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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