Index of reports
> Cases with Abnormal Behaviour (26)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Concerta (Methylphenidate) where reactions include abnormal behaviour. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Concerta side effects in 21 year old male
Reported by a physician from United States on 2012-08-07
Patient: 21 year old male
Reactions: Fatigue, Unresponsive To Stimuli, Abnormal Behaviour, Mental Status Changes
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Concerta
Administration route: Oral
Start date: 2012-06-01
End date: 2012-07-20
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2012-07-23
Possible Concerta side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: female, weighing 40.8 kg (89.8 pounds)
Reactions: Underweight, Drug Dose Omission, Mental Impairment, Abnormal Behaviour
Drug(s) suspected as cause:
Concerta
Other drugs received by patient: Clonidine
Possible Concerta 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:
Methylphenidate
Dosage: 27 mg daily
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2012-06-08
End date: 2012-06-20
Concerta
Dosage: 27 mg daily
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2012-03-05
End date: 2012-06-08
Possible Concerta side effects in male
Reported by a physician from South Africa on 2012-06-13
Patient: male
Reactions: Irritability, Apathy, Overdose, Poor Personal Hygiene, Abnormal Behaviour, Drug Abuse, Aggression
Drug(s) suspected as cause:
Concerta
Dosage: 2-3 times daily
Administration route: Oral
Concerta
Dosage: 108+mg
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2010-01-01
Possible Concerta side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-11
Patient: male
Reactions: Mydriasis, Abnormal Behaviour, Hyperhidrosis, Therapeutic Response Decreased, Road Traffic Accident, Visual Impairment, Feeling Jittery, Abnormal Loss of Weight, Adverse Event, Feeling Abnormal, Decreased Appetite
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-10-01
End date: 2011-01-01
Concerta
Administration route: Oral
Start date: 2012-04-01
Concerta
Administration route: Oral
Start date: 2011-01-01
End date: 2012-04-01
Concerta
Administration route: Oral
End date: 2011-01-01
Possible Concerta side effects in 10 year old male
Reported by a consumer/non-health professional from United States on 2012-04-30
Patient: 10 year old male
Reactions: Weight Decreased, Hypersensitivity, Growth Retardation, Abnormal Behaviour, Aggression, Eating Disorder, Therapeutic Response Decreased, Overdose, Insomnia, Abdominal Symptom
Drug(s) suspected as cause:
Methylphenidate HCL
Administration route: Oral
Methylphenidate HCL
Administration route: Oral
Concerta
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Methylphenidate HCL
Administration route: Oral
Methylphenidate HCL
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Concerta side effects in 10 year old male
Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-04-27
Patient: 10 year old male
Reactions: Abnormal Behaviour, Eye Movement Disorder, Staring, Psychotic Behaviour
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in male
Reported by a physician from South Africa on 2012-04-27
Patient: male
Reactions: Irritability, Apathy, Overdose, Poor Personal Hygiene, Abnormal Behaviour, Drug Abuse, Aggression
Drug(s) suspected as cause:
Concerta
Dosage: 108+mg
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2010-01-01
Concerta
Dosage: 2-3 times daily
Administration route: Oral
Possible Concerta side effects in 13 year old male
Reported by a physician from Turkey on 2012-03-28
Patient: 13 year old male
Reactions: Suicide Attempt, Abnormal Behaviour, Depression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Ritalin
Concerta
Concerta
Risperdal
Administration route: Oral
Ritalin
Indication: Attention Deficit / Hyperactivity Disorder
Concerta
Concerta
Risperdal
Administration route: Oral
Indication: Conduct Disorder
Concerta
Indication: Attention Deficit / Hyperactivity Disorder
Concerta
Concerta
Indication: Conduct Disorder
Sertraline Hydrochloride
Indication: Depression
Possible Concerta side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-23
Patient: male, weighing 63.5 kg (139.7 pounds)
Reactions: Product Quality Issue, Alcohol Use, Abnormal Behaviour, Treatment Noncompliance, Drug Abuse, Convulsion
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
End date: 2011-06-01
Concerta
Administration route: Oral
Start date: 2012-02-01
Possible Concerta side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-22
Patient: male
Reactions: Agitation, Blood Creatine Phosphokinase Increased, Rhabdomyolysis, Hyperthermia, Dyskinesia, Tachycardia, Impulsive Behaviour, Haemodynamic Instability, Renal Failure Acute, Dissociative Fugue, Cytolytic Hepatitis, General Physical Health Deterioration, Abnormal Behaviour, DRY Skin, Toxicity To Various Agents, Respiratory Distress, Convulsion, Aggression, Lung Disorder, Dehydration, Hypotonia, Altered State of Consciousness, Shock
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Nopron
Dosage: unk
Start date: 2010-06-28
End date: 2010-06-29
Tercian
Dosage: 12.5 mg, bid
Start date: 2010-05-01
End date: 2010-05-31
Concerta
Dosage: unk
Start date: 2010-05-01
Atarax
Dosage: unk
Indication: Agitation
Start date: 2010-05-01
End date: 2010-06-04
Atarax
Dosage: unk
Artane
Dosage: 30 mg, qd
Indication: Parkinsonism
Start date: 2010-06-23
End date: 2010-06-29
Neuleptil
Dosage: unk
Start date: 2010-05-01
End date: 2010-05-31
Ritalin
Dosage: 20 mg, qd
Administration route: Oral
Indication: Anxiety
Start date: 2008-01-01
End date: 2010-05-01
Atarax
Dosage: 200 mg, qd
Start date: 2010-06-21
End date: 2010-06-29
Ritalin
Dosage: 25 mg, qd
Administration route: Oral
Start date: 2010-06-21
End date: 2010-06-29
Risperdal
Dosage: 1 mg, bid
Start date: 2008-01-01
End date: 2010-05-01
Lepticur
Dosage: unk
Start date: 2010-06-04
End date: 2010-06-21
Clonazepam
Dosage: unk
Start date: 2010-06-04
End date: 2010-06-21
Other drugs received by patient: Valium; Sufentanyl; Midazolam HCL
Possible Concerta side effects in 13 year old male
Reported by a physician from Turkey on 2012-03-14
Patient: 13 year old male, weighing 4.5 kg (9.9 pounds)
Reactions: Suicide Attempt, Abnormal Behaviour, Depression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sertraline Hydrochloride
Indication: Depression
Concerta
Concerta
Ritalin
Indication: Attention Deficit / Hyperactivity Disorder
Concerta
Concerta
Indication: Conduct Disorder
Concerta
Concerta
Concerta
Indication: Attention Deficit / Hyperactivity Disorder
Concerta
Risperdal
Administration route: Oral
Ritalin
Risperdal
Administration route: Oral
Indication: Conduct Disorder
Possible Concerta side effects in male
Reported by a health professional (non-physician/pharmacist) from South Africa on 2012-02-27
Patient: male
Reactions: Weight Decreased, Abnormal Behaviour, Violence-Related Symptom
Drug(s) suspected as cause:
Concerta
Other drugs received by patient: Lovaza
Possible Concerta side effects in 16 year old male
Reported by a physician from Switzerland on 2012-02-23
Patient: 16 year old male
Reactions: Weight Increased, Secondary Hypogonadism, Abnormal Behaviour
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invega
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-01-01
End date: 2010-12-01
Trimipramine Maleate
Indication: Antidepressant Therapy
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2007-01-01
Possible Concerta side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-07
Patient: female
Reactions: Hypoacusis, Seasonal Allergy, Milk Allergy, Abnormal Behaviour, Visual Acuity Reduced, Allergy To Animal
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
End date: 2011-09-01
Concerta
Administration route: Oral
Concerta
Administration route: Oral
Start date: 2011-09-01
End date: 2012-01-01
Methylphenidate HCL
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2012-01-01
End date: 2012-01-01
Possible Concerta side effects in male
Reported by a consumer/non-health professional from United States on 2012-01-12
Patient: male
Reactions: Weight Increased, TIC, Abnormal Behaviour
Drug(s) suspected as cause:
Vyvanse
Indication: Product Used FOR Unknown Indication
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Unknown Multiple Medication
Indication: Product Used FOR Unknown Indication
Possible Concerta side effects in male
Reported by a consumer/non-health professional from United States on 2012-01-03
Patient: male, weighing 59.0 kg (129.7 pounds)
Reactions: Abnormal Behaviour, Mental Status Changes, Aggression, Suicidal Ideation, Hostility, Irritability, Psychotic Disorder, Bipolar Disorder, Expressive Language Disorder, Mental Disorder, Depression, Violence-Related Symptom, Tension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Start date: 2011-10-15
Concerta
Administration route: Oral
Start date: 2011-10-12
Concerta
Administration route: Oral
Start date: 2011-10-15
Concerta
Administration route: Oral
End date: 2011-09-12
Vyvanse
Start date: 2011-09-20
Concerta
Administration route: Oral
End date: 2011-09-12
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-10-13
Vyvanse
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-19
Concerta
Administration route: Oral
Start date: 2011-10-14
Concerta
Administration route: Oral
Start date: 2011-10-16
Vyvanse
Start date: 2011-09-21
Concerta
Administration route: Oral
Indication: Depression
Start date: 2011-10-13
Concerta
Administration route: Oral
Start date: 2011-10-16
Concerta
Administration route: Oral
Start date: 2011-10-12
Concerta
Administration route: Oral
Start date: 2011-10-14
Other drugs received by patient: Lithium Carbonate; Lithium Carbonate
Possible Concerta side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-27
Patient: male, weighing 59.0 kg (129.7 pounds)
Reactions: Mental Status Changes, Abnormal Behaviour, Aggression, Suicidal Ideation, Hostility, Irritability, Psychotic Disorder, Bipolar Disorder, Expressive Language Disorder, Mental Disorder, Depression, Violence-Related Symptom, Tension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Start date: 2011-10-16
Concerta
Administration route: Oral
Start date: 2011-10-12
Concerta
Administration route: Oral
Start date: 2011-10-14
Concerta
Administration route: Oral
Start date: 2011-10-15
Vyvanse
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-19
Vyvanse
Start date: 2011-09-20
Concerta
Administration route: Oral
End date: 2011-09-12
Concerta
Administration route: Oral
Indication: Depression
Start date: 2011-10-13
Concerta
Administration route: Oral
End date: 2011-09-12
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-10-13
Vyvanse
Start date: 2011-09-21
Concerta
Administration route: Oral
Start date: 2011-10-12
Concerta
Administration route: Oral
Start date: 2011-10-16
Concerta
Administration route: Oral
Start date: 2011-10-15
Concerta
Administration route: Oral
Start date: 2011-10-14
Other drugs received by patient: Lithium; Lithium
Possible Concerta side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-19
Patient: male, weighing 59.0 kg (129.7 pounds)
Reactions: Abnormal Behaviour, Mental Status Changes, Suicidal Ideation, Aggression, Hostility, Irritability, Psychotic Disorder, Bipolar Disorder, Expressive Language Disorder, Mental Disorder, Depression, Tension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Start date: 2011-10-13
Concerta
Administration route: Oral
Start date: 2011-10-13
Concerta
Administration route: Oral
End date: 2011-09-12
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
End date: 2011-09-12
Concerta
Administration route: Oral
Indication: Depression
Start date: 2011-10-15
Concerta
Administration route: Oral
Start date: 2011-10-15
Other drugs received by patient: Lithium Carbonate; Lithium Carbonate
Possible Concerta side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-16
Patient: male, weighing 59.0 kg (129.7 pounds)
Reactions: Abnormal Behaviour, Mental Status Changes, Suicidal Ideation, Aggression, Irritability, Hostility, Psychotic Disorder, Bipolar Disorder, Expressive Language Disorder, Mental Disorder, Depression, Tension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Start date: 2011-10-13
Concerta
Administration route: Oral
Start date: 2011-10-13
Concerta
Administration route: Oral
Indication: Depression
Start date: 2011-10-15
Concerta
Administration route: Oral
Start date: 2011-10-15
Concerta
Administration route: Oral
End date: 2011-09-12
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
End date: 2011-09-12
Other drugs received by patient: Lithium; Lithium
Possible Concerta side effects in 11 year old female
Reported by a physician from Spain on 2011-11-22
Patient: 11 year old female
Reactions: Abnormal Behaviour, Hallucination, Nervousness
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-11
Patient: female, weighing 40.8 kg (89.8 pounds)
Reactions: TIC, Hallucination, Auditory, Hallucination, Visual, Abnormal Behaviour, Appendicitis, Eye Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Concerta
Dosage: dose titrated
Administration route: Oral
Concerta
Administration route: Oral
Start date: 2011-10-27
End date: 2011-10-31
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-11-02
Concerta
Administration route: Oral
Start date: 2011-07-01
End date: 2011-10-01
Possible Concerta side effects in male
Reported by a consumer/non-health professional from United States on 2011-11-10
Patient: male, weighing 59.0 kg (129.7 pounds)
Reactions: Mental Status Changes, Abnormal Behaviour, Suicidal Ideation, Aggression, Irritability, Hostility, Psychotic Disorder, Bipolar Disorder, Expressive Language Disorder, Mental Disorder, Depression, Tension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Indication: Depression
End date: 2011-09-12
Concerta
Administration route: Oral
Start date: 2011-10-13
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
End date: 2011-09-12
Concerta
Administration route: Oral
Start date: 2011-10-13
Other drugs received by patient: Lithium; Lithium
Possible Concerta side effects in 12 year old male
Reported by a pharmacist from Japan on 2011-10-25
Patient: 12 year old male, weighing 59.0 kg (129.8 pounds)
Reactions: Overdose, Incorrect Dose Administered, Abnormal Behaviour
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in 6 year old male
Reported by a physician from United States on 2011-10-06
Patient: 6 year old male
Reactions: Drug Effect Decreased, Abnormal Behaviour
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in female
Reported by a consumer/non-health professional from United States on 2011-10-05
Patient: female, weighing 34.0 kg (74.8 pounds)
Reactions: Abdominal Pain, Agitation, Dyspnoea, Pain, Abnormal Behaviour, Constipation, Loss of Consciousness, Anxiety, Hospitalisation, Palpitations, Chest Pain, Suicide Attempt, Lethargy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
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