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Symbicort (Budesonide Inhalation) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Symbicort (Budesonide 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 (4895)
Death (120)
Life Threatening Events (60)
Disability (35)

Reports by Reaction Type

Dyspnoea (1177)Drug Dose Omission (965)Malaise (554)Asthma (476)Chronic Obstructive Pulmonary Disease (462)Intentional Drug Misuse (319)Off Label Use (282)Cough (273)Pneumonia (254)Drug Ineffective (235)Wheezing (148)Incorrect Dose Administered (147)

Below are a few examples of reports where side effects / adverse reactions may be related to Symbicort (Budesonide Inhalation). For a complete list or a specific selection of reports, please use the links above.

Possible Symbicort side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 61 year old female

Reactions: Transient Ischaemic Attack

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 36 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-27

Patient: 36 year old female, weighing 65.3 kg (143.7 pounds)

Reactions: Gallbladder Enlargement, Increased Upper Airway Secretion, Pneumonia, Vomiting, Pyrexia, Somnolence, Chronic Obstructive Pulmonary Disease, Loss of Consciousness, Sepsis, Abdominal Distension, Cough

Adverse event resulted in: life threatening event, hospitalization

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

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder

Symbicort
    Dosage: 160/4.5 mcg, 2 puffs, bid

Other drugs received by patient: Combivent; Clonazepam; Serrex Iron; Diltiazem



Possible Symbicort side effects in 6 year old male

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-27

Patient: 6 year old male, weighing 15.0 kg (33.0 pounds)

Reactions: Lactose Intolerance, Dyspnoea, Drug Hypersensitivity

Drug(s) suspected as cause:
Symbicort
    Dosage: 80 ug daily
    Start date: 2011-05-24
    End date: 2011-05-24

Symbicort
    Dosage: 160/90 ug bid
    Indication: Asthma



Possible Symbicort side effects in 67 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-27

Patient: 67 year old female

Reactions: Multiple Allergies

Drug(s) suspected as cause:
Symbicort

Accolate
    Administration route: Oral

Nexium
    Administration route: Oral

Crestor
    Administration route: Oral



Possible Symbicort side effects in 84 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 84 year old female

Reactions: Lung Neoplasm Malignant

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 64 year old male

Reactions: Lung Disorder, Respiratory Disorder, Pneumonia, Insomnia, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Symbicort



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 81 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 81 year old male

Reactions: Asthma, Drug Dose Omission, Nasopharyngitis, Dyspnoea, Prostate Cancer, Haemoptysis, Chronic Obstructive Pulmonary Disease, Abdominal Discomfort, Malaise, DRY Mouth, Disturbance in Attention, Hypertension, Myocardial Infarction

Drug(s) suspected as cause:
Symbicort
    Dosage: 80/4.5 mcg two puffs two times a day

Nexium
    Administration route: Oral

Toprol-XL
    Administration route: Oral

Crestor
    Administration route: Oral



Possible Symbicort side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 59 year old female

Reactions: Apparent Death

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Symbicort

Nexium
    Administration route: Oral



Possible Symbicort side effects in

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

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 64 year old male

Reactions: Road Traffic Accident

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 59 year old female

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 57 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 57 year old male

Reactions: Road Traffic Accident, Craniocerebral Injury

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 11 year old male

Reported by a physician from China on 2012-08-27

Patient: 11 year old male, weighing 25.0 kg (55.0 pounds)

Reactions: Osteonecrosis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Pulmicort
    Indication: Asthma
    Start date: 2006-01-01
    End date: 2010-01-01

Symbicort
    Dosage: 80/4.5 ug bid
    Indication: Asthma
    Start date: 2006-12-01
    End date: 2010-01-01

Other drugs received by patient: Dexamethasone; Theophylline; Dexamethasone



Possible Symbicort side effects in 84 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 84 year old female, weighing 57.2 kg (125.8 pounds)

Reactions: Drug Dose Omission, Productive Cough, Asthenopia, Drug Effect Decreased, Glaucoma, Decreased Activity, Upper-Airway Cough Syndrome, Pyrexia, Chronic Obstructive Pulmonary Disease, Macular Degeneration, Hepatic Enzyme Increased, Throat Irritation, Sinus Headache, Gait Disturbance

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

Symbicort
    Dosage: 640 mcg, two times a day
    Indication: Asthma
    Start date: 2010-02-17

Symbicort
    Dosage: 160/4.5 mcg, two puffs, two times a day

Symbicort
    Dosage: 640 mcg, two times a day
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2010-02-17

Other drugs received by patient: Albuterol; Steroids; Steroids; Vitamin TAB; Tylenol; Omeprazole



Possible Symbicort side effects in 68 year old male

Reported by a consumer/non-health professional from Canada on 2012-08-27

Patient: 68 year old male

Reactions: Dyspnoea, Hypersensitivity, Uvulitis, Intentional Drug Misuse, Throat Tightness, Palatal Oedema

Drug(s) suspected as cause:
Symbicort
    Dosage: occasionally up to four times a day

Symbicort
    Dosage: two inhalations, two times a day
    Indication: Asthma
    Start date: 2007-01-01

Other drugs received by patient: Bricanyl; Aspirin; Metformin HCL; Diamicron; Atorvastatin; Humulin R



Possible Symbicort side effects in 39 year old male

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

Patient: 39 year old male

Reactions: Asthma, Intentional Drug Misuse

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 65 year old female

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

Patient: 65 year old female

Reactions: Malaise

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: Asthma, Malaise

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in female

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

Patient: female

Reactions: Fibromyalgia

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 43 year old male

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

Patient: 43 year old male

Reactions: Malaise, Drug Prescribing Error

Drug(s) suspected as cause:
Symbicort
    Dosage: 80/4.5mcg unknown

Symbicort
    Dosage: 160/4.5mcg unknown



Possible Symbicort side effects in male

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

Patient: male

Reactions: Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 86 year old female

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

Patient: 86 year old female, weighing 62.6 kg (137.7 pounds)

Reactions: Asthma, Pain in Extremity, Adverse Event, Intentional Drug Misuse, Tinea Pedis

Drug(s) suspected as cause:
Symbicort
    Dosage: 160/4.5 micrograms unknown

Symbicort
    Dosage: 740mcg bid
    Indication: Asthma

Symbicort
    Dosage: 160 microgams two puffs twice a day
    Start date: 2008-01-01

Other drugs received by patient: Diltiazem; Aspirin; Zyrtec; Nexium; Hydralazine HCL



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: Lung Disorder, Neck Injury, Chronic Obstructive Pulmonary Disease

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: Asthma, Hearing Impaired

Drug(s) suspected as cause:
Symbicort



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

Reactions: Asthma, Lung Disorder, Malaise

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 54 year old female

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

Patient: 54 year old female

Reactions: Stress

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 69 year old male

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

Patient: 69 year old male, weighing 75.3 kg (165.7 pounds)

Reactions: Back Pain, Abnormal Dreams, Dyspnoea, Occupational Physical Problem, Viral Hepatitis Carrier, Incorrect Dose Administered, Headache, Hypersomnia

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 86 year old male

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

Patient: 86 year old male, weighing 72.6 kg (159.7 pounds)

Reactions: Drug Dose Omission, Off Label Use, Pain in Extremity, Musculoskeletal Pain, Increased Bronchial Secretion

Drug(s) suspected as cause:
Symbicort

Other drugs received by patient: Ibuprofen; Tamsulofin; Lipitor; Amlodipine; Nimenda; Prauvasid; Aricett; Ramperil



Possible Symbicort side effects in male

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

Patient: male

Reactions: Dyspepsia, Condition Aggravated

Drug(s) suspected as cause:
Symbicort
    Dosage: 160/ 4.5 mcg unknown

Symbicort
    Dosage: 160/ 4.5 mcg unknown

Symbicort
    Dosage: 80/ 4.5 mcg unknown

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