This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Advair HFA (Fluticasone / Salmeterol) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (12)
Death (1)
Disability (2)
Reports by Reaction Type
Tremor (4),
Dizziness (3),
Gastric Disorder (3),
Memory Impairment (3),
Agitation (2),
Contusion (2),
Pruritus (2),
Drug Ineffective (2),
Muscle Contractions Involuntary (2),
Disorientation (2),
Chronic Obstructive Pulmonary Disease (2),
Somnolence (2)
Possible Advair HFA side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: male, weighing 22.7 kg (49.9 pounds)
Reactions: Condition Aggravated, Drug Withdrawal Syndrome, Cardiac Disorder, Aggression, TIC, Palpitations, Tourette's Disorder, Drug Dependence
Drug(s) suspected as cause:
Advair HFA
Possible Advair HFA side effects in 59 year old female
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: 59 year old female, weighing 63.2 kg (139.0 pounds)
Reactions: Productive Cough, Dyspnoea, Ovarian Cyst, Rhinorrhoea, Pyrexia, Chronic Obstructive Pulmonary Disease, Anxiety, Death, Respiratory Failure, Sputum Discoloured
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Advair HFA
Dosage: 1puff twice per day
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2008-01-01
Advair HFA
Dosage: 2puff twice per day
Start date: 2011-11-01
Other drugs received by patient: Alprazolam; Atrovent; Theophylline; Albuterol; Buspirone HCL; Levaquin; Nystatin; Symbicort; Singulair
Possible Advair HFA side effects in 44 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-03
Patient: 44 year old female
Reactions: Glossodynia, Tongue Disorder, Wheezing, Transient Ischaemic Attack, Cough, Candidiasis, Aphonia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Advair HFA
Dosage: 2 df;bid;inh
Indication: Asthma
Start date: 2012-02-01
End date: 2012-05-31
Asmanex Twisthaler
Indication: Asthma
End date: 2011-08-01
Other drugs received by patient: Interferon
Possible Advair HFA side effects in 57 year old female
Reported by a consumer/non-health professional from United States on 2012-06-27
Patient: 57 year old female, weighing 58.5 kg (128.7 pounds)
Reactions: Scratch, Contusion, Pruritus, Muscle Contractions Involuntary, Pain, Tremor
Drug(s) suspected as cause:
Advair HFA
Possible Advair HFA side effects in 57 year old female
Reported by a consumer/non-health professional from United States on 2012-06-27
Patient: 57 year old female, weighing 58.5 kg (128.7 pounds)
Reactions: Scratch, Pruritus, Contusion, Muscle Contractions Involuntary, Insomnia, Feeling Abnormal, Tremor
Drug(s) suspected as cause:
Advair HFA
Possible Advair HFA side effects in 70 year old male
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: 70 year old male, weighing 74.8 kg (164.7 pounds)
Reactions: Skin Ulcer, Urticaria, Vision Blurred, Rash
Drug(s) suspected as cause:
Advair HFA
Dosage: 1 puff 5
Indication: Asthma
Start date: 2009-09-15
End date: 2012-03-01
Asmanex Twisthaler
Dosage: 1 puff 7
Indication: Asthma
Start date: 2012-04-10
End date: 2012-05-14
Possible Advair HFA side effects in 7 year old male
Reported by a physician from United States on 2012-05-08
Patient: 7 year old male, weighing 2543.7 kg (5596.1 pounds)
Reactions: Adrenal Suppression
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Advair HFA
Dosage: 2 puffs
Indication: Multiple Allergies
Start date: 2010-12-01
End date: 2012-04-20
Advair HFA
Dosage: 2 puffs
Indication: Asthma
Start date: 2010-12-01
End date: 2012-04-20
Other drugs received by patient: Veramyst
Possible Advair HFA side effects in 47 year old male
Reported by a individual with unspecified qualification from United States on 2012-04-11
Patient: 47 year old male, weighing 70.3 kg (154.7 pounds)
Reactions: Basedow's Disease, Diplopia, Hypothyroidism, Cyst, Sinusitis, Gastric Disorder, Candidiasis
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Advair HFA
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2011-01-01
End date: 2011-11-01
Spiriva
Dosage: 18 mcg caps
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2010-07-01
End date: 2011-11-01
Possible Advair HFA side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-27
Patient: female, weighing 65.8 kg (144.7 pounds)
Reactions: Migraine, Agitation, Drug Ineffective, Nausea, Disorientation, Stress, Gastric Disorder, Somnolence, Tremor, Irritability, DRY Mouth, Dizziness, Memory Impairment, Nervousness
Drug(s) suspected as cause:
Spiriva
Indication: Asthma
Combivent
Indication: Asthma
Trazodone Hydrochloride
Norvasc
Indication: Hypertension
Advair HFA
Indication: Asthma
Symbicort
Indication: Bronchitis
Unspecified Nebulizer
Indication: Bronchitis
Seroquel
Indication: Bipolar I Disorder
Advair HFA
Indication: Bronchitis
Symbicort
Indication: Emphysema
Unspecified Nebulizer
Indication: Emphysema
Inderal
Niaspan
Dosage: 500 mg
Indication: Blood Cholesterol Increased
Spiriva
Indication: Emphysema
Seroquel
Dosage: 100 mg
Indication: Postpartum Stress Disorder
Start date: 2006-01-01
Combivent
Indication: Emphysema
Geodon
Aspirin
Dosage: 81 mg
Lisinopril
Dosage: 40 mg
Indication: Hypertension
Unspecified Nebulizer
Indication: Asthma
Unspecified Patch
Spiriva
Indication: Bronchitis
Chantix
Medroxyprogesterone
Coreg
Dosage: 25 mg
Advair HFA
Indication: Emphysema
Symbicort
Indication: Asthma
Combivent
Indication: Bronchitis
Depakote
Estradiol
Chantix
Dosage: 0.5 mg
Administration route: Oral
Indication: Smoking Cessation Therapy
Start date: 2012-02-01
Possible Advair HFA side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-06
Patient: female, weighing 65.8 kg (144.7 pounds)
Reactions: Agitation, Migraine, Nausea, Drug Ineffective, Disorientation, Gastric Disorder, Stress, Somnolence, Tremor, Irritability, DRY Mouth, Dizziness, Memory Impairment, Nervousness
Drug(s) suspected as cause:
Geodon
Trazodone Hydrochloride
Symbicort
Indication: Asthma
Divalproex Sodium
Chantix
Dosage: 0.5 mg
Administration route: Oral
Indication: Smoking Cessation Therapy
Start date: 2012-02-01
Norvasc
Indication: Hypertension
Niaspan
Dosage: 500 mg
Indication: Blood Cholesterol Increased
Advair HFA
Indication: Bronchitis
Unspecified Nebulizer
Indication: Emphysema
Spiriva
Indication: Bronchitis
Combivent
Indication: Asthma
Coreg
Dosage: 25 mg
Combivent
Indication: Bronchitis
Aspirin
Dosage: 81 mg
Advair HFA
Indication: Asthma
Spiriva
Indication: Asthma
Spiriva
Indication: Emphysema
Lisinopril
Dosage: 40 mg
Indication: Hypertension
Medroxyprogesterone
Seroquel
Dosage: 100 mg
Indication: Postpartum Stress Disorder
Start date: 2006-01-01
Symbicort
Indication: Emphysema
Combivent
Indication: Emphysema
Chantix
Inderal
Seroquel
Indication: Bipolar I Disorder
Advair HFA
Indication: Emphysema
Symbicort
Indication: Bronchitis
Unspecified Nebulizer
Indication: Bronchitis
Estradiol
Unspecified Nebulizer
Indication: Asthma
Unspecified Patch
Possible Advair HFA side effects in female
Reported by a individual with unspecified qualification from United States on 2011-10-04
Patient: female
Reactions: Dizziness, Memory Impairment, Intracranial Aneurysm, Chronic Obstructive Pulmonary Disease
Drug(s) suspected as cause:
Spiriva
Dosage: inh
Indication: Product Used FOR Unknown Indication
Drug Used IN Diabetes (Drug Used IN Diabetes)
Dosage: po
Administration route: Oral
Indication: Diabetes Mellitus
Maxair
Dosage: 200 ug;inh
Indication: Product Used FOR Unknown Indication
Albuterol
Dosage: inh
Indication: Product Used FOR Unknown Indication
Advair HFA
Dosage: inh
Indication: Product Used FOR Unknown Indication
Possible Advair HFA side effects in 46 year old female
Reported by a individual with unspecified qualification from United States on 2011-10-04
Patient: 46 year old female, weighing 115.6 kg (254.3 pounds)
Reactions: Blood Pressure Increased, Cataract, Overdose, Drug Prescribing Error, Sinusitis
Drug(s) suspected as cause:
Zyflo
Dosage: 1200 mg;tid
Indication: Asthma
Theophylline
Dosage: 200 mg;qam ; 400 mg;hs
Indication: Asthma
Rhinocort
Dosage: 32 ug;qd
Indication: Seasonal Allergy
Advair HFA
Dosage: bid
Indication: Asthma
Medrol
Indication: Sinusitis
Milnacipran Hydrochloride (Milnacipran Hydrochloride)
Dosage: 200 mg;bid ; 12.5 mg;qd ; 12.5 mg;bid ; 50 mg;bid ; 50 mg;bid ; 100 mg;bid
Indication: Fibromyalgia
Start date: 2010-06-01
End date: 2010-06-01
Milnacipran Hydrochloride (Milnacipran Hydrochloride)
Dosage: 200 mg;bid ; 12.5 mg;qd ; 12.5 mg;bid ; 50 mg;bid ; 50 mg;bid ; 100 mg;bid
Indication: Fibromyalgia
Start date: 2010-06-01
End date: 2010-06-01
Milnacipran Hydrochloride (Milnacipran Hydrochloride)
Dosage: 200 mg;bid ; 12.5 mg;qd ; 12.5 mg;bid ; 50 mg;bid ; 50 mg;bid ; 100 mg;bid
Indication: Fibromyalgia
Start date: 2010-08-01
End date: 2010-09-14
Milnacipran Hydrochloride (Milnacipran Hydrochloride)
Dosage: 200 mg;bid ; 12.5 mg;qd ; 12.5 mg;bid ; 50 mg;bid ; 50 mg;bid ; 100 mg;bid
Indication: Fibromyalgia
Start date: 2010-06-01
End date: 2010-06-01
Milnacipran Hydrochloride (Milnacipran Hydrochloride)
Dosage: 200 mg;bid ; 12.5 mg;qd ; 12.5 mg;bid ; 50 mg;bid ; 50 mg;bid ; 100 mg;bid
Indication: Fibromyalgia
Start date: 2010-06-01
End date: 2010-06-01
Milnacipran Hydrochloride (Milnacipran Hydrochloride)
Dosage: 200 mg;bid ; 12.5 mg;qd ; 12.5 mg;bid ; 50 mg;bid ; 50 mg;bid ; 100 mg;bid
Indication: Fibromyalgia
Start date: 2010-07-01
End date: 2010-08-01
Maxair
Dosage: bid;inh
Indication: Asthma
Pulmicort
Dosage: 180 ug;bid
Indication: Asthma
Other drugs received by patient: B12 / 00056201 /; Percocet; Multi-Vitamins; Nexium; Xyzal; Relpax; Topamax; Calcium with Vitamin D / 00944201 /
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