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Ritalin-SR (Methylphenidate) - Side Effect Reports to FDA

 
 



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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