Index of reports
> All Cases (19)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Focalin (Dexmethylphenidate) all cases. The selected reports were submitted to the FDA during the sample period of about a year.
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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