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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