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Equasym Safety Reports submitted to FDA

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Total Equasym reports: 29.
Equasym FDA safety alerts: No.
   Reported hospitalizations: 12.
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FDA Reported Equasym Side Effects: condition aggravated, bipolar disorder, dyspepsia, strabismus, dysarthria, arrhythmia, sleep disorder, euphoric mood, depression, affective disorder, white blood cell count decreased.
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Equasym Side Effects Report #5225897-7
Consumer or non-health professional from GERMANY reported EQUASYM problem on Jan 12, 2007. Male patient, child 8 years of age, weighting 61.73 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: aggression, agitation, eye pain, headache, negativism, restlessness. EQUASYM dosage: 30 MG 1/D PO. During the same period patient was treated with MEDIKINET. Patient recovered.

Equasym Side Effects Report #5236687-3
EQUASYM problem was reported by a Consumer or non-health professional from GERMANY on Jan 26, 2007. Male patient, 17 years of age, was diagnosed with paronychia and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: abdominal pain, hepatic enzyme increased, paronychia. EQUASYM dosage: unknown. During the same period patient was treated with PENICILLIN, MEDIKINET. Patient was hospitalized. Patient recovered.

Equasym Side Effects Report #5261448-9
Consumer or non-health professional from UNITED KINGDOM reported EQUASYM problem on Feb 19, 2007. Male patient, child 10 years of age, weighting 81.57 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: chest pain, dyspepsia, palpitations. EQUASYM dosage: unknown. During the same period patient was treated with MELATONIN, METHYLPHENIDATE, OLANZAPINE, OMEGA. Patient recovered.

Equasym Side Effects Report #5266645-4
EQUASYM problem was reported by a Physician from UNITED KINGDOM on Feb 22, 2007. Female patient, child 12 years of age, weighting 88.41 lb, was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: urinary retention. EQUASYM dosage: 20 MG /D PO. During the same period patient was treated with EQUASYN, MELATONIN. Patient recovered.

Equasym Side Effects Report #5326898-0
Consumer or non-health professional from GERMANY reported EQUASYM problem on Apr 26, 2007. Female patient was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: tic. EQUASYM dosage: 30 MG/D. Patient recovered.

Equasym Side Effects Report #5361273-4
EQUASYM problem was reported by a Consumer or non-health professional from GERMANY on May 29, 2007. Male patient, child 7 years of age, was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: asthma, hypersensitivity, urticaria. EQUASYM dosage: unknown. Patient was hospitalized. Patient recovered.

Equasym Side Effects Report #5370556-3
Health Professional from UNITED KINGDOM reported EQUASYM problem on June 06, 2007. Male patient, child 8 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: blister, rash. EQUASYM dosage: 5 MG 2/D PO. Patient was hospitalized. Patient recovered.

Equasym Side Effects Report #5372008-3
EQUASYM problem was reported by a Pharmacist from UNITED KINGDOM on June 07, 2007. Female patient, 13 years of age, weighting 103.6 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, muscle twitching, overdose, tachycardia. EQUASYM dosage: unknown. Patient was hospitalized. Patient recovered.

Equasym Side Effects Report #5100808-3
Consumer or non-health professional from UNITED KINGDOM reported EQUASYM problem on Aug 21, 2006. Male patient was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: contusion, dyspepsia, white blood cell count decreased. EQUASYM dosage: 10 MG 3/D PO. During the same period patient was treated with CALCIPOTRIENE, GAVISCON. Patient recovered.

Equasym Side Effects Report #5159137-4
EQUASYM problem was reported by a Health Professional from GERMANY on Nov 03, 2006. Male patient, weighting 29.76 lb, was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: salivary hypersecretion. EQUASYM dosage: 15 MG ONCE PO. Patient was hospitalized. Patient recovered.

Equasym Side Effects Report #5173186-1
Physician from UNITED KINGDOM reported EQUASYM problem on Nov 16, 2006. Female patient, 13 years of age, was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: urinary retention. EQUASYM dosage: 20 MG. Patient was hospitalized. Patient recovered.

Equasym Side Effects Report #5387622-9
EQUASYM problem was reported by a Consumer or non-health professional from GERMANY on June 26, 2007. Male patient, child 10 years of age, weighting 88.41 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: nausea, tic, vomiting. EQUASYM dosage: 20 MG 1/D. Patient recovered.

Equasym Side Effects Report #5387635-7
Consumer or non-health professional from UNITED KINGDOM reported EQUASYM problem on June 26, 2007. Male patient, child 8 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: blister. EQUASYM dosage: 5 MG 2/D PO. Patient was hospitalized. Patient recovered.

Equasym Side Effects Report #5393089-7
EQUASYM problem was reported by a Consumer or non-health professional from GERMANY on July 03, 2007. Male patient, child 9 years of age, weighting 57.32 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: bipolar disorder. EQUASYM dosage: 30 MG 1/D. During the same period patient was treated with MEDIKINET. Patient was hospitalized. Patient recovered.

Equasym Side Effects Report #5393090-3
Consumer or non-health professional from GERMANY reported EQUASYM problem on July 03, 2007. Female patient, child 9 years of age, weighting 74.96 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: anger, eye rolling, tic. EQUASYM dosage: 10 MG 1/D. During the same period patient was treated with MEDIKINET. Patient recovered.

Equasym Side Effects Report #5393091-5
EQUASYM problem was reported by a Consumer or non-health professional from GERMANY on July 03, 2007. Male patient, child 8 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: tic. EQUASYM dosage: 20 MG 1/D. Patient recovered.

Equasym Side Effects Report #5400499-8
Physician from UNITED KINGDOM reported EQUASYM problem on July 09, 2007. Female patient, 14 years of age, weighting 155.4 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: syncope. EQUASYM dosage: 30 MG 1/D PO. During the same period patient was treated with RITALIN. Patient was hospitalized. Patient recovered.

Equasym Side Effects Report #5400500-1
EQUASYM problem was reported by a Physician from GERMANY on July 11, 2007. Male patient, child 9 years of age, weighting 57.32 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: affective disorder, bipolar disorder, condition aggravated, depression, euphoric mood, sleep disorder. EQUASYM dosage: 30 MG 1/D. During the same period patient was treated with MEDIKINET. Patient was hospitalized. Patient recovered.

Equasym Side Effects Report #5403534-6
Consumer or non-health professional from GERMANY reported EQUASYM problem on July 12, 2007. Male patient, child 8 years of age, weighting 73.41 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: condition aggravated, tic. EQUASYM dosage: 30 MG/D. During the same period patient was treated with MEDIKINET. Patient recovered.

Equasym Side Effects Report #5410386-7
EQUASYM problem was reported by a Consumer or non-health professional from UNITED KINGDOM on July 25, 2007. Male patient, 14 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: contusion, dyspepsia, white blood cell count decreased. EQUASYM dosage: 10 MG 3/D PO. During the same period patient was treated with CALCIPOTRIENE. Patient recovered.

Equasym Side Effects Report #5414989-5
Physician from UNITED KINGDOM reported EQUASYM problem on July 27, 2007. Male patient, 14 years of age, was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: arrhythmia, cardiac disorder, overdose. EQUASYM dosage: 600 MG ONCE. Patient was hospitalized. Patient recovered.

Equasym Side Effects Report #5414990-1
EQUASYM problem was reported by a Consumer or non-health professional from GERMANY on July 27, 2007. Male patient, child 12 years of age, weighting 145.9 lb, was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: arrhythmia. EQUASYM dosage: 20 MG /D. Patient recovered.

Equasym Side Effects Report #5420715-6
Physician from UNITED KINGDOM reported EQUASYM problem on July 31, 2007. Male patient, child 11 years of age, weighting 62.61 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: condition aggravated, dysarthria, strabismus, therapeutic response unexpected. EQUASYM dosage: 10 MG 1/D PO. During the same period patient was treated with METHYLPHENIDATE IMMEDIATE RELEASE, METHYLPHENIDATE IMMEDIATE RELEASE. Patient recovered.

Equasym Side Effects Report #5421891-1
EQUASYM problem was reported by a Physician from GERMANY on Aug 01, 2007. Male patient, child 8 years of age, weighting 73.41 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: condition aggravated, disease recurrence, encopresis, enuresis, tic. EQUASYM dosage: 30 MG /D. During the same period patient was treated with MEDIKINET. Patient recovered.

Equasym Side Effects Report #5421892-3
Physician from GERMANY reported EQUASYM problem on Aug 03, 2007. Male patient, child 10 years of age, weighting 57.32 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: affective disorder, bipolar disorder, condition aggravated, depression, euphoric mood, sleep disorder. EQUASYM dosage: 30 MG 1/D. During the same period patient was treated with MEDIKINET. Patient was hospitalized. Patient recovered.

Equasym Side Effects Report #5422461-1
EQUASYM problem was reported by a Physician from GERMANY on Aug 04, 2007. Male patient, 26 years of age, weighting 187.4 lb, was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: incorrect dose administered, suicide attempt. EQUASYM dosage: 500 MG PO. Patient recovered.

Equasym Side Effects Report #5447449-6
Physician from UNITED KINGDOM reported EQUASYM problem on Aug 20, 2007. Male patient, child 11 years of age, weighting 62.61 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: condition aggravated, dysarthria, strabismus. EQUASYM dosage: 10 MG 1/D PO. During the same period patient was treated with METHYLPHENIDATE IMMEDIATE RELEASE. Patient recovered.

Equasym Side Effects Report #5447450-2
EQUASYM problem was reported by a Physician from UNITED KINGDOM on Aug 20, 2007. Male patient, 13 years of age, weighting 61.07 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: tic. EQUASYM dosage: 30 MG 1/D PO. Patient recovered.

Equasym Side Effects Report #5448303-6
Consumer or non-health professional from GERMANY reported EQUASYM problem on Aug 21, 2007. Male patient, child 9 years of age, was treated with EQUASYM. After drug was administered, patient experienced the following problems/side effects: impulse-control disorder. EQUASYM dosage: 30 MG 1/D. Patient recovered.


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aggression, agitation, eye pain, headache, negativism, restlessness abdominal pain, hepatic enzyme increased, paronychia, was diagnosed with attention deficit/hyperactivity disorder and was diagnosed with paronychia and was diagnosed with attention deficit/hyperactivity disorder and