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 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
Possible Focalin XR side effects in 22 year old male
Reported by a physician from United States on 2011-12-23
Patient: 22 year old male
Reactions: Psychotic Disorder
Adverse event resulted in: hospitalization
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: 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
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