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 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 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 82 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 82 year old female
Reactions: Chronic Obstructive Pulmonary Disease
Drug(s) suspected as cause:
Symbicort
Possible Symbicort side effects in 80 year old male
Reported by a physician from United States on 2012-08-24
Patient: 80 year old male
Reactions: Blood Glucose Decreased
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
Reactions: Malaise
Drug(s) suspected as cause:
Symbicort
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: Herpes Zoster
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: Dysphonia
Drug(s) suspected as cause:
Symbicort
Nexium
Administration route: Oral
Crestor
Administration route: Oral
Possible Symbicort side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female
Reactions: Condition Aggravated, Intentional Drug Misuse
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 51.3 kg (112.9 pounds)
Reactions: Fatigue, Nausea, Chills, Wheezing, Pain, Cough
Drug(s) suspected as cause:
Symbicort
Other drugs received by patient: Acid Reflux Medications; Hypertension Medication; Aspirin
Possible Symbicort side effects in 65 year old female
Reported by a individual with unspecified qualification from United States on 2012-08-24
Patient: 65 year old female, weighing 40.8 kg (89.8 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Diabetes Mellitus
Drug(s) suspected as cause:
Symbicort
Dosage: 160/4.5 mcg, 2 puffs, bid
Indication: Asthma
Symbicort
Dosage: 160/4.5 mcg, 2 puffs, once a day
Other drugs received by patient: Thyroid Medicines; Metformin HCL; Pravastatin
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 77 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 77 year old female
Reactions: Thyroid Disorder
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: Dyspepsia, Gastric Disorder
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Crestor
Administration route: Oral
Symbicort
Possible Symbicort side effects in female
Reported by a pharmacist from United States on 2012-08-24
Patient: female
Reactions: Respiratory Disorder
Drug(s) suspected as cause:
Symbicort
Possible Symbicort side effects in 90 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 90 year old female
Reactions: Circumstance or Information Capable of Leading To Medication Error, Dysphonia
Drug(s) suspected as cause:
Symbicort
Possible Symbicort side effects in 70 year old male
Reported by a physician from United States on 2012-08-24
Patient: 70 year old male
Reactions: Tooth Fracture
Drug(s) suspected as cause:
Symbicort
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