This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Pulmicort (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 (427)
Death (12)
Life Threatening Events (15)
Disability (3)
Reports by Reaction Type
Asthma (88),
Dyspnoea (87),
Off Label Use (83),
Drug Dose Omission (70),
Malaise (62),
Cough (33),
Chronic Obstructive Pulmonary Disease (29),
Drug Ineffective (24),
Pneumonia (23),
Dysphonia (18),
Intentional Drug Misuse (17),
Fall (17)
Below are a few examples of reports where side effects / adverse reactions may be related to Pulmicort (Budesonide Inhalation). For a complete list or a specific selection of reports, please use the links above.
Possible Pulmicort side effects in 10 year old male
Reported by a consumer/non-health professional from China on 2012-08-27
Patient: 10 year old male
Reactions: Asthma, Drug Dose Omission, Bronchial Secretion Retention, Bronchitis, Varicella, Tracheitis
Drug(s) suspected as cause:
Pulmicort
Start date: 2009-01-01
Pulmicort
Dosage: 1 spray daily
Indication: Asthma
Start date: 2007-01-01
Other drugs received by patient: Bronchodilators
Possible Pulmicort side effects in 1 year old male
Reported by a physician from China on 2012-08-27
Patient: 1 year old male
Reactions: Dyspnoea
Drug(s) suspected as cause:
Pulmicort
Other drugs received by patient: Bricanyl; Atrovent
Possible Pulmicort side effects in male
Reported by a physician from China on 2012-08-27
Patient: male, weighing 55.8 kg (122.8 pounds)
Reactions: Asthma, Dyspnoea, Drug Ineffective, Oropharyngeal Discomfort
Drug(s) suspected as cause:
Pulmicort
Other drugs received by patient: Atrovent; Kebite
Possible Pulmicort side effects in female
Reported by a physician from China on 2012-08-27
Patient: female, weighing 55.8 kg (122.8 pounds)
Reactions: Asthma, Drug Ineffective
Drug(s) suspected as cause:
Pulmicort
Indication: Asthma
Start date: 2011-05-01
End date: 2011-05-30
Pulmicort
Indication: Bronchitis Chronic
Start date: 2011-05-01
End date: 2011-05-30
Terbutaline Sulfate
Indication: Bronchitis Chronic
Start date: 2011-05-01
End date: 2012-05-30
Terbutaline Sulfate
Indication: Asthma
Start date: 2011-05-01
End date: 2012-05-30
Possible Pulmicort 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 Pulmicort side effects in male
Reported by a physician from China on 2012-08-27
Patient: male, weighing 55.8 kg (122.8 pounds)
Reactions: Dyspnoea
Drug(s) suspected as cause:
Pulmicort
Possible Pulmicort side effects in 51 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 51 year old female
Reactions: Weight Increased, Hypersensitivity, Arthralgia, Insomnia, Depression, Gastric Disorder
Drug(s) suspected as cause:
Allegra
Asmanex Twisthaler
Administration route: Oral
Indication: Asthma
Dulera
Fluticasone Propionate
Loratadine and Pseudoephedrine Sulfate
Prednisone TAB
Pulmicort
Singulair
Symbicort
Zyrtec
Other drugs received by patient: Albuterol; Albuterol
Possible Pulmicort side effects in 92 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 92 year old female
Reactions: Off Label Use, Lung Infection, Drug Intolerance
Drug(s) suspected as cause:
Pulmicort
Possible Pulmicort side effects in 61 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 61 year old female
Reactions: Off Label Use, Drug Dose Omission, Cervical Vertebral Fracture, Dyspnoea, Malaise, Upper Limb Fracture, Fall
Drug(s) suspected as cause:
Pulmicort
Other drugs received by patient: Xanax
Possible Pulmicort side effects in 68 year old female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 68 year old female
Reactions: Off Label Use, Lung Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pulmicort
Dosage: generic
Pulmicort
Possible Pulmicort side effects in 61 year old female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 61 year old female, weighing 63.5 kg (139.7 pounds)
Reactions: Back Pain, Fatigue, Vomiting, Nausea, Dyspepsia, Salivary Hypersecretion, Feeling Abnormal
Drug(s) suspected as cause:
Crestor
Administration route: Oral
Indication: Hypercholesterolaemia
Start date: 2007-08-20
Pulmicort
Symbicort
Start date: 2012-02-01
End date: 2012-02-28
Other drugs received by patient: Vitamin D Supplements; Lamictal; Neurontin; Plavix; Combivent; Seroquel; Forteo; Calcium; Fish OIL; Lithium Sulfate
Possible Pulmicort side effects in 64 year old female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 64 year old female
Reactions: Drug Dose Omission, Pneumonia, Dyspnoea, non-Cardiac Chest Pain, Malaise, Bronchitis, Nocturnal Dyspnoea, Arthritis, Gastrooesophageal Reflux Disease
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Pulmicort
Rhinocort
Symbicort
Dosage: 160/4.5 mcg with unknown frequency
Indication: Chronic Obstructive Pulmonary Disease
Other drugs received by patient: Prednisone TAB
Possible Pulmicort side effects in 80 year old male
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 80 year old male
Reactions: Drug Dose Omission, Dyspnoea, Insomnia
Drug(s) suspected as cause:
Pulmicort
Possible Pulmicort side effects in male
Reported by a physician from China on 2012-08-20
Patient: male, weighing 70.0 kg (154.0 pounds)
Reactions: Dyspnoea, Chest Discomfort, Cyanosis, Tachycardia, Rash, Erythema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pulmicort
Indication: Asthma
Start date: 2010-02-10
End date: 2010-02-10
Sodium Chloride
Start date: 2010-02-10
End date: 2010-02-10
Other drugs received by patient: Ipratropium Bromide
Possible Pulmicort side effects in 74 year old female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: 74 year old female
Reactions: Drug Dose Omission, Asthma, Off Label Use, Malaise, Dyspnoea, Feeling Abnormal, Pulmonary Function Test Decreased
Drug(s) suspected as cause:
Pulmicort
Dosage: generic
Pulmicort
Pulmicort
Other drugs received by patient: Prednisone TAB
Possible Pulmicort side effects in 78 year old female
Reported by a pharmacist from United States on 2012-08-16
Patient: 78 year old female
Reactions: Off Label Use, Agitation
Drug(s) suspected as cause:
Pulmicort
Other drugs received by patient: Xopenex
Possible Pulmicort side effects in male
Reported by a physician from China on 2012-08-16
Patient: male, weighing 13.0 kg (28.6 pounds)
Reactions: Dyspnoea, Diarrhoea, Cyanosis, Tachycardia, Oliguria, Mental Disorder DUE To A General Medical Condition
Drug(s) suspected as cause:
Pulmicort
Other drugs received by patient: Terbutaline Sulfate; Cefmetazole Sodium; Diprophylline
Possible Pulmicort side effects in female
Reported by a physician from China on 2012-08-15
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Vomiting, LIP DRY, Dizziness, Pallor
Drug(s) suspected as cause:
Pulmicort
Possible Pulmicort side effects in 62 year old female
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: 62 year old female
Reactions: Drug Dose Omission, Off Label Use, Lung Disorder, Activities of Daily Living Impaired, Chronic Obstructive Pulmonary Disease
Drug(s) suspected as cause:
Pulmicort
Possible Pulmicort side effects in male
Reported by a physician from Japan on 2012-08-13
Patient: male
Reactions: Asthma, Cerebral Infarction, Hyperkalaemia, Ventricular Fibrillation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aliskiren
Dosage: unk
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-02-18
End date: 2010-03-03
Aliskiren
Dosage: unk
Administration route: Oral
Start date: 2010-03-04
End date: 2012-02-02
Aliskiren
Dosage: unk
Administration route: Oral
Start date: 2012-02-15
End date: 2012-03-22
Allopurinol
Dosage: 200 mg, unk
Administration route: Oral
Start date: 2008-09-18
Aspirin
Dosage: 200 mg, unk
Administration route: Oral
Start date: 2011-08-10
End date: 2011-08-18
Aspirin
Dosage: 200 mg, unk
Administration route: Oral
Indication: Prophylaxis
Start date: 2008-07-22
Aspirin
Dosage: 100 mg, unk
Administration route: Oral
Start date: 2011-10-21
Aspirin
Dosage: 200 mg, unk
Administration route: Oral
Start date: 2011-07-28
Carvedilol
Dosage: 10 mg, unk
Administration route: Oral
Indication: Cardiac Failure Chronic
Start date: 2008-12-11
Enalapril Maleate
Dosage: unk
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-01-07
End date: 2010-03-03
Enalapril Maleate
Dosage: unk
Administration route: Oral
Start date: 2010-03-04
End date: 2012-02-02
Enalapril Maleate
Dosage: unk
Administration route: Oral
Start date: 2012-02-15
End date: 2012-03-22
Lasix
Dosage: 40 mg, unk
Administration route: Oral
Indication: Cardiac Failure Chronic
Start date: 2008-07-22
Lipitor
Dosage: 10 mg, unk
Administration route: Oral
Start date: 2008-07-22
Pulmicort
Dosage: unk
Start date: 2011-09-15
Rabeprazole Sodium
Dosage: 10 mg, unk
Administration route: Oral
Indication: Prophylaxis
Start date: 2008-07-22
Sigmart
Dosage: 15 mg, unk
Administration route: Oral
Indication: Prophylaxis
Start date: 2008-07-22
Slow-K
Dosage: 600 mg, unk
Administration route: Oral
Indication: Hypokalaemia
Start date: 2010-09-16
Warfarin Sodium
Dosage: 3.25 mg, unk
Administration route: Oral
Start date: 2011-09-16
Warfarin Sodium
Dosage: 3.5 mg, unk
Administration route: Oral
Start date: 2011-04-28
End date: 2011-08-03
Warfarin Sodium
Dosage: 3.5 mg, unk
Administration route: Oral
Start date: 2011-08-10
End date: 2011-08-21
Warfarin Sodium
Dosage: 3.5 mg, unk
Administration route: Oral
Start date: 2011-08-27
End date: 2011-09-05
Possible Pulmicort side effects in male
Reported by a physician from Japan on 2012-08-13
Patient: male
Reactions: Asthma, Cerebral Infarction, Hyperkalaemia, Ventricular Fibrillation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aliskiren
Dosage: unk
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-02-18
End date: 2010-03-03
Aliskiren
Dosage: unk
Administration route: Oral
Start date: 2010-03-04
End date: 2012-02-02
Aliskiren
Dosage: unk
Administration route: Oral
Start date: 2012-02-15
End date: 2012-03-22
Allopurinol
Dosage: 200 mg, unk
Administration route: Oral
Start date: 2008-09-18
Aspirin
Dosage: 200 mg, unk
Administration route: Oral
Start date: 2011-07-28
Aspirin
Dosage: 200 mg, unk
Administration route: Oral
Start date: 2011-08-10
End date: 2011-08-18
Aspirin
Dosage: 200 mg, unk
Administration route: Oral
Indication: Prophylaxis
Start date: 2008-07-22
Aspirin
Dosage: 100 mg, unk
Administration route: Oral
Start date: 2011-10-21
Carvedilol
Dosage: 10 mg, unk
Administration route: Oral
Indication: Cardiac Failure Chronic
Start date: 2008-12-11
Enalapril Maleate
Dosage: unk
Administration route: Oral
Start date: 2012-02-15
End date: 2012-03-22
Enalapril Maleate
Dosage: unk
Administration route: Oral
Start date: 2010-03-04
End date: 2012-02-02
Enalapril Maleate
Dosage: unk
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-01-07
End date: 2010-03-03
Lasix
Dosage: 40 mg, unk
Administration route: Oral
Indication: Cardiac Failure Chronic
Start date: 2008-07-22
Lipitor
Dosage: 10 mg, unk
Administration route: Oral
Start date: 2008-07-22
Pulmicort
Dosage: unk
Start date: 2011-09-15
Rabeprazole Sodium
Dosage: 10 mg, unk
Administration route: Oral
Indication: Prophylaxis
Start date: 2008-07-22
Sigmart
Dosage: 15 mg, unk
Administration route: Oral
Indication: Prophylaxis
Start date: 2008-07-22
Slow-K
Dosage: 600 mg, unk
Administration route: Oral
Indication: Hypokalaemia
Start date: 2010-09-16
Warfarin Sodium
Dosage: 3.5 mg, unk
Administration route: Oral
Start date: 2011-08-27
End date: 2011-09-05
Warfarin Sodium
Dosage: 3.5 mg, unk
Administration route: Oral
Start date: 2011-04-28
End date: 2011-08-03
Warfarin Sodium
Dosage: 3.5 mg, unk
Administration route: Oral
Start date: 2011-08-10
End date: 2011-08-21
Warfarin Sodium
Dosage: 3.25 mg, unk
Administration route: Oral
Start date: 2011-09-16
Possible Pulmicort side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: female
Reactions: Weight Decreased, Malaise, Intentional Drug Misuse, Chronic Obstructive Pulmonary Disease
Drug(s) suspected as cause:
Pulmicort
Dosage: 0.5 mcg/2 ml, half of the respule in the morning and half at night
Start date: 2012-07-01
Pulmicort
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2011-01-01
Possible Pulmicort side effects in 62 year old female
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: 62 year old female
Reactions: Malaise
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pulmicort
Possible Pulmicort side effects in female
Reported by a physician from China on 2012-08-13
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Pharyngeal Hypoaesthesia, Convulsion
Drug(s) suspected as cause:
Pulmicort
Possible Pulmicort side effects in 65 year old female
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: 65 year old female
Reactions: Drug Intolerance
Drug(s) suspected as cause:
Pulmicort
Possible Pulmicort side effects in male
Reported by a physician from Japan on 2012-08-13
Patient: male
Reactions: Asthma, Cerebral Infarction, Hyperkalaemia, Ventricular Fibrillation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aliskiren
Dosage: unk
Administration route: Oral
Start date: 2010-03-04
End date: 2012-02-02
Aliskiren
Dosage: unk
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-02-18
End date: 2010-03-03
Allopurinol
Dosage: 200 mg, unk
Administration route: Oral
Start date: 2008-09-18
Aspirin
Dosage: 200 mg, unk
Administration route: Oral
Start date: 2011-07-28
Aspirin
Dosage: 100 mg, unk
Administration route: Oral
Start date: 2011-10-21
Aspirin
Dosage: 200 mg, unk
Administration route: Oral
Start date: 2011-08-10
End date: 2011-08-18
Aspirin
Dosage: 200 mg, unk
Administration route: Oral
Indication: Prophylaxis
Start date: 2008-07-22
Carvedilol
Dosage: 10 mg, unk
Administration route: Oral
Indication: Cardiac Failure Chronic
Start date: 2008-12-11
Enalapril Maleate
Dosage: unk
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-01-07
End date: 2010-03-03
Enalapril Maleate
Dosage: unk
Administration route: Oral
Start date: 2010-03-04
End date: 2012-02-02
Lasix
Dosage: 40 mg, unk
Administration route: Oral
Indication: Cardiac Failure Chronic
Start date: 2008-07-22
Lipitor
Dosage: 10 mg, unk
Administration route: Oral
Start date: 2008-07-22
Pulmicort
Dosage: unk
Start date: 2011-09-15
Rabeprazole Sodium
Dosage: 10 mg, unk
Administration route: Oral
Indication: Prophylaxis
Start date: 2008-07-22
Sigmart
Dosage: 15 mg, unk
Administration route: Oral
Indication: Prophylaxis
Start date: 2008-07-22
Slow-K
Dosage: 600 mg, unk
Administration route: Oral
Indication: Hypokalaemia
Start date: 2010-09-16
Warfarin Sodium
Dosage: 3.5 mg, unk
Administration route: Oral
Start date: 2011-08-27
End date: 2011-09-05
Warfarin Sodium
Dosage: 3.5 mg, unk
Administration route: Oral
Start date: 2011-08-10
End date: 2011-08-21
Warfarin Sodium
Dosage: 3.5 mg, unk
Administration route: Oral
Start date: 2011-04-28
End date: 2011-08-03
Warfarin Sodium
Dosage: 3.25 mg, unk
Administration route: Oral
Start date: 2011-09-16
Possible Pulmicort side effects in male
Reported by a physician from China on 2012-08-13
Patient: male, weighing 50.0 kg (110.0 pounds)
Reactions: Asthma
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Pulmicort
Other drugs received by patient: Atrovent; Bricanyl
Possible Pulmicort side effects in male
Reported by a physician from Japan on 2012-08-10
Patient: male
Reactions: Asthma, Cerebral Infarction, Hyperkalaemia, Ventricular Fibrillation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aliskiren
Dosage: unk
Administration route: Oral
Start date: 2010-03-04
End date: 2012-02-02
Aliskiren
Dosage: unk
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-02-18
End date: 2010-03-03
Allopurinol
Dosage: 200 mg, unk
Administration route: Oral
Start date: 2008-09-18
Aspirin
Dosage: 100 mg, unk
Administration route: Oral
Start date: 2011-10-21
Aspirin
Dosage: 200 mg, unk
Administration route: Oral
Start date: 2011-08-10
End date: 2011-08-18
Aspirin
Dosage: 200 mg, unk
Administration route: Oral
Indication: Prophylaxis
Start date: 2008-07-22
Aspirin
Dosage: 200 mg, unk
Administration route: Oral
Start date: 2011-07-28
Carvedilol
Dosage: 10 mg, unk
Administration route: Oral
Indication: Cardiac Failure Chronic
Start date: 2008-12-11
Enalapril Maleate
Dosage: unk
Administration route: Oral
Start date: 2010-03-04
End date: 2012-02-02
Enalapril Maleate
Dosage: unk
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-01-07
End date: 2010-03-03
Lasix
Dosage: 40 mg, unk
Administration route: Oral
Indication: Cardiac Failure Chronic
Start date: 2008-07-22
Lipitor
Dosage: 10 mg, unk
Administration route: Oral
Start date: 2008-07-22
Pulmicort
Dosage: unk
Start date: 2011-09-15
Rabeprazole Sodium
Dosage: 10 mg, unk
Administration route: Oral
Indication: Prophylaxis
Start date: 2008-07-22
Sigmart
Dosage: 15 mg, unk
Administration route: Oral
Indication: Prophylaxis
Start date: 2008-07-22
Slow-K
Dosage: 600 mg, unk
Administration route: Oral
Indication: Hypokalaemia
Start date: 2010-09-16
Warfarin Sodium
Dosage: 3.25 mg, unk
Administration route: Oral
Start date: 2011-09-16
Warfarin Sodium
Dosage: 3.5 mg, unk
Administration route: Oral
Start date: 2011-04-28
End date: 2011-08-03
Warfarin Sodium
Dosage: 3.5 mg, unk
Administration route: Oral
Start date: 2011-08-10
End date: 2011-08-21
Warfarin Sodium
Dosage: 3.5 mg, unk
Administration route: Oral
Start date: 2011-08-27
End date: 2011-09-05
Possible Pulmicort side effects in 46 year old female
Reported by a consumer/non-health professional from United States on 2012-08-09
Patient: 46 year old female
Reactions: Asthma, Nasopharyngitis, Adverse Drug Reaction, Drug Hypersensitivity, Chronic Obstructive Pulmonary Disease, Muscle Twitching, Anxiety, Rheumatoid Arthritis, Fibromyalgia, Insomnia, Musculoskeletal Stiffness, Muscle Spasms
Drug(s) suspected as cause:
Pulmicort
Seroquel
Administration route: Oral
Symbicort
Possible Pulmicort side effects in 20 year old female
Reported by a consumer/non-health professional from United States on 2012-08-08
Patient: 20 year old female
Reactions: Asthma
Drug(s) suspected as cause:
Pulmicort
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