Drug information for XOPENEX HFA

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
AEROSOL, METERED; INHALATION	EQ 0.045MG BASE/INH	Prescription	(Reference Drug)	LEVALBUTEROL TARTRATE	Albuterol	SUNOVION	21730 2008-02-14 Label 2008-02-07 Letter 2006-12-13 Review 2006-09-20 Letter 2006-04-07 Letter 2005-03-14 Letter 2005-03-14 Label

Drug Adverse Effects information for XOPENEX HFA

Role code	Indications	Reaction	# Reports
PS	ASTHMA	BLOOD GLUCOSE INCREASED	1
PS	ASTHMA	HIP ARTHROPLASTY	1
PS	ASTHMA	HYPERSENSITIVITY	1
PS	ASTHMA	HYPOKALAEMIA	1
PS	ASTHMA	HYPONATRAEMIA	1
PS	ASTHMA	KNEE ARTHROPLASTY	1
PS	ASTHMA	METABOLIC DISORDER	1
PS	ASTHMA	RASH	1
PS	ASTHMA	ROTATOR CUFF REPAIR	1
PS	BRONCHITIS	BLOOD GLUCOSE INCREASED	1
PS	BRONCHITIS	HIP ARTHROPLASTY	1
PS	BRONCHITIS	HYPOKALAEMIA	1
PS	BRONCHITIS	HYPONATRAEMIA	1
PS	BRONCHITIS	KNEE ARTHROPLASTY	1
PS	BRONCHITIS	METABOLIC DISORDER	1
PS	BRONCHITIS	ROTATOR CUFF REPAIR	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	BLOOD GLUCOSE INCREASED	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	HIP ARTHROPLASTY	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	HYPOKALAEMIA	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	HYPONATRAEMIA	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	KNEE ARTHROPLASTY	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	METABOLIC DISORDER	1
PS	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	ROTATOR CUFF REPAIR	1
SS	ASTHMA	FOOD ALLERGY	1
SS	ASTHMA	MALAISE	1
C	ANXIETY	DYSPNOEA	2
C	ANXIETY	PNEUMONIA	2
C	ASTHMA	BLOOD PRESSURE DECREASED	1
C	ASTHMA	BRONCHOSPASM	6
C	ASTHMA	COELIAC DISEASE	5
C	ASTHMA	COUGH	1
C	ASTHMA	DIARRHOEA	1
C	ASTHMA	DIZZINESS	1
C	ASTHMA	DRUG DOSE OMISSION	1
C	ASTHMA	DRUG HYPERSENSITIVITY	1
C	ASTHMA	DRUG INEFFECTIVE	2
C	ASTHMA	DRUG INTOLERANCE	1
C	ASTHMA	DYSPEPSIA	6
C	ASTHMA	FALL	1
C	ASTHMA	FLUSHING	6
C	ASTHMA	GESTATIONAL HYPERTENSION	5
C	ASTHMA	HEADACHE	1
C	ASTHMA	HOT FLUSH	6
C	ASTHMA	HYPOTENSION	1
C	ASTHMA	MATERNAL EXPOSURE DURING PREGNANCY	5
C	ASTHMA	NASAL CONGESTION	6
C	ASTHMA	PALLOR	1
C	ASTHMA	POLYMYALGIA RHEUMATICA	3
C	ASTHMA	PRESYNCOPE	1
C	ASTHMA	PRURITUS	6
C	ASTHMA	RHINITIS ALLERGIC	1
C	ASTHMA	TEMPORAL ARTERITIS	3
C	ASTHMA	VOMITING	1
C	BIPOLAR DISORDER	DRUG INEFFECTIVE	1
C	BRONCHITIS	DRUG INEFFECTIVE	1
C	CARDIAC FAILURE	ABDOMINAL PAIN	2
C	CARDIAC FAILURE	COLON CANCER METASTATIC	2
C	CARDIAC FAILURE	DEHYDRATION	2
C	CARDIAC FAILURE	METASTASES TO LIVER	2
C	CARDIAC FAILURE	NAUSEA	2
C	CARDIAC FAILURE	VOMITING	2
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	DYSPNOEA	10
C	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	PNEUMONIA	10
C	CONTRACEPTION	DEEP VEIN THROMBOSIS	1
C	CONTRACEPTION	HAEMOGLOBINURIA	1
C	CONTRACEPTION	HEPATIC CYST	1
C	CONTRACEPTION	LUNG CONSOLIDATION	1
C	CONTRACEPTION	PULMONARY EMBOLISM	1
C	CONTRACEPTION	PULMONARY INFARCTION	1
C	CONTRACEPTION	TACHYCARDIA	1
C	CROHN'S DISEASE	DRUG INEFFECTIVE	1
C	DEPRESSION	DRUG INEFFECTIVE	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	DRUG INEFFECTIVE	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	DYSPNOEA	2
C	GASTROOESOPHAGEAL REFLUX DISEASE	PNEUMONIA	2
C	GASTROOESOPHAGEAL REFLUX DISEASE	POLYMYALGIA RHEUMATICA	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	TEMPORAL ARTERITIS	1
C	HIATUS HERNIA	DRUG INEFFECTIVE	1
C	HYPERSENSITIVITY	POLYMYALGIA RHEUMATICA	2
C	HYPERSENSITIVITY	TEMPORAL ARTERITIS	2
C	HYPERTENSION	DRUG INEFFECTIVE	1
C	LARYNGEAL CANCER METASTATIC	FEBRILE NEUTROPENIA	12
C	LARYNGEAL CANCER METASTATIC	METABOLIC ENCEPHALOPATHY	8
C	LARYNGEAL CANCER METASTATIC	NEOPLASM MALIGNANT	12
C	LARYNGEAL CANCER METASTATIC	OFF LABEL USE	12
C	LARYNGEAL CANCER METASTATIC	STAPHYLOCOCCAL SEPSIS	8
C	LARYNGEAL CANCER METASTATIC	URINARY TRACT INFECTION	8
C	LARYNGEAL CANCER METASTATIC	UROSEPSIS	4
C	MIGRAINE	DRUG INEFFECTIVE	2
C	NAUSEA	DRUG INEFFECTIVE	1
C	OSTEOPOROSIS	DYSPNOEA	4
C	OSTEOPOROSIS	PNEUMONIA	4
C	PAIN	DRUG INEFFECTIVE	2
C	POST-TRAUMATIC STRESS DISORDER	DRUG INEFFECTIVE	1
C	PRODUCT USED FOR UNKNOWN INDICATION	ABDOMINAL PAIN	1
C	PRODUCT USED FOR UNKNOWN INDICATION	CONSTIPATION	2
C	PRODUCT USED FOR UNKNOWN INDICATION	FEBRILE NEUTROPENIA	46
C	PRODUCT USED FOR UNKNOWN INDICATION	METABOLIC ENCEPHALOPATHY	31
C	PRODUCT USED FOR UNKNOWN INDICATION	NAUSEA	1
C	PRODUCT USED FOR UNKNOWN INDICATION	NEOPLASM MALIGNANT	46
C	PRODUCT USED FOR UNKNOWN INDICATION	OFF LABEL USE	46
C	PRODUCT USED FOR UNKNOWN INDICATION	SINUSITIS	1
C	PRODUCT USED FOR UNKNOWN INDICATION	STAPHYLOCOCCAL SEPSIS	31
C	PRODUCT USED FOR UNKNOWN INDICATION	URINARY TRACT INFECTION	31
C	PRODUCT USED FOR UNKNOWN INDICATION	UROSEPSIS	15
C	RHINITIS ALLERGIC	BRONCHOSPASM	1
C	RHINITIS ALLERGIC	DYSPEPSIA	1
C	RHINITIS ALLERGIC	FLUSHING	1
C	RHINITIS ALLERGIC	HOT FLUSH	1
C	RHINITIS ALLERGIC	NASAL CONGESTION	1
C	RHINITIS ALLERGIC	PRURITUS	1
C	SLEEP DISORDER	DRUG INEFFECTIVE	1
C	SUPPLEMENTATION THERAPY	DYSPNOEA	2
C	SUPPLEMENTATION THERAPY	PNEUMONIA	2
C	THROMBOSIS	DRUG INEFFECTIVE	1
C	UTERINE HAEMORRHAGE	DRUG INEFFECTIVE	1
C	VOMITING	DRUG INEFFECTIVE	1

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