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Pulmicort Turbuhaler

"Nov. 23, 2011 -- Daily inhaled steroids are currently recommended for preschoolers with frequent wheezing who have a high risk for developing persistent asthma or high risk for severe asthma, but the treatment may cause a small decrease in their "...

Pulmicort Turbuhaler

Pulmicort Turbuhaler Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Pulmicort Turbuhaler (budesonide) Inhalation Powder 200 mcg is a corticosteroid used to treat asthma. Common side effects of Pulmicort Turbuhaler include dry/irritated throat, hoarseness, voice changes, bad taste in mouth, runny nose, and nose bleeds.

The recommended dose of Pulmicort Turbuhaler is one metered inhalation daily. Talk to your doctor about your individual dosage recommendation. Aldesleukin, cancer chemotherapy, ciprofloxacin, and levofloxacin may interact with Pulmicort Turbuhaler. Tell your doctor all medication you take. Do not stop taking or reduce your dose of Pulmicort Turbuhaler unless directed to do so by your doctor. Before taking Pulmicort Turbuhaler tell your doctor if you are allergic to orally inhaled corticosteroids, have any infections, have had tuberculosis, have osteoporosis, or are planning to have surgery. If you are pregnant only use Pulmicort Turbuhaler if clearly needed. Do not take Pulmicort Turbuhaler if you are breastfeeding.

Our Pulmicort Turbuhaler (budesonide) Inhalation Powder 200 mcg 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 Overview?

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

Pulmicort Turbuhaler 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 Turbuhaler (Budesonide)»

What is Prescribing information?

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

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

SIDE EFFECTS

The following adverse reactions were reported in patients treated with PULMICORT TURBUHALER (budesonide) .

The incidence of common adverse events is based upon double-blind, placebo-controlled US clinical trials in which 1116 adult and pediatric patients age 6-70 years (472 females and 644 males) were treated with PULMICORT TURBUHALER (budesonide) (200 to 800 mcg twice daily for 12 to 20 weeks) or placebo.

The following table shows the incidence of adverse events in patients previously receiving bronchodilators and/or inhaled corticosteroids in US controlled clinical trials. This population included 232 male and 62 female pediatric patients (age 6 to 17 years) and 332 male and 331 female adult patients (age 18 years and greater).

Adverse Events with ≥ 3% Incidence reported by Patients on PULMICORT TURBUHALER (budesonide)

    PULMICORT TURBUHALER
Adverse Event Placebo
N=284
%
200 mcg
twice daily
N=286
%
400 mcg
twice daily
N=289
%
800 mcg
twice daily
N=98
%
Respiratory System        
  Respiratory infection 17 20 24 19
  Pharyngitis 9 10 9 5
  Sinusitis 7 11 7 2
  Voice alteration 0 1 2 6
Body As A Whole        
  Headache 7 14 13 14
  Flu syndrome 6 6 6 14
  Pain 2 5 5 5
  Back pain 1 2 3 6
  Fever 2 2 4 0
Digestive System        
  Oral candidiasis 2 2 4 4
  Dyspepsia 2 1 2 4
  Gastroenteritis 1 1 2 3
  Nausea 2 2 1 3
Average Duration of Exposure (days) 59 79 80 80

The table above includes all events (whether considered drug-related or non-drug-related by the investigators) that occurred at a rate of ≥3% in any one PULMICORT TURBUHALER (budesonide) group and were more common than in the placebo group. In considering these data, the increased average duration of exposure for PULMICORT TURBUHALER (budesonide) patients should be taken into account.

The following other adverse events occurred in these clinical trials using PULMICORT TURBUHALER (budesonide) with an incidence of 1 to 3% and were more common on PULMICORT TURBUHALER (budesonide) than on placebo.

Body As A Whole:neck pain

Cardiovascular: syncope

Digestive: abdominal pain, dry mouth, vomiting

Metabolic and Nutritional: weight gain

Musculoskeletal: fracture, myalgia

Nervous: hypertonia, migraine

Platelet, Bleeding and Clotting: ecchymosis

Psychiatric: insomnia

Resistance Mechanisms: infection

Special Senses: taste perversion

In a 20-week trial in adult asthmatics who previously required oral corticosteroids, the effects of PULMICORT TURBUHALER (budesonide) 400 mcg twice daily (N=53) and 800 mcg twice daily (N=53) were compared with placebo (N=53) on the frequency of reported adverse events. Adverse events, whether considered drug-related or non-drug-related by the investigators, reported in more than five patients in the PULMICORT TURBUHALER (budesonide) group and which occurred more frequently with PULMICORT TURBUHALER (budesonide) than placebo are shown below (% PULMICORT TURBUHALER (budesonide) and % placebo). In considering these data, the increased average duration of exposure for PULMICORT TURBUHALER (budesonide) patients (78 days for PULMICORT TURBUHALER (budesonide) vs. 41 days for placebo) should be taken into account.

Body As A Whole: asthenia (9% and 2%) headache (12% and 2%) pain (10% and 2%)
Digestive: dyspepsia (8% and 0%)nausea (6% and 0%)oral candidiasis (10% and 0%)
Musculoskeletal: arthralgia (6% and 0%)
Respiratory: cough increased (6% and 2%) respiratory infection (32% and 13%) rhinitis (6% and 2%) sinusitis (16% and 11%)

Patients Receiving PULMICORT TURBUHALER (budesonide) Once Daily

The adverse event profile of once-daily administration of PULMICORT TURBUHALER (budesonide) 200 mcg and 400 mcg, and placebo, was evaluated in 309 adult asthmatic patients in an 18-week study. The study population included both patients previously treated with inhaled corticosteroids, and patients not previously receiving corticosteroid therapy. There was no clinically relevant difference in the pattern of adverse events following once-daily administration of PULMICORT TURBUHALER (budesonide) when compared with twice-daily dosing.

Pediatric Studies: In a 12-week placebo-controlled trial in 404 pediatric patients 6 to 18 years of age previously maintained on inhaled corticosteroids, the frequency of adverse events for each age category (6 to 12 years, 13 to 18 years) was comparable for PULMICORT TURBUHALER (budesonide) (at 100, 200 and 400 mcg twice daily) and placebo. There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults.

Adverse Event Reports From Other Sources: Rare adverse events reported in the published literature or from worldwide marketing experience with any formulation of inhaled budesonide include: immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema and bronchospasm; symptoms of hypocorticism and hypercorticism; glaucoma, cataracts; psychiatric symptoms including depression, aggressive reactions, irritability, anxiety and psychosis.

Read the entire FDA prescribing information for Pulmicort Turbuhaler (Budesonide) »

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Pulmicort Turbuhaler - User Reviews

Pulmicort Turbuhaler User Reviews

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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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