Drug information for FOCALIN XR

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE, EXTENDED RELEASE; ORAL 10MG Prescription   DEXMETHYLPHENIDATE HYDROCHLORIDE Methylphenidate NOVARTIS 21802
2012-05-07 Label
2012-05-04 Letter
2011-11-29 Label
2010-11-22 Letter
2010-11-19 Label
2010-05-07 Label
2010-05-07 Letter
2009-12-11 Letter
2009-12-11 Letter
2009-10-30 Medication Guide
2009-10-30 Label
2009-10-30 Label
2008-10-22 Letter
2007-07-02 Review
2007-05-10 Other Important Information from FDA
2007-05-01 Label
2007-05-01 Letter
2006-08-04 Letter
2006-08-04 Letter
2006-08-04 Label
2006-08-04 Label
2006-04-13 Letter
2006-04-13 Letter
2006-04-12 Label
2006-04-12 Label
2005-06-07 Letter
2005-06-07 Label
CAPSULE, EXTENDED RELEASE; ORAL 15MG Prescription   DEXMETHYLPHENIDATE HYDROCHLORIDE Methylphenidate NOVARTIS   "
CAPSULE, EXTENDED RELEASE; ORAL 20MG Prescription   DEXMETHYLPHENIDATE HYDROCHLORIDE Methylphenidate NOVARTIS   "
CAPSULE, EXTENDED RELEASE; ORAL 25MG Prescription   DEXMETHYLPHENIDATE HYDROCHLORIDE Methylphenidate NOVARTIS   "
CAPSULE, EXTENDED RELEASE; ORAL 30MG Prescription   DEXMETHYLPHENIDATE HYDROCHLORIDE Methylphenidate NOVARTIS   "
CAPSULE, EXTENDED RELEASE; ORAL 35MG Prescription   DEXMETHYLPHENIDATE HYDROCHLORIDE Methylphenidate NOVARTIS   "
CAPSULE, EXTENDED RELEASE; ORAL 40MG Prescription  (Reference Drug) DEXMETHYLPHENIDATE HYDROCHLORIDE Methylphenidate NOVARTIS   "
CAPSULE, EXTENDED RELEASE; ORAL 5MG Prescription   DEXMETHYLPHENIDATE HYDROCHLORIDE Methylphenidate NOVARTIS   "

Drug Adverse Effects information for FOCALIN XR

Role code Indications Reaction # Reports
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER CEREBROVASCULAR ACCIDENT 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER CRYING 2
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DEPRESSED MOOD 2
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DISTURBANCE IN SOCIAL BEHAVIOUR 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DIZZINESS 5
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DRUG INEFFECTIVE 5
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DRY MOUTH 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DYSPEPSIA 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER ELECTROCARDIOGRAM QT PROLONGED 2
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER ERECTILE DYSFUNCTION 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER EXTRASYSTOLES 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER HALLUCINATION, VISUAL 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER HEADACHE 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER LIP SWELLING 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER MUSCLE TWITCHING 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER MYDRIASIS 4
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER PRURITUS 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER RASH 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER SUPRAVENTRICULAR TACHYCARDIA 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER SWELLING FACE 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER TACHYCARDIA 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER TARDIVE DYSKINESIA 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER TREMOR 5
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER WITHDRAWAL SYNDROME 4
PS CROHN'S DISEASE BLOOD PRESSURE INCREASED 1
PS CROHN'S DISEASE DIZZINESS 1
PS CROHN'S DISEASE FEELING ABNORMAL 1
PS CROHN'S DISEASE HEART RATE INCREASED 1
PS CROHN'S DISEASE WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
PS IMPULSIVE BEHAVIOUR DISTURBANCE IN SOCIAL BEHAVIOUR 1
PS IMPULSIVE BEHAVIOUR DRUG INEFFECTIVE 1
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER CONSTIPATION 1
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER CRYING 6
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DEPRESSED MOOD 6
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DRUG EFFECT DECREASED 1
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER ELECTROCARDIOGRAM QT PROLONGED 6
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER FEAR 1
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER HALLUCINATION 1
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER INSOMNIA 1
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER PSYCHOTIC DISORDER 1
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER WEIGHT DECREASED 1
SS CROHN'S DISEASE BLOOD PRESSURE INCREASED 1
SS CROHN'S DISEASE DIZZINESS 1
SS CROHN'S DISEASE FEELING ABNORMAL 1
SS CROHN'S DISEASE HEART RATE INCREASED 1
SS CROHN'S DISEASE WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
C ASTROCYTOMA ATONIC SEIZURES 1
C ASTROCYTOMA BLOOD PRESSURE DECREASED 1
C ASTROCYTOMA CONVULSION 1
C ASTROCYTOMA COUGH 1
C ASTROCYTOMA CYANOSIS 1
C ASTROCYTOMA DISORIENTATION 1
C ASTROCYTOMA DYSPNOEA 1
C ASTROCYTOMA FALL 1
C ASTROCYTOMA FOAMING AT MOUTH 1
C ASTROCYTOMA GAIT DISTURBANCE 1
C ASTROCYTOMA HERPANGINA 1
C ASTROCYTOMA NASAL CONGESTION 1
C ASTROCYTOMA PYREXIA 1
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER FEAR 1
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER HALLUCINATION 1
C BLOOD PRESSURE ATONIC SEIZURES 2
C BLOOD PRESSURE BLOOD PRESSURE DECREASED 2
C BLOOD PRESSURE CONVULSION 2
C BLOOD PRESSURE COUGH 2
C BLOOD PRESSURE CYANOSIS 2
C BLOOD PRESSURE DISORIENTATION 2
C BLOOD PRESSURE DYSPNOEA 2
C BLOOD PRESSURE FALL 2
C BLOOD PRESSURE FOAMING AT MOUTH 2
C BLOOD PRESSURE GAIT DISTURBANCE 2
C BLOOD PRESSURE HERPANGINA 2
C BLOOD PRESSURE NASAL CONGESTION 2
C BLOOD PRESSURE PYREXIA 2
C CONVULSION ATONIC SEIZURES 1
C CONVULSION BLOOD PRESSURE DECREASED 1
C CONVULSION CONVULSION 1
C CONVULSION COUGH 1
C CONVULSION CYANOSIS 1
C CONVULSION DISORIENTATION 1
C CONVULSION DYSPNOEA 1
C CONVULSION FALL 1
C CONVULSION FOAMING AT MOUTH 1
C CONVULSION GAIT DISTURBANCE 1
C CONVULSION HERPANGINA 1
C CONVULSION NASAL CONGESTION 1
C CONVULSION PYREXIA 1
C PROPHYLAXIS ATONIC SEIZURES 1
C PROPHYLAXIS BLOOD PRESSURE DECREASED 1
C PROPHYLAXIS CONVULSION 1
C PROPHYLAXIS COUGH 1
C PROPHYLAXIS CYANOSIS 1
C PROPHYLAXIS DISORIENTATION 1
C PROPHYLAXIS DYSPNOEA 1
C PROPHYLAXIS FALL 1
C PROPHYLAXIS FOAMING AT MOUTH 1
C PROPHYLAXIS GAIT DISTURBANCE 1
C PROPHYLAXIS HERPANGINA 1
C PROPHYLAXIS NASAL CONGESTION 1
C PROPHYLAXIS PYREXIA 1
C TUBEROUS SCLEROSIS ATONIC SEIZURES 1
C TUBEROUS SCLEROSIS BLOOD PRESSURE DECREASED 1
C TUBEROUS SCLEROSIS CONVULSION 1
C TUBEROUS SCLEROSIS COUGH 1
C TUBEROUS SCLEROSIS CYANOSIS 1
C TUBEROUS SCLEROSIS DISORIENTATION 1
C TUBEROUS SCLEROSIS DYSPNOEA 1
C TUBEROUS SCLEROSIS FALL 1
C TUBEROUS SCLEROSIS FOAMING AT MOUTH 1
C TUBEROUS SCLEROSIS GAIT DISTURBANCE 1
C TUBEROUS SCLEROSIS HERPANGINA 1
C TUBEROUS SCLEROSIS NASAL CONGESTION 1
C TUBEROUS SCLEROSIS PYREXIA 1
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