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Ritalin (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 (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 (328)
Death (18)
Life Threatening Events (23)
Disability (15)

Reports by Reaction Type

Drug Ineffective (30)Depression (21)Suicidal Ideation (20)Fatigue (20)Aggression (20)Attention Deficit / Hyperactivity Disorder (20)Agitation (19)Anxiety (19)Disturbance in Attention (19)Tremor (17)Insomnia (17)Somnolence (15)

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

Possible Ritalin side effects in 22 year old female

Reported by a physician from Austria on 2012-08-24

Patient: 22 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion

Drug(s) suspected as cause:
Ritalin



Possible Ritalin side effects in 56 year old female

Reported by a physician from France on 2012-08-21

Patient: 56 year old female

Reactions: Myalgia, Blood Creatine Phosphokinase Increased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Ritalin

Other drugs received by patient: Colchicine



Possible Ritalin side effects in 86 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-08-21

Patient: 86 year old female

Reactions: Death, Renal Impairment, Diabetes Mellitus, Dementia, Drug Administered To Patient of Inappropriate AGE, Cardiac Disorder

Adverse event resulted in: death

Drug(s) suspected as cause:
Ritalin



Possible Ritalin 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 side effects in female

Reported by a physician from Denmark on 2012-08-20

Patient: female, weighing 47.0 kg (103.4 pounds)

Reactions: Sudden Cardiac Death, Tachyarrhythmia, Cardiac Hypertrophy

Adverse event resulted in: death

Drug(s) suspected as cause:
Concerta
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2010-09-22

Ritalin
    Dosage: 10 mg
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2010-08-16



Possible Ritalin side effects in female

Reported by a physician from United States on 2012-08-17

Patient: female, weighing 60.4 kg (132.8 pounds)

Reactions: Foetal Distress Syndrome, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Provigil
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2002-01-01
    End date: 2011-01-01

Provigil
    Dosage: 28.5714 milligram daily;
    Administration route: Oral
    Start date: 2002-01-01
    End date: 2011-01-01

Ritalin
    Dosage: 10 milligram daily;
    Indication: Narcolepsy
    Start date: 2011-01-02

Other drugs received by patient: Zyrtec; Multi-Vitamins



Possible Ritalin side effects in female

Reported by a physician from Denmark on 2012-08-16

Patient: female, weighing 47.0 kg (103.4 pounds)

Reactions: Cardiac Murmur, Tachyarrhythmia, Hypertrophic Cardiomyopathy

Adverse event resulted in: death

Drug(s) suspected as cause:
Concerta
    Dosage: 36 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2010-09-22

Ritalin
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2010-08-16



Possible Ritalin side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-14

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Osteoarthritis, Arthritis

Drug(s) suspected as cause:
Ritalin

Other drugs received by patient: Glucosamine Sulfate; Alprazolam; Clogretina Sulphate; Bupropion HCL; Citalopram



Possible Ritalin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Abilify

Adderall

Antidepressants

Beta Blocking Agents

Buspar

Darvocet-N 50

Daytrana

Depakote

Desyrel

Effexor

Elavil

Erythromycin

Lunesta

MAO Inhibitors

Neurontin

Pamelor

Paxil

Prozac

Reglan

Remeron

Requip

Ritalin

Seroquel

Sinequan

Skelaxin

Steroids NOS

Sumatriptan

Tegretol

Tizanidine Hydrochloride
    Indication: Migraine

Tofranil

Topamax

Trileptal

Valium
    Indication: Agitation

Wellbutrin

Zoloft

Zonegran

Zyprexa

Other drugs received by patient: Aspirin; Vitamin B-Complex, Other Combinations; Ensure; Caltrate +D; ONE A DAY



Possible Ritalin side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-10

Patient: female

Reactions: Anxiety, Agitation, School Refusal, Intentional Self-Injury, Learning Disorder

Drug(s) suspected as cause:
Ritalin



Possible Ritalin side effects in male

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

Patient: male

Reactions: Head Injury, Fall, Skull Fracture

Drug(s) suspected as cause:
Ritalin
    Dosage: 0.5 df, daily

Ritalin
    Dosage: 10 mg, daily
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2012-07-04
    End date: 2012-07-10



Possible Ritalin side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-07

Patient: male

Reactions: Diabetes Mellitus, Pain, Hypertension

Drug(s) suspected as cause:
Ritalin



Possible Ritalin side effects in 18 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: 18 year old male

Reactions: Product Substitution Issue, Agitation, Anger, Disturbance in Attention, Rash, Oppositional Defiant Disorder, Aggression

Drug(s) suspected as cause:
Ritalin

Other drugs received by patient: Strattera; Concerta; Seroquel



Possible Ritalin side effects in 35 year old female

Reported by a physician from Germany on 2012-08-06

Patient: 35 year old female

Reactions: Myelitis, Overdose, Thrombocytopenia

Drug(s) suspected as cause:
Ritalin
    Dosage: 140 mg daily
    Administration route: Oral

Ritalin
    Administration route: Oral



Possible Ritalin side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-06

Patient: female

Reactions: Middle Insomnia, Hearing Disability, Cognitive Disorder

Drug(s) suspected as cause:
Ritalin



Possible Ritalin side effects in male

Reported by a physician from Germany on 2012-08-02

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Intentional Overdose, Tachycardia, Suicide Attempt, Hypertension

Drug(s) suspected as cause:
Alcohol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Concerta
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-23
    End date: 2012-07-23

Ritalin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Ritalin side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-01

Patient: female

Reactions: Abdominal Pain, Pain, Maternal Exposure During Pregnancy, Abortion Spontaneous, Anxiety, Cervical Discharge, Uterine Haemorrhage, Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ritalin



Possible Ritalin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female

Reactions: Nephrolithiasis, Cholelithiasis, Pancreatitis

Drug(s) suspected as cause:
Ritalin



Possible Ritalin side effects in female

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

Patient: female

Reactions: Cholelithiasis, Nephrolithiasis, Pancreatitis

Drug(s) suspected as cause:
Fentanyl-100
    Dosage: q72h

Fentanyl-100
    Dosage: q72h
    Indication: Pain in Extremity

Fentanyl-100
    Dosage: q72h

Fentanyl-100
    Dosage: q72h

Ritalin
    Administration route: Oral
    Indication: Viith Nerve Paralysis
    Start date: 2011-01-01

Other drugs received by patient: Lorazepam



Possible Ritalin side effects in female

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

Patient: female

Reactions: Aphasia, Muscular Weakness, Feeling Abnormal

Drug(s) suspected as cause:
Ritalin
    Dosage: 10 mg, daily
    Indication: Brain Injury
    Start date: 1992-07-01

Ritalin
    Indication: Narcolepsy

Ritalin
    Indication: Perinatal Brain Damage

Other drugs received by patient: Dolo-Neurobion Forte; Omeprazole



Possible Ritalin side effects in 51 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-27

Patient: 51 year old female, weighing 87.1 kg (191.6 pounds)

Reactions: Drug Dose Omission, Anxiety Disorder, Wrong Technique in Drug Usage Process, Delirium, Somnolence, Anxiety, Off Label Use, Middle Insomnia, Fatigue, Hyperphagia, Bipolar Disorder, Insomnia, Hypersomnia

Drug(s) suspected as cause:
Anti-Depressant

Ritalin
    Indication: Depression

Seroquel
    Administration route: Oral
    Indication: Sleep Disorder

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Insomnia

Other drugs received by patient: Generic OF Norvasc; Losartan Potassium and Hydrochlorothiazide; Garlique; Potassium Chloride; Garlique; Klonipine; Calcium with Vitamin D; Metoprolol Tartrate; Lovaza



Possible Ritalin 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 side effects in female

Reported by a physician from United States on 2012-07-26

Patient: female, weighing 37.6 kg (82.8 pounds)

Reactions: Product Substitution Issue, Dysphemia

Drug(s) suspected as cause:
Ritalin



Possible Ritalin side effects in female

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

Patient: female

Reactions: Paranoia, Depression, Delusion, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ritalin

Other drugs received by patient: Rebif



Possible Ritalin side effects in 9 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-25

Patient: 9 year old male

Reactions: Mitral Valve Disease

Drug(s) suspected as cause:
Concerta
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-05-01
    End date: 2011-07-06

Ritalin
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2008-01-01
    End date: 2011-05-01

Other drugs received by patient: Atarax; Risperdal



Possible Ritalin side effects in 11 year old male

Reported by a physician from Greece on 2012-07-25

Patient: 11 year old male

Reactions: Peripheral Coldness, Dyskinesia, Blood Sodium Decreased, Hyperhidrosis

Drug(s) suspected as cause:
Ritalin
    Dosage: 5 mg, unk

Ritalin
    Dosage: unk ukn, unk



Possible Ritalin side effects in male

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

Patient: male

Reactions: Parkinson's Disease

Drug(s) suspected as cause:
Ritalin



Possible Ritalin 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 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 side effects in 20 year old male

Reported by a physician from United States on 2012-07-23

Patient: 20 year old male

Reactions: Mental Impairment

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Ritalin

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