Index of reports
> Life Threatening Events (15)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Pulmicort (Budesonide Inhalation) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
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 China on 2012-08-08
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: Bricanyl; Aijinle
Possible Pulmicort side effects in male
Reported by a physician from United States on 2012-07-17
Patient: male, weighing 68.2 kg (150.0 pounds)
Reactions: Angina Unstable, Myocardial Infarction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
NON Teva Study Drug
Dosage: twice daily
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2012-03-23
End date: 2012-04-08
Proair HFA
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2012-01-01
Pulmicort
Dosage: 360 mcg twice daily
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2012-03-01
End date: 2012-04-08
Other drugs received by patient: Fluticasone Propionate / Salmeterol
Possible Pulmicort side effects in female
Reported by a consumer/non-health professional from Canada on 2012-07-06
Patient: female, weighing 102.3 kg (225.1 pounds)
Reactions: Hypersensitivity, Hypoaesthesia Oral, Pruritus, Urticaria, Rash, Swollen Tongue
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Advair Diskus 100 / 50
Dosage: 1puff twice per day
Indication: Asthma
Start date: 2010-09-16
End date: 2011-09-13
Pulmicort
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Loratadine; Bricanyl; Fluticasone Propionate; Vitamin B-12; Singulair
Possible Pulmicort side effects in 47 year old male
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: 47 year old male
Reactions: Off Label Use, Coma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Pulmicort
Possible Pulmicort side effects in 74 year old female
Reported by a consumer/non-health professional from United States on 2012-05-11
Patient: 74 year old female
Reactions: Mycotic Allergy, Weight Decreased, Respiratory Disorder, Pruritus, Tinnitus, Tinea Infection, Flatulence, Pyrexia, Oropharyngeal Pain, Erythema, Apparent Death, Brain Injury, Malaise, Dyspepsia, Oropharyngitis Fungal, Skin Degenerative Disorder, Pharyngitis Streptococcal, Nasal Dryness, Aneurysm, Blood Test Abnormal, Cough, Back Pain, Oesophageal Pain, Chest Discomfort, Pain in Extremity, Musculoskeletal Discomfort, Sleep Disorder DUE To A General Medical Condition, Vocal Cord Paralysis, Gastric Disorder, Hyperphagia, Dysphonia, Choking, Thyroid Disorder, Disturbance in Attention, Bronchitis Fungal, Lacrimation Increased, Glaucoma, Hypersensitivity, Head Injury, Chills, Pain, Intentional Drug Misuse, Fall, Fatigue, Road Traffic Accident, Rotator Cuff Syndrome, Dizziness, Blood Sodium Decreased, Decreased Appetite, Blood Glucose Increased, Cataract, Urinary Tract Infection, Condition Aggravated, Rash, Amnesia, Nerve Compression, Anxiety, Hypothyroidism, Multiple Allergies, Arthritis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Pulmicort
Indication: Asthma
Pulmicort
Dosage: twice a day
Pulmicort
Other drugs received by patient: Sedia; Hydrocodone Bitartrate; Darvon; Ibuprofen; Tramadol Hydrochloride; Azmacort; Tylenol (Caplet)
Possible Pulmicort side effects in 63 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-08
Patient: 63 year old male, weighing 68.2 kg (150.0 pounds)
Reactions: Hyperlipidaemia, Dyspepsia, Angina Unstable, Hypertension, Acute Myocardial Infarction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Proair HFA
Dosage: as required
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2012-01-01
Pulmicort
Start date: 2012-03-01
End date: 2012-04-08
Study Drug
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2012-03-27
End date: 2012-04-08
Other drugs received by patient: Advair Diskus 100 / 50; Norvasc; Plavix; Aspirin; Simvastatin; Nitroglycerin
Possible Pulmicort side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-30
Patient: male, weighing 68.2 kg (150.0 pounds)
Reactions: Angina Unstable, Myocardial Infarction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Proair HFA
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2012-01-01
Pulmicort
Start date: 2012-03-01
End date: 2012-04-08
Study Drug
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2012-03-27
End date: 2012-04-08
Other drugs received by patient: Advair Diskus 100 / 50
Possible Pulmicort side effects in 74 year old female
Reported by a consumer/non-health professional from United States on 2012-03-19
Patient: 74 year old female
Reactions: Mycotic Allergy, Drug Dose Omission, Weight Decreased, Respiratory Disorder, Pruritus, Tinnitus, Tinea Infection, Flatulence, Oropharyngeal Pain, Pyrexia, Erythema, Apparent Death, Brain Injury, Malaise, Dyspepsia, Oropharyngitis Fungal, Skin Degenerative Disorder, Nasal Dryness, Pharyngitis Streptococcal, Aneurysm, Cough, Blood Test Abnormal, Oesophageal Pain, Chest Discomfort, Pain in Extremity, Musculoskeletal Discomfort, Vocal Cord Paralysis, Gastric Disorder, Hyperphagia, Dysphonia, Choking, Thyroid Disorder, Disturbance in Attention, Bronchitis Fungal, Lacrimation Increased, Glaucoma, Hypersensitivity, Head Injury, Chills, Pain, Fall, Fatigue, Road Traffic Accident, Rotator Cuff Syndrome, Dizziness, Blood Sodium Decreased, Blood Glucose Increased, Decreased Appetite, Cataract, Urinary Tract Infection, Rhinorrhoea, Rash, Amnesia, Nerve Compression, Anxiety, Pollakiuria, Hypothyroidism, Multiple Allergies, Arthritis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Pulmicort
Indication: Asthma
Pulmicort
Pulmicort
Dosage: twice a day
Other drugs received by patient: Tramadol HCL; Sedia; Ibuprofen; Azmacort; Hydrocodone; Darvon; Tylenol
Possible Pulmicort side effects in female
Reported by a consumer/non-health professional from Sweden on 2012-03-19
Patient: female
Reactions: Anaphylactic Shock
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Formoterol Fumarate
Indication: Asthma
Formoterol Fumarate
Indication: Emphysema
Pulmicort
Indication: Emphysema
Pulmicort
Indication: Asthma
Possible Pulmicort side effects in female
Reported by a pharmacist from Sweden on 2012-02-28
Patient: female
Reactions: Anaphylactic Shock
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Formoterol Fumarate
Pulmicort
Possible Pulmicort side effects in 47 year old female
Reported by a consumer/non-health professional from United States on 2012-02-06
Patient: 47 year old female, weighing 111.1 kg (244.4 pounds)
Reactions: Thrombosis, Asthma, Malaise, Respiratory Failure, Fungal Infection, Candidiasis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Pulmicort
Symbicort
Dosage: 160/4.5 mcg two puffs two times a day
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2008-10-01
Symbicort
Dosage: 160/4.5 mcg two puffs two times a day
Indication: Asthma
Start date: 2008-10-01
Other drugs received by patient: Fosamax; Coumadin; Prevacid; Simvastatin; Xoponex
Possible Pulmicort side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-01-30
Patient: 50 year old female
Reactions: Gastrointestinal Infection, Apparent Death, Asthma, Gastrointestinal Disorder, Reproductive Tract Disorder, Cyst
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Pulmicort
Symbicort
Possible Pulmicort side effects in 3 month old
Reported by a pharmacist from Japan on 2011-12-19
Patient: 3 month old
Reactions: Off Label Use, Pneumonia, Dehydration
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Pulmicort
Other drugs received by patient: Asverin; Meptin; Onon; Mucodyne; Erythrocin Lactobionate
Possible Pulmicort side effects in 3 month old
Reported by a pharmacist from Japan on 2011-11-01
Patient: 3 month old
Reactions: Pneumonia, Dehydration
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Pulmicort
Other drugs received by patient: Meptin; Mucodyne; Asverin; Erythrocin Lactobionate; Onon
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