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Ritalin LA (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 LA (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 (86)
Death (3)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Drug Ineffective (13)Somnolence (9)Agitation (8)Anxiety (8)Insomnia (8)Fatigue (7)Aggression (7)Loss of Consciousness (6)Dizziness (6)Abnormal Behaviour (6)Attention Deficit / Hyperactivity Disorder (6)Disturbance in Attention (5)

Below are a few examples of reports where side effects / adverse reactions may be related to Ritalin LA (Methylphenidate). For a complete list or a specific selection of reports, please use the links above.

Possible Ritalin LA side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: male

Reactions: Incorrect Dose Administered, Enophthalmos, Depressed Mood, Nervousness, Crying

Drug(s) suspected as cause:
Ritalin LA
    Dosage: half tablet
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder

Ritalin LA
    Dosage: 1 tablet a day
    Administration route: Oral



Possible Ritalin LA side effects in 29 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-20

Patient: 29 year old female

Reactions: Laziness, Wrong Technique in Drug Usage Process, Drug Ineffective, Pain, Somnolence, Depressed Mood

Drug(s) suspected as cause:
Ritalin
    Indication: Distractibility

Ritalin
    Dosage: 10 mg, bid
    Indication: Disturbance in Attention

Ritalin LA
    Dosage: 20 mg, qd
    Indication: Distractibility

Ritalin LA
    Dosage: 10 mg, qd
    Indication: Disturbance in Attention

Other drugs received by patient: Tramadol HCL; Toradiazic



Possible Ritalin LA side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-13

Patient: male, weighing 62.0 kg (136.4 pounds)

Reactions: Agitation, Disturbance in Attention, Eye Pain, Intraocular Pressure Test Abnormal

Drug(s) suspected as cause:
Ritalin LA
    Dosage: 20 mg, unk
    Administration route: Oral

Ritalin LA
    Dosage: 10 mg, bid, one tab at 8 am and one tab at 12 am
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder

Ritalin LA
    Dosage: 10 mg, one capsule daily
    Start date: 2012-07-11

Other drugs received by patient: Amitril



Possible Ritalin LA side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-13

Patient: male, weighing 62.0 kg (136.4 pounds)

Reactions: Agitation, Disturbance in Attention, Eye Pain, Intraocular Pressure Test Abnormal

Drug(s) suspected as cause:
Ritalin LA
    Dosage: 10 mg, one capsule daily
    Start date: 2012-07-11

Ritalin LA
    Dosage: 20 mg, unk
    Administration route: Oral

Ritalin LA
    Dosage: 10 mg, bid, one tab at 8 am and one tab at 12 am
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder

Other drugs received by patient: Amitril



Possible Ritalin LA side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-08

Patient: female

Reactions: Emphysema, Osteoarthritis, Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diclofenac Sodium
    Dosage: unk ukn, unk

Ritalin LA
    Dosage: 40 mg, unk
    Administration route: Oral



Possible Ritalin LA side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-03

Patient: male

Reactions: Developmental Delay

Drug(s) suspected as cause:
Ritalin LA

Other drugs received by patient: Neuleptil



Possible Ritalin LA side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-07-31

Patient: male

Reactions: Upper Limb Fracture

Drug(s) suspected as cause:
Ritalin LA



Possible Ritalin LA side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-07-30

Patient: male

Reactions: Enophthalmos, Depressed Mood, Crying, Nervousness

Drug(s) suspected as cause:
Ritalin LA



Possible Ritalin LA side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-07-26

Patient: male, weighing 32.0 kg (70.4 pounds)

Reactions: Affective Disorder, Depression, Tremor

Drug(s) suspected as cause:
Ritalin
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-10-01

Ritalin LA
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-10-01



Possible Ritalin LA side effects in 12 year old female

Reported by a consumer/non-health professional from Brazil on 2012-07-25

Patient: 12 year old female

Reactions: Agitation, Drug Ineffective, Laceration, Memory Impairment

Drug(s) suspected as cause:
Ritalin LA



Possible Ritalin LA side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-07-25

Patient: male

Reactions: Suicidal Behaviour, Retching, Dizziness, Aggression

Drug(s) suspected as cause:
Ritalin LA



Possible Ritalin LA side effects in 17 year old male

Reported by a consumer/non-health professional from Brazil on 2012-07-24

Patient: 17 year old male

Reactions: Anxiety, Distractibility, Cerebral Hypoperfusion, Drug Ineffective, Abnormal Behaviour, Depressed Mood, Abdominal Pain Upper, Aggression

Drug(s) suspected as cause:
Ritalin LA
    Dosage: 40 mg, unk
    Start date: 2005-01-01

Ritalin LA
    Dosage: 20 mg, unk
    Indication: Attention Deficit / Hyperactivity Disorder



Possible Ritalin LA side effects in 12 year old male

Reported by a consumer/non-health professional from Brazil on 2012-07-24

Patient: 12 year old male

Reactions: Agitation, Drug Intolerance, Hyperhidrosis, Decreased Appetite, Feeling Cold

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ritalin LA



Possible Ritalin LA side effects in 29 year old female

Reported by a consumer/non-health professional from Brazil on 2012-07-24

Patient: 29 year old female

Reactions: Laziness, Wrong Technique in Drug Usage Process, Drug Ineffective, Pain, Somnolence, Depressed Mood

Drug(s) suspected as cause:
Ritalin
    Dosage: 10 mg, bid
    Indication: Disturbance in Attention

Ritalin
    Indication: Distractibility

Ritalin LA
    Dosage: 10 mg, qd
    Indication: Disturbance in Attention

Ritalin LA
    Dosage: 20 mg, qd
    Indication: Distractibility

Other drugs received by patient: Toradiazic; Tramadol Hydrochloride



Possible Ritalin LA side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-07-24

Patient: female, weighing 42.0 kg (92.4 pounds)

Reactions: Mood Altered, Sacroiliitis, Pyrexia, Dengue Fever

Drug(s) suspected as cause:
Ritalin
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder

Ritalin
    Dosage: 10 mg, bid
    Administration route: Oral
    Start date: 2012-01-01

Ritalin LA
    Dosage: 30 mg, daily
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder



Possible Ritalin LA side effects in 10 year old male

Reported by a consumer/non-health professional from Germany on 2012-07-11

Patient: 10 year old male

Reactions: Benign Rolandic Epilepsy

Drug(s) suspected as cause:
Ritalin LA
    Dosage: 20 mg per day
    Administration route: Oral
    Start date: 2010-01-01

Ritalin LA
    Dosage: 20 mg per day
    Administration route: Oral
    Start date: 2008-01-01
    End date: 2009-01-01



Possible Ritalin LA side effects in 6 year old male

Reported by a physician from Germany on 2012-07-09

Patient: 6 year old male, weighing 65.5 kg (144.1 pounds)

Reactions: Dyspnoea, Hypersensitivity, Loss of Consciousness

Drug(s) suspected as cause:
Methylphenidate HCL
    Dosage: unk
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder

Ritalin LA
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2005-01-01
    End date: 2005-01-01

Other drugs received by patient: Risperdal



Possible Ritalin LA side effects in male

Reported by a physician from South Africa on 2012-07-04

Patient: male

Reactions: Hepatic Enzyme Abnormal, Jaundice, Fatigue, Drug Ineffective, Somnolence

Drug(s) suspected as cause:
Ritalin
    Dosage: 10 mg, unk
    Indication: Attention Deficit / Hyperactivity Disorder

Ritalin LA
    Dosage: 30 mg, unk

Ritalin LA
    Dosage: 20 mg, unk
    Indication: Attention Deficit / Hyperactivity Disorder

Other drugs received by patient: Concerta



Possible Ritalin LA side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-07-02

Patient: male, weighing 32.0 kg (70.4 pounds)

Reactions: Affective Disorder, Tremor

Drug(s) suspected as cause:
Ritalin
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-10-01

Ritalin LA
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-10-01



Possible Ritalin LA side effects in 32 year old male

Reported by a consumer/non-health professional from Brazil on 2012-06-29

Patient: 32 year old male

Reactions: Arthralgia, Pain in Extremity, Systemic Lupus Erythematosus, Oedema Peripheral, Sjogren's Syndrome

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Ritalin LA

Other drugs received by patient: Wellbutrin XL



Possible Ritalin LA side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-06-28

Patient: male

Reactions: Restlessness, Food Poisoning, Urticaria, Nervousness, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ritalin LA

Other drugs received by patient: Hixizine; Prednisolone



Possible Ritalin LA side effects in 2 year old male

Reported by a physician from Israel on 2012-06-27

Patient: 2 year old male

Reactions: Accidental Drug Intake by Child

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ritalin LA



Possible Ritalin LA side effects in 10 year old male

Reported by a pharmacist from Germany on 2012-06-27

Patient: 10 year old male

Reactions: Benign Rolandic Epilepsy

Drug(s) suspected as cause:
Ritalin LA



Possible Ritalin LA side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-06-27

Patient: male

Reactions: Insomnia, Accident AT Work, Coma, Gastrointestinal Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ritalin LA
    Indication: Anxiety

Trileptal
    Dosage: 1 df, bid
    Indication: Convulsion



Possible Ritalin LA side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-06-27

Patient: male

Reactions: Insomnia, Accident AT Work, Coma, Gastrointestinal Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ritalin LA
    Indication: Psychomotor Hyperactivity

Ritalin LA
    Dosage: unk ukn, unk
    Administration route: Oral
    Indication: Anxiety

Other drugs received by patient: Trileptal



Possible Ritalin LA side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-06-26

Patient: male

Reactions: Autism, Developmental Delay

Drug(s) suspected as cause:
Ritalin LA



Possible Ritalin LA side effects in male

Reported by a physician from South Africa on 2012-06-22

Patient: male

Reactions: Jaundice, Hepatic Enzyme Abnormal, Fatigue, Drug Ineffective, Somnolence

Drug(s) suspected as cause:
Ritalin
    Dosage: 10 mg, unk
    Indication: Attention Deficit / Hyperactivity Disorder

Ritalin LA
    Dosage: 30 mg, unk

Ritalin LA
    Dosage: 20 mg, unk
    Indication: Attention Deficit / Hyperactivity Disorder

Other drugs received by patient: Concerta



Possible Ritalin LA side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-06-15

Patient: male, weighing 50.0 kg (110.0 pounds)

Reactions: Foot Fracture, Agitation, Drug Ineffective, Stubbornness, Disturbance in Attention, Fall, Aggression

Drug(s) suspected as cause:
Ritalin
    Dosage: 2 df, daily, one in morning one in afternoon
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2006-01-01
    End date: 2011-01-01

Ritalin LA
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-01-01



Possible Ritalin LA side effects in male

Reported by a physician from South Africa on 2012-06-01

Patient: male

Reactions: Hepatic Enzyme Abnormal, Jaundice, Fatigue, Drug Ineffective, Somnolence

Drug(s) suspected as cause:
Ritalin
    Dosage: 10 mg, unk
    Indication: Attention Deficit / Hyperactivity Disorder

Ritalin LA
    Dosage: 20 mg, unk
    Indication: Attention Deficit / Hyperactivity Disorder

Ritalin LA
    Dosage: 30 mg, unk

Other drugs received by patient: Concerta



Possible Ritalin LA side effects in male

Reported by a physician from Germany on 2012-05-31

Patient: male, weighing 26.0 kg (57.2 pounds)

Reactions: Myositis, Peripheral Coldness, Blood Creatine Phosphokinase Increased, Pain in Extremity, Alanine Aminotransferase Increased, Livedo Reticularis, Headache, Arthralgia, Aspartate Aminotransferase Increased, Dizziness, Myoglobin Blood Increased, Gait Disturbance, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methylphenidate HCL
    Dosage: 5 mg daily
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-10-01
    End date: 2012-04-08

Ritalin LA
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2012-03-28
    End date: 2012-04-08

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