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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 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 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 43 year old female

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

Patient: 43 year old female

Reactions: Adverse Event, Intentional Drug Misuse, Chronic Obstructive Pulmonary Disease

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: Drug Dose Omission, Dysphonia

Drug(s) suspected as cause:
Symbicort

Other drugs received by patient: Albuterol



Possible Symbicort side effects in 64 year old female

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

Patient: 64 year old female

Reactions: Drug Dose Omission, Dyspnoea

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 50 year old female

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

Patient: 50 year old female

Reactions: LIP Swelling

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: Pneumonia

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 75 year old male

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

Patient: 75 year old male, weighing 102.1 kg (224.6 pounds)

Reactions: Choking Sensation, Off Label Use, Lung Infection, Wheezing, Epiglottitis, Blood Pressure Abnormal, Cough

Drug(s) suspected as cause:
Symbicort

Other drugs received by patient: Ranitidine; Magnesium; Luten; Medicine TO Stop Acid Reflux; Lisinopril; Beta-Carotene; Jalyn; Jalyn; Zinc Sulfate; Iron; Lovaza



Possible Symbicort side effects in 75 year old female

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

Patient: 75 year old female

Reactions: Weight Increased, Central Obesity

Drug(s) suspected as cause:
Symbicort

Other drugs received by patient: Blood Pressure Medication



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, Dyspnoea

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 67 year old female

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

Patient: 67 year old female

Reactions: Diverticulitis

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

Nexium
    Dosage: daily
    Administration route: Oral

Nexium
    Dosage: twice daily
    Administration route: Oral

Nexium
    Dosage: once daily
    Administration route: Oral

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



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

Reactions: Confusional State

Drug(s) suspected as cause:
Symbicort



Possible Symbicort side effects in 61 year old female

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

Patient: 61 year old female

Reactions: Drug Ineffective, Drug Prescribing Error, Chronic Obstructive Pulmonary Disease

Drug(s) suspected as cause:
Nexium
    Dosage: once per day
    Administration route: Oral

Symbicort

Nexium
    Dosage: two per day
    Administration route: Oral



Possible Symbicort side effects in 52 year old female

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

Patient: 52 year old female, weighing 83.5 kg (183.7 pounds)

Reactions: Wheezing, Chronic Obstructive Pulmonary Disease, Hyperhidrosis, Histoplasmosis, Fatigue, Chest Pain, Intervertebral Disc Degeneration, Carpal Tunnel Syndrome, Cough, Blood Pressure Increased, Chest Discomfort, Dyspnoea, Pneumonia, Spondylolisthesis, Dyspnoea Paroxysmal Nocturnal, Palatal Disorder, Convulsion, Hyperlipidaemia, Anxiety

Drug(s) suspected as cause:
Symbicort

Other drugs received by patient: Proventil-HFA; Singulair



Possible Symbicort side effects in 42 year old male

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

Patient: 42 year old male

Reactions: Respiratory Disorder

Drug(s) suspected as cause:
Symbicort

Seroquel XR
    Administration route: Oral

Other drugs received by patient: Proventil

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