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Pulmicort (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 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 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 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 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 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 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 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 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 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 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 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 2012-08-13

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 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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