Drug information for ADVAIR HFA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
AEROSOL, METERED; INHALATION 0.045MG/INH;EQ 0.021MG BASE/INH Prescription  (Reference Drug) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE fluticasone, salmeterol drug combination GLAXOSMITHKLINE 21254
2011-07-05 Letter

2011-05-16 Label

2011-05-16 Medication Guide

2011-05-12 Letter

2011-01-07 Letter

2011-01-05 Medication Guide

2010-06-29 Letter

2010-06-28 Label

2009-12-04 Other

2009-10-30 Medication Guide

2009-10-26 Letter

2009-09-21 Other

2009-09-21 Label

2008-08-05 Letter

2008-05-06 Review

2008-03-24 Label

2008-03-21 Letter

2006-06-19 Other Important Information from FDA

2006-06-14 Label

2006-06-14 Letter
AEROSOL, METERED; INHALATION 0.115MG/INH;EQ 0.021MG BASE/INH Prescription  (Reference Drug) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE fluticasone, salmeterol drug combination GLAXOSMITHKLINE   "
AEROSOL, METERED; INHALATION 0.23MG/INH;EQ 0.021MG BASE/INH Prescription  (Reference Drug) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE fluticasone, salmeterol drug combination GLAXOSMITHKLINE   "

Drug Adverse Effects information for ADVAIR HFA

Role code Indications Reaction # Reports
SS ASTHMA BLOOD PRESSURE INCREASED 5
SS ASTHMA CATARACT 5
SS ASTHMA DRUG PRESCRIBING ERROR 5
SS ASTHMA OVERDOSE 5
SS ASTHMA SINUSITIS 5
SS DIABETES MELLITUS CHRONIC OBSTRUCTIVE PULMONARY DISEASE 1
SS DIABETES MELLITUS DIZZINESS 1
SS DIABETES MELLITUS INTRACRANIAL ANEURYSM 1
SS DIABETES MELLITUS MEMORY IMPAIRMENT 1
SS FIBROMYALGIA BLOOD PRESSURE INCREASED 1
SS FIBROMYALGIA CATARACT 1
SS FIBROMYALGIA DRUG PRESCRIBING ERROR 1
SS FIBROMYALGIA OVERDOSE 1
SS FIBROMYALGIA SINUSITIS 1
SS PRODUCT USED FOR UNKNOWN INDICATION CHRONIC OBSTRUCTIVE PULMONARY DISEASE 4
SS PRODUCT USED FOR UNKNOWN INDICATION DIZZINESS 4
SS PRODUCT USED FOR UNKNOWN INDICATION INTRACRANIAL ANEURYSM 4
SS PRODUCT USED FOR UNKNOWN INDICATION MEMORY IMPAIRMENT 4
SS SEASONAL ALLERGY BLOOD PRESSURE INCREASED 1
SS SEASONAL ALLERGY CATARACT 1
SS SEASONAL ALLERGY DRUG PRESCRIBING ERROR 1
SS SEASONAL ALLERGY OVERDOSE 1
SS SEASONAL ALLERGY SINUSITIS 1
SS SINUSITIS BLOOD PRESSURE INCREASED 1
SS SINUSITIS CATARACT 1
SS SINUSITIS DRUG PRESCRIBING ERROR 1
SS SINUSITIS OVERDOSE 1
SS SINUSITIS SINUSITIS 1
C ALPHA-1 ANTI-TRYPSIN DEFICIENCY BRONCHITIS 1
C ALPHA-1 ANTI-TRYPSIN DEFICIENCY RESPIRATORY TRACT INFECTION 1
C ANAEMIA CARDIO-RESPIRATORY ARREST 1
C ANKYLOSING SPONDYLITIS HEART RATE IRREGULAR 1
C ANKYLOSING SPONDYLITIS HYPERTENSION 1
C ANKYLOSING SPONDYLITIS MUSCULOSKELETAL STIFFNESS 1
C ANKYLOSING SPONDYLITIS NEOPLASM MALIGNANT 1
C ANKYLOSING SPONDYLITIS PAIN 1
C ANKYLOSING SPONDYLITIS TUBERCULOSIS 1
C APLASTIC ANAEMIA ABDOMINAL PAIN 1
C APLASTIC ANAEMIA DISEASE PROGRESSION 1
C APLASTIC ANAEMIA NAUSEA 1
C ASTHMA BRONCHOSPASM 6
C ASTHMA DYSPEPSIA 6
C ASTHMA FLUSHING 6
C ASTHMA HOT FLUSH 6
C ASTHMA NASAL CONGESTION 6
C ASTHMA PRURITUS 6
C BLADDER TRANSITIONAL CELL CARCINOMA CARDIO-RESPIRATORY ARREST 1
C BLOOD PRESSURE BLOOD GLUCOSE INCREASED 2
C BLOOD PRESSURE GLYCOSYLATED HAEMOGLOBIN INCREASED 2
C BLOOD PRESSURE HYPERCHOLESTEROLAEMIA 2
C BLOOD PRESSURE LABORATORY TEST ABNORMAL 2
C BLOOD PRESSURE RHINITIS ALLERGIC 2
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE ABDOMINAL PAIN UPPER 2
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE ANAPHYLACTIC REACTION 2
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE ARTHRALGIA 2
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE ATRIAL FIBRILLATION 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE BUNDLE BRANCH BLOCK RIGHT 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE DEATH 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE DECREASED APPETITE 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE ELECTROCARDIOGRAM ST-T SEGMENT ABNORMAL 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE FACIAL BONES FRACTURE 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE FALL 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE GLAUCOMA 2
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE HAEMATOCRIT DECREASED 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE HAEMOGLOBIN DECREASED 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE MYALGIA 2
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE OSTEOPOROSIS 2
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE PRODUCT QUALITY ISSUE 2
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE SINUS TACHYCARDIA 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE WEIGHT DECREASED 1
C COUGH BLOOD GLUCOSE INCREASED 1
C COUGH GLYCOSYLATED HAEMOGLOBIN INCREASED 1
C COUGH HYPERCHOLESTEROLAEMIA 1
C COUGH LABORATORY TEST ABNORMAL 1
C COUGH RHINITIS ALLERGIC 1
C DEPRESSION AGITATION 1
C DEPRESSION COORDINATION ABNORMAL 1
C DEPRESSION DIZZINESS 1
C DEPRESSION GINGIVAL SWELLING 1
C DEPRESSION PARAESTHESIA 1
C DEPRESSION UNEVALUABLE EVENT 1
C DYSKINESIA DRUG EFFECT DECREASED 1
C DYSKINESIA DRUG TOLERANCE INCREASED 1
C DYSKINESIA FOOD INTERACTION 1
C DYSPNOEA BLOOD GLUCOSE INCREASED 1
C DYSPNOEA GLYCOSYLATED HAEMOGLOBIN INCREASED 1
C DYSPNOEA HYPERCHOLESTEROLAEMIA 1
C DYSPNOEA LABORATORY TEST ABNORMAL 1
C DYSPNOEA RHINITIS ALLERGIC 1
C FUNGAL INFECTION ANAEMIA 1
C FUNGAL INFECTION ARTHRALGIA 1
C FUNGAL INFECTION INCREASED TENDENCY TO BRUISE 1
C FUNGAL INFECTION IRON DEFICIENCY ANAEMIA 1
C FUNGAL INFECTION MENOPAUSAL SYMPTOMS 1
C FUNGAL INFECTION OSTEOARTHRITIS 1
C FUNGAL INFECTION OSTEOPOROSIS POSTMENOPAUSAL 1
C FUNGAL INFECTION PALINDROMIC RHEUMATISM 1
C FUNGAL INFECTION POLYARTHRITIS 1
C FUNGAL INFECTION SINUSITIS 1
C FUNGAL INFECTION SPINAL OSTEOARTHRITIS 1
C HYPERTENSION MASS 2
C HYPERTENSION PRURITUS 2
C HYPERTENSION RASH GENERALISED 2
C HYPERTENSION SCAR 2
C HYPERTENSION SKIN HYPERPIGMENTATION 2
C HYPOGAMMAGLOBULINAEMIA BLOOD GLUCOSE INCREASED 1
C HYPOGAMMAGLOBULINAEMIA COUGH 1
C HYPOGAMMAGLOBULINAEMIA KIDNEY INFECTION 1
C HYPOGAMMAGLOBULINAEMIA LOWER RESPIRATORY TRACT INFECTION 1
C HYPOGAMMAGLOBULINAEMIA LUNG INFECTION 1
C HYPOGAMMAGLOBULINAEMIA MULTI-ORGAN FAILURE 1
C HYPOGAMMAGLOBULINAEMIA ORGAN FAILURE 1
C HYPOGAMMAGLOBULINAEMIA PLATELET COUNT INCREASED 1
C HYPOGAMMAGLOBULINAEMIA PRURITUS GENERALISED 1
C HYPOGAMMAGLOBULINAEMIA RESPIRATORY TRACT INFECTION 1
C HYPOGAMMAGLOBULINAEMIA SERUM SICKNESS 2
C HYPOGAMMAGLOBULINAEMIA SPUTUM DISCOLOURED 1
C HYPOGAMMAGLOBULINAEMIA UPPER RESPIRATORY TRACT INFECTION 1
C IMMUNODEFICIENCY BLOOD GLUCOSE INCREASED 1
C IMMUNODEFICIENCY MULTI-ORGAN FAILURE 1
C IMMUNODEFICIENCY ORGAN FAILURE 1
C IMMUNODEFICIENCY PLATELET COUNT INCREASED 1
C IMMUNODEFICIENCY SERUM SICKNESS 2
C IMMUNODEFICIENCY COMMON VARIABLE ANAPHYLACTIC REACTION 1
C IMMUNODEFICIENCY COMMON VARIABLE ASTHENIA 2
C IMMUNODEFICIENCY COMMON VARIABLE COUGH 2
C IMMUNODEFICIENCY COMMON VARIABLE FATIGUE 2
C IMMUNODEFICIENCY COMMON VARIABLE GASTROOESOPHAGEAL REFLUX DISEASE 2
C IMMUNODEFICIENCY COMMON VARIABLE INFECTION 2
C IMMUNODEFICIENCY COMMON VARIABLE INFUSION RELATED REACTION 1
C IMMUNODEFICIENCY COMMON VARIABLE INFUSION SITE HAEMATOMA 2
C IMMUNODEFICIENCY COMMON VARIABLE INFUSION SITE HAEMORRHAGE 2
C IMMUNODEFICIENCY COMMON VARIABLE NAUSEA 2
C IMMUNODEFICIENCY COMMON VARIABLE PYREXIA 2
C IMMUNODEFICIENCY COMMON VARIABLE RESPIRATORY TRACT INFECTION 1
C IRON DEFICIENCY ANAEMIA ANXIETY 1
C IRON DEFICIENCY ANAEMIA BACK PAIN 1
C IRON DEFICIENCY ANAEMIA CHEST PAIN 1
C IRON DEFICIENCY ANAEMIA EYE MOVEMENT DISORDER 1
C IRON DEFICIENCY ANAEMIA FLUSHING 1
C IRON DEFICIENCY ANAEMIA HYPOTENSION 1
C IRON DEFICIENCY ANAEMIA LOSS OF CONSCIOUSNESS 1
C MULTIPLE SCLEROSIS INSOMNIA 1
C MULTIPLE SCLEROSIS SLEEP DISORDER 1
C MYELODYSPLASTIC SYNDROME DIARRHOEA 1
C MYELODYSPLASTIC SYNDROME WHITE BLOOD CELL COUNT DECREASED 1
C OSTEOPENIA ABASIA 2
C OSTEOPENIA ANAEMIA POSTOPERATIVE 2
C OSTEOPENIA ARTHRALGIA 2
C OSTEOPENIA BONE DISORDER 2
C OSTEOPENIA BONE PAIN 2
C OSTEOPENIA DEVICE DISLOCATION 2
C OSTEOPENIA DYSSTASIA 2
C OSTEOPENIA FALL 4
C OSTEOPENIA FEMUR FRACTURE 4
C OSTEOPENIA FRACTURE DELAYED UNION 2
C OSTEOPENIA FRACTURE DISPLACEMENT 4
C OSTEOPENIA FRACTURE MALUNION 2
C OSTEOPENIA JOINT SWELLING 2
C OSTEOPENIA LIMB ASYMMETRY 4
C OSTEOPENIA LOW TURNOVER OSTEOPATHY 2
C OSTEOPENIA MUSCULAR WEAKNESS 2
C OSTEOPENIA MUSCULOSKELETAL PAIN 2
C OSTEOPENIA OEDEMA PERIPHERAL 4
C OSTEOPENIA OPERATIVE HAEMORRHAGE 2
C OSTEOPENIA PAIN IN EXTREMITY 4
C OSTEOPENIA PATHOLOGICAL FRACTURE 2
C OSTEOPENIA POST PROCEDURAL HAEMORRHAGE 2
C OSTEOPENIA SPINAL LAMINECTOMY 1
C OSTEOPENIA STRESS FRACTURE 2
C OSTEOPENIA TREATMENT NONCOMPLIANCE 1
C OSTEOPOROSIS ACETABULUM FRACTURE 3
C OSTEOPOROSIS ANAEMIA POSTOPERATIVE 8
C OSTEOPOROSIS ARTHRALGIA 16
C OSTEOPOROSIS BACK PAIN 5
C OSTEOPOROSIS BEDRIDDEN 1
C OSTEOPOROSIS BONE DISORDER 2
C OSTEOPOROSIS BONE LOSS 3
C OSTEOPOROSIS BONE METABOLISM DISORDER 6
C OSTEOPOROSIS BONE PAIN 2
C OSTEOPOROSIS BRADYCARDIA 3
C OSTEOPOROSIS BURSITIS 3
C OSTEOPOROSIS CARDIAC FAILURE CONGESTIVE 6
C OSTEOPOROSIS CHONDROMALACIA 3
C OSTEOPOROSIS COMMINUTED FRACTURE 10
C OSTEOPOROSIS CONDITION AGGRAVATED 2
C OSTEOPOROSIS DEVICE DISLOCATION 6
C OSTEOPOROSIS DRUG INEFFECTIVE 3
C OSTEOPOROSIS DYSPHAGIA 3
C OSTEOPOROSIS DYSSTASIA 3
C OSTEOPOROSIS FALL 14
C OSTEOPOROSIS FEMUR FRACTURE 16
C OSTEOPOROSIS FRACTURE DELAYED UNION 2
C OSTEOPOROSIS FRACTURE DISPLACEMENT 12
C OSTEOPOROSIS GAIT DISTURBANCE 3
C OSTEOPOROSIS GASTROINTESTINAL HAEMORRHAGE 6
C OSTEOPOROSIS GASTROINTESTINAL TRACT IRRITATION 3
C OSTEOPOROSIS GASTROOESOPHAGEAL REFLUX DISEASE 3
C OSTEOPOROSIS HAEMATEMESIS 3
C OSTEOPOROSIS HIP FRACTURE 3
C OSTEOPOROSIS HUMERUS FRACTURE 6
C OSTEOPOROSIS HYPERKALAEMIA 6
C OSTEOPOROSIS IATROGENIC INJURY 4
C OSTEOPOROSIS INADEQUATE ANALGESIA 3
C OSTEOPOROSIS INCISION SITE CELLULITIS 6
C OSTEOPOROSIS INSOMNIA 3
C OSTEOPOROSIS INTERNATIONAL NORMALISED RATIO INCREASED 6
C OSTEOPOROSIS JOINT SWELLING 8
C OSTEOPOROSIS LIMB ASYMMETRY 2
C OSTEOPOROSIS LOSS OF ANATOMICAL ALIGNMENT AFTER FRACTURE REDUCTION 6
C OSTEOPOROSIS LOW TURNOVER OSTEOPATHY 2
C OSTEOPOROSIS MUSCULAR WEAKNESS 3
C OSTEOPOROSIS MUSCULOSKELETAL PAIN 2
C OSTEOPOROSIS NODAL ARRHYTHMIA 6
C OSTEOPOROSIS OEDEMA PERIPHERAL 6
C OSTEOPOROSIS OPERATIVE HAEMORRHAGE 2
C OSTEOPOROSIS OSTEOARTHRITIS 6
C OSTEOPOROSIS OSTEOMALACIA 1
C OSTEOPOROSIS PAIN IN EXTREMITY 12
C OSTEOPOROSIS PATHOLOGICAL FRACTURE 10
C OSTEOPOROSIS POST PROCEDURAL HAEMORRHAGE 6
C OSTEOPOROSIS POST-TRAUMATIC PAIN 3
C OSTEOPOROSIS PUBIS FRACTURE 3
C OSTEOPOROSIS RENAL ATROPHY 3
C OSTEOPOROSIS RENAL FAILURE 6
C OSTEOPOROSIS RESPIRATORY DISORDER 6
C OSTEOPOROSIS RHABDOMYOLYSIS 6
C OSTEOPOROSIS SOMNAMBULISM 3
C OSTEOPOROSIS STRESS FRACTURE 6
C OSTEOPOROSIS STRESS ULCER 6
C OSTEOPOROSIS SYSTEMIC LUPUS ERYTHEMATOSUS 3
C OSTEOPOROSIS TENDONITIS 3
C OSTEOPOROSIS WALKING AID USER 1
C OSTEOPOROSIS WEIGHT BEARING DIFFICULTY 6
C OSTEOPOROSIS WHITE BLOOD CELL COUNT INCREASED 3
C PAIN ANAEMIA 1
C PAIN ARTHRALGIA 1
C PAIN INCREASED TENDENCY TO BRUISE 1
C PAIN IRON DEFICIENCY ANAEMIA 1
C PAIN MENOPAUSAL SYMPTOMS 1
C PAIN OSTEOARTHRITIS 1
C PAIN OSTEOPOROSIS POSTMENOPAUSAL 1
C PAIN PALINDROMIC RHEUMATISM 1
C PAIN POLYARTHRITIS 1
C PAIN SINUSITIS 1
C PAIN SPINAL OSTEOARTHRITIS 1
C PRODUCT USED FOR UNKNOWN INDICATION BURNING SENSATION 1
C PRODUCT USED FOR UNKNOWN INDICATION COUGH 1
C PRODUCT USED FOR UNKNOWN INDICATION FATIGUE 1
C PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 1
C PRODUCT USED FOR UNKNOWN INDICATION HYPERSENSITIVITY 1
C PRODUCT USED FOR UNKNOWN INDICATION HYPOAESTHESIA 1
C PULMONARY ARTERIAL HYPERTENSION CONDITION AGGRAVATED 1
C PULMONARY ARTERIAL HYPERTENSION DISEASE PROGRESSION 1
C PULMONARY ARTERIAL HYPERTENSION DYSPNOEA 1
C PULMONARY ARTERIAL HYPERTENSION PULMONARY HYPERTENSION 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS HEART RATE INCREASED 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS PAIN 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS PARAESTHESIA 1
C RHEUMATOID ARTHRITIS ANAEMIA 1
C RHEUMATOID ARTHRITIS ARTHRALGIA 1
C RHEUMATOID ARTHRITIS INCREASED TENDENCY TO BRUISE 1
C RHEUMATOID ARTHRITIS IRON DEFICIENCY ANAEMIA 1
C RHEUMATOID ARTHRITIS MENOPAUSAL SYMPTOMS 1
C RHEUMATOID ARTHRITIS OSTEOARTHRITIS 1
C RHEUMATOID ARTHRITIS OSTEOPOROSIS POSTMENOPAUSAL 1
C RHEUMATOID ARTHRITIS PALINDROMIC RHEUMATISM 1
C RHEUMATOID ARTHRITIS POLYARTHRITIS 1
C RHEUMATOID ARTHRITIS SINUSITIS 1
C RHEUMATOID ARTHRITIS SPINAL OSTEOARTHRITIS 1
C RHINITIS ALLERGIC BLOOD GLUCOSE INCREASED 1
C RHINITIS ALLERGIC BRONCHOSPASM 1
C RHINITIS ALLERGIC DYSPEPSIA 1
C RHINITIS ALLERGIC FLUSHING 1
C RHINITIS ALLERGIC GLYCOSYLATED HAEMOGLOBIN INCREASED 1
C RHINITIS ALLERGIC HOT FLUSH 1
C RHINITIS ALLERGIC HYPERCHOLESTEROLAEMIA 1
C RHINITIS ALLERGIC LABORATORY TEST ABNORMAL 1
C RHINITIS ALLERGIC NASAL CONGESTION 1
C RHINITIS ALLERGIC PRURITUS 1
C RHINITIS ALLERGIC RHINITIS ALLERGIC 1
C SICKLE CELL ANAEMIA BLOOD URINE PRESENT 1
C SICKLE CELL ANAEMIA DIARRHOEA 1
C SICKLE CELL ANAEMIA DIZZINESS 1
C SICKLE CELL ANAEMIA MEMORY IMPAIRMENT 1
C SICKLE CELL ANAEMIA MUSCULAR WEAKNESS 1
C SICKLE CELL ANAEMIA NAUSEA 1
C SICKLE CELL ANAEMIA THROMBOCYTOPENIA 1
C SICKLE CELL ANAEMIA VOMITING 1
C THYROID DISORDER BLOOD GLUCOSE INCREASED 1
C THYROID DISORDER GLYCOSYLATED HAEMOGLOBIN INCREASED 1
C THYROID DISORDER HYPERCHOLESTEROLAEMIA 1
C THYROID DISORDER LABORATORY TEST ABNORMAL 1
C THYROID DISORDER RHINITIS ALLERGIC 1
C TORTICOLLIS DRUG INEFFECTIVE 1
C TYPE 2 DIABETES MELLITUS BLOOD CREATININE INCREASED 1
C TYPE 2 DIABETES MELLITUS OFF LABEL USE 1
C TYPE 2 DIABETES MELLITUS RENAL FAILURE 1
C TYPE 2 DIABETES MELLITUS RENAL FAILURE ACUTE 1
C TYPE 2 DIABETES MELLITUS RENAL FAILURE CHRONIC 1
C WHEEZING BLOOD GLUCOSE INCREASED 1
C WHEEZING GLYCOSYLATED HAEMOGLOBIN INCREASED 1
C WHEEZING HYPERCHOLESTEROLAEMIA 1
C WHEEZING LABORATORY TEST ABNORMAL 1
C WHEEZING RHINITIS ALLERGIC 1
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