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Focalin XR (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 XR (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 (43)
Death (1)
Life Threatening Events (3)
Disability (5)

Reports by Reaction Type

Headache (7)Drug Ineffective (6)Dizziness (4)Tremor (4)Pruritus (3)TIC (3)Raynaud's Phenomenon (3)Dyspnoea (3)Suicide Attempt (3)Intentional Overdose (2)Disorientation (2)Hyperaemia (2)

Below are a few examples of reports where side effects / adverse reactions may be related to Focalin XR (Dexmethylphenidate). For a complete list or a specific selection of reports, please use the links above.

Possible Focalin XR side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: male

Reactions: Suicide Attempt, Suicidal Ideation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Focalin XR

Other drugs received by patient: Fluoxetine HCL; Risperidone



Possible Focalin XR side effects in male

Reported by a physician from United States on 2012-07-25

Patient: male, weighing 52.0 kg (114.4 pounds)

Reactions: Dyspnoea, Visual Impairment, Headache, Disorientation, Amnesia, Abdominal Pain Upper

Drug(s) suspected as cause:
Focalin XR
    Dosage: 25mg in the morning and 15 mg later in the day
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder

Focalin XR
    Dosage: 15 mg
    Administration route: Oral
    Start date: 2012-02-02
    End date: 2012-04-27



Possible Focalin XR side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: male

Reactions: Bladder Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in male

Reported by a physician from United States on 2012-06-14

Patient: male

Reactions: Hypermetabolism, Asperger's Disorder, Drug Ineffective, Disturbance in Attention

Drug(s) suspected as cause:
Focalin XR

Other drugs received by patient: Melatonin



Possible Focalin XR side effects in 7 year old male

Reported by a physician from United States on 2012-06-05

Patient: 7 year old male, weighing 22.5 kg (49.5 pounds)

Reactions: TIC, Tooth Extraction, Abnormal Behaviour

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Focalin XR

Other drugs received by patient: Albuterol



Possible Focalin XR side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: male

Reactions: Accident AT Work, Back Injury

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-14

Patient: female, weighing 27.7 kg (60.9 pounds)

Reactions: Formication

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-03

Patient: male

Reactions: Dyspnoea, Visual Impairment, Headache, Disorientation, Amnesia, Abdominal Pain Upper

Drug(s) suspected as cause:
Focalin XR
    Dosage: 2.5mg in the morning and 1.5 mg later in the day

Focalin XR
    Dosage: 15 mg
    End date: 2012-02-03

Focalin XR



Possible Focalin XR side effects in 9 year old male

Reported by a consumer/non-health professional from United States on 2012-04-26

Patient: 9 year old male

Reactions: Capsule Physical Issue, Incorrect Dose Administered

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in male

Reported by a physician from Switzerland on 2012-04-25

Patient: male

Reactions: Pruritus, Oedema Peripheral, Vasoconstriction, Raynaud's Phenomenon, Hyperaemia

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in 14 year old female

Reported by a consumer/non-health professional from United States on 2012-03-26

Patient: 14 year old female, weighing 47.6 kg (104.8 pounds)

Reactions: Drug Ineffective, Condition Aggravated, Erythema, Skin Discolouration, Impaired Healing, Nail Disorder, Raynaud's Phenomenon, Blister

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Focalin XR

Other drugs received by patient: Focalin



Possible Focalin XR side effects in 14 year old female

Reported by a consumer/non-health professional from United States on 2012-02-24

Patient: 14 year old female

Reactions: Abdominal Discomfort, Migraine, Anxiety, Intentional Overdose, Headache, Attention Deficit / Hyperactivity Disorder, Suicidal Ideation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Focalin XR
    Dosage: 15 mg, qd
    Start date: 2010-12-23
    End date: 2012-01-09

Vyvanse
    Dosage: unk ukn, unk



Possible Focalin XR side effects in male

Reported by a physician from Switzerland on 2012-02-24

Patient: male

Reactions: Pruritus, Vasoconstriction, Oedema Peripheral, Raynaud's Phenomenon, Hyperaemia

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-15

Patient: male, weighing 58.0 kg (127.6 pounds)

Reactions: Speech Disorder, Flushing, Nervousness, Crying

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-02-13

Patient: 64 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in male

Reported by a individual with unspecified qualification from United States on 2012-02-09

Patient: male

Reactions: Dyspnoea, Malaise, Lung Infection, Tremor, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Albuterol Sulfate
    Dosage: 0.083 %, unk
    Indication: Dyspnoea

Cetirizine HCL
    Dosage: 5 mg, qd
    Administration route: Oral

Focalin XR
    Dosage: 15 mg, qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder

Proventil
    Dosage: 6.7 g, unk
    Indication: Wheezing

Qvar 40
    Dosage: 80 ug, bid

Singulair
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Asthma

Veramyst
    Dosage: 27.5 ug, bid



Possible Focalin XR side effects in 13 year old

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-24

Patient: 13 year old

Reactions: Medication Error, Intercepted Drug Dispensing Error

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in male

Reported by a individual with unspecified qualification from United States on 2012-01-24

Patient: male

Reactions: Atrial Fibrillation

Drug(s) suspected as cause:
Focalin XR

Other drugs received by patient: Meloxicam; Cymbalta; Aciphex; Amlodipine; Acetaminophen; Asacol; Lipitor; Nortriptyline HCL; Skelaxin; Zyrtec; Wellbutrin SR; Tramadol HCL; Klor-CON; Lisinopril and Hydrochlorothiazide



Possible Focalin XR side effects in

Reported by a consumer/non-health professional from United States on 2012-01-24

Patient:

Reactions: Road Traffic Accident

Drug(s) suspected as cause:
Focalin XR

Other drugs received by patient: Zoloft; Xanax



Possible Focalin XR side effects in 14 year old female

Reported by a individual with unspecified qualification from United States on 2012-01-20

Patient: 14 year old female

Reactions: Abdominal Discomfort, Migraine, Intentional Overdose, Suicide Attempt, Headache

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in 6 year old

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

Patient: 6 year old , weighing 20.4 kg (44.9 pounds)

Reactions: Blepharospasm, Tardive Dyskinesia, Muscle Spasms

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in male

Reported by a individual with unspecified qualification from United States on 2012-01-11

Patient: male, weighing 38.1 kg (83.8 pounds)

Reactions: Drug Ineffective, Disturbance in Social Behaviour

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Focalin XR

Other drugs received by patient: Trileptal; Atarax / 00058403 /; Intivua; Adderall 5



Possible Focalin XR side effects in 6 year old male

Reported by a consumer/non-health professional from United States on 2012-01-09

Patient: 6 year old male, weighing 22.7 kg (49.9 pounds)

Reactions: Convulsion

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in 14 year old female

Reported by a consumer/non-health professional from United States on 2012-01-09

Patient: 14 year old female, weighing 49.9 kg (109.8 pounds)

Reactions: Confusional State, Abnormal Behaviour, Headache, Gastric Disorder, Aggression, Mood Altered, Insomnia, Suicide Attempt, Depression, Depressed Mood, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in 5 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-23

Patient: 5 year old female, weighing 20.4 kg (44.9 pounds)

Reactions: Pruritus, Hallucination, Visual, Rash, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in 11 year old male

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

Patient: 11 year old male

Reactions: TIC

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in 59 year old female

Reported by a physician from United States on 2011-12-23

Patient: 59 year old female

Reactions: LIP Swelling, Swelling Face, Dyspepsia, DRY Mouth, Headache, Tardive Dyskinesia, Muscle Twitching

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Focalin XR

Other drugs received by patient: Cymbalta; Simvastatin; Antihypertensives (NO Ingredient / Substances); Cogentin; Klonopin



Possible Focalin XR side effects in female

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

Patient: female

Reactions: Sleep Disorder, Convulsion

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in 4 year old male

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

Patient: 4 year old male

Reactions: Hypertension

Drug(s) suspected as cause:
Focalin XR



Possible Focalin XR side effects in male

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

Patient: male

Reactions: TIC, Tourette's Disorder

Drug(s) suspected as cause:
Focalin XR

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