SYMBICORT for your asthma patients ≥12 years of age uncontrolled on an ICS or whose disease severity clearly warrants an ICS/LABA

SYMBICORT safety profile

  • SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms

  • Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (for example, discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an ICS

SYMBICORT for your asthma patients ≥12 years of age uncontrolled on an ICS or whose disease severity clearly warrants an ICS/LABA

SYMBICORT safety profile

  • SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms
  • Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (for example, discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an ICS

Adverse reactions in asthma clinical studies†1

Adverse reactions in asthma clinical studies†‡1

Adverse reactions occurring at an incidence of ≥3% and more commonly than placebo in the SYMBICORT group1

SYMBICORT 80

SYMBICORT 160

TREATMENT SYMBICORT 80 BUDESONIDE FORMOTEROL PLACEBO
Adverse reaction (%)

80/4.5 mcg (n=277)

80 mcg (n=121)

4.5 mcg (n=237)

(n=400)

Nasopharyngitis 10.5 14.0 10.1 9.0
Headache 6.5 11.6 8.9 6.5
Upper respiratory tract infection 7.6 8.3 7.6 7.8
Pharyngolaryngeal pain 6.1 5.0 3.0 4.8
Sinusitis 5.8 5.8 6.3 4.8
Influenza 3.2 6.6 3.0 1.3
Back pain 3.2 2.5 2.1 0.8
Nasal congestion 2.5 2.5 1.3 1.0
Stomach discomfort 1.1 2.5 1.3 1.8
Vomiting 1.4 0.8 1.7 1.0
Oral candidiasis 1.4 0 0 0.8
Average duration of exposure (days) 77.7 77.0 62.4 55.9
TREATMENT SYMBICORT 160 BUDESONIDE FORMOTEROL PLACEBO
Adverse reaction (%)

160/4.5 mcg (n=124)

160 mcg (n=109)

4.5 mcg (n=237)

(n=400)

Nasopharyngitis 9.7 11.0 10.1 9.0
Headache 11.3 12.8 8.9 6.5
Upper respiratory tract infection 10.5 9.2 7.6 7.8
Pharyngolaryngeal pain 8.9 7.3 3.0 4.8
Sinusitis 4.8 2.8 6.3 4.8
Influenza 2.4 0.9 3.0 1.3
Back pain 1.6 5.5 2.1 0.8
Nasal congestion 3.2 3.7 1.3 1.0
Stomach discomfort 6.5 4.6 1.3 1.8
Vomiting 3.2 2.8 1.7 1.0
Oral candidiasis 3.2 0 0 0.8
Average duration of exposure (days) 73.8 71.4 62.4 55.9

All treatments were administered as 2 inhalations twice daily.

The incidence of adverse reactions in this table is based upon pooled data from three 12-week, double-blind, placebo-controlled US asthma clinical trials in patients aged 12 years and older.

SYMBICORT 80

SYMBICORT 160

NASOPHARYNGITIS %
SYMBICORT 80/4.5 mcg (n=277) 10.5
Budesonide 80 mcg (n=121) 14.0
Formoterol 4.5 mcg (n=237) 10.1
Placebo (n=400) 9.0
HEADACHE %
SYMBICORT 80/4.5 mcg (n=277) 6.5
Budesonide 80 mcg (n=121) 11.6
Formoterol 4.5 mcg (n=237) 8.9
Placebo (n=400) 6.5
UPPER RESPIRATORY TRACT INFECTION %
SYMBICORT 80/4.5 mcg (n=277) 7.6
Budesonide 80 mcg (n=121) 8.3
Formoterol 4.5 mcg (n=237) 7.6
Placebo (n=400) 7.8
PHARYNGOLARYNGEAL PAIN %
SYMBICORT 80/4.5 mcg (n=277) 6.1
Budesonide 80 mcg (n=121) 5.0
Formoterol 4.5 mcg (n=237) 3.0
Placebo (n=400) 4.8
SINUSITIS %
SYMBICORT 80/4.5 mcg (n=277) 5.8
Budesonide 80 mcg (n=121) 5.8
Formoterol 4.5 mcg (n=237) 6.3
Placebo (n=400) 4.8
INFLUENZA %
SYMBICORT 80/4.5 mcg (n=277) 3.2
Budesonide 80 mcg (n=121) 6.6
Formoterol 4.5 mcg (n=237) 3.0
Placebo (n=400) 1.3
BACK PAIN %
SYMBICORT 80/4.5 mcg (n=277) 3.2
Budesonide 80 mcg (n=121) 2.5
Formoterol 4.5 mcg (n=237) 2.1
Placebo (n=400) 0.8
NASAL CONGESTION %
SYMBICORT 80/4.5 mcg (n=277) 2.5
Budesonide 80 mcg (n=121) 2.5
Formoterol 4.5 mcg (n=237) 1.3
Placebo (n=400) 1.0
STOMACH DISCOMFORT %
SYMBICORT 80/4.5 mcg (n=277) 1.1
Budesonide 80 mcg (n=121) 2.5
Formoterol 4.5 mcg (n=237) 1.3
Placebo (n=400) 1.8
VOMITING %
SYMBICORT 80/4.5 mcg (n=277) 1.4
Budesonide 80 mcg (n=121) 0.8
Formoterol 4.5 mcg (n=237) 1.7
Placebo (n=400) 1.0
ORAL CANDIDIASIS %
SYMBICORT 80/4.5 mcg (n=277) 1.4
Budesonide 80 mcg (n=121) 0
Formoterol 4.5 mcg (n=237) 0
Placebo (n=400) 0.8
AVERAGE DURATION OF EXPOSURE (DAYS)
SYMBICORT 80/4.5 mcg (n=277) 77.7
Budesonide 80 mcg (n=121) 77.0
Formoterol 4.5 mcg (n=237) 62.4
Placebo (n=400) 55.9
NASOPHARYNGITIS %
SYMBICORT 160/4.5 mcg (n=124) 9.7
Budesonide 160 mcg (n=109) 11.0
Formoterol 4.5 mcg (n=237) 10.1
Placebo (n=400) 9.0
HEADACHE %
SYMBICORT 160/4.5 mcg (n=124) 11.3
Budesonide 160 mcg (n=109) 12.8
Formoterol 4.5 mcg (n=237) 8.9
Placebo (n=400) 6.5
UPPER RESPIRATORY TRACT INFECTION %
SYMBICORT 160/4.5 mcg (n=124) 10.5
Budesonide 160 mcg (n=109) 9.2
Formoterol 4.5 mcg (n=237) 7.6
Placebo (n=400) 7.8
PHARYNGOLARYNGEAL PAIN %
SYMBICORT 160/4.5 mcg (n=124) 8.9
Budesonide 160 mcg (n=109) 7.3
Formoterol 4.5 mcg (n=237) 3.0
Placebo (n=400) 4.8
SINUSITIS %
SYMBICORT 160/4.5 mcg (n=124) 4.8
Budesonide 160 mcg (n=109) 2.8
Formoterol 4.5 mcg (n=237) 6.3
Placebo (n=400) 4.8
INFLUENZA %
SYMBICORT 160/4.5 mcg (n=124) 2.4
Budesonide 160 mcg (n=109) 0.9
Formoterol 4.5 mcg (n=237) 3.0
Placebo (n=400) 1.3
BACK PAIN %
SYMBICORT 160/4.5 mcg (n=124) 1.6
Budesonide 160 mcg (n=109) 5.5
Formoterol 4.5 mcg (n=237) 2.1
Placebo (n=400) 0.8
NASAL CONGESTION %
SYMBICORT 160/4.5 mcg (n=124) 3.2
Budesonide 160 mcg (n=109) 3.7
Formoterol 4.5 mcg (n=237) 1.3
Placebo (n=400) 1.0
STOMACH DISCOMFORT %
SYMBICORT 160/4.5 mcg (n=124) 6.5
Budesonide 160 mcg (n=109) 4.6
Formoterol 4.5 mcg (n=237) 1.3
Placebo (n=400) 1.8
VOMITING %
SYMBICORT 160/4.5 mcg (n=124) 3.2
Budesonide 160 mcg (n=109) 2.8
Formoterol 4.5 mcg (n=237) 1.7
Placebo (n=400) 1.0
ORAL CANDIDIASIS %
SYMBICORT 160/4.5 mcg (n=124) 3.2
Budesonide 160 mcg (n=109) 0
Formoterol 4.5 mcg (n=237) 0
Placebo (n=400) 0.8
AVERAGE DURATION OF EXPOSURE (DAYS)
SYMBICORT 160/4.5 mcg (n=124) 73.8
Budesonide 160 mcg (n=109) 71.4
Formoterol 4.5 mcg (n=237) 62.4
Placebo (n=400) 55.9

All treatments were administered as 2 inhalations twice daily.

The incidence of adverse reactions in this table is based upon pooled data from three 12-week, double-blind, placebo-controlled US asthma clinical trials in patients aged 12 years and older.