Drug information for PULMICORT FLEXHALER

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
POWDER, METERED; INHALATION 0.08MG/INH Prescription   BUDESONIDE Budesonide ASTRAZENECA 21949
2010-07-08 Letter
2010-07-06 Label
2008-11-17 Review
2008-06-19 Letter
2008-06-18 Label
2008-04-16 Letter
2008-04-16 Label
2007-07-05 Letter
2007-06-27 Label
2007-02-23 Letter
2007-02-23 Label
2006-07-21 Letter
2006-07-13 Label
POWDER, METERED; INHALATION 0.16MG/INH Prescription  (Reference Drug) BUDESONIDE Budesonide ASTRAZENECA   "

Drug Adverse Effects information for PULMICORT FLEXHALER

Role code Indications Reaction # Reports
PS ASTHMA AGGRESSION 1
PS ASTHMA ASTHMA 4
PS ASTHMA BLOOD TESTOSTERONE DECREASED 4
PS ASTHMA DEAFNESS UNILATERAL 4
PS ASTHMA DEPRESSION 5
PS ASTHMA EMOTIONAL POVERTY 1
PS ASTHMA FATIGUE 4
PS ASTHMA SKIN STRIAE 5
PS ASTHMA STRESS 4
PS HYPERLIPIDAEMIA ABDOMINAL PAIN UPPER 1
PS HYPERLIPIDAEMIA ACUTE CORONARY SYNDROME 1
PS HYPERLIPIDAEMIA ACUTE MYOCARDIAL INFARCTION 1
PS HYPERLIPIDAEMIA BACK PAIN 1
PS HYPERLIPIDAEMIA BRONCHITIS CHRONIC 1
PS HYPERLIPIDAEMIA CARDIOMEGALY 1
PS HYPERLIPIDAEMIA CHEST DISCOMFORT 1
PS HYPERLIPIDAEMIA CHEST PAIN 1
PS HYPERLIPIDAEMIA COLONIC POLYP 1
PS HYPERLIPIDAEMIA CORONARY ARTERY DISEASE 1
PS HYPERLIPIDAEMIA DYSPEPSIA 1
PS HYPERLIPIDAEMIA DYSPNOEA 1
PS HYPERLIPIDAEMIA ERUCTATION 1
PS HYPERLIPIDAEMIA HYPERHIDROSIS 1
PS HYPERLIPIDAEMIA NAUSEA 1
PS HYPERLIPIDAEMIA PEPTIC ULCER HAEMORRHAGE 1
PS HYPERSENSITIVITY SKIN STRIAE 1
PS PRURITUS ASTHMA 1
PS PRURITUS BLOOD TESTOSTERONE DECREASED 1
PS PRURITUS DEAFNESS UNILATERAL 1
PS PRURITUS DEPRESSION 1
PS PRURITUS FATIGUE 1
PS PRURITUS STRESS 1
PS RHINITIS ALLERGIC SKIN STRIAE 4
PS TYPE 2 DIABETES MELLITUS ABDOMINAL PAIN UPPER 2
PS TYPE 2 DIABETES MELLITUS ACUTE CORONARY SYNDROME 2
PS TYPE 2 DIABETES MELLITUS ACUTE MYOCARDIAL INFARCTION 2
PS TYPE 2 DIABETES MELLITUS BACK PAIN 2
PS TYPE 2 DIABETES MELLITUS BRONCHITIS CHRONIC 2
PS TYPE 2 DIABETES MELLITUS CARDIOMEGALY 2
PS TYPE 2 DIABETES MELLITUS CHEST DISCOMFORT 2
PS TYPE 2 DIABETES MELLITUS CHEST PAIN 2
PS TYPE 2 DIABETES MELLITUS COLONIC POLYP 2
PS TYPE 2 DIABETES MELLITUS CORONARY ARTERY DISEASE 2
PS TYPE 2 DIABETES MELLITUS DYSPEPSIA 2
PS TYPE 2 DIABETES MELLITUS DYSPNOEA 2
PS TYPE 2 DIABETES MELLITUS ERUCTATION 2
PS TYPE 2 DIABETES MELLITUS HYPERHIDROSIS 2
PS TYPE 2 DIABETES MELLITUS NAUSEA 2
PS TYPE 2 DIABETES MELLITUS PEPTIC ULCER HAEMORRHAGE 2
SS ARTHRITIS AMNESIA 1
SS ARTHRITIS BRAIN INJURY 1
SS ARTHRITIS CEREBRAL HAEMORRHAGE 1
SS ARTHRITIS CEREBROVASCULAR ACCIDENT 1
SS ARTHRITIS EYE INJURY 1
SS ARTHRITIS FALL 1
SS ARTHRITIS HAEMORRHOIDS 2
SS ASTHMA HAEMORRHOIDS 1
SS ASTHMA SKIN STRIAE 8
SS BLOOD GLUCOSE ABNORMAL AMNESIA 1
SS BLOOD GLUCOSE ABNORMAL BRAIN INJURY 1
SS BLOOD GLUCOSE ABNORMAL CEREBRAL HAEMORRHAGE 1
SS BLOOD GLUCOSE ABNORMAL CEREBROVASCULAR ACCIDENT 1
SS BLOOD GLUCOSE ABNORMAL EYE INJURY 1
SS BLOOD GLUCOSE ABNORMAL FALL 1
SS BLOOD PRESSURE ABNORMAL AMNESIA 3
SS BLOOD PRESSURE ABNORMAL BRAIN INJURY 3
SS BLOOD PRESSURE ABNORMAL CEREBRAL HAEMORRHAGE 3
SS BLOOD PRESSURE ABNORMAL CEREBROVASCULAR ACCIDENT 3
SS BLOOD PRESSURE ABNORMAL EYE INJURY 3
SS BLOOD PRESSURE ABNORMAL FALL 3
SS CARDIAC DISORDER AMNESIA 1
SS CARDIAC DISORDER BRAIN INJURY 1
SS CARDIAC DISORDER CEREBRAL HAEMORRHAGE 1
SS CARDIAC DISORDER CEREBROVASCULAR ACCIDENT 1
SS CARDIAC DISORDER EYE INJURY 1
SS CARDIAC DISORDER FALL 1
SS CHOLINERGIC SYNDROME AMNESIA 1
SS CHOLINERGIC SYNDROME BRAIN INJURY 1
SS CHOLINERGIC SYNDROME CEREBRAL HAEMORRHAGE 1
SS CHOLINERGIC SYNDROME CEREBROVASCULAR ACCIDENT 1
SS CHOLINERGIC SYNDROME EYE INJURY 1
SS CHOLINERGIC SYNDROME FALL 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE AMNESIA 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE BRAIN INJURY 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE CEREBRAL HAEMORRHAGE 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE CEREBROVASCULAR ACCIDENT 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE DIABETES MELLITUS 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE DRUG INEFFECTIVE 2
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE EYE INJURY 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE FALL 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE INCORRECT DOSE ADMINISTERED 2
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE MALAISE 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE ROAD TRAFFIC ACCIDENT 1
SS COUGH ABDOMINAL DISCOMFORT 2
SS COUGH ASPIRATION 2
SS COUGH ASTHMA 2
SS COUGH BIPOLAR DISORDER 2
SS COUGH DRUG DOSE OMISSION 2
SS COUGH DRUG HYPERSENSITIVITY 1
SS COUGH DRUG INTOLERANCE 2
SS COUGH GASTROOESOPHAGEAL REFLUX DISEASE 2
SS COUGH HEADACHE 2
SS COUGH INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
SS COUGH MIGRAINE 2
SS COUGH MULTIPLE ALLERGIES 2
SS COUGH OBESITY 2
SS COUGH OEDEMA 2
SS COUGH POLYCYSTIC OVARIES 2
SS DYSPNOEA ABDOMINAL DISCOMFORT 2
SS DYSPNOEA ASPIRATION 2
SS DYSPNOEA ASTHMA 2
SS DYSPNOEA BIPOLAR DISORDER 2
SS DYSPNOEA DRUG DOSE OMISSION 2
SS DYSPNOEA DRUG HYPERSENSITIVITY 1
SS DYSPNOEA DRUG INTOLERANCE 2
SS DYSPNOEA GASTROOESOPHAGEAL REFLUX DISEASE 2
SS DYSPNOEA HEADACHE 2
SS DYSPNOEA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
SS DYSPNOEA MIGRAINE 2
SS DYSPNOEA MULTIPLE ALLERGIES 2
SS DYSPNOEA OBESITY 2
SS DYSPNOEA OEDEMA 2
SS DYSPNOEA POLYCYSTIC OVARIES 2
SS GASTRIC ULCER HAEMORRHOIDS 1
SS GASTROOESOPHAGEAL REFLUX DISEASE ABDOMINAL DISCOMFORT 1
SS GASTROOESOPHAGEAL REFLUX DISEASE ASPIRATION 1
SS GASTROOESOPHAGEAL REFLUX DISEASE ASTHMA 1
SS GASTROOESOPHAGEAL REFLUX DISEASE BIPOLAR DISORDER 1
SS GASTROOESOPHAGEAL REFLUX DISEASE DRUG DOSE OMISSION 1
SS GASTROOESOPHAGEAL REFLUX DISEASE DRUG HYPERSENSITIVITY 1
SS GASTROOESOPHAGEAL REFLUX DISEASE DRUG INTOLERANCE 1
SS GASTROOESOPHAGEAL REFLUX DISEASE GASTROOESOPHAGEAL REFLUX DISEASE 1
SS GASTROOESOPHAGEAL REFLUX DISEASE HEADACHE 1
SS GASTROOESOPHAGEAL REFLUX DISEASE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
SS GASTROOESOPHAGEAL REFLUX DISEASE MIGRAINE 1
SS GASTROOESOPHAGEAL REFLUX DISEASE MULTIPLE ALLERGIES 1
SS GASTROOESOPHAGEAL REFLUX DISEASE OBESITY 1
SS GASTROOESOPHAGEAL REFLUX DISEASE OEDEMA 1
SS GASTROOESOPHAGEAL REFLUX DISEASE POLYCYSTIC OVARIES 1
SS HYPERCHOLESTEROLAEMIA HAEMORRHOIDS 1
SS HYPERLIPIDAEMIA ABDOMINAL PAIN UPPER 1
SS HYPERLIPIDAEMIA ACUTE CORONARY SYNDROME 1
SS HYPERLIPIDAEMIA ACUTE MYOCARDIAL INFARCTION 1
SS HYPERLIPIDAEMIA BACK PAIN 1
SS HYPERLIPIDAEMIA BRONCHITIS CHRONIC 1
SS HYPERLIPIDAEMIA CARDIOMEGALY 1
SS HYPERLIPIDAEMIA CHEST DISCOMFORT 1
SS HYPERLIPIDAEMIA CHEST PAIN 1
SS HYPERLIPIDAEMIA COLONIC POLYP 1
SS HYPERLIPIDAEMIA CORONARY ARTERY DISEASE 1
SS HYPERLIPIDAEMIA DYSPEPSIA 1
SS HYPERLIPIDAEMIA DYSPNOEA 1
SS HYPERLIPIDAEMIA ERUCTATION 1
SS HYPERLIPIDAEMIA HYPERHIDROSIS 1
SS HYPERLIPIDAEMIA NAUSEA 1
SS HYPERLIPIDAEMIA PEPTIC ULCER HAEMORRHAGE 1
SS HYPERSENSITIVITY SKIN STRIAE 2
SS HYPERTENSION HAEMORRHOIDS 3
SS IRON DEFICIENCY AMNESIA 1
SS IRON DEFICIENCY BRAIN INJURY 1
SS IRON DEFICIENCY CEREBRAL HAEMORRHAGE 1
SS IRON DEFICIENCY CEREBROVASCULAR ACCIDENT 1
SS IRON DEFICIENCY EYE INJURY 1
SS IRON DEFICIENCY FALL 1
SS MULTIPLE ALLERGIES AMNESIA 1
SS MULTIPLE ALLERGIES BRAIN INJURY 1
SS MULTIPLE ALLERGIES CEREBRAL HAEMORRHAGE 1
SS MULTIPLE ALLERGIES CEREBROVASCULAR ACCIDENT 1
SS MULTIPLE ALLERGIES EYE INJURY 1
SS MULTIPLE ALLERGIES FALL 1
SS NASAL CONGESTION AMNESIA 1
SS NASAL CONGESTION BRAIN INJURY 1
SS NASAL CONGESTION CEREBRAL HAEMORRHAGE 1
SS NASAL CONGESTION CEREBROVASCULAR ACCIDENT 1
SS NASAL CONGESTION EYE INJURY 1
SS NASAL CONGESTION FALL 1
SS NEUROPATHY PERIPHERAL AMNESIA 1
SS NEUROPATHY PERIPHERAL BRAIN INJURY 1
SS NEUROPATHY PERIPHERAL CEREBRAL HAEMORRHAGE 1
SS NEUROPATHY PERIPHERAL CEREBROVASCULAR ACCIDENT 1
SS NEUROPATHY PERIPHERAL EYE INJURY 1
SS NEUROPATHY PERIPHERAL FALL 1
SS PAIN ABDOMINAL DISCOMFORT 4
SS PAIN ASPIRATION 4
SS PAIN ASTHMA 4
SS PAIN BIPOLAR DISORDER 4
SS PAIN DRUG DOSE OMISSION 4
SS PAIN DRUG HYPERSENSITIVITY 2
SS PAIN DRUG INTOLERANCE 4
SS PAIN GASTROOESOPHAGEAL REFLUX DISEASE 4
SS PAIN HEADACHE 4
SS PAIN INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 4
SS PAIN MIGRAINE 4
SS PAIN MULTIPLE ALLERGIES 4
SS PAIN OBESITY 4
SS PAIN OEDEMA 4
SS PAIN POLYCYSTIC OVARIES 4
SS RHINITIS ALLERGIC SKIN STRIAE 6
SS TYPE 2 DIABETES MELLITUS ABDOMINAL PAIN UPPER 2
SS TYPE 2 DIABETES MELLITUS ACUTE CORONARY SYNDROME 2
SS TYPE 2 DIABETES MELLITUS ACUTE MYOCARDIAL INFARCTION 2
SS TYPE 2 DIABETES MELLITUS BACK PAIN 2
SS TYPE 2 DIABETES MELLITUS BRONCHITIS CHRONIC 2
SS TYPE 2 DIABETES MELLITUS CARDIOMEGALY 2
SS TYPE 2 DIABETES MELLITUS CHEST DISCOMFORT 2
SS TYPE 2 DIABETES MELLITUS CHEST PAIN 2
SS TYPE 2 DIABETES MELLITUS COLONIC POLYP 2
SS TYPE 2 DIABETES MELLITUS CORONARY ARTERY DISEASE 2
SS TYPE 2 DIABETES MELLITUS DYSPEPSIA 2
SS TYPE 2 DIABETES MELLITUS DYSPNOEA 2
SS TYPE 2 DIABETES MELLITUS ERUCTATION 2
SS TYPE 2 DIABETES MELLITUS HYPERHIDROSIS 2
SS TYPE 2 DIABETES MELLITUS NAUSEA 2
SS TYPE 2 DIABETES MELLITUS PEPTIC ULCER HAEMORRHAGE 2
SS WHEEZING ABDOMINAL DISCOMFORT 2
SS WHEEZING ASPIRATION 2
SS WHEEZING ASTHMA 2
SS WHEEZING BIPOLAR DISORDER 2
SS WHEEZING DRUG DOSE OMISSION 2
SS WHEEZING DRUG HYPERSENSITIVITY 1
SS WHEEZING DRUG INTOLERANCE 2
SS WHEEZING GASTROOESOPHAGEAL REFLUX DISEASE 2
SS WHEEZING HEADACHE 2
SS WHEEZING INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
SS WHEEZING MIGRAINE 2
SS WHEEZING MULTIPLE ALLERGIES 2
SS WHEEZING OBESITY 2
SS WHEEZING OEDEMA 2
SS WHEEZING POLYCYSTIC OVARIES 2
C ASTHMA CHEST PAIN 1
C ASTHMA DRUG HYPERSENSITIVITY 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE COUGH 3
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE DRUG DOSE OMISSION 3
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE NASAL CONGESTION 3
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE SINUS CONGESTION 3
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE WRONG TECHNIQUE IN DRUG USAGE PROCESS 3
C COUGH ABDOMINAL DISCOMFORT 1
C COUGH ASPIRATION 1
C COUGH DRUG DOSE OMISSION 1
C COUGH DRUG HYPERSENSITIVITY 1
C COUGH DRUG INTOLERANCE 1
C COUGH HEADACHE 1
C COUGH INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
C COUGH OEDEMA 1
C DYSPNOEA ABDOMINAL DISCOMFORT 1
C DYSPNOEA ASPIRATION 1
C DYSPNOEA DRUG DOSE OMISSION 1
C DYSPNOEA DRUG HYPERSENSITIVITY 1
C DYSPNOEA DRUG INTOLERANCE 1
C DYSPNOEA HEADACHE 1
C DYSPNOEA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
C DYSPNOEA OEDEMA 1
C GASTROOESOPHAGEAL REFLUX DISEASE CHEST PAIN 2
C GASTROOESOPHAGEAL REFLUX DISEASE DRUG DOSE OMISSION 2
C GASTROOESOPHAGEAL REFLUX DISEASE DRUG INEFFECTIVE 2
C GASTROOESOPHAGEAL REFLUX DISEASE DYSPEPSIA 2
C GASTROOESOPHAGEAL REFLUX DISEASE GASTROOESOPHAGEAL REFLUX DISEASE 2
C GASTROOESOPHAGEAL REFLUX DISEASE MALAISE 2
C PAIN ABDOMINAL DISCOMFORT 2
C PAIN ASPIRATION 2
C PAIN DRUG DOSE OMISSION 2
C PAIN DRUG HYPERSENSITIVITY 2
C PAIN DRUG INTOLERANCE 2
C PAIN HEADACHE 2
C PAIN INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
C PAIN OEDEMA 2
C PULMONARY HYPERTENSION CARDIAC FAILURE 1
C WHEEZING ABDOMINAL DISCOMFORT 1
C WHEEZING ASPIRATION 1
C WHEEZING DRUG DOSE OMISSION 1
C WHEEZING DRUG HYPERSENSITIVITY 1
C WHEEZING DRUG INTOLERANCE 1
C WHEEZING HEADACHE 1
C WHEEZING INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
C WHEEZING OEDEMA 1
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