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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 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 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 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 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 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 69 year old male

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

Patient: 69 year old male, weighing 105.7 kg (232.5 pounds)

Reactions: Off Label Use, Diabetes Mellitus, Pollakiuria, Muscle Spasms

Drug(s) suspected as cause:
Symbicort
    Dosage: 160/4.5 mcg, 2 puffs two times a day
    Start date: 2012-04-01

Symbicort
    Dosage: 160/4.5 mcg, 1 puff two times a day
    Start date: 2012-04-29

Symbicort
    Dosage: 160/4.5 mcg, 2 puffs two times a day
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-11-01

Other drugs received by patient: Metoprolol Tartrate; Aspirin; Simvastatin; Losartan Potassium; Omeprazole



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



Possible Symbicort side effects in female

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

Patient: female

Reactions: Drug Dose Omission, Off Label Use, Respiratory Disorder, Insomnia, Disturbance in Attention, Hangover

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Indication: Sleep Disorder

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Depression

Seroquel
    Administration route: Oral

Symbicort
    Indication: Chronic Obstructive Pulmonary Disease

Other drugs received by patient: Nasacort; Imatrix; Albuterol; Elavil



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, Respiratory Tract Congestion

Drug(s) suspected as cause:
Symbicort
    Dosage: two puffs, two times a day
    Indication: Bronchitis

Symbicort
    Dosage: two puffs, two times a day
    Indication: Respiratory Tract Congestion



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, Drug Ineffective, Oropharyngeal Pain

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 57 year old female

Reported by a physician from United States on 2012-08-24

Patient: 57 year old female

Reactions: Off Label Use

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

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Nexium
    Administration route: Oral
    Indication: Essential Hypertension

Nexium
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus

Nexium
    Administration route: Oral
    Indication: Type V Hyperlipidaemia

Symbicort
    Dosage: 160/4.5 mcg 2 puffs two times daily
    Indication: Essential Hypertension

Symbicort
    Dosage: 160/4.5 mcg 2 puffs two times daily
    Indication: Gastrooesophageal Reflux Disease

Symbicort
    Dosage: 160/4.5 mcg 2 puffs two times daily
    Indication: Chest Pain

Symbicort
    Dosage: 160/4.5 mcg 2 puffs two times daily
    Indication: Type V Hyperlipidaemia

Symbicort
    Dosage: 160/4.5 mcg 2 puffs two times daily
    Indication: Type 2 Diabetes Mellitus



Possible Symbicort side effects in 69 year old female

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

Patient: 69 year old female, weighing 52.2 kg (114.8 pounds)

Reactions: Off Label Use, Dyspnoea, Drug Ineffective, Adverse Reaction

Drug(s) suspected as cause:
Symbicort
    Dosage: 2 puffs when needed

Symbicort
    Dosage: 2 puffs qam
    Indication: Emphysema

Symbicort
    Dosage: 2 puffs when needed

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

Other drugs received by patient: Blood Pressure Medication; Spiriva



Possible Symbicort side effects in 69 year old female

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

Patient: 69 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Off Label Use, Dyspnoea, Drug Ineffective, Dysphonia, Wheezing, Hypoxia, Respiratory Tract Infection

Drug(s) suspected as cause:
Symbicort
    Dosage: 160/4.5 mcg, 1 puff bid
    Indication: Asthma

Symbicort
    Dosage: 80/4.5 mcg, 1 puff bid

Other drugs received by patient: Singulair; Multiple Vitamin with Herbal Supplement; Levothyroxine Sodium; Ventolin; Xolair; Nitrofurantoin; Multivitamin with Iron; Calcium with Vitamin D; Singulair



Possible Symbicort side effects in female

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

Patient: female

Reactions: Hypoacusis, Drug Dose Omission, Off Label Use

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 55 year old female

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

Patient: 55 year old female

Reactions: Off Label Use, Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Symbicort

Other drugs received by patient: Three Different Medication



Possible Symbicort side effects in 39 year old female

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

Patient: 39 year old female, weighing 53.1 kg (116.8 pounds)

Reactions: Off Label Use, Drug Dose Omission, Asthma

Drug(s) suspected as cause:
Symbicort
    Dosage: 160/4.5 mcg, two puffs, two times a day

Symbicort
    Dosage: one puff, per day
    Indication: Asthma



Possible Symbicort side effects in 74 year old female

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

Patient: 74 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Off Label Use, Dyspnoea, Nervousness

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Indication: Nervousness
    Start date: 2011-11-01

Seroquel
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2011-11-01

Symbicort
    Dosage: 160/4.5 mcg, 1 puffs two times daily

Symbicort
    Dosage: 160/4.5 mcg, 2 puffs two times daily
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-06-07

Other drugs received by patient: Trazidone; Xanax; Ventolin; Dulcolax; Protonic; Aspirin; Paxil; Lasix



Possible Symbicort side effects in female

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

Patient: female, weighing 72.6 kg (159.7 pounds)

Reactions: Back Pain, Off Label Use, Heart Rate Increased, Bone Pain, Chills, Candidiasis, Inflammation

Drug(s) suspected as cause:
Symbicort

Other drugs received by patient: Aspirin; Vitamin B Complex CAP; Spirva; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Garlic; Vitamin D; Vitamin B-12; Bumex; Purinol



Possible Symbicort side effects in 54 year old male

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

Patient: 54 year old male, weighing 91.6 kg (201.5 pounds)

Reactions: Off Label Use, Drug Dose Omission, Dyspnoea

Drug(s) suspected as cause:
Symbicort

Other drugs received by patient: Bystolic; Lozartan Potassium; Hydrochlorothiazide; Pravastatin



Possible Symbicort side effects in 10 year old

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

Patient: 10 year old

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, Visual Field Defect

Drug(s) suspected as cause:
Symbicort

Other drugs received by patient: Serevent; Vitamin TAB; Three Different EYE Drops



Possible Symbicort side effects in 69 year old male

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

Patient: 69 year old male, weighing 78.9 kg (173.6 pounds)

Reactions: Drug Dose Omission, Off Label Use, Hiatus Hernia, Cough

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

Symbicort
    Dosage: 160/4.5 mcg, 120 inhalations, bid

Other drugs received by patient: Little White Pill



Possible Symbicort side effects in 50 year old female

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

Patient: 50 year old female, weighing 66.7 kg (146.7 pounds)

Reactions: Off Label Use, Wheezing, Intentional Drug Misuse, 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, Malaise

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 62 year old female

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

Patient: 62 year old female, weighing 99.8 kg (219.6 pounds)

Reactions: Drug Ineffective, Intentional Drug Misuse, Nasal Congestion, Lower Respiratory Tract Infection, Off Label Use, Adverse Event, Bronchitis, Cough

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

Nexium
    Dosage: twice daily
    Administration route: Oral

Nexium
    Dosage: once daily
    Administration route: Oral

Symbicort
    Dosage: 320 mcg bid
    Indication: Chronic Obstructive Pulmonary Disease

Other drugs received by patient: Vitamin TAB; Crestor; Water Pill



Possible Symbicort side effects in 55 year old male

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

Patient: 55 year old male, weighing 106.1 kg (233.4 pounds)

Reactions: Weight Decreased, Off Label Use, Drug Dose Omission, Cough

Drug(s) suspected as cause:
Lisinopril and Hydrochlorothiazide
    Administration route: Oral

Symbicort
    Dosage: 160/4.5 mcg, 2 puffs as required
    Indication: Oesophageal Oedema

Other drugs received by patient: Bystolic; Simvastatin; Metformin HCL



Possible Symbicort side effects in 83 year old male

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

Patient: 83 year old male

Reactions: Off Label Use, Hypertension

Drug(s) suspected as cause:
Symbicort
    Dosage: 160-4.5 mcg, every day
    Indication: Respiratory Disorder
    Start date: 2011-11-01

Symbicort
    Dosage: one puff or two puffs bid prn

Other drugs received by patient: Celebrex; Detrol; Hydrocodone Bitartrate



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, weighing 97.5 kg (214.5 pounds)

Reactions: Off Label Use, Adverse Drug Reaction, Gait Disturbance, Muscle Spasms, Influenza Like Illness

Drug(s) suspected as cause:
Symbicort
    Dosage: total daily dosage 80/4.5 one puff twice a day
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-11-10
    End date: 2012-01-15

Symbicort
    Dosage: total daily dosage 80/4.5 one puff twice a day
    Indication: Pleurisy
    Start date: 2011-11-10
    End date: 2012-01-15

Other drugs received by patient: Lisinopril; Thyroid Medications; Insulin Lantis



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