|
Index of reports
> Life Threatening Events (22)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Concerta (Methylphenidate) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Concerta side effects in 16 year old male
Reported by a consumer/non-health professional from Sweden on 2012-08-07
Patient: 16 year old male
Reactions: Anxiety, Psychomotor Hyperactivity, Cardiac Arrest, Arrhythmia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Concerta
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Concerta
Administration route: Oral
Possible Concerta side effects in 13 year old male
Reported by a consumer/non-health professional from Turkey on 2012-08-06
Patient: 13 year old male, weighing 70.0 kg (154.0 pounds)
Reactions: Deep Vein Thrombosis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Abilify
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-12-30
End date: 2012-06-02
Concerta
Dosage: 54mg tablet
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-08-23
End date: 2012-06-02
Possible Concerta side effects in 15 year old male
Reported by a consumer/non-health professional from Canada on 2012-06-15
Patient: 15 year old male
Reactions: Insomnia, Depression, Suicidal Ideation, Decreased Appetite
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in female
Reported by a physician from Canada on 2012-06-11
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Hodgkin's Disease
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Concerta
Dosage: 50 (unit unspecified)
Administration route: Oral
Indication: Psychotic Disorder
Start date: 2011-09-01
Risperdal Consta
Indication: Psychotic Disorder
Start date: 2011-09-01
Other drugs received by patient: Clonazepam
Possible Concerta side effects in female
Reported by a physician from Canada on 2012-06-05
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Hodgkin's Disease
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Concerta
Dosage: 50 (unit unspecified)
Administration route: Oral
Indication: Psychotic Disorder
Start date: 2011-09-01
Risperdal Consta
Indication: Psychotic Disorder
Other drugs received by patient: Clonazepam
Possible Concerta side effects in 14 year old male
Reported by a physician from Portugal on 2012-03-30
Patient: 14 year old male
Reactions: Poisoning, Suicide Attempt
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in male
Reported by a physician from Norway on 2012-03-30
Patient: male, weighing 139.0 kg (305.8 pounds)
Reactions: Congestive Cardiomyopathy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Concerta
Dosage: 36mg in the morning, 18mg in the evening
Administration route: Oral
Start date: 2005-10-31
Concerta
Dosage: 36mg in the morning, 18mg in the evening
Administration route: Oral
Start date: 2006-08-10
End date: 2006-08-11
Seroquel
Dosage: 900mg+300 mg
Administration route: Oral
Start date: 2006-08-10
End date: 2006-08-11
Seroquel
Dosage: 900mg+300 mg
Administration route: Oral
Start date: 2006-08-04
Seroquel
Dosage: 300mg in the morning, 600mg in the evening
Administration route: Oral
End date: 2005-06-12
Seroquel
Dosage: 300mg in the morning, 600mg in the evening
Administration route: Oral
Indication: Mental Disorder
Start date: 2005-04-01
Seroquel
Dosage: 900mg+300 mg
Administration route: Oral
Start date: 2005-06-13
End date: 2005-08-22
Concerta
Dosage: 36mg in the morning, 18mg in the evening
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2005-10-03
End date: 2005-10-30
Concerta
Dosage: 36mg in the morning, 18mg in the evening
Administration route: Oral
Start date: 2005-06-01
Seroquel
Dosage: 900mg+300 mg
Administration route: Oral
Start date: 2006-02-09
End date: 2006-08-03
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 18 year old male
Reported by a physician from Norway on 2012-03-05
Patient: 18 year old male, weighing 139.0 kg (305.8 pounds)
Reactions: Renal Failure, Cardiac Failure, Hepatic Failure, Congestive Cardiomyopathy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Seroquel
Administration route: Oral
Start date: 2006-08-10
End date: 2006-08-11
Concerta
Administration route: Oral
Start date: 2006-08-10
End date: 2006-08-11
Concerta
Administration route: Oral
Start date: 2005-06-01
Seroquel
Administration route: Oral
Start date: 2005-06-13
End date: 2005-08-22
Seroquel
Administration route: Oral
End date: 2005-06-12
Seroquel
Administration route: Oral
Start date: 2006-02-09
End date: 2006-08-03
Seroquel
Administration route: Oral
Start date: 2006-08-10
End date: 2006-08-11
Seroquel
Administration route: Oral
Start date: 2005-06-13
End date: 2005-08-22
Concerta
Administration route: Oral
Start date: 2005-10-31
Seroquel
Administration route: Oral
Start date: 2006-08-04
Seroquel
Administration route: Oral
Start date: 2006-08-04
Seroquel
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2005-04-01
Seroquel
Administration route: Oral
Indication: Mental Disorder
Start date: 2005-04-01
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2005-10-03
End date: 2005-10-30
Seroquel
Administration route: Oral
End date: 2005-06-12
Seroquel
Administration route: Oral
Start date: 2006-02-09
End date: 2006-08-03
Possible Concerta side effects in 18 year old male
Reported by a physician from Netherlands on 2012-02-28
Patient: 18 year old male, weighing 70.0 kg (154.0 pounds)
Reactions: Acute Myeloid Leukaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methylphenidate HCL
Indication: Psychomotor Hyperactivity
Start date: 2008-10-01
Concerta
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2008-10-01
Methylphenidate HCL
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2008-10-01
Methylphenidate HCL
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2008-10-01
Possible Concerta side effects in male
Reported by a physician from Norway on 2012-02-27
Patient: male, weighing 139.0 kg (305.8 pounds)
Reactions: Congestive Cardiomyopathy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Concerta
Dosage: 36mg in the morning, 18mg in the evening
Administration route: Oral
Start date: 2005-10-31
Seroquel
Dosage: 900mg+300 mg
Administration route: Oral
Indication: Mental Disorder
Start date: 2006-08-10
End date: 2006-08-11
Seroquel
Dosage: 300mg in the morning, 600mg in the evening
Administration route: Oral
End date: 2005-06-12
Seroquel
Dosage: 900mg+300 mg
Administration route: Oral
Start date: 2005-06-13
End date: 2005-08-22
Concerta
Dosage: 36mg in the morning, 18mg in the evening
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2006-08-10
End date: 2006-08-11
Concerta
Dosage: 36mg in the morning, 18mg in the evening
Administration route: Oral
Start date: 2005-06-01
Seroquel
Dosage: 300mg in the morning, 600mg in the evening
Administration route: Oral
Start date: 2005-04-01
Seroquel
Dosage: 900mg+300 mg
Administration route: Oral
Start date: 2006-08-04
Concerta
Dosage: 36mg in the morning, 18mg in the evening
Administration route: Oral
Start date: 2005-10-03
End date: 2005-10-30
Seroquel
Dosage: 900mg+300 mg
Administration route: Oral
Start date: 2006-02-09
End date: 2006-08-03
Possible Concerta side effects in 18 year old male
Reported by a physician from Netherlands on 2012-02-16
Patient: 18 year old male, weighing 70.0 kg (154.0 pounds)
Reactions: Acute Myeloid Leukaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methylphenidate HCL
Indication: Psychomotor Hyperactivity
Start date: 2008-10-01
Methylphenidate HCL
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2008-10-01
Concerta
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2008-10-01
Methylphenidate HCL
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2008-10-01
Possible Concerta side effects in male
Reported by a physician from Netherlands on 2012-02-02
Patient: male, weighing 70.0 kg (154.0 pounds)
Reactions: Acute Myeloid Leukaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methylphenidate HCL
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2008-10-01
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2008-10-01
Methylphenidate HCL
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2008-10-01
Possible Concerta side effects in male
Reported by a physician from Netherlands on 2012-01-27
Patient: male, weighing 70.0 kg (154.0 pounds)
Reactions: Acute Myeloid Leukaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methylphenidate HCL
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2008-10-01
Methylphenidate HCL
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2008-10-01
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2008-10-01
Possible Concerta side effects in male
Reported by a physician from Germany on 2012-01-09
Patient: male, weighing 34.4 kg (75.7 pounds)
Reactions: Anaemia, Leukopenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Carbamazepine
Administration route: Oral
Indication: Epilepsy
End date: 2011-11-01
Concerta
Administration route: Oral
Indication: Mild Mental Retardation
Start date: 2011-05-30
End date: 2011-12-05
Other drugs received by patient: Strattera
Possible Concerta side effects in 8 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-12-22
Patient: 8 year old male, weighing 28.1 kg (61.8 pounds)
Reactions: Psychotic Disorder, Paranoia, Intentional Self-Injury, Suicidal Ideation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Concerta
Other drugs received by patient: Melatonin
Possible Concerta side effects in 58 year old female
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2011-12-20
Patient: 58 year old female
Reactions: Migraine, Brain Stem Infarction, Horner's Syndrome, Dysarthria, Aortic Occlusion, Cardiac Septal Defect, Speech Disorder, Miosis, Eyelid Ptosis, Hemiplegia, Coordination Abnormal, Feeling Abnormal, Arteriosclerosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methylphenidate HCL
Dosage: 84 mg, unk
Start date: 2011-01-01
Concerta
Dosage: 27 mg, bid
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2006-01-01
End date: 2011-10-21
Ritalin
Dosage: 10 mg, tid
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2006-01-01
End date: 2011-10-21
Other drugs received by patient: Bisoprolol Fumarate; Abilify
Possible Concerta side effects in 58 year old female
Reported by a physician from Switzerland on 2011-12-20
Patient: 58 year old female
Reactions: Ischaemic Cerebral Infarction, Horner's Syndrome
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Concerta
Dosage: one in morning and one in afternoon
Administration route: Oral
Start date: 2006-01-01
End date: 2011-10-21
Abilify
Dosage: 1 at night
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2007-01-01
End date: 2011-10-21
Concerta
Dosage: one in morning and one in afternoon
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2006-01-01
End date: 2011-10-21
Ritalin
Dosage: 1 in morning, 1 in afternoon and 1 at night
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2006-01-01
End date: 2011-10-21
Other drugs received by patient: Bisoprolol Fumarate
Possible Concerta side effects in male
Reported by a health professional (non-physician/pharmacist) from Germany on 2011-11-22
Patient: male, weighing 12.0 kg (26.4 pounds)
Reactions: Agitation, Daydreaming, Restlessness, Body Temperature Increased, Accidental Exposure
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in 58 year old female
Reported by a physician from Switzerland on 2011-11-17
Patient: 58 year old female
Reactions: Ischaemic Cerebral Infarction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ritalin
Indication: Product Used FOR Unknown Indication
Concerta
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Concerta side effects in male
Reported by a physician from United States on 2011-11-09
Patient: male, weighing 53.0 kg (116.6 pounds)
Reactions: Contusion, Dyspnoea, Status Asthmaticus, Excoriation, Cyanosis, Chest Pain, Circulatory Collapse, Toxicity To Various Agents, Epistaxis
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Risperidone
Dosage: unknown
Indication: Product Used FOR Unknown Indication
End date: 2010-11-07
Propranolol
Dosage: unknown
Indication: Product Used FOR Unknown Indication
End date: 2010-11-07
Concerta
Dosage: unknown
Indication: Product Used FOR Unknown Indication
End date: 2010-11-07
Chantax
Dosage: unknown
Indication: Product Used FOR Unknown Indication
End date: 2010-11-07
Xyrem
Dosage: unknown
Indication: Product Used FOR Unknown Indication
End date: 2010-11-07
Albuterol
Dosage: unknown
Indication: Product Used FOR Unknown Indication
End date: 2010-11-07
Suboxone
Dosage: dosing details unknown
Indication: Product Used FOR Unknown Indication
Possible Concerta side effects in 8 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-26
Patient: 8 year old male, weighing 28.1 kg (61.8 pounds)
Reactions: Psychotic Disorder, Suicidal Ideation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Concerta
Other drugs received by patient: Melatonin
|
