Drug information for ACCOLATE
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
10MG
Prescription
AB
ZAFIRLUKAST
zafirlukast
ASTRAZENECA
20547
2011-08-10 Letter
2011-08-08 Label
2010-10-19 Letter
2010-10-19 Label
2010-07-19 Label
2010-07-15 Letter
2009-11-19 Letter
2009-08-28 Label
2008-06-02 Letter
2005-06-08 Letter
2005-06-08 Label
2004-05-25 Letter
2004-05-25 Review
2004-05-25 Review
2004-04-14 Review
2004-04-05 Label
2003-07-29 Letter
1999-09-17 Letter
TABLET; ORAL
20MG
Prescription
AB (Reference Drug)
ZAFIRLUKAST
zafirlukast
ASTRAZENECA
"
Drug Adverse Effects information for ACCOLATE
Role code
Indications
Reaction
# Reports
PS
ASTHMA
ARTHRITIS
1
PS
ASTHMA
ASTHMA
1
PS
ASTHMA
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
1
PS
ASTHMA
CONDITION AGGRAVATED
1
PS
ASTHMA
DIVERTICULITIS
1
PS
ASTHMA
DYSPNOEA
1
PS
ASTHMA
EMPHYSEMA
1
PS
ASTHMA
MALAISE
1
PS
ASTHMA
NERVE COMPRESSION
1
PS
ASTHMA
PRODUCT SUBSTITUTION ISSUE
1
PS
ASTHMA
SPONDYLITIS
1
PS
ASTHMA
WEIGHT DECREASED
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
ARTHRITIS
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
DIVERTICULITIS
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
DYSPNOEA
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
EMPHYSEMA
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
MALAISE
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
NERVE COMPRESSION
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
SPONDYLITIS
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
WEIGHT DECREASED
1
PS
EMPHYSEMA
ARTHRITIS
1
PS
EMPHYSEMA
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
1
PS
EMPHYSEMA
DIVERTICULITIS
1
PS
EMPHYSEMA
DYSPNOEA
1
PS
EMPHYSEMA
EMPHYSEMA
1
PS
EMPHYSEMA
MALAISE
1
PS
EMPHYSEMA
NERVE COMPRESSION
1
PS
EMPHYSEMA
SPONDYLITIS
1
PS
EMPHYSEMA
WEIGHT DECREASED
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
ARTHRITIS
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
DIVERTICULITIS
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
DYSPNOEA
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
EMPHYSEMA
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
MALAISE
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
NERVE COMPRESSION
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
SPONDYLITIS
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
WEIGHT DECREASED
1
SS
ASTHMA
DYSPEPSIA
1
SS
ASTHMA
INFECTION
1
SS
ASTHMA
LUNG TRANSPLANT REJECTION
1
SS
ASTHMA
RENAL FAILURE CHRONIC
1
SS
GASTROOESOPHAGEAL REFLUX DISEASE
INFECTION
1
SS
GASTROOESOPHAGEAL REFLUX DISEASE
LUNG TRANSPLANT REJECTION
1
SS
GASTROOESOPHAGEAL REFLUX DISEASE
RENAL FAILURE CHRONIC
1
SS
MIGRAINE
ASTHMA
1
SS
MIGRAINE
DRUG HYPERSENSITIVITY
1
SS
MIGRAINE
OEDEMA PERIPHERAL
1
SS
MIGRAINE
RASH
1
SS
ORAL HERPES
ASTHMA
1
SS
ORAL HERPES
DRUG HYPERSENSITIVITY
1
SS
ORAL HERPES
OEDEMA PERIPHERAL
1
SS
ORAL HERPES
RASH
1
SS
PAIN
ASTHMA
1
SS
PAIN
DRUG HYPERSENSITIVITY
1
SS
PAIN
OEDEMA PERIPHERAL
1
SS
PAIN
RASH
1
C
ASTHMA
COUGH
1
C
ASTHMA
FEELING JITTERY
1
C
ASTHMA
GINGIVAL PAIN
1
C
ASTHMA
GINGIVITIS
1
C
ASTHMA
HYPERHIDROSIS
1
C
ASTHMA
ORAL DISCOMFORT
1
C
ASTHMA
ORAL INFECTION
1
C
ASTHMA
OVERDOSE
1
C
ASTHMA
PRODUCT QUALITY ISSUE
1
C
ASTHMA
PRODUCTIVE COUGH
1
C
ASTHMA
THROAT TIGHTNESS
1
C
ASTHMA
TOOTHACHE
1
C
ASTHMA
WHEEZING
1
C
BLOOD CHOLESTEROL INCREASED
FEELING ABNORMAL
1
C
BLOOD CHOLESTEROL INCREASED
NERVOUSNESS
1
C
BLOOD CHOLESTEROL INCREASED
TREMOR
1
C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
DYSPHONIA
2
C
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
DYSPNOEA
2
C
DYSPNOEA
FEELING ABNORMAL
1
C
DYSPNOEA
NERVOUSNESS
1
C
DYSPNOEA
TREMOR
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
DYSGEUSIA
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
FEELING ABNORMAL
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
HOT FLUSH
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
NERVOUSNESS
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
THROMBOSIS
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
TREMOR
1
C
HYPERSENSITIVITY
ABDOMINAL PAIN
3
C
HYPERSENSITIVITY
BREAST TENDERNESS
3
C
HYPERSENSITIVITY
FATIGUE
3
C
NAUSEA
DRUG DOSE OMISSION
1
C
OSTEOPOROSIS
ACUTE RESPIRATORY FAILURE
2
C
OSTEOPOROSIS
ANXIETY
2
C
OSTEOPOROSIS
ARTHROPATHY
2
C
OSTEOPOROSIS
BACK PAIN
2
C
OSTEOPOROSIS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
2
C
OSTEOPOROSIS
DEPRESSION
2
C
OSTEOPOROSIS
DIVERTICULITIS
2
C
OSTEOPOROSIS
DIVERTICULUM
2
C
OSTEOPOROSIS
ERECTILE DYSFUNCTION
2
C
OSTEOPOROSIS
FEMUR FRACTURE
2
C
OSTEOPOROSIS
GASTROOESOPHAGEAL REFLUX DISEASE
2
C
OSTEOPOROSIS
GOITRE
2
C
OSTEOPOROSIS
HAEMORRHOIDS
2
C
OSTEOPOROSIS
HIATUS HERNIA
2
C
OSTEOPOROSIS
IMPAIRED HEALING
2
C
OSTEOPOROSIS
LEUKOCYTOSIS
2
C
OSTEOPOROSIS
MUSCULOSKELETAL CHEST PAIN
2
C
OSTEOPOROSIS
PLEURAL EFFUSION
2
C
OSTEOPOROSIS
RADICULITIS LUMBOSACRAL
2
C
OSTEOPOROSIS
RECTAL HAEMORRHAGE
2
C
OSTEOPOROSIS
RHINITIS ALLERGIC
2
C
OSTEOPOROSIS
RIB FRACTURE
2
C
OSTEOPOROSIS
SPINAL COMPRESSION FRACTURE
2
C
OSTEOPOROSIS
THORACIC VERTEBRAL FRACTURE
2
C
OSTEOPOROSIS
THYROID NEOPLASM
2
C
OSTEOPOROSIS
UMBILICAL HERNIA
2
C
POST COITAL CONTRACEPTION
ABDOMINAL PAIN
1
C
POST COITAL CONTRACEPTION
BREAST TENDERNESS
1
C
POST COITAL CONTRACEPTION
FATIGUE
1
C
PRODUCT USED FOR UNKNOWN INDICATION
ERYTHEMA
1
C
PRODUCT USED FOR UNKNOWN INDICATION
LOCAL SWELLING
1
C
PRURITUS
DRUG DOSE OMISSION
2
C
WEIGHT DECREASED
DRUG DOSE OMISSION
1
C
WEIGHT INCREASED
DRUG DOSE OMISSION
1
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