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Advair HFA (Fluticasone / Salmeterol) - Side Effect Reports to FDA

 
 



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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