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Symbicort (Budesonide Inhalation) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use (282)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Symbicort (Budesonide Inhalation) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 282   Next >>

Possible Symbicort side effects in 76 year old male

Reported by a physician from United States on 2012-08-27

Patient: 76 year old male, weighing 133.4 kg (293.5 pounds)

Reactions: Pulmonary Hypertension, Asthma, Diabetes Mellitus, Oropharyngeal Pain, Nocturia, Headache, Left Ventricular Failure, Weight Increased, Off Label Use, Chest Pain, Heart Rate Irregular, Nocturnal Dyspnoea, Gastrooesophageal Reflux Disease, Cellulitis, Dyspnoea, Atrial Fibrillation, Gingival Disorder, Nasal Congestion, Hypoaesthesia, Cardiomyopathy, Hyperlipidaemia, Renal Failure, Arthralgia, Hypertension, Arthritis, Tooth Disorder, Sleep Apnoea Syndrome, Essential Hypertension, Aphonia

Drug(s) suspected as cause:
Symbicort
    Dosage: 80/ 4.5 unknown
    Indication: Pulmonary Hypertension

Symbicort
    Dosage: 160/4.5 two puffs bid

Symbicort
    Dosage: 160/4.5 two puffs bid

Symbicort
    Dosage: 80/ 4.5 unknown
    Indication: Cough

Other drugs received by patient: Vitamin; Prevacid; Prilosec; Amaryl; Proair HFA; Actuation HFA; Combivent; Carvedilol; Aspirin; Lasix; Plavix; Isosorbide; Glucosamine Chondroitin; Benicar; Simvastatin



Possible Symbicort side effects in 57 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 57 year old female

Reactions: Off Label Use, Asthma

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Off Label Use, Increased Upper Airway Secretion, Nasopharyngitis, Sneezing, Lacrimation Increased

Drug(s) suspected as cause:
Symbicort
    Dosage: one puff, daily

Symbicort
    Dosage: one puff, twice a day
    Indication: Chemical Burn of Respiratory Tract

Other drugs received by patient: Steroids



Possible Symbicort side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Off Label Use, Dyspnoea, Pulmonary Congestion, Gait Disturbance

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Off Label Use, Dyspnoea

Drug(s) suspected as cause:
Pulmicort Flexhaler
    Indication: Cystic Fibrosis

Symbicort
    Dosage: 2 puffs bid
    Indication: Cystic Fibrosis

Other drugs received by patient: Albuterol; Ipratropium Bromide



Possible Symbicort side effects in 74 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 74 year old male

Reactions: Off Label Use, Drug Ineffective FOR Unapproved Indication, Chest Pain

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 46 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 46 year old female

Reactions: Drug Dose Omission, Burning Sensation, Off Label Use, Aphagia, Dyspnoea

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Indication: Hiatus Hernia

Symbicort
    Dosage: dose unknown



Possible Symbicort side effects in 60 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 60 year old male

Reactions: Drug Dose Omission, LIP Swelling, Swelling Face, Intentional Drug Misuse, Abdominal Pain Upper, Skin Tightness, Off Label Use, Arthropod Bite

Drug(s) suspected as cause:
Symbicort

Other drugs received by patient: Hydrozyne; Altace



Possible Symbicort side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Off Label Use, Dyspnoea, Fear of Death, Presyncope

Drug(s) suspected as cause:
Symbicort
    Dosage: 4 puffs, unknown

Symbicort
    Dosage: 2 puffs, unknown



Possible Symbicort side effects in 48 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient: 48 year old male, weighing 113.4 kg (249.5 pounds)

Reactions: Off Label Use, Hypersensitivity, Pain in Extremity, Arthralgia

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Indication: Abdominal Distension
    Start date: 2012-02-01

Symbicort
    Dosage: 2 puffs bid
    Indication: Chronic Obstructive Pulmonary Disease

Other drugs received by patient: Singulair; Singulair; Zyrtex OTC; Nasonex



Possible Symbicort side effects in 9 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 9 year old female

Reactions: Off Label Use, Wheezing, Cough

Drug(s) suspected as cause:
Symbicort
    Dosage: as required

Symbicort
    Dosage: daily
    Indication: Asthma



Possible Symbicort side effects in 45 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 45 year old male, weighing 104.3 kg (229.5 pounds)

Reactions: Off Label Use, Oropharyngeal Pain, Headache

Drug(s) suspected as cause:
Symbicort

Other drugs received by patient: Regular Albuterol



Possible Symbicort side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 60 year old female

Reactions: Off Label Use, Wheezing

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female

Reactions: Off Label Use, Respiratory Tract Congestion

Drug(s) suspected as cause:
Symbicort
    Dosage: 80/4.5 mcg, two puffs, twice a day
    Indication: Chronic Obstructive Pulmonary Disease

Symbicort
    Dosage: 80/4.5 mcg, two puffs, as required

Other drugs received by patient: Other Medications



Possible Symbicort side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 63 year old female, weighing 70.3 kg (154.7 pounds)

Reactions: Dysgeusia, Off Label Use, Wrong Technique in Drug Usage Process, Circumstance or Information Capable of Leading To Medication Error

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Off Label Use, Wheezing

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 88 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 88 year old male, weighing 83.9 kg (184.6 pounds)

Reactions: Off Label Use, Aphonia, Cough

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 64 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 64 year old female

Reactions: Off Label Use, Dyspnoea

Drug(s) suspected as cause:
Symbicort

Other drugs received by patient: Novolog; Nexium; Crestor



Possible Symbicort side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 77 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Off Label Use, Abdominal Pain, Abdominal Discomfort, Dizziness

Drug(s) suspected as cause:
Symbicort

Other drugs received by patient: Bystolic; Hyralazine; Norvasc



Possible Symbicort side effects in 70 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient: 70 year old male, weighing 95.3 kg (209.7 pounds)

Reactions: Myalgia, Off Label Use, Muscle Spasms

Drug(s) suspected as cause:
Symbicort
    Indication: Chronic Obstructive Pulmonary Disease

Symbicort
    Dosage: 160/4.5 mcg, bid
    Start date: 2012-02-09

Symbicort
    Dosage: 160/4.5 mcg, one puff qd

Other drugs received by patient: Tamsulosin Hydrochloride; Keppra; Stomach Pills



Possible Symbicort side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 71 year old female, weighing 65.8 kg (144.8 pounds)

Reactions: Off Label Use, Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pulmicort Flexhaler
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2012-01-01

Pulmicort Flexhaler
    Indication: Bronchitis Chronic
    Start date: 2012-01-01

Symbicort
    Dosage: 160/4.5 mcg two puffs, two times a day
    Start date: 2010-01-01

Symbicort
    Dosage: 160/4.5 mcg two puffs, two times a day
    Start date: 2010-01-01

Symbicort
    Dosage: 160/4.5 mcg unknown
    Indication: Chronic Obstructive Pulmonary Disease

Symbicort
    Dosage: 160/4.5 mcg unknown
    Indication: Bronchitis Chronic

Other drugs received by patient: Blood Pressure Pills; Pain Medication; Plavix; Lasix



Possible Symbicort side effects in 45 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient: 45 year old female

Reactions: Off Label Use, Bronchitis, Sinusitis, Cough

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

Symbicort
    Dosage: unknown frequency.
    Indication: Cough



Possible Symbicort side effects in 84 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 84 year old female, weighing 70.3 kg (154.7 pounds)

Reactions: Off Label Use, Dyspnoea, Disease Recurrence

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 73 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 73 year old female

Reactions: Off Label Use, Dyspnoea

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 86 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 86 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Off Label Use, Oropharyngeal Pain, Pharyngitis

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 9 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient: 9 year old male, weighing 38.6 kg (84.9 pounds)

Reactions: Off Label Use, Drug Ineffective

Drug(s) suspected as cause:
Pulmicort Flexhaler

Symbicort
    Dosage: 2 puffs every day
    Indication: Asthma
    Start date: 2009-01-01

Other drugs received by patient: Benadryl



Possible Symbicort side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 65 year old male

Reactions: Off Label Use, Hypertension, Diabetes Mellitus Inadequate Control

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 71 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient: 71 year old female, weighing 47.2 kg (103.8 pounds)

Reactions: Off Label Use, Dyspnoea

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 56 year old female

Reactions: Off Label Use, Headache, Drug Dispensing Error

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 67 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 67 year old male, weighing 68.0 kg (149.6 pounds)

Reactions: Off Label Use, Urinary Tract Disorder, Prostatic Disorder

Drug(s) suspected as cause:
Symbicort

Other drugs received by patient: Flomax



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