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Concerta (Methylphenidate) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (505)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Concerta (Methylphenidate) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 505   Next >>

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 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 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 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 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 2012-08-16

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 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 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

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 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 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 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 female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female, weighing 17.2 kg (37.9 pounds)

Reactions: Bipolar Disorder, Paraesthesia

Drug(s) suspected as cause:
Concerta
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2012-07-21
    End date: 2012-07-25

Risperidone
    Indication: Bipolar Disorder
    Start date: 2012-04-17



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



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