Drug information for FOCALIN

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 10MG Prescription AB (Reference Drug) DEXMETHYLPHENIDATE HYDROCHLORIDE Methylphenidate NOVARTIS 21278
2012-05-07 Label
2012-05-04 Letter
2010-12-15 Letter
2010-12-10 Label
2010-11-22 Letter
2010-11-19 Label
2009-10-30 Medication Guide
2007-05-10 Other Important Information from FDA
2007-05-01 Letter
2007-05-01 Label
2007-03-15 Letter
2007-03-15 Label
2006-09-18 Letter
2006-09-18 Letter
2006-08-29 Label
2006-08-29 Label
2001-11-13 Letter
2001-11-13 Label
2001-11-13 Review
TABLET; ORAL 2.5MG Prescription AB  DEXMETHYLPHENIDATE HYDROCHLORIDE Methylphenidate NOVARTIS   "
TABLET; ORAL 5MG Prescription AB  DEXMETHYLPHENIDATE HYDROCHLORIDE Methylphenidate NOVARTIS   "

Drug Adverse Effects information for FOCALIN

Role code Indications Reaction # Reports
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER ABDOMINAL PAIN UPPER 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER CONSTIPATION 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DEATH 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DECREASED APPETITE 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DRUG EFFECT DECREASED 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER FEAR 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER HALLUCINATION 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER INSOMNIA 2
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER PSYCHOTIC DISORDER 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER VOMITING 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER WEIGHT DECREASED 2
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER CONVULSION 2
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DYSARTHRIA 2
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER VIITH NERVE PARALYSIS 2
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER WITHDRAWAL SYNDROME 2
SS PRODUCT USED FOR UNKNOWN INDICATION CONDITION AGGRAVATED 2
SS PRODUCT USED FOR UNKNOWN INDICATION COORDINATION ABNORMAL 2
SS PRODUCT USED FOR UNKNOWN INDICATION DYSARTHRIA 2
SS PRODUCT USED FOR UNKNOWN INDICATION DYSPHAGIA 2
C ACNE DEEP VEIN THROMBOSIS 4
C ACNE PAIN 4
C ACNE PULMONARY EMBOLISM 4
C ANXIETY DEEP VEIN THROMBOSIS 1
C ANXIETY PAIN 1
C ANXIETY PULMONARY EMBOLISM 1
C ASTROCYTOMA APHTHOUS STOMATITIS 1
C ASTROCYTOMA GINGIVAL ERYTHEMA 1
C ASTROCYTOMA ORAL PAIN 1
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER ADVERSE EVENT 3
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER CHEST PAIN 3
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER DEEP VEIN THROMBOSIS 1
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER DEPRESSED MOOD 2
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER HEART RATE INCREASED 3
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER PAIN 1
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER PANIC ATTACK 1
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER PULMONARY EMBOLISM 1
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER SELF-INJURIOUS IDEATION 2
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER SYNCOPE 1
C AUTISM TARDIVE DYSKINESIA 1
C BALANCE DISORDER BALANCE DISORDER 1
C BALANCE DISORDER CREPITATIONS 1
C BALANCE DISORDER FATIGUE 1
C BALANCE DISORDER FIBULA FRACTURE 1
C BALANCE DISORDER GAIT DISTURBANCE 1
C BALANCE DISORDER MUSCULAR WEAKNESS 1
C BALANCE DISORDER OEDEMA PERIPHERAL 1
C BALANCE DISORDER PAIN IN EXTREMITY 1
C BALANCE DISORDER TIBIA FRACTURE 1
C CONTRACEPTION CHOLELITHIASIS 1
C CONTRACEPTION DEEP VEIN THROMBOSIS 3
C CONTRACEPTION EMOTIONAL DISTRESS 1
C CONTRACEPTION GALLBLADDER DISORDER 1
C CONTRACEPTION PAIN 4
C CONTRACEPTION PULMONARY EMBOLISM 3
C DEPRESSION DEEP VEIN THROMBOSIS 2
C DEPRESSION DRUG INEFFECTIVE 1
C DEPRESSION PAIN 2
C DEPRESSION PULMONARY EMBOLISM 2
C FATIGUE BALANCE DISORDER 2
C FATIGUE CREPITATIONS 2
C FATIGUE FATIGUE 2
C FATIGUE FIBULA FRACTURE 2
C FATIGUE GAIT DISTURBANCE 2
C FATIGUE MUSCULAR WEAKNESS 2
C FATIGUE OEDEMA PERIPHERAL 2
C FATIGUE PAIN IN EXTREMITY 2
C FATIGUE TIBIA FRACTURE 2
C INFLAMMATORY BOWEL DISEASE ILEAL STENOSIS 3
C MULTIPLE SCLEROSIS BALANCE DISORDER 1
C MULTIPLE SCLEROSIS CREPITATIONS 1
C MULTIPLE SCLEROSIS FATIGUE 1
C MULTIPLE SCLEROSIS FIBULA FRACTURE 1
C MULTIPLE SCLEROSIS GAIT DISTURBANCE 1
C MULTIPLE SCLEROSIS MUSCULAR WEAKNESS 1
C MULTIPLE SCLEROSIS OEDEMA PERIPHERAL 1
C MULTIPLE SCLEROSIS PAIN IN EXTREMITY 1
C MULTIPLE SCLEROSIS TIBIA FRACTURE 1
C PAIN CHOLELITHIASIS 1
C PAIN EMOTIONAL DISTRESS 1
C PAIN GALLBLADDER DISORDER 1
C PAIN PAIN 1
C SLEEP DISORDER ADVERSE EVENT 1
C SLEEP DISORDER CHEST PAIN 1
C SLEEP DISORDER HEART RATE INCREASED 1
C THYROID DISORDER DEEP VEIN THROMBOSIS 1
C THYROID DISORDER PAIN 1
C THYROID DISORDER PULMONARY EMBOLISM 1
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