Drug information for ZYFLO CR

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, EXTENDED RELEASE; ORAL 600MG Prescription  (Reference Drug) ZILEUTON zileuton CORNERSTONE THERAP 22052
2011-12-02 Label

2011-12-01 Letter

2009-11-12 Letter

2009-08-28 Label

2008-10-03 Review

2007-06-04 Label

2007-06-04 Letter

Drug Adverse Effects information for ZYFLO CR

Role code Indications Reaction # Reports
PS ASTHMA ARTHRALGIA 1
PS ASTHMA DECREASED ACTIVITY 1
PS ASTHMA EXERCISE TOLERANCE DECREASED 1
PS ASTHMA MOOD ALTERED 1
PS ASTHMA PRODUCT FORMULATION ISSUE 1
PS ASTHMA TREATMENT FAILURE 1
PS BRONCHIAL HYPERREACTIVITY ARTHRALGIA 1
PS BRONCHIAL HYPERREACTIVITY DECREASED ACTIVITY 1
PS BRONCHIAL HYPERREACTIVITY EXERCISE TOLERANCE DECREASED 1
PS BRONCHIAL HYPERREACTIVITY MOOD ALTERED 1
PS BRONCHIAL HYPERREACTIVITY PRODUCT FORMULATION ISSUE 1
PS BRONCHIAL HYPERREACTIVITY TREATMENT FAILURE 1
PS OSTEOPENIA ANGIOEDEMA 1
PS OSTEOPENIA HYPERHIDROSIS 1
PS OSTEOPENIA HYPERSENSITIVITY 1
PS OSTEOPENIA MIDDLE EAR EFFUSION 1
PS OSTEOPENIA NAUSEA 1
PS OSTEOPENIA RHINORRHOEA 1
PS OSTEOPENIA SINUS HEADACHE 1
PS PRODUCT USED FOR UNKNOWN INDICATION ANGIOEDEMA 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERHIDROSIS 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERSENSITIVITY 1
PS PRODUCT USED FOR UNKNOWN INDICATION MIDDLE EAR EFFUSION 1
PS PRODUCT USED FOR UNKNOWN INDICATION NAUSEA 1
PS PRODUCT USED FOR UNKNOWN INDICATION RHINORRHOEA 1
PS PRODUCT USED FOR UNKNOWN INDICATION SINUS HEADACHE 1
C PRODUCT USED FOR UNKNOWN INDICATION ARTHRITIS 1
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