ADVERSE REACTIONS
The following adverse reactions were reported in patients treated with PULMICORT TURBUHALER.
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 (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
|
| |
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
Pharyngitis
Sinusitis
Voice alteration
|
17
9
7
0
|
20
10
11
1
|
24
9
7
2
|
19
5
2
6
|
|
Body As A Whole
|
|
|
|
|
|
Headache
Flu syndrome
Pain
Back pain
Fever
|
7
6
2
1
2
|
14
6
5
2
2
|
13
6
5
3
4
|
14
14
5
6
0
|
|
Digestive System
|
|
|
|
|
|
Oral candidiasis
Dyspepsia
Gastroenteritis
Nausea
|
2
2
1
2
|
2
1
1
2
|
4
2
2
1
|
4
4
3
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 group and were more common than in the placebo group. In considering these data, the increased average duration of exposure for PULMICORT TURBUHALER patients should be taken into account.
The following other adverse events occurred in these clinical trials using PULMICORT TURBUHALER with an incidence of 1 to 3% and were more common on PULMICORT TURBUHALER 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 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 group and which occurred more frequently with PULMICORT TURBUHALER than placebo are shown below (% PULMICORT TURBUHALER and % placebo). In considering these data, the increased average duration of exposure for PULMICORT TURBUHALER patients (78 days for PULMICORT TURBUHALER 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 Once Daily
The adverse event profile of once-daily administration of PULMICORT TURBUHALER 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 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 (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.
|
