may cause the muscles around the airways to tighten (bronchospasm) right after you use it, instead of relaxing these muscles. In some cases this can be serious. Stop using Pulmicort Flexhaler and contact your healthcare provider right away if your breathing gets worse instead of better right after using Pulmicort Flexhaler.

Eye Problems. Pulmicort Flexhaler may increase pressure inside the eye and cause or worsen narrow-angle glaucoma, which can lead to blindness. It can also cause cataracts (clouding of the eye lens). It is important to have regular eye exams while using Pulmicort Flexhaler. Tell your healthcare provider right away if you have any of the following symptoms of glaucoma or cataracts.

• Loss of vision or vision changes
• Eye pain or redness
• Severe headache or vomiting
• Vision that is cloudy, blurry, foggy, or filmy
• Seeing bright, colorful circles around lights (vision halos)

Reduced Adrenal Function. Long-term use of Pulmicort Flexhaler can cause your adrenal glands to stop making as much cortisol (the stress hormone). This is known as adrenal insufficiency. This is especially a concern if you have been taking a corticosteroid by mouth, such as prednisone, and you stop it and switch to Pulmicort Flexhaler. Adrenal insufficiency can get worse if your body is under stress because of fever, surgery, or trauma. Tell your healthcare provider if you have any of the following symptoms of adrenal insufficiency.

• Nausea and vomiting
• Weakness, tiredness, or lack of energy
• Dizziness

Infection. Pulmicort Flexhaler can weaken your immune system, making you more likely to get an infection, including a serious infection. Tell your healthcare provider if you have any of the following symptoms of an infection, or if you have been exposed to chickenpox or measles.

• Fever
• Chills
• Feeling tired
• Body aches and pains
• Nausea or vomiting

Weak Bones. Using Pulmicort Flexhaler for a long time may cause the bones to become weaker, leading to reduced bone density (osteopenia). It may also cause a more serious condition called osteoporosis, which can cause bones to break (fracture) more easily. Talk with your healthcare provider about any risk factors you have for weak bones, such as limited ability to move around, family history of weak bones, poor eating habits, long-term use of a corticosteroid, which is a medicine for certain inflammatory conditions or medicine to treat and prevent seizures. If you use Pulmicort Flexhaler, your healthcare provider may monitor your bone density or recommend treatment based on the results. Tell your healthcare provider if you break a bone, and get a bone mineral density test if one is ordered for you.

Slow Growth. Pulmicort Flexhaler may slow down growth in children and adolescents who are still growing. Talk with the healthcare provider if you have any concerns about how your child is growing.

Immune System Reaction. Rarely, using Pulmicort Flexhaler may increase your risk of developing an immune system reaction. The reaction is sometimes called Churg-Strauss Syndrome or eosinophilic granulomatosis with polyangiitis. You may have high levels of eosinophils, including small masses of immune cells in inflamed tissues, and vasculitis. This is especially a concern if you have been taking a corticosteroid by mouth, such as prednisone, and you stop it and switch to Pulmicort Flexhaler. Tell your healthcare provider if you have any of the following symptoms.

• Rash
• Worsening breathing problems
• Heart problems
• Pain, burning, tingling, numbness, or weakness in your arms, hands, legs, or feet