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Pulmicort Flexhaler

  • Generic Name: budesonide inhalation powder
  • Brand Name: Pulmicort Flexhaler

Pulmicort Flexhaler (Budesonide Inhalation Powder) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Pulmicort Flexhaler Side Effects Center

What Is Pulmicort Flexhaler?

Pulmicort Flexhaler (budesonide inhalation powder) is a steroid used to prevent asthma attacks. Pulmicort will not treat an asthma attack that has already begun.

What Are Side Effects of Pulmicort Flexhaler?

Common side effects of Pulmicort Flexhaler include:

Pulmicort Flexhaler may lower your ability to fight infections. Tell your doctor if you have signs of infection (such as ear pain, sore throat, fever, chills). Tell your doctor if you have rare but serious side effects of Pulmicort Flexhaler including:

  • unusual tiredness,
  • vision problems,
  • easy bruising or bleeding,
  • puffy face,
  • unusual hair growth,
  • mental/mood changes (such as depression, mood swings, agitation),
  • muscle weakness or pain,
  • thinning skin,
  • slow wound healing, or
  • increased thirst or urination.

Dosage for Pulmicort Flexhaler

For patients 18 years of age and older, the recommended starting dosage of Pulmicort is 360 mcg twice daily. The maximum dose should not exceed 720 mcg twice daily. Patients 6 to 17 Years of Age: The recommended starting dosage is 180 mcg twice daily. The maximum dose should not exceed 360 mcg twice daily.

What Drugs, Substances, or Supplements Interact with Pulmicort Flexhaler?

Pulmicort may interact with HIV /AIDS medicines, antibiotics, antifungal medications, or antidepressants. Tell your doctor all medications you use.

Pulmicort Flexhaler During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant before using Pulmicort Flexhaler. Infants born to mothers who have used corticosteroids for a long time may have hormone problems. Tell your doctor if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness. This drug passes into breast milk and may have undesirable effects in a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Pulmicort Flexhaler (budesonide inhalation powder) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Pulmicort Flexhaler Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, rash, severe itching; chest pain, difficult breathing, feeling anxious; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • worsening asthma symptoms;
  • wheezing, choking, or other breathing problems after using this medication;
  • white patches or sores inside your mouth or on your lips;
  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • signs of infection--fever, chills, body aches, ear pain, nausea, vomiting; or
  • signs of low adrenal gland hormones--worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting.

Budesonide inhalation can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

  • runny or stuffy nose, sneezing;
  • red, itchy, and watery eyes;
  • fever, sore throat, cough;
  • nausea, vomiting, diarrhea, stomach pain, loss of appetite;
  • nosebleed; or
  • headache, back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Pulmicort Flexhaler (Budesonide Inhalation Powder)

 

Pulmicort Flexhaler Professional Information

SIDE EFFECTS

Systemic and inhaled corticosteroid use may result in the following:

  • Candida albicans Infection [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Including Anaphylaxis [see WARNINGS AND PRECAUTIONS]
  • Immunosuppression [see WARNINGS AND PRECAUTIONS]
  • Hypercorticism and Adrenal Suppression [see WARNINGS AND PRECAUTIONS]
  • Reduction in Bone Mineral Density [see WARNINGS AND PRECAUTIONS]
  • Growth Effects [see WARNINGS AND PRECAUTIONS, Use In Specific Populations]
  • Glaucoma and Cataracts [see WARNINGS AND PRECAUTIONS]
  • Eosinophilic Conditions and Churg-Strauss [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Pulmicort Flexhaler

Patients 6 Years And Older

The incidence of common adverse reactions in Table 1 is based upon pooled data reported in patients treated with PULMICORT FLEXHALER 180 or 90 mcg in two double-blind, placebo-controlled clinical trials in which 226 patients (106 females and 120 males) with mild to moderate asthma, previously receiving bronchodilators, inhaled corticosteroids, or both, were treated with PULMICORT FLEXHALER, administered as 360 mcg twice daily for 12 weeks. In these trials, the patients on PULMICORT FLEXHALER had a mean age of 28 years (range 6-80 years) and were predominantly Caucasian (59.7%) and Asian (31.4%). Table 1 includes all adverse reactions (regardless of investigator causality assessment) that occurred at a rate of ≥1% in the PULMICORT FLEXHALER group and more commonly than the placebo group.

Table 1 : Adverse Reactions occurring at an incidence of ≥1% and more commonly than placebo in the PULMICORT FLEXHALER group: pooled data from two 12-week, double-blind, placebo-controlled clinical asthma trials in patients 6 years and older

Adverse EventPULMICORT FLEXHALER 360 mcg twice daily
N=226 %		Placebo
N=230 %
Nasopharyngitis9.38.3
Nasal congestion2.70.4
Pharyngitis2.71.7
Rhinitis allergic2.21.3
Viral upper respiratory tract infection2.21.3
Nausea1.80.9
Viral gastroenteritis1.80.4
Otitis media1.30.9
Oral candidiasis1.30.4
Average exposure duration (days)76.268.2

Long-Term Safety In Patients 6 Years Of Age And Older

Non-placebo controlled long-term studies in children (at doses up to 360 mcg daily), and adolescent and adult subjects (at doses up to 720 mcg daily), treated for up to one year with PULMICORT FLEXHALER, revealed a similar pattern and incidence of adverse events.

PULMICORT TURBUHALER; a different PULMICORT DPI

The following adverse reactions occurred in placebo-controlled clinical trials with similar or lower doses with inhaled budesonide via a different PULMICORT dry powder inhaler with an incidence of ≥1% in the budesonide group and were more common than in the placebo group:

≥3%: respiratory infection, sinusitis, headache, pain, back pain, fever.

≥1-3%: neck pain, syncope, abdominal pain, dry mouth, vomiting, weight gain, fracture, myalgia, hypertonia, migraine, ecchymosis, insomnia, infection, taste perversion, voice alteration.

Higher doses of inhaled budesonide (800 mcg twice daily) via a different PULMICORT dry powder inhaler resulted in an increased incidence of voice alteration, flu syndrome, dyspepsia, gastroenteritis, nausea, and back pain, compared with doses of 400 mcg twice daily.

In a 20-week trial in adult asthmatics who previously required oral corticosteroids, the incidence of adverse reactions was evaluated with 400 mcg twice daily (N=53) and 800 mcg twice daily (N=53) of inhaled budesonide via a different PULMICORT dry powder inhaler and compared with placebo (N=53). In considering these data, the increased average duration of exposure for inhaled budesonide patients (78 days for inhaled budesonide vs. 41 days for placebo) should be taken into account. Adverse reactions, regardless of investigator causality assessment, reported in more than five patients in the budesonide group and which occurred more commonly than the placebo group in decreasing order of frequency include: respiratory infection, sinusitis, headache, oral candidiasis, pain, asthenia, dyspepsia, arthralgia, cough increased, nausea and rhinitis.

Postmarketing Experience

The following adverse reactions have been reported during post-approval use of PULMICORT FLEXHALER. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune system disorders: immediate and delayed hypersensitivity reactions including anaphylactic reaction, angioedema, bronchospasm, rash, contact dermatitis, urticaria, and cough, wheezing or bronchospasm in patients with severe milk protein hypersensitivity [see WARNINGS AND PRECAUTIONS, CONTRAINDICATIONS]

Endocrine disorders: symptoms of hypocorticism and hypercorticism [see WARNINGS AND PRECAUTIONS]

Eye disorders: cataracts, glaucoma, increased intraocular pressure [see WARNINGS AND PRECAUTIONS]

Psychiatric disorders: psychiatric symptoms including psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, and anxiety

Respiratory, thoracic, and mediastinal disorders: throat irritation

Skin and subcutaneous tissue disorders: skin bruising

Read the entire FDA prescribing information for Pulmicort Flexhaler (Budesonide Inhalation Powder)

&Copy; Pulmicort Flexhaler Patient Information is supplied by Cerner Multum, Inc. and Pulmicort Flexhaler Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.