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Review Metadate Safety Reports submitted to FDA

Total Metadate reports: 21.
Metadate FDA safety alerts: No.
   Reported hospitalizations: 3.
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FDA Reported Metadate Side Effects: panic attack, convulsion, ventricular fibrillation, cardio-respiratory arrest, anoxic encephalopathy, suicidal ideation, homicidal ideation, anger, aggression, tic, somnolence.
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Metadate Side Effects Report #5509433-3
Consumer or non-health professional from UNITED STATES reported METADATE problem on Oct 19, 2007. Male patient, child 9 years of age, weighting 75.18 lb, was diagnosed with disturbance in attention, psychomotor hyperactivity and was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: movement disorder, psychomotor hyperactivity, tic. METADATE dosage: 10 MG 1/D PO. During the same period patient was treated with METADATE CD. Patient recovered.

Metadate Side Effects Report #5483516-9
METADATE problem was reported by a Physician from UNITED STATES on Sept 20, 2007. Male patient, child 8 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: agitation, flushing, heart rate increased, tremor. METADATE dosage: 20 MG 1/D PO. During the same period patient was treated with DEPAKOTE, CLONIDINE, RISPERDAL. Patient was hospitalized. Patient recovered.

Metadate Side Effects Report #5494520-9
Consumer or non-health professional from UNITED STATES reported METADATE problem on Oct 05, 2007. Male patient, child 9 years of age, was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: psychomotor hyperactivity, tic. METADATE dosage: 10 MG 1/D PO. Patient recovered.

Metadate Side Effects Report #5405950-5
METADATE problem was reported by a Physician from UNITED STATES on July 17, 2007. Male patient, child 8 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: agitation, blood pressure increased, flushing, heart rate increased, somnolence. METADATE dosage: 20 MG. During the same period patient was treated with DEPAKOTE, CLONIDINE, RISPERDAL, VALIUM. Patient was hospitalized. Patient recovered.

Metadate Side Effects Report #5766781-X
Consumer or non-health professional from UNITED STATES reported METADATE problem on June 10, 2008. Male patient, child 10 years of age, weighting 50.00 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, depression, feeling abnormal, social avoidant behaviour, tic. METADATE dosage: unknown. Patient recovered.

Metadate Side Effects Report #5705868-4
METADATE problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 14, 2008. Male patient, child 9 years of age, was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, incorrect dose administered, thinking abnormal. METADATE dosage: unknown. Patient recovered.

Metadate Side Effects Report #5707542-7
Consumer or non-health professional from UNITED STATES reported METADATE problem on Aug 14, 2007. Female patient, 60 years of age, weighting 170.4 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: anxiety, chest discomfort, depression, dyspnoea, suicidal ideation. METADATE dosage: 40 MG /D PO. During the same period patient was treated with EFFEXOR, TRAZADOL, TOPAMAX, ASTHMA INHALER. Patient recovered.

Metadate Side Effects Report #5707545-2
METADATE problem was reported by a Physician from UNITED STATES on Mar 06, 2007. Male patient, 14 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: convulsion. METADATE dosage: 20 MG /D PO. During the same period patient was treated with METADATE CD, METADATE CD, CATAPRES. Patient recovered.

Metadate Side Effects Report #5707546-4
Physician from UNITED STATES reported METADATE problem on Sept 27, 2006. Male patient, child 6 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: vision blurred. METADATE dosage: 30 MG PO. Patient recovered.

Metadate Side Effects Report #5707547-6
METADATE problem was reported by a Health Professional from UNITED STATES on Oct 19, 2006. Female patient, 14 years of age, was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: facial palsy. METADATE dosage: unknown. Patient recovered.

Metadate Side Effects Report #5707563-4
Consumer or non-health professional from UNITED STATES reported METADATE problem on Nov 07, 2006. Male patient, child 5 years of age, was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: crying, fatigue, limb discomfort. METADATE dosage: 40 MG. Patient recovered.

Metadate Side Effects Report #5707586-5
METADATE problem was reported by a Pharmacist from UNITED STATES on Feb 09, 2007. Male patient, child 12 years of age, was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour. METADATE dosage: 20 MG 1/D. During the same period patient was treated with METADATE CD. Patient recovered.

Metadate Side Effects Report #5707587-7
Consumer or non-health professional from UNITED STATES reported METADATE problem on Mar 02, 2007. Male patient, child 4 years of age, weighting 50.09 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: disturbance in attention. METADATE dosage: 10 MG /D. During the same period patient was treated with METADATE CD, METADATE CD. Patient recovered.

Metadate Side Effects Report #5354882-X
METADATE problem was reported by a Pharmacist from UNITED STATES on May 23, 2007. Female patient, 21 years of age, weighting 251.3 lb, was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: anoxic encephalopathy, cardio-respiratory arrest, ventricular fibrillation. METADATE dosage: 20 MG /D PO. During the same period patient was treated with RITALIN, AMOXICILL, RISPERDAL, ROZEREM, MELATONIN, LEXAPRO, VITAMIN CAP. Patient was hospitalized. Patient recovered.

Metadate Side Effects Report #5355338-0
Consumer or non-health professional from UNITED STATES reported METADATE problem on May 18, 2006. Male patient, child 7 years of age, was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: arrhythmia. METADATE dosage: unknown. Patient recovered.

Metadate Side Effects Report #5355340-9
METADATE problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 21, 2006. Female patient, child 10 years of age, was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: convulsion, tic. METADATE dosage: unknown. Patient recovered.

Metadate Side Effects Report #5355345-8
Physician from UNITED STATES reported METADATE problem on Mar 06, 2007. Male patient, 14 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: convulsion. METADATE dosage: 20 MG /D PO. During the same period patient was treated with METADATE CD, METADATE CD, CATAPRES. Patient recovered.

Metadate Side Effects Report #5355349-5
METADATE problem was reported by a Physician from UNITED STATES on Apr 13, 2006. Female patient, 17 years of age, was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: incorrect dose administered, muscle spasms, panic attack, partial seizures. METADATE dosage: 60 MG 1/2D PO. Patient recovered.

Metadate Side Effects Report #5363033-7
Consumer or non-health professional from UNITED STATES reported METADATE problem on June 01, 2007. Female patient, 54 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation. METADATE dosage: 30 MG/ D PO. During the same period patient was treated with NEXIUM. Patient recovered.

Metadate Side Effects Report #5341865-9
METADATE problem was reported by a Pharmacist from UNITED STATES on May 29, 2007. Female patient, 21 years of age, weighting 251.3 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: anoxic encephalopathy, cardio-respiratory arrest, ventricular fibrillation. METADATE dosage: 20MG DAILY PO. During the same period patient was treated with METHYLPHENIDATE, LEXAPRO, MELATONIN, RISPERDAL, ROXEREM, AMOXICILLIN. Patient recovered.

Metadate Side Effects Report #5259864-4
Consumer or non-health professional from UNITED STATES reported METADATE problem on Feb 20, 2007. Male patient, child 10 years of age, weighting 103.2 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with METADATE. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, aggression, anger, homicidal ideation, schizophreniform disorder, suicidal ideation. METADATE dosage: 20 MG /D PO. During the same period patient was treated with METADATE CD, FLUOXETINE. Patient recovered.


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