Drug information for RITALIN-SR

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, EXTENDED RELEASE; ORAL 20MG Prescription AB  METHYLPHENIDATE HYDROCHLORIDE Methylphenidate NOVARTIS 18029
2010-12-15 Letter

2010-12-10 Label

2010-11-18 Letter

2010-11-17 Label

2009-11-20 Medication Guide

2007-05-10 Other Important Information from FDA

2007-05-01 Letter

2007-05-01 Label

2006-08-11 Letter

2006-08-11 Letter

2006-08-09 Label

2006-08-09 Label

2004-05-27 Letter

2004-05-27 Letter

2002-01-11 Letter

Drug Adverse Effects information for RITALIN-SR

Role code Indications Reaction # Reports
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER AGGRESSION 2
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER CRYING 2
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER INSOMNIA 2
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER IRRITABILITY 2
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER SOMNAMBULISM 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER UNDERWEIGHT 2
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER ABNORMAL BEHAVIOUR 8
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER AFFECT LABILITY 8
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER AGGRESSION 8
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER ATTENTION DEFICIT/HYPERACTIVITY DISORDER 8
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER CARDIAC FAILURE 2
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER CRYING 8
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DISTURBANCE IN ATTENTION 8
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DRUG INEFFECTIVE 8
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DYSPNOEA 2
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER IMPULSIVE BEHAVIOUR 8
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER IRRITABILITY 8
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER LEARNING DISABILITY 8
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER LEFT VENTRICULAR DYSFUNCTION 2
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER OPPOSITIONAL DEFIANT DISORDER 8
SS ATTENTION DEFICIT/HYPERACTIVITY DISORDER OVERDOSE 2
C ANXIETY BLOOD GLUCOSE DECREASED 2
C ANXIETY BLOOD PRESSURE DECREASED 2
C ANXIETY CORONARY ARTERY OCCLUSION 2
C ANXIETY DIZZINESS 2
C ANXIETY NAUSEA 2
C ANXIETY OFF LABEL USE 2
C ANXIETY VOMITING 2
C ANXIETY WEIGHT DECREASED 2
C ARTHRITIS BLOOD GLUCOSE DECREASED 1
C ARTHRITIS BLOOD PRESSURE DECREASED 1
C ARTHRITIS CORONARY ARTERY OCCLUSION 1
C ARTHRITIS DIZZINESS 1
C ARTHRITIS NAUSEA 1
C ARTHRITIS OFF LABEL USE 1
C ARTHRITIS VOMITING 1
C ARTHRITIS WEIGHT DECREASED 1
C BENIGN PROSTATIC HYPERPLASIA BLOOD GLUCOSE DECREASED 2
C BENIGN PROSTATIC HYPERPLASIA BLOOD PRESSURE DECREASED 2
C BENIGN PROSTATIC HYPERPLASIA CORONARY ARTERY OCCLUSION 2
C BENIGN PROSTATIC HYPERPLASIA DIZZINESS 2
C BENIGN PROSTATIC HYPERPLASIA NAUSEA 2
C BENIGN PROSTATIC HYPERPLASIA OFF LABEL USE 2
C BENIGN PROSTATIC HYPERPLASIA VOMITING 2
C BENIGN PROSTATIC HYPERPLASIA WEIGHT DECREASED 2
C CARDIOVASCULAR EVENT PROPHYLAXIS BLOOD GLUCOSE DECREASED 2
C CARDIOVASCULAR EVENT PROPHYLAXIS BLOOD PRESSURE DECREASED 2
C CARDIOVASCULAR EVENT PROPHYLAXIS CORONARY ARTERY OCCLUSION 2
C CARDIOVASCULAR EVENT PROPHYLAXIS DIZZINESS 2
C CARDIOVASCULAR EVENT PROPHYLAXIS NAUSEA 2
C CARDIOVASCULAR EVENT PROPHYLAXIS OFF LABEL USE 2
C CARDIOVASCULAR EVENT PROPHYLAXIS VOMITING 2
C CARDIOVASCULAR EVENT PROPHYLAXIS WEIGHT DECREASED 2
C DEPRESSION BLOOD GLUCOSE DECREASED 2
C DEPRESSION BLOOD PRESSURE DECREASED 2
C DEPRESSION CORONARY ARTERY OCCLUSION 2
C DEPRESSION DIZZINESS 2
C DEPRESSION NAUSEA 2
C DEPRESSION OFF LABEL USE 2
C DEPRESSION VOMITING 2
C DEPRESSION WEIGHT DECREASED 2
C DYSPNOEA BLOOD GLUCOSE DECREASED 2
C DYSPNOEA BLOOD PRESSURE DECREASED 2
C DYSPNOEA CORONARY ARTERY OCCLUSION 2
C DYSPNOEA DIZZINESS 2
C DYSPNOEA NAUSEA 2
C DYSPNOEA OFF LABEL USE 2
C DYSPNOEA VOMITING 2
C DYSPNOEA WEIGHT DECREASED 2
C GASTROOESOPHAGEAL REFLUX DISEASE BLOOD GLUCOSE DECREASED 2
C GASTROOESOPHAGEAL REFLUX DISEASE BLOOD PRESSURE DECREASED 2
C GASTROOESOPHAGEAL REFLUX DISEASE CORONARY ARTERY OCCLUSION 2
C GASTROOESOPHAGEAL REFLUX DISEASE DIZZINESS 2
C GASTROOESOPHAGEAL REFLUX DISEASE NAUSEA 2
C GASTROOESOPHAGEAL REFLUX DISEASE OFF LABEL USE 2
C GASTROOESOPHAGEAL REFLUX DISEASE VOMITING 2
C GASTROOESOPHAGEAL REFLUX DISEASE WEIGHT DECREASED 2
C GOUT BLOOD GLUCOSE DECREASED 2
C GOUT BLOOD PRESSURE DECREASED 2
C GOUT CORONARY ARTERY OCCLUSION 2
C GOUT DIZZINESS 2
C GOUT NAUSEA 2
C GOUT OFF LABEL USE 2
C GOUT VOMITING 2
C GOUT WEIGHT DECREASED 2
C HYPERTENSION BLOOD GLUCOSE DECREASED 6
C HYPERTENSION BLOOD PRESSURE DECREASED 6
C HYPERTENSION CORONARY ARTERY OCCLUSION 6
C HYPERTENSION DIZZINESS 6
C HYPERTENSION NAUSEA 6
C HYPERTENSION OFF LABEL USE 6
C HYPERTENSION VOMITING 6
C HYPERTENSION WEIGHT DECREASED 6
C LIPIDS INCREASED BLOOD GLUCOSE DECREASED 4
C LIPIDS INCREASED BLOOD PRESSURE DECREASED 4
C LIPIDS INCREASED CORONARY ARTERY OCCLUSION 4
C LIPIDS INCREASED DIZZINESS 4
C LIPIDS INCREASED NAUSEA 4
C LIPIDS INCREASED OFF LABEL USE 4
C LIPIDS INCREASED VOMITING 4
C LIPIDS INCREASED WEIGHT DECREASED 4
C MYALGIA BLOOD GLUCOSE DECREASED 2
C MYALGIA BLOOD PRESSURE DECREASED 2
C MYALGIA CORONARY ARTERY OCCLUSION 2
C MYALGIA DIZZINESS 2
C MYALGIA NAUSEA 2
C MYALGIA OFF LABEL USE 2
C MYALGIA VOMITING 2
C MYALGIA WEIGHT DECREASED 2
C NEUROPATHY PERIPHERAL BLOOD GLUCOSE DECREASED 2
C NEUROPATHY PERIPHERAL BLOOD PRESSURE DECREASED 2
C NEUROPATHY PERIPHERAL CORONARY ARTERY OCCLUSION 2
C NEUROPATHY PERIPHERAL DIZZINESS 2
C NEUROPATHY PERIPHERAL NAUSEA 2
C NEUROPATHY PERIPHERAL OFF LABEL USE 2
C NEUROPATHY PERIPHERAL VOMITING 2
C NEUROPATHY PERIPHERAL WEIGHT DECREASED 2
C PAIN BLOOD GLUCOSE DECREASED 4
C PAIN BLOOD PRESSURE DECREASED 4
C PAIN CORONARY ARTERY OCCLUSION 4
C PAIN DIZZINESS 4
C PAIN NAUSEA 4
C PAIN OFF LABEL USE 4
C PAIN VOMITING 4
C PAIN WEIGHT DECREASED 4
C POOR QUALITY SLEEP BLOOD GLUCOSE DECREASED 2
C POOR QUALITY SLEEP BLOOD PRESSURE DECREASED 2
C POOR QUALITY SLEEP CORONARY ARTERY OCCLUSION 2
C POOR QUALITY SLEEP DIZZINESS 2
C POOR QUALITY SLEEP NAUSEA 2
C POOR QUALITY SLEEP OFF LABEL USE 2
C POOR QUALITY SLEEP VOMITING 2
C POOR QUALITY SLEEP WEIGHT DECREASED 2
C PRODUCT USED FOR UNKNOWN INDICATION BLOOD GLUCOSE DECREASED 5
C PRODUCT USED FOR UNKNOWN INDICATION BLOOD PRESSURE DECREASED 5
C PRODUCT USED FOR UNKNOWN INDICATION CORONARY ARTERY OCCLUSION 5
C PRODUCT USED FOR UNKNOWN INDICATION DIZZINESS 5
C PRODUCT USED FOR UNKNOWN INDICATION NAUSEA 5
C PRODUCT USED FOR UNKNOWN INDICATION OFF LABEL USE 5
C PRODUCT USED FOR UNKNOWN INDICATION VOMITING 5
C PRODUCT USED FOR UNKNOWN INDICATION WEIGHT DECREASED 5
C SUPPLEMENTATION THERAPY BLOOD GLUCOSE DECREASED 1
C SUPPLEMENTATION THERAPY BLOOD PRESSURE DECREASED 1
C SUPPLEMENTATION THERAPY CORONARY ARTERY OCCLUSION 1
C SUPPLEMENTATION THERAPY DIZZINESS 1
C SUPPLEMENTATION THERAPY NAUSEA 1
C SUPPLEMENTATION THERAPY OFF LABEL USE 1
C SUPPLEMENTATION THERAPY VOMITING 1
C SUPPLEMENTATION THERAPY WEIGHT DECREASED 1
C TYPE 2 DIABETES MELLITUS BLOOD GLUCOSE DECREASED 4
C TYPE 2 DIABETES MELLITUS BLOOD PRESSURE DECREASED 4
C TYPE 2 DIABETES MELLITUS CORONARY ARTERY OCCLUSION 4
C TYPE 2 DIABETES MELLITUS DIZZINESS 4
C TYPE 2 DIABETES MELLITUS NAUSEA 4
C TYPE 2 DIABETES MELLITUS OFF LABEL USE 4
C TYPE 2 DIABETES MELLITUS VOMITING 4
C TYPE 2 DIABETES MELLITUS WEIGHT DECREASED 4
C VITAMIN D DEFICIENCY BLOOD GLUCOSE DECREASED 2
C VITAMIN D DEFICIENCY BLOOD PRESSURE DECREASED 2
C VITAMIN D DEFICIENCY CORONARY ARTERY OCCLUSION 2
C VITAMIN D DEFICIENCY DIZZINESS 2
C VITAMIN D DEFICIENCY NAUSEA 2
C VITAMIN D DEFICIENCY OFF LABEL USE 2
C VITAMIN D DEFICIENCY VOMITING 2
C VITAMIN D DEFICIENCY WEIGHT DECREASED 2
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