Drug information for ADVAIR DISKUS 500/50
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
POWDER; INHALATION
0.5MG/INH;EQ 0.05MG BASE/INH
Prescription
(Reference Drug)
FLUTICASONE PROPIONATE
;
SALMETEROL XINAFOATE
fluticasone, salmeterol drug combination
GLAXOSMITHKLINE
21077
2011-07-05 Letter
2011-05-16 Label
2011-05-16 Medication Guide
2011-05-12 Letter
2011-02-02 Other
2011-01-07 Letter
2011-01-05 Medication Guide
2010-06-29 Letter
2010-06-28 Label
2009-12-04 Other
2009-11-16 Medication Guide
2009-04-03 Letter
2008-08-01 Review
2008-07-16 Summary Review
2008-05-02 Label
2008-05-01 Letter
2007-09-24 Review
2007-03-01 Letter
2007-02-26 Label
2006-10-02 Letter
2006-09-28 Label
2006-03-23 Letter
2006-03-03 Label
2005-11-30 Other Important Information from FDA
2004-10-04 Label
2004-10-04 Letter
2004-05-04 Label
2004-04-29 Letter
2003-12-02 Label
2003-11-25 Letter
2003-08-28 Review
2003-08-15 Letter
2003-08-15 Label
2002-08-21 Letter
Drug Adverse Effects information for ADVAIR DISKUS 500/50
Role code
Indications
Reaction
# Reports
PS
PULMONARY FUNCTION TEST DECREASED
APHONIA
1
PS
PULMONARY FUNCTION TEST DECREASED
DYSPHONIA
1
PS
PULMONARY FUNCTION TEST DECREASED
OROPHARYNGEAL PAIN
1
PS
PULMONARY FUNCTION TEST DECREASED
SPEECH DISORDER
1
C
ASTHMA
CHILLS
7
C
ASTHMA
DECREASED APPETITE
7
C
ASTHMA
DIZZINESS
7
C
ASTHMA
DYSPEPSIA
7
C
ASTHMA
DYSPNOEA
7
C
ASTHMA
FATIGUE
7
C
ASTHMA
HYPOAESTHESIA
7
C
ASTHMA
NAUSEA
7
C
ASTHMA
PARAESTHESIA
7
C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
CHILLS
1
C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
DECREASED APPETITE
1
C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
DIZZINESS
1
C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
DYSPEPSIA
1
C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
DYSPNOEA
1
C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
FATIGUE
1
C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
HYPOAESTHESIA
1
C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
NAUSEA
1
C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
PARAESTHESIA
1
C
DIABETES MELLITUS
CHILLS
1
C
DIABETES MELLITUS
DECREASED APPETITE
1
C
DIABETES MELLITUS
DIZZINESS
1
C
DIABETES MELLITUS
DYSPEPSIA
1
C
DIABETES MELLITUS
DYSPNOEA
1
C
DIABETES MELLITUS
FATIGUE
1
C
DIABETES MELLITUS
HYPOAESTHESIA
1
C
DIABETES MELLITUS
NAUSEA
1
C
DIABETES MELLITUS
PARAESTHESIA
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
CHILLS
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
DECREASED APPETITE
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
DIZZINESS
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
DYSPEPSIA
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
DYSPNOEA
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
FATIGUE
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
HYPOAESTHESIA
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
NAUSEA
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
PARAESTHESIA
1
C
GOUT
CHILLS
2
C
GOUT
DECREASED APPETITE
2
C
GOUT
DIZZINESS
2
C
GOUT
DYSPEPSIA
2
C
GOUT
DYSPNOEA
2
C
GOUT
FATIGUE
2
C
GOUT
HYPOAESTHESIA
2
C
GOUT
NAUSEA
2
C
GOUT
PARAESTHESIA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
CHILLS
2
C
PRODUCT USED FOR UNKNOWN INDICATION
DECREASED APPETITE
2
C
PRODUCT USED FOR UNKNOWN INDICATION
DIZZINESS
2
C
PRODUCT USED FOR UNKNOWN INDICATION
DYSPEPSIA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
DYSPNOEA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
FATIGUE
2
C
PRODUCT USED FOR UNKNOWN INDICATION
HYPOAESTHESIA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
NAUSEA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
PARAESTHESIA
2
C
PULMONARY OEDEMA
CHILLS
1
C
PULMONARY OEDEMA
DECREASED APPETITE
1
C
PULMONARY OEDEMA
DIZZINESS
1
C
PULMONARY OEDEMA
DYSPEPSIA
1
C
PULMONARY OEDEMA
DYSPNOEA
1
C
PULMONARY OEDEMA
FATIGUE
1
C
PULMONARY OEDEMA
HYPOAESTHESIA
1
C
PULMONARY OEDEMA
NAUSEA
1
C
PULMONARY OEDEMA
PARAESTHESIA
1
C
SCHIZOPHRENIA
HYPERSENSITIVITY
1
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