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Symbicort (Budesonide Inhalation) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death (See Boxed WARNING, WARNINGS, and PRECAUTIONS sections).

The incidence of common adverse events in the table below is based upon three 12-week, double-blind, placebo-controlled US clinical studies in which 401 adult and adolescent patients (148 males and 253 females) age 12 years and older were treated twice daily with 2 inhalations of SYMBICORT 80/4.5 or SYMBICORT 160/4.5, budesonide HFA metered dose inhaler (MDI) 80 or 160 mcg, formoterol dry powder inhaler (DPI) 4.5 mcg, or placebos (MDI and DPI).

Table 4 — Adverse Events (regardless of causality) Occurring at an Incidence of ≥3% and more Commonly than Placebo in any SYMBICORT Group
Treatment*SYMBICORTBudesonide HFA MDIFormoterol DPIPlacebo MDI and DPI
Adverse Event80/4.5 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

*All treatments were administered as two inhalations twice daily.

The table above includes all events (whether or not considered drug-related by the investigators) that occurred at an incidence of ≥3% in any one SYMBICORT group and that were more common than in the placebo group with twice-daily dosing. In considering these data, the increased average duration of exposure for SYMBICORT patients should be taken into account, as incidences are not adjusted for unequal treatment duration.

The following additional adverse events occurred in patients ≥12 years of age in the active- and placebo-controlled clinical studies among 2344 patients treated with SYMBICORT twice daily with an incidence of ≥1% to <3% regardless of relationship to treatment, and are listed in decreasing order of incidence: asthma, nausea, dysphonia, pyrexia, sinus headache, diarrhea, pharyngitis, tremor, lower respiratory tract infection, muscle spasms, urinary tract infection, rhinitis, arthralgia, myalgia, dyspepsia, gastroenteritis viral, abdominal pain upper, dizziness, sinus congestion, rhinitis allergic, pain in extremity, palpitations, bronchitis acute, tension headache, migraine, post procedural pain. Additionally, the incidence of cough, bronchitis, and viral upper respiratory tract infection was ≥3% (but each <4%) in this population but did not meet criteria for inclusion in the above table, as these data are not derived from placebo-controlled trials for subjects ≥12 years old.

The following adverse events occurred in this same population (patients ≥12 years of age) with an incidence <1%, and are listed because they have previously been reported during treatment with any formulation of inhaled SYMBICORT, budesonide and/or formoterol, regardless of the indication: immediate and delayed hypersensitivity reactions, e.g., rash, pruritus, urticaria, angioedema; cardiac events, e.g., tachycardia, coronary ischemia, atrial and ventricular tachyarrhythmias; variations in blood pressure, e.g., hypotension, hypertension, hypertensive crisis; hypokalemia; hyperglycemia; taste disturbance; psychiatric symptoms, e.g., irritability, anxiety, restlessness, nervousness, agitation, depression; skin bruising.

Long-Term Safety: Long-term safety studies in adolescent and adult patients 12 years of age and older, treated for up to one 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 one year in safety measures including chemistry, hematology, ECG, Holter monitor, and HPA-axis assessments.

Adverse Event Reports From Other Sources: Other relevant rare adverse events reported in the published literature, clinical trials or from worldwide marketing experience with any formulation of inhaled SYMBICORT, budesonide and/or formoterol, regardless of the indication include: immediate hypersensitivity reactions, such as anaphylactic reaction and bronchospasm; symptoms of hypocorticism and hypercorticism; glaucoma, cataracts, psychiatric symptoms, including aggressive reactions, behavioral disturbances, psychosis.



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: 2006-11-24

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