This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Concerta (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 (505)
Death (10)
Life Threatening Events (22)
Disability (17)
Reports by Reaction Type
Drug Ineffective (34),
Suicidal Ideation (31),
Overdose (27),
Abnormal Behaviour (26),
Decreased Appetite (25),
Aggression (23),
Psychotic Disorder (21),
Drug Dose Omission (19),
Dizziness (17),
Growth Retardation (17),
Insomnia (17),
Suicide Attempt (17)
Below are a few examples of reports where side effects / adverse reactions may be related to Concerta (Methylphenidate). For a complete list or a specific selection of reports, please use the links above.
Possible Concerta side effects in female
Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-08-27
Patient: female
Reactions: Vomiting, Pain, Skin Disorder, Social Phobia, Drug Withdrawal Syndrome, Tremor, Suicidal Ideation, Anxiety, Post-Traumatic Stress Disorder, Fatigue, Heart Rate Increased, Zinc Deficiency, Disturbance in Attention, Injury, Depression, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Clonazepam
Indication: Product Used FOR Unknown Indication
Concerta
Indication: Product Used FOR Unknown Indication
Possible Concerta side effects in 16 year old
Reported by a physician from Sweden on 2012-08-27
Patient: 16 year old
Reactions: Hepatic Neoplasm Malignant
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in female
Reported by a physician from United Kingdom on 2012-08-27
Patient: female, weighing 30.0 kg (66.0 pounds)
Reactions: Completed Suicide
Adverse event resulted in: death
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Start date: 2010-09-10
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-08-30
End date: 2011-10-26
Other drugs received by patient: Melatonin; Methylphenidate; Methylphenidate; Melatonin; Methylphenidate; Methylphenidate
Possible Concerta side effects in 10 year old male
Reported by a physician from Germany on 2012-08-27
Patient: 10 year old male
Reactions: Stupor
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in male
Reported by a pharmacist from Spain on 2012-08-27
Patient: male
Reactions: Growth Retardation
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2012-08-24
Patient: female
Reactions: Maternal Exposure During Pregnancy, Ectopic Pregnancy
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in female
Reported by a physician from Germany on 2012-08-23
Patient: female, weighing 55.0 kg (121.0 pounds)
Reactions: Restlessness, Sleep Disorder, Intentional Overdose, Suicide Attempt, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Dosage: 9 tablets of 36 mg
Administration route: Oral
Start date: 2012-07-28
End date: 2012-07-28
Concerta
Administration route: Oral
Concerta
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Concerta side effects in
Reported by a pharmacist from Japan on 2012-08-22
Patient:
Reactions: Nephrotic Syndrome
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: female, weighing 79.4 kg (174.6 pounds)
Reactions: Weight Increased, Off Label Use, Abdominal Pain, Dyspnoea, Heart Rate Increased, Abnormal Loss of Weight, Abdominal Distension, Heart Rate Abnormal
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Indication: Narcolepsy
Start date: 2007-01-01
End date: 2011-05-01
Methylphenidate HCL
Administration route: Oral
Indication: Narcolepsy
Start date: 2011-05-01
Other drugs received by patient: Synthroid; Savella; Unknown Medication; Clonazepam
Possible Concerta side effects in 8 year old female
Reported by a pharmacist from Japan on 2012-08-20
Patient: 8 year old female
Reactions: Growth Retardation
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in
Reported by a physician from Japan on 2012-08-20
Patient:
Reactions: Visual Acuity Reduced
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Concerta
Administration route: Oral
Other drugs received by patient: Strattera
Possible Concerta side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: female
Reactions: Abdominal Discomfort, Surgery, Gastrointestinal Disorder, Constipation
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Methylphenidate HCL
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Vitamins NOS
Indication: Product Used FOR Unknown Indication
Possible Concerta side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: male, weighing 47.2 kg (103.8 pounds)
Reactions: Loss of Consciousness
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in male
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-20
Patient: male, weighing 70.0 kg (154.0 pounds)
Reactions: Hallucination, Auditory, Withdrawal Syndrome, Treatment Noncompliance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in male
Reported by a physician from Sweden on 2012-08-20
Patient: male
Reactions: Dysarthria, Head Injury, Dizziness, Headache, Hypoaesthesia, Feeling Abnormal, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Possible Concerta 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 Concerta side effects in male
Reported by a physician from Switzerland on 2012-08-20
Patient: male
Reactions: Gynaecomastia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Methylphenidate Hydrochloride
Indication: Product Used FOR Unknown Indication
Possible Concerta side effects in female
Reported by a physician from Germany on 2012-08-16
Patient: female
Reactions: Colitis Ulcerative, Crohn's Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Possible Concerta 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 Concerta side effects in 32 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-13
Patient: 32 year old male
Reactions: Photosensitivity Reaction, Off Label Use, Burns Second Degree
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in 22 year old male
Reported by a physician from Germany on 2012-08-13
Patient: 22 year old male, weighing 83.0 kg (182.6 pounds)
Reactions: Overdose, Tachycardia, Dizziness, Hypertension, Drug Abuse, Tremor
Drug(s) suspected as cause:
Alcohol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-08-03
End date: 2012-08-03
Aspirin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-08-03
End date: 2012-08-03
Concerta
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-08-03
End date: 2012-08-03
Possible Concerta side effects in 7 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09
Patient: 7 year old male, weighing 24.9 kg (54.9 pounds)
Reactions: Nightmare, Homicidal Ideation
Drug(s) suspected as cause:
Concerta
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2012-04-04
End date: 2012-07-29
Intuniv 3MG
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-11-01
End date: 2012-07-22
Possible Concerta side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-08
Patient: male, weighing 30.8 kg (67.8 pounds)
Reactions: Colonic Polyp
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2006-01-01
End date: 2011-07-01
Methylphenidate HCL
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2011-07-01
End date: 2012-06-08
Methylphenidate HCL
Administration route: Oral
Start date: 2008-01-01
Other drugs received by patient: Singulair
Possible Concerta side effects in
Reported by a physician from Australia on 2012-08-08
Patient:
Reactions: Premature Baby
Drug(s) suspected as cause:
Concerta
Indication: Foetal Exposure During Pregnancy
Duloxetime Hydrochloride
Dosage: 60 mg mane
Indication: Foetal Exposure During Pregnancy
Start date: 2009-05-18
Sertraline Hydrochloride
Dosage: 50 mg mane
Indication: Foetal Exposure During Pregnancy
Start date: 2009-05-18
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 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 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 female
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient: female
Reactions: Abdominal Discomfort, Surgery, Gastrointestinal Disorder, Constipation
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Vitamins NOS
Indication: Product Used FOR Unknown Indication
Possible Concerta side effects in 14 year old female
Reported by a physician from Spain on 2012-08-06
Patient: 14 year old female, weighing 40.0 kg (88.0 pounds)
Reactions: Delayed Puberty
Drug(s) suspected as cause:
Concerta
Possible Concerta side effects in female
Reported by a physician from Germany on 2012-08-06
Patient: female, weighing 55.0 kg (121.0 pounds)
Reactions: Intentional Overdose, Restlessness, Sleep Disorder, Suicide Attempt, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Concerta
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Concerta
Dosage: 9 tablets of 36 mg
Administration route: Oral
Start date: 2012-07-28
End date: 2012-07-28
Concerta
Administration route: Oral
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