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Brovana (Arformoterol Inhalation) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Brovana (Arformoterol Inhalation) 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 (24)
Death (4)

Reports by Reaction Type

Dyspnoea (6)Malaise (3)Dyspepsia (3)Chest Pain (3)Oedema Peripheral (3)Blood Pressure Increased (3)Heart Rate Increased (3)Drug Ineffective (2)Tachycardia (2)Petechiae (2)Off Label Use (2)Muscle Spasms (2)

Possible Brovana side effects in 51 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 51 year old female

Reactions: Middle Insomnia, Dyspnoea, Drug Ineffective, Thymoma Malignant Recurrent, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xopenex
    Start date: 2012-08-01

Budesonide

Brovana
    Indication: Bronchiectasis
    Start date: 2011-01-01
    End date: 2012-08-03

Budesonide
    Indication: Product Used FOR Unknown Indication

Xopenex
    Start date: 2012-01-01
    End date: 2012-01-01

Xopenex
    Indication: Bronchiectasis
    Start date: 2012-08-01

Other drugs received by patient: Xanax; Allegra; Spiriva; Spiriva; Prednisone TAB



Possible Brovana side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient:

Reactions: Blood Pressure Increased, Dyspepsia, Chest Pain, Heart Rate Increased

Drug(s) suspected as cause:
Proventil

Ipratropium Bromide

Allegra
    Administration route: Oral

Budesonide

Spiriva

Brovana

Nasonex

Astepro

Fluticasone Propionate



Possible Brovana side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Brovana



Possible Brovana side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: male

Reactions: Alopecia

Drug(s) suspected as cause:
Brovana
    Dosage: 1df:15 ug/2ml
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-04-01

Coumadin



Possible Brovana side effects in 82 year old female

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: 82 year old female

Reactions: Oedema Peripheral, Petechiae

Drug(s) suspected as cause:
Atacand
    Administration route: Oral

Symbicort
    Dosage: twice daily

Brovana

Budesonide

Other drugs received by patient: Diuretics



Possible Brovana side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: female

Reactions: Off Label Use, Dyspnoea, Terminal Insomnia, Feeling Abnormal

Drug(s) suspected as cause:
Ipratropium Bromide
    Dosage: qid
    Indication: Emphysema
    Start date: 2012-04-30

Budesonide
    Dosage: bid
    Indication: Emphysema
    Start date: 2012-04-30

Brovana
    Indication: Emphysema
    Start date: 2012-04-30

Brovana
    Indication: Pulmonary Oedema
    Start date: 2012-04-30

Other drugs received by patient: Ferrous Sulfate TAB; Spiriva; Clonazepam; Advair Diskus 100 / 50; Vitamin D; Benicar; Fish OIL; Levothyroxine; Multi-Vitamins; Omeprazole; Aspirin; Unspecified Medication FOR Blood Pressure; Ventolin HFA



Possible Brovana side effects in 82 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 82 year old female

Reactions: Oedema Peripheral, Petechiae

Drug(s) suspected as cause:
Atacand
    Administration route: Oral

Brovana

Budesonide

Other drugs received by patient: Diuretics



Possible Brovana side effects in 79 year old male

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: 79 year old male

Reactions: Off Label Use, Fatigue, Somnolence

Drug(s) suspected as cause:
Pulmicort
    Indication: Pneumonia
    Start date: 2012-03-06

Brovana
    Dosage: 15mcg, twice daily
    Indication: Pneumonia
    Start date: 2012-03-06

Other drugs received by patient: Glipizide; Omeprazole; Oxygen; Metformin Hydrochloride



Possible Brovana side effects in female

Reported by a physician from United States on 2012-06-08

Patient: female

Reactions: Tachycardia

Drug(s) suspected as cause:
Brovana

Pulmicort

Spiriva



Possible Brovana side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: 69 year old female

Reactions: Drug Dose Omission, Dyspnoea, Adverse Event, Respiratory Distress

Drug(s) suspected as cause:
Brovana

Pulmicort

Pulmicort

Pulmicort



Possible Brovana side effects in female

Reported by a consumer/non-health professional from France on 2012-06-08

Patient: female

Reactions: Blood Pressure Increased, Dyspepsia, Chest Pain, Heart Rate Increased

Drug(s) suspected as cause:
Ipratropium Bromide
    Start date: 2011-04-26

Albuterol

Brovana

Unspecified Breathing Treatments

Budesonide

Ipratropium Bromide
    End date: 2011-04-24

Nasonex
    Start date: 2011-04-26

Astepro
    End date: 2011-04-24

Spiriva
    Start date: 2011-04-26

Nasonex
    End date: 2011-04-24

Allegra
    Administration route: Oral
    Indication: Hypersensitivity
    Start date: 2011-04-01

Spiriva
    End date: 2011-04-24

Astepro
    Start date: 2011-04-26

Advair Diskus 100 / 50
    End date: 2011-04-01

Other drugs received by patient: Other Anti-Histamatics, Inhalants; Prev Meds



Possible Brovana side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: male

Reactions: Dyspnoea, Wrong Technique in Drug Usage Process, Drug Ineffective, Rash

Drug(s) suspected as cause:
Brovana

Pulmicort



Possible Brovana side effects in 68 year old male

Reported by a consumer/non-health professional from United States on 2012-05-31

Patient: 68 year old male

Reactions: Viral Infection, Coronary Artery Occlusion, Local Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Brovana

Other drugs received by patient: Budesonide; Warfarin Sodium



Possible Brovana side effects in 69 year old female

Reported by a physician from United States on 2012-05-04

Patient: 69 year old female, weighing 40.0 kg (88.0 pounds)

Reactions: Anxiety, Sepsis, Tachycardia, Clostridium Difficile Colitis, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Brovana

Other drugs received by patient: Duoneb



Possible Brovana side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-03

Patient: female, weighing 55.4 kg (121.9 pounds)

Reactions: Dyspnoea, Chest Discomfort, Pain in Extremity, Hypoaesthesia, Myocardial Infarction

Drug(s) suspected as cause:
Budesonide

Brovana
    Dosage: 15 ug
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2012-01-01

Naproxen
    Indication: Pain Management

Other drugs received by patient: Fluticasone Propionate / Salmeterol; Salbutamol (Proair); Tiotropium Bromide



Possible Brovana side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2012-04-13

Patient: 65 year old male

Reactions: Cold-Stimulus Headache, Chills, Headache, Pyrexia, Malaise, Diarrhoea, Cold Sweat, Muscle Spasms, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Brovana

Other drugs received by patient: Albuterol; Budesonide; Symbicort



Possible Brovana side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-26

Patient: female

Reactions: Pruritus Generalised, Tongue Discolouration, DRY Mouth, Aptyalism, Candidiasis

Drug(s) suspected as cause:
Brovana



Possible Brovana side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-02-15

Patient: 69 year old female

Reactions: Pneumonia, Laboratory Test Abnormal, Blood Creatine Phosphokinase Decreased, Fungal Infection, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Brovana

Other drugs received by patient: Celebrex; Baclofen; Ropinirole; Prednisone TAB; Orphenadrine Citrate



Possible Brovana side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-10

Patient: male, weighing 106.1 kg (233.5 pounds)

Reactions: Nausea, Feeling Abnormal

Drug(s) suspected as cause:
Brovana
    Dosage: 15 mcg/2 ml q 12 hr nebulizer
    Indication: Asthma
    Start date: 2011-12-10
    End date: 2011-12-14

Brovana
    Dosage: 15 mcg/2 ml q 12 hr nebulizer
    Indication: Dyspnoea
    Start date: 2011-12-10
    End date: 2011-12-14



Possible Brovana side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-09

Patient: female

Reactions: Terminal State

Adverse event resulted in: death

Drug(s) suspected as cause:
Brovana



Possible Brovana side effects in 76 year old female

Reported by a physician from United States on 2012-01-09

Patient: 76 year old female

Reactions: Malaise, Hypersensitivity, Dyspnoea, Polyp, Joint Swelling, Oedema Peripheral, Anaemia, Rectal Haemorrhage, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Brovana

Other drugs received by patient: Spironolactone; Metoprolol Succinate; Tracleer; Furosemide



Possible Brovana side effects in female

Reported by a consumer/non-health professional from United States on 2011-11-27

Patient: female

Reactions: Stomatitis

Drug(s) suspected as cause:
Brovana

Other drugs received by patient possibly interacting with the suspect drug:
Budesonide
    Indication: Chronic Obstructive Pulmonary Disease

Alendronate Sodium

Other drugs received by patient: Omeprazole; Furosemide; Combivent; Alprazolam; Tiopronin; Sertraline Hydrochloride; Loratadine



Possible Brovana side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2011-10-28

Patient: 77 year old female

Reactions: Blood Pressure Increased, Malaise, Dyspepsia, Heart Rate Increased, Chest Pain

Drug(s) suspected as cause:
Brovana
    Indication: Dyspnoea
    End date: 2011-04-25

Nasonex

Astepro

Advair Diskus 100 / 50
    Indication: Product Used FOR Unknown Indication

Spiriva

Albuterol
    Indication: Product Used FOR Unknown Indication

Allegra
    Dosage: 180mg per day
    Administration route: Oral
    Indication: Multiple Allergies
    Start date: 2011-04-01

Unspecified Treatment
    Indication: Dyspnoea
    End date: 2011-04-25



Possible Brovana side effects in female

Reported by a consumer/non-health professional from United States on 2011-10-14

Patient: female

Reactions: Pneumonia

Adverse event resulted in: death

Drug(s) suspected as cause:
Brovana

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