Drug information for BROVANA
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
SOLUTION; INHALATION
EQ 0.015MG BASE/2ML
Prescription
(Reference Drug)
ARFORMOTEROL TARTRATE
formoterol
SUNOVION
21912
2011-09-07 Letter
2011-07-18 Letter
2011-07-18 Label
2011-03-01 Other
2011-02-24 Label
2011-02-24 Medication Guide
2011-02-18 Letter
2011-02-07 Letter
2011-02-04 Medication Guide
2010-06-03 Letter
2010-06-02 Label
2009-11-16 Medication Guide
2009-04-14 Summary Review
2009-04-14 Review
2008-01-09 Letter
2008-01-08 Label
2007-02-20 Other Important Information from FDA
2006-10-13 Letter
2006-10-11 Label
Drug Adverse Effects information for BROVANA
Role code
Indications
Reaction
# Reports
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
PNEUMONIA
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
STOMATITIS
1
SS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
COUGH
1
SS
DYSPNOEA
BLOOD PRESSURE INCREASED
2
SS
DYSPNOEA
CHEST PAIN
2
SS
DYSPNOEA
DYSPEPSIA
2
SS
DYSPNOEA
HEART RATE INCREASED
2
SS
DYSPNOEA
MALAISE
2
SS
MULTIPLE ALLERGIES
BLOOD PRESSURE INCREASED
1
SS
MULTIPLE ALLERGIES
CHEST PAIN
1
SS
MULTIPLE ALLERGIES
DYSPEPSIA
1
SS
MULTIPLE ALLERGIES
HEART RATE INCREASED
1
SS
MULTIPLE ALLERGIES
MALAISE
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
BLOOD PRESSURE INCREASED
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
CHEST PAIN
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
COUGH
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
DYSPEPSIA
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
HEART RATE INCREASED
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
MALAISE
2
C
ANKYLOSING SPONDYLITIS
ARTHRALGIA
1
C
ANKYLOSING SPONDYLITIS
BLISTER
1
C
ANKYLOSING SPONDYLITIS
DIVERTICULUM
1
C
ANKYLOSING SPONDYLITIS
DUODENITIS
1
C
ANKYLOSING SPONDYLITIS
DYSPNOEA
1
C
ANKYLOSING SPONDYLITIS
HEPATIC ENZYME INCREASED
1
C
ANKYLOSING SPONDYLITIS
HERPES ZOSTER
1
C
ANKYLOSING SPONDYLITIS
HIATUS HERNIA
1
C
ANKYLOSING SPONDYLITIS
PLATELET COUNT DECREASED
1
C
ANKYLOSING SPONDYLITIS
POST PROCEDURAL INFECTION
1
C
ANKYLOSING SPONDYLITIS
RASH
1
C
BRONCHIECTASIS
BRONCHOSPASM
1
C
BRONCHIECTASIS
CANDIDIASIS
1
C
BRONCHIECTASIS
CHEST DISCOMFORT
1
C
BRONCHIECTASIS
DEVICE MALFUNCTION
1
C
BRONCHIECTASIS
EMPHYSEMA
1
C
BRONCHIECTASIS
OXYGEN SATURATION DECREASED
1
C
BRONCHIECTASIS
PULMONARY CONGESTION
1
C
BRONCHIECTASIS
TOOTH DISORDER
1
C
CHRONIC MYELOID LEUKAEMIA
ATRIAL FIBRILLATION
1
C
CHRONIC MYELOID LEUKAEMIA
CEREBROVASCULAR ACCIDENT
1
C
CHRONIC MYELOID LEUKAEMIA
CHEST PAIN
1
C
CHRONIC MYELOID LEUKAEMIA
COMPRESSION FRACTURE
1
C
CHRONIC MYELOID LEUKAEMIA
COUGH
1
C
CHRONIC MYELOID LEUKAEMIA
FATIGUE
1
C
CHRONIC MYELOID LEUKAEMIA
HERPES ZOSTER
1
C
CHRONIC MYELOID LEUKAEMIA
LYMPHADENOPATHY MEDIASTINAL
1
C
CHRONIC MYELOID LEUKAEMIA
OEDEMA PERIPHERAL
1
C
CHRONIC MYELOID LEUKAEMIA
PAIN
1
C
CHRONIC MYELOID LEUKAEMIA
PRURITUS
1
C
CHRONIC MYELOID LEUKAEMIA
PULMONARY FIBROSIS
1
C
CHRONIC MYELOID LEUKAEMIA
RASH
1
C
CHRONIC MYELOID LEUKAEMIA
RASH PRURITIC
1
C
CHRONIC MYELOID LEUKAEMIA
RIB FRACTURE
1
C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
JOINT SWELLING
2
C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
MUSCLE SPASMS
1
C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
OEDEMA PERIPHERAL
2
C
MYELODYSPLASTIC SYNDROME
COLITIS ULCERATIVE
2
C
PRODUCT USED FOR UNKNOWN INDICATION
CHILLS
2
C
PRODUCT USED FOR UNKNOWN INDICATION
DIARRHOEA
4
C
PRODUCT USED FOR UNKNOWN INDICATION
DYSPNOEA
4
C
PRODUCT USED FOR UNKNOWN INDICATION
ERYTHEMA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
ESCHERICHIA URINARY TRACT INFECTION
4
C
PRODUCT USED FOR UNKNOWN INDICATION
PAIN
4
C
PRODUCT USED FOR UNKNOWN INDICATION
PRURITUS
4
C
PRODUCT USED FOR UNKNOWN INDICATION
PYREXIA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
RASH
4
C
PRODUCT USED FOR UNKNOWN INDICATION
SKIN BURNING SENSATION
4
C
PRODUCT USED FOR UNKNOWN INDICATION
SWELLING FACE
4
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