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Pulmicort Flexhaler

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Pulmicort Flexhaler

Pulmicort Flexhaler Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Pulmicort Flexhaler (budesonide inhalation powder) is used to prevent asthma attacks. It will not treat an asthma attack that has already begun. It is a steroid. Common side effects include dry/irritated throat, hoarseness, voice changes, bad taste in the mouth, runny nose, or nosebleeds.

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

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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Pulmicort Flexhaler in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • weakness, tired feeling, nausea, vomiting, feeling like you might pass out;
  • wheezing or breathing problems after using this medication;
  • worsening respiratory symptoms;
  • ear pain with fever;
  • vision problems; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

Less serious side effects may include:

  • white patches or sores inside your mouth or on your lips;
  • runny or stuffy nose, sneezing;
  • sore throat, cough;
  • nausea, vomiting, diarrhea, stomach pain;
  • nosebleed; or
  • headache.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Pulmicort Flexhaler Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Precautions section.

Dry/irritated throat, hoarseness, voice changes, bad taste in the mouth, runny nose, or nosebleeds may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and seek immediate medical attention.

Because this drug works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor immediately if you have any signs of infection (such as ear pain, sore throat, fever, chills). Use of this medication for prolonged or repeated periods may result in oral thrush (yeast infection). Contact your doctor if you notice white patches in your mouth or on your tongue.

Tell your doctor immediately if any of these rare but serious side effects occur: unusual tiredness, vision problems, easy bruising/bleeding, puffy face, unusual hair growth, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, thinning skin, slow wound healing, increased thirst/urination.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Pulmicort Flexhaler (Budesonide Inhalation Powder)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Pulmicort Flexhaler FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Systemic and inhaled corticosteroid use may result in the following:

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 (budesonide inhalation powder)

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 (budesonide inhalation powder) 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 (budesonide inhalation powder) , 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 (budesonide inhalation powder) 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 (budesonide inhalation powder) group: pooled data from two 12-week, double-blind, placebo-controlled clinical asthma trials in patients 6 years and older

Adverse Event PULMICORT FLEXHALER (budesonide inhalation powder) 360 mcg
twice daily
N=226 %
Placebo
N=230
%
Nasopharyngitis 9.3 8.3
Nasal congestion 2.7 0.4
Pharyngitis 2.7 1.7
Rhinitis allergic 2.2 1.3
Viral upper respiratory tract infection 2.2 1.3
Nausea 1.8 0.9
Viral gastroenteritis 1.8 0.4
Otitis media 1.3 0.9
Oral candidiasis 1.3 0.4
Average exposure duration (days) 76.2 68.2

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 (budesonide inhalation powder) , 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.

Post-marketing Experience

The following adverse reactions have been reported during post-approval use of PULMICORT FLEXHALER (budesonide inhalation powder) . 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 and 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) »

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Pulmicort Flexhaler - User Reviews

Pulmicort Flexhaler User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Pulmicort Flexhaler sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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