Drug information for RAZADYNE ER
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
CAPSULE, EXTENDED RELEASE; ORAL
EQ 16MG BASE
Prescription
AB
GALANTAMINE HYDROBROMIDE
Galantamine
JANSSEN PHARMS
21615
2012-05-01 Label
2012-03-06 Label
2012-03-06 Label
2012-03-05 Letter
2012-03-05 Letter
2012-03-05 Letter
2006-05-01 Letter
2006-05-01 Letter
2006-05-01 Letter
2006-05-01 Letter
2005-12-05 Review
2005-07-29 Other Important Information from FDA
2005-05-03 Letter
2004-12-29 Letter
2004-12-29 Label
CAPSULE, EXTENDED RELEASE; ORAL
EQ 24MG BASE
Prescription
AB
GALANTAMINE HYDROBROMIDE
Galantamine
JANSSEN PHARMS
"
CAPSULE, EXTENDED RELEASE; ORAL
EQ 8MG BASE
Prescription
AB (Reference Drug)
GALANTAMINE HYDROBROMIDE
Galantamine
JANSSEN PHARMS
"
Drug Adverse Effects information for RAZADYNE ER
Role code
Indications
Reaction
# Reports
PS
DEPRESSION
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
4
PS
DEPRESSION
DEPRESSION
4
PS
DEPRESSION
HYPERHIDROSIS
4
PS
DEPRESSION
THERAPY CESSATION
4
PS
HEAD INJURY
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
4
PS
HEAD INJURY
DEPRESSION
4
PS
HEAD INJURY
HYPERHIDROSIS
4
PS
HEAD INJURY
THERAPY CESSATION
4
C
ARTHRALGIA
ACTIVITIES OF DAILY LIVING IMPAIRED
1
C
ARTHRALGIA
AMNESIA
1
C
ARTHRALGIA
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
1
C
ARTHRALGIA
CEREBRAL ATROPHY
1
C
ARTHRALGIA
COMA
1
C
ARTHRALGIA
CRANIOCEREBRAL INJURY
1
C
ARTHRALGIA
DEPRESSION
1
C
ARTHRALGIA
FEELING ABNORMAL
1
C
ARTHRALGIA
HYPERHIDROSIS
1
C
ARTHRALGIA
PAIN
1
C
ARTHRALGIA
PRODUCT QUALITY ISSUE
1
C
ARTHRALGIA
ROAD TRAFFIC ACCIDENT
1
C
ARTHRALGIA
ROTATOR CUFF SYNDROME
1
C
ARTHRALGIA
SPINAL COLUMN INJURY
1
C
ASTHMA
ACTIVITIES OF DAILY LIVING IMPAIRED
1
C
ASTHMA
AMNESIA
1
C
ASTHMA
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
1
C
ASTHMA
CEREBRAL ATROPHY
1
C
ASTHMA
COMA
1
C
ASTHMA
CRANIOCEREBRAL INJURY
1
C
ASTHMA
DEPRESSION
1
C
ASTHMA
FEELING ABNORMAL
1
C
ASTHMA
HYPERHIDROSIS
1
C
ASTHMA
PAIN
1
C
ASTHMA
PRODUCT QUALITY ISSUE
1
C
ASTHMA
ROAD TRAFFIC ACCIDENT
1
C
ASTHMA
ROTATOR CUFF SYNDROME
1
C
ASTHMA
SPINAL COLUMN INJURY
1
C
BREAKTHROUGH PAIN
ACTIVITIES OF DAILY LIVING IMPAIRED
1
C
BREAKTHROUGH PAIN
AMNESIA
1
C
BREAKTHROUGH PAIN
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
1
C
BREAKTHROUGH PAIN
CEREBRAL ATROPHY
1
C
BREAKTHROUGH PAIN
COMA
1
C
BREAKTHROUGH PAIN
CRANIOCEREBRAL INJURY
1
C
BREAKTHROUGH PAIN
DEPRESSION
1
C
BREAKTHROUGH PAIN
FEELING ABNORMAL
1
C
BREAKTHROUGH PAIN
HYPERHIDROSIS
1
C
BREAKTHROUGH PAIN
PAIN
1
C
BREAKTHROUGH PAIN
PRODUCT QUALITY ISSUE
1
C
BREAKTHROUGH PAIN
ROAD TRAFFIC ACCIDENT
1
C
BREAKTHROUGH PAIN
ROTATOR CUFF SYNDROME
1
C
BREAKTHROUGH PAIN
SPINAL COLUMN INJURY
1
C
CRANIOCEREBRAL INJURY
ACTIVITIES OF DAILY LIVING IMPAIRED
1
C
CRANIOCEREBRAL INJURY
AMNESIA
1
C
CRANIOCEREBRAL INJURY
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
1
C
CRANIOCEREBRAL INJURY
CEREBRAL ATROPHY
1
C
CRANIOCEREBRAL INJURY
COMA
1
C
CRANIOCEREBRAL INJURY
CRANIOCEREBRAL INJURY
1
C
CRANIOCEREBRAL INJURY
DEPRESSION
1
C
CRANIOCEREBRAL INJURY
FEELING ABNORMAL
1
C
CRANIOCEREBRAL INJURY
HYPERHIDROSIS
1
C
CRANIOCEREBRAL INJURY
PAIN
1
C
CRANIOCEREBRAL INJURY
PRODUCT QUALITY ISSUE
1
C
CRANIOCEREBRAL INJURY
ROAD TRAFFIC ACCIDENT
1
C
CRANIOCEREBRAL INJURY
ROTATOR CUFF SYNDROME
1
C
CRANIOCEREBRAL INJURY
SPINAL COLUMN INJURY
1
C
HEAD INJURY
ACTIVITIES OF DAILY LIVING IMPAIRED
1
C
HEAD INJURY
AMNESIA
1
C
HEAD INJURY
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
1
C
HEAD INJURY
CEREBRAL ATROPHY
1
C
HEAD INJURY
COMA
1
C
HEAD INJURY
CRANIOCEREBRAL INJURY
1
C
HEAD INJURY
DEPRESSION
1
C
HEAD INJURY
FEELING ABNORMAL
1
C
HEAD INJURY
HYPERHIDROSIS
1
C
HEAD INJURY
PAIN
1
C
HEAD INJURY
PRODUCT QUALITY ISSUE
1
C
HEAD INJURY
ROAD TRAFFIC ACCIDENT
1
C
HEAD INJURY
ROTATOR CUFF SYNDROME
1
C
HEAD INJURY
SPINAL COLUMN INJURY
1
C
PAIN
ACTIVITIES OF DAILY LIVING IMPAIRED
1
C
PAIN
AMNESIA
1
C
PAIN
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
1
C
PAIN
CEREBRAL ATROPHY
1
C
PAIN
COMA
1
C
PAIN
CRANIOCEREBRAL INJURY
1
C
PAIN
DEPRESSION
1
C
PAIN
FEELING ABNORMAL
1
C
PAIN
HYPERHIDROSIS
1
C
PAIN
PAIN
1
C
PAIN
PRODUCT QUALITY ISSUE
1
C
PAIN
ROAD TRAFFIC ACCIDENT
1
C
PAIN
ROTATOR CUFF SYNDROME
1
C
PAIN
SPINAL COLUMN INJURY
1
C
PAIN IN EXTREMITY
ACTIVITIES OF DAILY LIVING IMPAIRED
1
C
PAIN IN EXTREMITY
AMNESIA
1
C
PAIN IN EXTREMITY
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
1
C
PAIN IN EXTREMITY
CEREBRAL ATROPHY
1
C
PAIN IN EXTREMITY
COMA
1
C
PAIN IN EXTREMITY
CRANIOCEREBRAL INJURY
1
C
PAIN IN EXTREMITY
DEPRESSION
1
C
PAIN IN EXTREMITY
FEELING ABNORMAL
1
C
PAIN IN EXTREMITY
HYPERHIDROSIS
1
C
PAIN IN EXTREMITY
PAIN
1
C
PAIN IN EXTREMITY
PRODUCT QUALITY ISSUE
1
C
PAIN IN EXTREMITY
ROAD TRAFFIC ACCIDENT
1
C
PAIN IN EXTREMITY
ROTATOR CUFF SYNDROME
1
C
PAIN IN EXTREMITY
SPINAL COLUMN INJURY
1
C
PRODUCT USED FOR UNKNOWN INDICATION
ACTIVITIES OF DAILY LIVING IMPAIRED
1
C
PRODUCT USED FOR UNKNOWN INDICATION
AMNESIA
1
C
PRODUCT USED FOR UNKNOWN INDICATION
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
1
C
PRODUCT USED FOR UNKNOWN INDICATION
CEREBRAL ATROPHY
1
C
PRODUCT USED FOR UNKNOWN INDICATION
COMA
1
C
PRODUCT USED FOR UNKNOWN INDICATION
CRANIOCEREBRAL INJURY
1
C
PRODUCT USED FOR UNKNOWN INDICATION
DEPRESSION
1
C
PRODUCT USED FOR UNKNOWN INDICATION
FEELING ABNORMAL
1
C
PRODUCT USED FOR UNKNOWN INDICATION
HYPERHIDROSIS
1
C
PRODUCT USED FOR UNKNOWN INDICATION
PAIN
1
C
PRODUCT USED FOR UNKNOWN INDICATION
PRODUCT QUALITY ISSUE
1
C
PRODUCT USED FOR UNKNOWN INDICATION
ROAD TRAFFIC ACCIDENT
1
C
PRODUCT USED FOR UNKNOWN INDICATION
ROTATOR CUFF SYNDROME
1
C
PRODUCT USED FOR UNKNOWN INDICATION
SPINAL COLUMN INJURY
1
C
SLEEP DISORDER
ACTIVITIES OF DAILY LIVING IMPAIRED
1
C
SLEEP DISORDER
AMNESIA
1
C
SLEEP DISORDER
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
1
C
SLEEP DISORDER
CEREBRAL ATROPHY
1
C
SLEEP DISORDER
COMA
1
C
SLEEP DISORDER
CRANIOCEREBRAL INJURY
1
C
SLEEP DISORDER
DEPRESSION
1
C
SLEEP DISORDER
FEELING ABNORMAL
1
C
SLEEP DISORDER
HYPERHIDROSIS
1
C
SLEEP DISORDER
PAIN
1
C
SLEEP DISORDER
PRODUCT QUALITY ISSUE
1
C
SLEEP DISORDER
ROAD TRAFFIC ACCIDENT
1
C
SLEEP DISORDER
ROTATOR CUFF SYNDROME
1
C
SLEEP DISORDER
SPINAL COLUMN INJURY
1
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