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Metadate CD (Methylphenidate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Metadate CD (Methylphenidate) 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 (18)

Reports by Reaction Type

Contusion (3)Head Injury (3)Delusion (3)Suicidal Ideation (3)Mania (3)Malaise (3)TIC (3)Dystonia (3)Euphoric Mood (3)Insomnia (3)Energy Increased (3)Glaucoma (2)

Possible Metadate CD side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: male

Reactions: TIC, Dystonia

Drug(s) suspected as cause:
Abilify
    Dosage: 40 mg, qd

Clonidine
    Dosage: 0.02 mg, bid

Clozaril
    Indication: Schizophrenia

Depakote
    Dosage: 125 mg, qd

Klonopin
    Dosage: 1 mg, qd (mrn)

Lithium Carbonate
    Dosage: 900 mg, qd

Metadate CD
    Dosage: 25 mg

Risperidone
    Dosage: 50 mg, bid

Seroquel
    Dosage: 25 mg, qd

Strattera
    Dosage: 50 mg, qd

Tegretol
    Dosage: 150 mg, tid

Trileptal
    Dosage: 25 mg, qd

Zoloft
    Dosage: 25 mg, qd

Other drugs received by patient: Zyprexa



Possible Metadate CD side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: male

Reactions: Dystonia, TIC

Drug(s) suspected as cause:
Abilify
    Dosage: 40 mg, qd

Clonidine
    Dosage: 0.02 mg, bid

Clozaril
    Indication: Schizophrenia

Depakote
    Dosage: 125 mg, qd

Klonopin
    Dosage: 1 mg, qd (mrn)

Lithium Carbonate
    Dosage: 900 mg, qd

Metadate CD
    Dosage: 25 mg

Risperidone
    Dosage: 50 mg, bid

Seroquel
    Dosage: 25 mg, qd

Strattera
    Dosage: 50 mg, qd

Tegretol
    Dosage: 150 mg, tid

Trileptal
    Dosage: 25 mg, qd

Zoloft
    Dosage: 25 mg, qd

Other drugs received by patient: Zyprexa



Possible Metadate CD side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: male, weighing 72.6 kg (159.7 pounds)

Reactions: Product Substitution Issue, Drug Ineffective

Drug(s) suspected as cause:
Metadate CD



Possible Metadate CD side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: 71 year old female

Reactions: Glaucoma

Drug(s) suspected as cause:
Metadate CD
    Dosage: extended release
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2012-01-01

Metadate CD
    Dosage: extended release
    Administration route: Oral
    Indication: Depression
    Start date: 2012-01-01

Other drugs received by patient: Lithium Carbonate; Paxil; Quetiapine; Mirtazapine; Lamotrigine



Possible Metadate CD side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-06-25

Patient: 71 year old female

Reactions: Glaucoma, Trismus

Drug(s) suspected as cause:
Metadate CD



Possible Metadate CD side effects in male

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

Patient: male

Reactions: Substance Abuse

Drug(s) suspected as cause:
Metadate CD



Possible Metadate CD side effects in 7 year old female

Reported by a physician from United States on 2012-05-11

Patient: 7 year old female, weighing 39.5 kg (86.8 pounds)

Reactions: Cheilitis, Stomatitis, Dystonia, Tardive Dyskinesia

Drug(s) suspected as cause:
Metadate CD



Possible Metadate CD side effects in 8 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-25

Patient: 8 year old male, weighing 40.8 kg (89.8 pounds)

Reactions: TIC, Dyskinesia

Drug(s) suspected as cause:
Metadate CD
    Dosage: metadate cd once daily po
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-11-08
    End date: 2012-01-31

Methylphenidate Hydrochloride
    Dosage: methylphenidate hcl 10mg once bid po
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder



Possible Metadate CD side effects in female

Reported by a pharmacist from United States on 2012-04-18

Patient: female, weighing 68.0 kg (149.7 pounds)

Reactions: Malaise, Capsule Physical Issue, Product Packaging Quantity Issue

Drug(s) suspected as cause:
Metadate CD



Possible Metadate CD side effects in 10 year old male

Reported by a consumer/non-health professional from United States on 2012-04-11

Patient: 10 year old male

Reactions: Convulsion

Drug(s) suspected as cause:
Metadate CD



Possible Metadate CD side effects in 6 year old male

Reported by a pharmacist from United States on 2012-03-19

Patient: 6 year old male

Reactions: Malaise, Nasal Congestion

Drug(s) suspected as cause:
Metadate CD



Possible Metadate CD side effects in 6 year old male

Reported by a pharmacist from United States on 2012-03-19

Patient: 6 year old male

Reactions: Malaise, Nasal Congestion

Drug(s) suspected as cause:
Metadate CD



Possible Metadate CD side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-12-29

Patient: male

Reactions: Adrenomegaly

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Escitalopram
    Administration route: Oral
    Indication: Depression

Metadate CD
    Administration route: Oral



Possible Metadate CD side effects in 43 year old female

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

Patient: 43 year old female

Reactions: Dyspnoea, Vomiting, Muscle Spasticity, Muscle Twitching, Somnolence, Feeling Abnormal, Altered State of Consciousness

Drug(s) suspected as cause:
Metadate CD
    Dosage: total daily dose of 30 mg
    Indication: Narcolepsy

Propranolol
    Dosage: total daily dose 240 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-05-01

Xyrem
    Dosage: nightly
    Administration route: Oral
    Indication: Cataplexy
    Start date: 2011-11-02
    End date: 2011-11-01

Xyrem
    Dosage: nightly
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2011-11-02
    End date: 2011-11-01



Possible Metadate CD side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-13

Patient: female

Reactions: Vomiting, Dyspnoea, Muscle Spasticity, Somnolence, Muscle Twitching, Altered State of Consciousness, Feeling Abnormal

Drug(s) suspected as cause:
Metadate CD
    Dosage: 30 mg, 1x/day:qd
    Indication: Narcolepsy

Propranolol
    Dosage: 240 mg, 1x/day:qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-05-01

Xyrem
    Dosage: 2.25 mg, one dose
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2011-11-02
    End date: 2011-11-02

Xyrem
    Dosage: 2.25 g, 2x/day:bid(twice nightly)
    Administration route: Oral
    Start date: 2011-11-02



Possible Metadate CD side effects in male

Reported by a health professional (non-physician/pharmacist) from Belgium on 2011-11-16

Patient: male

Reactions: Inappropriate Schedule of Drug Administration, Contusion, Head Injury, Delusion, Suicidal Ideation, Mania, Off Label Use, Overdose, Euphoric Mood, Insomnia, Energy Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Metadate CD



Possible Metadate CD side effects in 40 year old male

Reported by a consumer/non-health professional from United States on 2011-11-14

Patient: 40 year old male, weighing 92.5 kg (203.5 pounds)

Reactions: Contusion, Head Injury, Delusion, Suicidal Ideation, Mania, Euphoric Mood, Overdose, Insomnia, Energy Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Metadate CD



Possible Metadate CD side effects in male

Reported by a consumer/non-health professional from Belgium on 2011-10-04

Patient: male

Reactions: Contusion, Head Injury, Suicidal Ideation, Delusion, Mania, Euphoric Mood, Insomnia, Energy Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Metadate CD

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