This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ritalin-SR (Methylphenidate) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (14)
Life Threatening Events (2)
Reports by Reaction Type
Drug Ineffective (3),
Crying (3),
Abnormal Behaviour (3),
Aggression (3),
Irritability (3),
Disturbance in Attention (3),
Impulsive Behaviour (2),
Learning Disability (2),
Oppositional Defiant Disorder (2),
Affect Lability (2),
Insomnia (2),
Feeling Abnormal (2)
Possible Ritalin-SR side effects in male
Reported by a pharmacist from Canada on 2012-08-09
Patient: male
Reactions: Personality Change, Drug Ineffective, Abnormal Behaviour, Amnesia, Euphoric Mood, Insomnia, Disturbance in Attention, Feeling Abnormal, Depressed Mood
Drug(s) suspected as cause:
Ritalin-SR
Possible Ritalin-SR side effects in 17 year old male
Reported by a physician from Germany on 2012-07-25
Patient: 17 year old male
Reactions: Acute Lymphocytic Leukaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methylphenidate HCL
Dosage: 10 mg per day
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2003-01-01
Ritalin-SR
Dosage: 20 mg per day
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2003-01-01
Other drugs received by patient: Aspirin
Possible Ritalin-SR side effects in male
Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-03-06
Patient: male, weighing 25.0 kg (55.0 pounds)
Reactions: Diplopia, Drooling, Dystonia, Dyskinesia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Aripiprazole
Dosage: 10 mg, qd
Start date: 2012-02-10
Methylphenidate HCL
Dosage: 10 mg, qd
Start date: 2007-01-01
Ritalin-SR
Dosage: 20 mg, qd
Start date: 2007-01-01
Possible Ritalin-SR side effects in 8 year old male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-03-05
Patient: 8 year old male
Reactions: Drug Ineffective, Abnormal Behaviour, Impulsive Behaviour, Oppositional Defiant Disorder, Aggression, Irritability, Affect Lability, Learning Disability, Disturbance in Attention, Attention Deficit / Hyperactivity Disorder, Crying
Drug(s) suspected as cause:
Ritalin
Dosage: 5 mg, bid- in morning and at noon
Indication: Attention Deficit / Hyperactivity Disorder
Ritalin
Dosage: 10 mg, bid, in morning and at noon
Ritalin
Dosage: 20 mg, bid, in morning and at noon
Ritalin
Dosage: 36 mg
Indication: Attention Deficit / Hyperactivity Disorder
Ritalin-SR
Dosage: 20 mg, bid, in morning and in afternoon
Ritalin-SR
Dosage: 10 mg, bid, in morning and in afternoon
Indication: Attention Deficit / Hyperactivity Disorder
Other drugs received by patient: Atomoxetine HCL; Atomoxetine HCL; Atomoxetine HCL; Atomoxetine HCL
Possible Ritalin-SR side effects in female
Reported by a consumer/non-health professional from United States on 2011-12-23
Patient: female
Reactions: Fatigue, Paraesthesia
Drug(s) suspected as cause:
Ritalin-SR
Possible Ritalin-SR side effects in 6 year old male
Reported by a physician from United States on 2011-12-23
Patient: 6 year old male, weighing 29.5 kg (64.9 pounds)
Reactions: Irritability, Underweight, Insomnia, Crying, Aggression
Drug(s) suspected as cause:
Adderall 10
Ritalin
Dosage: 5 mg, oral
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-03-02
Ritalin-SR
Dosage: 20 mg, qd, oral
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-02-25
End date: 2011-03-02
Possible Ritalin-SR side effects in 14 year old male
Reported by a consumer/non-health professional from United States on 2011-12-23
Patient: 14 year old male
Reactions: Joint Swelling, Nausea, Oedema Peripheral, Nodule, Headache, Withdrawal Syndrome
Drug(s) suspected as cause:
Ritalin
Ritalin-SR
Dosage: 20 mg, qd
Possible Ritalin-SR side effects in 20 year old male
Reported by a consumer/non-health professional from United States on 2011-12-23
Patient: 20 year old male
Reactions: Feeling Abnormal
Drug(s) suspected as cause:
Ritalin-SR
Possible Ritalin-SR side effects in female
Reported by a pharmacist from United States on 2011-12-23
Patient: female
Reactions: Sleep Disorder
Drug(s) suspected as cause:
Ritalin-SR
Possible Ritalin-SR side effects in female
Reported by a physician from United States on 2011-12-23
Patient: female
Reactions: Sedation
Drug(s) suspected as cause:
Ritalin-SR
Possible Ritalin-SR side effects in 5 year old female
Reported by a consumer/non-health professional from United States on 2011-12-02
Patient: 5 year old female, weighing 20.9 kg (45.9 pounds)
Reactions: Somnambulism
Drug(s) suspected as cause:
Ritalin-SR
Possible Ritalin-SR side effects in 24 year old male
Reported by a individual with unspecified qualification from Norway on 2011-11-28
Patient: 24 year old male
Reactions: Blood Creatine Phosphokinase Increased
Drug(s) suspected as cause:
Ritalin-SR
Other drugs received by patient: Zyrtec
Possible Ritalin-SR side effects in 8 year old male
Reported by a health professional (non-physician/pharmacist) from Canada on 2011-11-17
Patient: 8 year old male
Reactions: Drug Ineffective, Abnormal Behaviour, Impulsive Behaviour, Oppositional Defiant Disorder, Aggression, Irritability, Affect Lability, Learning Disability, Disturbance in Attention, Attention Deficit / Hyperactivity Disorder, Crying
Drug(s) suspected as cause:
Ritalin
Dosage: 10 mg, bid, in morning and at noon
Ritalin
Dosage: 20 mg, bid, in morning and at noon
Ritalin
Dosage: 36 mg
Indication: Attention Deficit / Hyperactivity Disorder
Ritalin
Dosage: 5 mg, bid- in morning and at noon
Indication: Attention Deficit / Hyperactivity Disorder
Ritalin-SR
Dosage: 10 mg, bid, in morning and in afternoon
Indication: Attention Deficit / Hyperactivity Disorder
Ritalin-SR
Dosage: 20 mg, bid, in morning and in afternoon
Other drugs received by patient: Atomoxetine HCL; Atomoxetine HCL; Atomoxetine HCL; Atomoxetine HCL
Possible Ritalin-SR side effects in male
Reported by a physician from Sweden on 2011-10-27
Patient: male
Reactions: Dyspnoea, Left Ventricular Dysfunction, Overdose, Cardiac Failure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ritalin
Dosage: 80 mg, daily
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2001-01-01
End date: 2011-09-01
Ritalin-SR
Dosage: 240 mg, daily
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2007-01-01
End date: 2011-09-01
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