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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