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Symbicort (Budesonide Inhalation) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Long-acting beta2-adrenergic agonists, such as formoterol one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. [see Warnings and Precautions].

Systemic and inhaled corticosteroid use may result in the following:

  • •Candida albicans infection [see Warnings and Precautions ]
  • •Pneumonia or lower respiratory tract infections in patients with COPD [see Warnings and Precautions ]
  • •Immunosuppression [see Warnings and Precautions ]
  • •Hypercorticism and adrenal suppression [see Warnings and Precautions ]
  • •Growth effects in pediatric patients [see Warnings and Precautions ]
  • •Glaucoma and cataracts [see Warnings and Precautions ]

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.

Clinical Trials Experience in Asthma Patients 12 years and older

The overall safety data in adults and adolescents are based upon 10 active- and placebo-controlled clinical trials in which 3393 patients ages 12 years and older (2052 females and 1341 males) with asthma of varying severity were treated with SYMBICORT 80/4.5 or 160/4.5 mcg taken two inhalations once or twice daily for 12 to 52 weeks. In these trials, the patients on SYMBICORT had a mean age of 38 years and were predominantly Caucasian (82%).

The incidence of common adverse events in Table 1 below is based upon pooled data from three 12-week, double-blind, placebo-controlled clinical studies in which 401 adult and adolescent patients (148 males and 253 females) age 12 years and older were treated with two inhalations of SYMBICORT 80/4.5 or SYMBICORT 160/4.5 twice daily. The SYMBICORT group was composed of mostly Caucasian (84%) patients with a mean age of 38 years, and a mean percent predicted FEV1 at baseline of 76 and 68 for the 80/4.5 mcg and 160/4.5 mcg treatment groups, respectively. Control arms for comparison included two inhalations of budesonide HFA metered dose inhaler (MDI) 80 or 160 mcg, formoterol dry powder inhaler (DPI) 4.5 mcg, or placebo (MDI and DPI) twice daily. Table 1 includes all adverse events that occurred at an incidence of > 3% in any one SYMBICORT group and more commonly than in the placebo group with twice-daily dosing. In considering these data, the increased average duration of patient exposure for SYMBICORT patients should be taken into account, as incidences are not adjusted for an imbalance of treatment duration.

Table 1 Adverse-reactions occurring at an incidence of ≥ 3% and more commonly than placebo in the SYMBICORT groups: pooled data from three 12-week, double-blind, placebo-controlled clinical asthma trials in patients 12 years and older
Treatment 1 SYMBICORT Budesonide Formoterol Placebo
Adverse Event 80/4.5 mcg
N= 277
%
160/4.5 mcg
N =124
%
80 mcg
N =121
%
160 mcg
N = 109
%
4.5 mcg
N = 237
%
N = 400
%

Nasopharyngitis

10.5

9.7

14.0

11.0

10.1

9.0

Headache

6.5

11.3

11.6

12.8

8.9

6.5

Upper respiratory tract infection

7.6

10.5

8.3

9.2

7.6

7.8

Pharyngolaryngeal pain

6.1

8.9

5.0

7.3

3.0

4.8

Sinusitis

5.8

4.8

5.8

2.8

6.3

4.8

Influenza

3.2

2.4

6.6

0.9

3.0

1.3

Back pain

3.2

1.6

2.5

5.5

2.1

0.8

Nasal congestion

2.5

3.2

2.5

3.7

1.3

1.0

Stomach discomfort

1.1

6.5

2.5

4.6

1.3

1.8

Vomiting

1.4

3.2

0.8

2.8

1.7

1.0

Oral Candidiasis

1.4

3.2

0

0

0

0.8

Average Duration of Exposure (days)

77.7

73.8

77.0

71.4

62.4

55.9

1 All treatments were administered as two inhalations twice daily.

Long-term safety - asthma clinical trials in patients 12 years and older

Long-term safety studies in adolescent and adult patients 12 years of age and older, treated for up to 1 year at doses up to 1280/36 mcg/day (640/18 mcg twice daily), revealed neither clinically important changes in the incidence nor new types of adverse events emerging after longer periods of treatment. Similarly, no significant or unexpected patterns of abnormalities were observed for up to 1 year in safety measures including chemistry, hematology, ECG, Holter monitor, and HPA-axis assessments.

Clinical Trials Experience in Chronic Obstructive Pulmonary Disease

The incidence of common adverse events in Table 2 below is based upon pooled data from two double-blind, placebo-controlled clinical studies (6 and 12 months in duration) in which 771 adult COPD patients (496 males and 275 females) 40 years of age and older were treated with SYMBICORT 160/4.5, two inhalations twice daily. Of these patients 651 were treated for 6 months and 366 were treated for 12 months. The SYMBICORT group was composed of mostly Caucasian (93%) patients with a mean age of 63 years, and a mean percent predicted FEV1 at baseline of 33%. Control arms for comparison included two inhalations of budesonide HFA (MDI) 160 mcg, formoterol (DPI) 4.5 mcg or placebo (MDI and DPI) twice daily. Table 2 includes all adverse events that occurred at an incidence of ≥ 3% in the SYMBICORT group and more commonly than in the placebo group. In considering these data, the increased average duration of patient exposure to SYMBICORT should be taken into account, as incidences are not adjusted for an imbalance of treatment duration.

Table 2 Adverse reactions occurring at an incidence of ≥ 3% and more commonly than placebo in the SYMBICORT group: pooled data from two double-blind, placebo-controlled clinical COPD trials

Treatment 1

SYMBICORT

Budesonide

Formoterol

Placebo

Adverse Event

160/4.5 mcg

N=771

%

160 mcg

N=275

%

4.5 mcg

N=779

%

N=781

%

Nasopharyngitis

7.3

3.3

5.8

4.9

Oral candidiasis

6.0

4.4

1.2

1.8

Bronchitis

5.4

4.7

4.5

3.5

Sinusitis

3.5

1.5

3.1

1.8

Upper respiratory tract infection viral

3.5

1.8

3.6

2.7

Average Duration of Exposure (days)

255.2

157.1

240.3

223.7

1 All treatments were administered as two inhalations twice daily.

Lung infections other than pneumonia (mostly bronchitis) occurred in a greater percentage of subjects treated with SYMBICORT 160/4.5 compared with placebo (7.9% vs. 5.1%, respectively). There were no clinically important or unexpected patterns of abnormalities observed for up to 1 year in chemistry, haematology, ECG, ECG (Holter) monitoring, HPA-axis, bone mineral density and ophthalmology assessments.

Postmarketing Experience

The following adverse reactions have been reported during post-approval use of SYMBICORT. 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. Some of these adverse reactions may also have been observed in clinical studies with SYMBICORT.

Cardiac disorders: angina pectoris, tachycardia, atrial and ventricular tachyarrhythmias, atrial fibrillation, extrasystoles, palpitations

Endocrine disorders: hypercorticism, growth velocity reduction in pediatric patients

Eye disorders: cataract, glaucoma, increased intraocular pressure

Gastrointestinal disorders: oropharyngeal candidiasis, nausea

Immune system disorders: immediate and delayed hypersensitivity reactions, such as anaphylactic reaction, angioedema, bronchospasm, urticaria, exanthema, dermatitis, pruritus

Metabolic and nutrition disorders: hyperglycemia, hypokalemia

Musculoskeletal, connective tissue, and bone disorders: muscle cramps

Nervous system disorders: tremor, dizziness

Psychiatric disorders: behavior disturbances, sleep disturbances, nervousness, agitation, depression, restlessness

Respiratory, thoracic, and mediastinal disorders: dysphonia, cough, throat irritation

Skin and subcutaneous tissue disorders: skin bruising

Vascular disorders: hypotension, hypertension



REPORTS OF SUSPECTED SYMBICORT SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Symbicort. The information is not vetted and should not be considered as verified clinical evidence.

Possible Symbicort side effects / adverse reactions in 56 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-07-05

Patient: 56 year old female weighing 84.0 kg (184.8 pounds)

Reactions: Chest Discomfort, Chest Pain, Tachycardia, Headache, Hypertension, Rash Pruritic, Infusion Related Reaction

Adverse event resulted in: hospitalization

Suspect drug(s):
Gammaplex
    Dosage: 30g
    Indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
    Start date: 2010-09-06

Symbicort

Captopril

Ezetimibe

Other drugs received by patient: Bendroflumethazide; Metformin HCL; Insulin; Gliclazide



Possible Symbicort side effects / adverse reactions in 75 year old male

Reported by a individual with unspecified qualification from United States on 2011-10-03

Patient: 75 year old male

Reactions: Small Cell Lung Cancer Stage Unspecified

Adverse event resulted in: death

Suspect drug(s):
Symbicort



Possible Symbicort side effects / adverse reactions in 53 year old male

Reported by a individual with unspecified qualification from United States on 2011-10-03

Patient: 53 year old male

Reactions: Drug Dose Omission, Emphysema, Dyspnoea, Road Traffic Accident, Pneumonia

Adverse event resulted in: hospitalization

Suspect drug(s):
Symbicort
    Dosage: 160/4.5 mcg two puffs bid

Symbicort
    Dosage: 160/4.5 mcg unknown
    Indication: Chronic Obstructive Pulmonary Disease

Symbicort
    Dosage: 160/4.5 mcg two puffs bid

Symbicort
    Dosage: 160/4.5 mcg unknown
    Indication: Emphysema

Other drugs received by patient: Ventilaire



See index of all Symbicort side effect reports >>

Drug label data at the top of this Page last updated: 2012-05-08

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