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Focalin (Dexmethylphenidate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Focalin (Dexmethylphenidate) 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 (19)
Death (1)

Reports by Reaction Type

Weight Decreased (4)Insomnia (4)Product Substitution Issue (2)Wrong Technique in Drug Usage Process (2)Drug Ineffective (2)Off Label Use (2)Autism (2)TIC (2)Product Quality Issue (2)Drug Prescribing Error (2)Convulsion (2)Dysarthria (2)

Possible Focalin side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: male

Reactions: Visual Impairment, Intervertebral Disc Degeneration

Drug(s) suspected as cause:
Focalin



Possible Focalin 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 Focalin side effects in 15 year old male

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 15 year old male

Reactions: Intentional Overdose

Drug(s) suspected as cause:
Focalin

Seroquel
    Administration route: Oral



Possible Focalin side effects in

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient:

Reactions: Hypersensitivity, Bipolar II Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Focalin
    Dosage: 30 mg, unk

Zyrtec

Other drugs received by patient: Celexa; Ramipril; Junel 1.5 / 30; Dexmethylphenidate Hydrochloride; Xanax; Singulair; Vitamin B-12; Flonase



Possible Focalin side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: male, weighing 18.1 kg (39.9 pounds)

Reactions: Product Quality Issue, Weight Decreased, Off Label Use, Wrong Technique in Drug Usage Process, Insomnia, Drug Prescribing Error

Drug(s) suspected as cause:
Daytrana
    Dosage: 15 mg, qd every am
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-01-01

Daytrana
    Dosage: 1/2 15 mg patch
    Start date: 2012-03-01

Focalin
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder



Possible Focalin side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-04

Patient: male, weighing 18.1 kg (39.9 pounds)

Reactions: Weight Decreased, Off Label Use, Product Quality Issue, Wrong Technique in Drug Usage Process, Insomnia, Drug Prescribing Error

Drug(s) suspected as cause:
Daytrana
    Dosage: 1/2 15 mg patch
    Start date: 2012-03-01

Daytrana
    Dosage: 15 mg, qd every am
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-01-01

Focalin
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder



Possible Focalin side effects in male

Reported by a physician from United States on 2012-05-02

Patient: male, weighing 20.9 kg (45.9 pounds)

Reactions: Product Substitution Issue, TIC

Drug(s) suspected as cause:
Focalin



Possible Focalin side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-17

Patient: male, weighing 20.9 kg (45.9 pounds)

Reactions: Product Substitution Issue, TIC

Drug(s) suspected as cause:
Focalin



Possible Focalin side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-10

Patient: male

Reactions: Autism

Drug(s) suspected as cause:
Focalin



Possible Focalin side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-09

Patient: male

Reactions: Autism

Drug(s) suspected as cause:
Focalin



Possible Focalin side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-20

Patient: male

Reactions: Dystonia, Grimacing, Tardive Dyskinesia, Lethargy

Drug(s) suspected as cause:
Focalin
    Dosage: 30 mg, daily

Focalin
    Dosage: 60 mg, daily



Possible Focalin side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-19

Patient: female

Reactions: Drug Ineffective, Feeling Jittery

Drug(s) suspected as cause:
Focalin



Possible Focalin side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-29

Patient: female

Reactions: Drug Ineffective, Feeling Jittery

Drug(s) suspected as cause:
Focalin



Possible Focalin side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-23

Patient: male, weighing 27.2 kg (59.8 pounds)

Reactions: Convulsion

Drug(s) suspected as cause:
Focalin

Focalin



Possible Focalin side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-23

Patient: male

Reactions: Weight Decreased, Psychotic Disorder, Drug Effect Decreased, Insomnia, Fear, Constipation, Hallucination

Drug(s) suspected as cause:
Focalin
    Dosage: 10 mg, bid ; 30 mg (15 mg one tablet and 1/2 tablet in the morning and 15 mg)
    End date: 2011-04-06

Focalin XR
    Dosage: 15 mg ; 30 mg, qd

Guanfacine Hydrochloride
    Dosage: 1 ml

Vyvanse
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2010-12-14



Possible Focalin side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-23

Patient: female

Reactions: Muscle Spasms

Drug(s) suspected as cause:
Focalin



Possible Focalin side effects in 4 year old male

Reported by a consumer/non-health professional from United States on 2011-12-21

Patient: 4 year old male

Reactions: Weight Decreased, Death, Vomiting, Insomnia, Abdominal Pain Upper, Decreased Appetite

Adverse event resulted in: death

Drug(s) suspected as cause:
Focalin



Possible Focalin side effects in 20 year old female

Reported by a consumer/non-health professional from United States on 2011-12-19

Patient: 20 year old female

Reactions: Dysarthria, Dysphagia, Condition Aggravated, Coordination Abnormal

Drug(s) suspected as cause:
Focalin
    Dosage: 5 mg, as req'd
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01

Vyvanse
    Dosage: 40 mg, 1x/day:qd
    Administration route: Oral
    Start date: 2011-01-01

Vyvanse
    Dosage: 40 mg, 1x/day:qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01
    End date: 2011-01-01



Possible Focalin side effects in female

Reported by a consumer/non-health professional from United States on 2011-11-23

Patient: female, weighing 21.8 kg (47.9 pounds)

Reactions: Dysarthria, Withdrawal Syndrome, Convulsion, Viith Nerve Paralysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Focalin
    Dosage: 10 mg, 1x/day:qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-05-01
    End date: 2011-11-15

Intuniv
    Dosage: 1 mg, 1x/day:qd
    Administration route: Oral
    Start date: 2011-05-01
    End date: 2011-05-01

Intuniv
    Dosage: 2 mg, 1x/day:qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-05-01
    End date: 2011-11-15

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