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Methylphenidate (Methylphenidate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to 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 (174)
Death (51)
Life Threatening Events (6)
Disability (3)

Reports by Reaction Type

Completed Suicide (26)Toxicity To Various Agents (17)Drug Ineffective (15)Death (12)Product Substitution Issue (11)Agitation (10)Anxiety (10)Tachycardia (9)Drug Abuse (8)Decreased Appetite (7)Aggression (7)Insomnia (7)

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

Possible Methylphenidate side effects in 9 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-24

Patient: 9 year old male, weighing 40.0 kg (88.0 pounds)

Reactions: Weight Decreased, Blood Pressure Increased, Sensation of Foreign Body, TIC, Tachycardia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atomoxetine HCL
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2010-02-03
    End date: 2012-02-06

Methylphenidate
    Dosage: 30 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    End date: 2012-02-13

Risperidone
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2010-10-21
    End date: 2012-02-11



Possible Methylphenidate side effects in 9 year old male

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

Patient: 9 year old male, weighing 40.0 kg (88.0 pounds)

Reactions: Blood Pressure Increased, Weight Decreased, Sensation of Foreign Body, TIC, Tachycardia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atomoxetine HCL
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2010-02-03
    End date: 2012-02-06

Methylphenidate
    Dosage: 30 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    End date: 2012-02-13

Risperidone
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2010-10-21
    End date: 2012-02-11



Possible Methylphenidate side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-23

Patient:

Reactions: Blood Pressure Increased, Weight Decreased, Sensation of Foreign Body, TIC, Tachycardia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atomoxetine HCL
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2010-11-03
    End date: 2012-02-06

Methylphenidate
    Dosage: 30 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    End date: 2012-02-13

Risperidone
    Dosage: 0.5 mg, bid
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2010-10-21
    End date: 2012-02-11



Possible Methylphenidate side effects in

Reported by a physician from Germany on 2012-08-23

Patient:

Reactions: Blood Pressure Increased, Weight Decreased, Sensation of Foreign Body, TIC, Tachycardia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atomoxetine HCL
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2010-11-03
    End date: 2012-02-06

Methylphenidate
    Dosage: 30 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    End date: 2012-02-13

Risperidone
    Dosage: 0.5 mg, bid
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2010-10-21
    End date: 2012-02-11



Possible Methylphenidate side effects in 27 year old female

Reported by a physician from United States on 2012-08-23

Patient: 27 year old female

Reactions: Agitation, Maternal Exposure During Pregnancy, Drug Abuse, Premature Labour, Vaginal Haemorrhage, Anxiety, Psychotic Disorder, Labour Pain, Heart Rate Increased, Eye Movement Disorder, Premature Delivery, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Barbiturates
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Benzodiazepines
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Cocaine
    Indication: Product Used FOR Unknown Indication

Generic Amphetamine Salts
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Methylphenidate
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Seroquel
    Dosage: unknown dosing details
    Indication: Product Used FOR Unknown Indication

Suboxone
    Dosage: dosing details unknown
    Indication: Drug Dependence

Subutex
    Dosage: dosing details unknown
    Indication: Drug Dependence



Possible Methylphenidate side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Premature Baby, Foetal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amphetamines
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Barbiturates
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Benzodiazepines
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Cocaine
    Indication: Product Used FOR Unknown Indication

Hydroxyzine
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Lorazepam
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Methylphenidate
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Nifedipine
    Dosage: dosing details unknown
    Indication: Premature Labour

Seroquel
    Dosage: unknown dosing details
    Indication: Product Used FOR Unknown Indication

Suboxone
    Dosage: dosing details unknown
    Indication: Drug Dependence

Subutex
    Dosage: dosing details unknown
    Indication: Drug Dependence

Terbutaline
    Indication: Premature Labour



Possible Methylphenidate side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 30 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Peptic Ulcer, Biliary Dilatation, Cholecystitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methylphenidate



Possible Methylphenidate side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-10

Patient:

Reactions: Tourette's Disorder

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Adenosine
    Indication: Product Used FOR Unknown Indication

AN Unknown Medication
    Indication: Product Used FOR Unknown Indication

Carbamazepine
    Indication: Product Used FOR Unknown Indication

Cefaclor
    Indication: Product Used FOR Unknown Indication

Celiprolol
    Indication: Product Used FOR Unknown Indication

Fluoxetine HCL
    Indication: Product Used FOR Unknown Indication

Fluvoxamine Maleate
    Indication: Product Used FOR Unknown Indication

H1n1 Vaccine
    Indication: Product Used FOR Unknown Indication

Hepatitis B Vaccine
    Indication: Product Used FOR Unknown Indication

Influenza Vaccine
    Indication: Product Used FOR Unknown Indication

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

Metoclopramide
    Indication: Product Used FOR Unknown Indication

Mirtazapine
    Indication: Product Used FOR Unknown Indication

Montelukast
    Indication: Product Used FOR Unknown Indication

Moxifloxacin
    Indication: Product Used FOR Unknown Indication

Niaprazine
    Indication: Product Used FOR Unknown Indication

Oxatomide
    Indication: Product Used FOR Unknown Indication

Pregabalin
    Indication: Product Used FOR Unknown Indication

Theophylline
    Indication: Product Used FOR Unknown Indication

Tramadol HCL
    Indication: Product Used FOR Unknown Indication

Valpromide
    Indication: Product Used FOR Unknown Indication

Venlafaxine
    Indication: Product Used FOR Unknown Indication

Zolmitriptan
    Indication: Product Used FOR Unknown Indication

Zolmitriptan



Possible Methylphenidate side effects in 13 year old male

Reported by a physician from United Kingdom on 2012-08-08

Patient: 13 year old male, weighing 41.7 kg (91.7 pounds)

Reactions: Malaise, Hallucination, Visual, Dizziness, Aggression

Drug(s) suspected as cause:
Methylphenidate



Possible Methylphenidate side effects in male

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

Patient: male, weighing 25.4 kg (55.9 pounds)

Reactions: Drug Ineffective, Decreased Appetite, Negativism, Aggression

Drug(s) suspected as cause:
Concerta
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2012-06-22

Concerta
    Administration route: Oral
    Start date: 2012-07-21

Methylphenidate
    Indication: Attention Deficit / Hyperactivity Disorder
    End date: 2012-07-20



Possible Methylphenidate side effects in 6 year old female

Reported by a health professional (non-physician/pharmacist) from NEW Zealand on 2012-08-03

Patient: 6 year old female

Reactions: Anxiety, Self Injurious Behaviour, Depression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methylphenidate



Possible Methylphenidate side effects in 56 year old female

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

Patient: 56 year old female, weighing 62.6 kg (137.7 pounds)

Reactions: Visual Acuity Reduced

Drug(s) suspected as cause:
Methylphenidate



Possible Methylphenidate side effects in 10 year old

Reported by a physician from United States on 2012-07-31

Patient: 10 year old

Reactions: Agitation, Muscle Rigidity, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Concerta
    Administration route: Oral

Focalin
    Administration route: Oral

Imipramine HCL
    Administration route: Oral

Lithium Carbonate
    Administration route: Oral

Methylphenidate
    Administration route: Oral

Quetiapine
    Administration route: Oral

Risperidone
    Administration route: Oral

Valproate Sodium
    Administration route: Oral



Possible Methylphenidate side effects in male

Reported by a physician from Spain on 2012-07-26

Patient: male, weighing 32.0 kg (70.4 pounds)

Reactions: Astigmatism, Visual Acuity Reduced, Eye Pruritus

Drug(s) suspected as cause:
Concerta
    Dosage: approximately 2.5 years ago
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder

Methylphenidate
    Indication: Attention Deficit / Hyperactivity Disorder



Possible Methylphenidate side effects in

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

Patient:

Reactions: Tourette's Disorder

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Adenosine
    Indication: Product Used FOR Unknown Indication

AN Unknown Medication
    Indication: Product Used FOR Unknown Indication

Carbamazepine
    Indication: Product Used FOR Unknown Indication

Cefaclor
    Indication: Product Used FOR Unknown Indication

Celiprolol
    Indication: Product Used FOR Unknown Indication

Fluoxetine HCL
    Indication: Product Used FOR Unknown Indication

Fluvoxamine Maleate
    Indication: Product Used FOR Unknown Indication

H1n1 Vaccine
    Indication: Product Used FOR Unknown Indication

Hepatitis B Vaccine
    Indication: Product Used FOR Unknown Indication

Influenza Vaccine
    Indication: Product Used FOR Unknown Indication

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

Metoclopramide
    Indication: Product Used FOR Unknown Indication

Mirtazapine
    Indication: Product Used FOR Unknown Indication

Montelukast
    Indication: Product Used FOR Unknown Indication

Moxifloxacin
    Indication: Product Used FOR Unknown Indication

Niaprazine
    Indication: Product Used FOR Unknown Indication

Oxatomide
    Indication: Product Used FOR Unknown Indication

Pregabalin
    Indication: Product Used FOR Unknown Indication

Theophylline
    Indication: Product Used FOR Unknown Indication

Tramadol HCL
    Indication: Product Used FOR Unknown Indication

Valpromide
    Indication: Product Used FOR Unknown Indication

Venlafaxine
    Indication: Product Used FOR Unknown Indication

Zolmitriptan

Zolmitriptan
    Indication: Product Used FOR Unknown Indication



Possible Methylphenidate side effects in

Reported by a physician from Germany on 2012-07-19

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Methylphenidate



Possible Methylphenidate side effects in 12 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-18

Patient: 12 year old male, weighing 72.0 kg (158.4 pounds)

Reactions: Drug Effect Decreased, Vomiting, Nausea, Headache

Drug(s) suspected as cause:
Methylphenidate



Possible Methylphenidate side effects in 5 year old male

Reported by a physician from United States on 2012-07-13

Patient: 5 year old male

Reactions: Klinefelter's Syndrome, Dyskinesia, Muscular Weakness, Abnormal Behaviour, Ataxia, Rash, Toxicity To Various Agents, Aggression, Affect Lability, Chorea, Gait Disturbance, Coordination Abnormal, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aripiprazole

Dextroamphetamine
    Indication: Abnormal Behaviour

Lamotrigine
    Indication: Abnormal Behaviour

Levetiracetam
    Indication: Guillain-Barre Syndrome

Methylphenidate
    Indication: Abnormal Behaviour

Valproic Acid



Possible Methylphenidate side effects in 18 year old

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-11

Patient: 18 year old

Reactions: Sexual Abuse

Drug(s) suspected as cause:
Methylphenidate



Possible Methylphenidate side effects in 6 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-11

Patient: 6 year old female, weighing 17.7 kg (38.9 pounds)

Reactions: Dyskinesia

Drug(s) suspected as cause:
Methylphenidate



Possible Methylphenidate side effects in

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

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Methylphenidate



Possible Methylphenidate side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-09

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Methylphenidate



Possible Methylphenidate side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-09

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Methylphenidate



Possible Methylphenidate side effects in 58 year old female

Reported by a physician from United States on 2012-07-05

Patient: 58 year old female

Reactions: Supraventricular Tachycardia, Hypotension, Drug Interaction, Cardiac Arrest, Atrioventricular Block Second Degree

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Dopamine HCL
    Dosage: 2.5 mcg/kg/minute
    Indication: Ill-Defined Disorder

Methylphenidate
    Indication: Psychomotor Retardation

Methylphenidate
    Dosage: 5 mg/day
    Indication: Depression

Sertraline Hydrochloride
    Indication: Psychomotor Retardation

Sertraline Hydrochloride
    Dosage: 25 mg/day
    Indication: Depression

Verapamil HCL
    Dosage: 40 mg daily
    Administration route: Oral
    Indication: Supraventricular Tachycardia

Other drugs received by patient: Valganciclovir; Furosemide; Erythropoietin; Docusate Sodium; Amphotericin B; Sulfamethoxazole and Trimethoprim; Isophane Insulin; Aspirin; Pantoprazole; Levofloxacin; Tacrolimus; Vancomycin; Heparin; Multi-Vitamins; Pravastatin; Calcium Citrate; Sulfamethoxazole; Cyclophosphamide; Ferrous Gluconate; Prednisone; Nystatin



Possible Methylphenidate side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-03

Patient:

Reactions: Syncope, Dizziness, Drug Interaction

Drug(s) suspected as cause:
Clomipramine HCL

Methylphenidate

Selegiline



Possible Methylphenidate side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-03

Patient:

Reactions: Syncope, Drug Interaction, Dizziness

Drug(s) suspected as cause:
Clomipramine HCL

Methylphenidate

Selegiline



Possible Methylphenidate side effects in 6 year old female

Reported by a health professional (non-physician/pharmacist) from NEW Zealand on 2012-07-03

Patient: 6 year old female

Reactions: Anxiety, Self Injurious Behaviour, Depression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methylphenidate



Possible Methylphenidate side effects in 7 year old male

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

Patient: 7 year old male, weighing 27.2 kg (59.9 pounds)

Reactions: Nasopharyngitis, TIC, Head Titubation

Drug(s) suspected as cause:
Methylphenidate



Possible Methylphenidate side effects in 4 year old male

Reported by a physician from United States on 2012-06-26

Patient: 4 year old male, weighing 16.1 kg (35.4 pounds)

Reactions: Abnormal Behaviour, Aggression

Drug(s) suspected as cause:
Concerta
    Dosage: 27 mg daily
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2012-03-05
    End date: 2012-06-08

Methylphenidate
    Dosage: 27 mg daily
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2012-06-08
    End date: 2012-06-20



Possible Methylphenidate side effects in 41 year old female

Reported by a physician from United States on 2012-06-25

Patient: 41 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Initial Insomnia, Vomiting, Drug Ineffective, Somnolence, Irritability, Anxiety, Drug Tolerance, Fatigue, Malaise, Impatience, Anger, Depression, Violence-Related Symptom, Homicidal Ideation, Hypersomnia

Drug(s) suspected as cause:
Methylphenidate
    Dosage: unknown
    Indication: Narcolepsy

Xyrem
    Dosage: 9 gm (4.5 gm, 2 in 1 d)
    Indication: Narcolepsy
    Start date: 2009-01-01

Other drugs received by patient: Amphetamine, Dextrophetamine Mixed Salts; Bupropion Hydrochloride; Gabapentin; Atenolol

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