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Review Symbyax Safety Reports submitted to FDA

Total Symbyax reports: 38.
Symbyax FDA safety alerts: No.
Reported deaths: 10    Reported hospitalizations: 12.
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FDA Reported Symbyax Side Effects: weight increased, death, hypertension, blood glucose increased, diabetes mellitus, dizziness, intentional overdose, convulsion, prescribed overdose, hiv infection, suicidal ideation.
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Symbyax Side Effects Report #5636071-4
Consumer or non-health professional from UNITED STATES reported SYMBYAX problem on Feb 20, 2008. Female patient, 58 years of age, weighting 225.0 lb, was diagnosed with bipolar disorder, depression and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus, weight increased. SYMBYAX dosage: unknown. Patient recovered.

Symbyax Side Effects Report #5600641-X
SYMBYAX problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 11, 2008. Male patient was diagnosed with bipolar disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, blood glucose increased, coagulopathy, delirium, diabetes mellitus, diabetic ketoacidosis, dialysis, electrolyte imbalance, encephalopathy. SYMBYAX dosage: unknown. During the same period patient was treated with ZYPREXA, FLUOXETINE. Patient was hospitalized. Patient recovered.

Symbyax Side Effects Report #5614640-5
Consumer or non-health professional from UNITED STATES reported SYMBYAX problem on Jan 11, 2008. Male patient, 36 years of age, was diagnosed with bipolar disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, blood glucose increased, coagulopathy, delirium, diabetes mellitus, diabetes mellitus inadequate control, diabetic ketoacidosis, dialysis, electrolyte imbalance. SYMBYAX dosage: unknown. During the same period patient was treated with ZYPREXA, FLUOXETINE. Patient was hospitalized. Patient recovered.

Symbyax Side Effects Report #5507444-5
SYMBYAX problem was reported by a Physician from UNITED STATES on Oct 31, 2007. Female patient, 26 years of age, was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: loss of consciousness, somnolence. SYMBYAX dosage: unknown. Patient recovered.


Symbyax Side Effects Report #5509723-4
Physician from UNITED STATES reported SYMBYAX problem on Nov 01, 2007. Male patient, 49 years of age, was diagnosed with bipolar disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: blood alkaline phosphatase increased, jaundice, liver disorder, pyrexia, transaminases increased. SYMBYAX dosage: unknown. During the same period patient was treated with LITHIUM CARBONATE, AMBIEN. Patient was hospitalized. Patient recovered.

Symbyax Side Effects Report #5526366-7
SYMBYAX problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 21, 2007. Female patient, 76 years of age, weighting 123.5 lb, was diagnosed with bipolar disorder, hallucination and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: atrophy, electroencephalogram abnormal, encephalopathy, grand mal convulsion. SYMBYAX dosage: unknown. Patient was hospitalized. Patient recovered.

Symbyax Side Effects Report #5488242-8
Physician from UNITED STATES reported SYMBYAX problem on Oct 15, 2007. Male patient was diagnosed with bipolar i disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: infection, pyrexia, sepsis. SYMBYAX dosage: unknown. Patient was hospitalized. Patient died on 10/13/2007.

Symbyax Side Effects Report #5492799-0
SYMBYAX problem was reported by a Physician from UNITED STATES on Oct 17, 2007. Female patient, 26 years of age, was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: cardiopulmonary failure, loss of consciousness. SYMBYAX dosage: unknown. Patient recovered.

Symbyax Side Effects Report #5492803-X
Physician from UNITED STATES reported SYMBYAX problem on Oct 15, 2007. Male patient was diagnosed with bipolar i disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: infection, pyrexia, sepsis. SYMBYAX dosage: unknown. Patient was hospitalized. Patient died on 10/13/2007.


Symbyax Side Effects Report #5427778-2
SYMBYAX problem was reported by a Physician from MEXICO on Aug 23, 2007. Male patient, 30 years of age, was diagnosed with bipolar disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, hypertension. SYMBYAX dosage: unknown. Patient was hospitalized. Patient died on 05/01/2007.

Symbyax Side Effects Report #5436065-8
Physician from UNITED STATES reported SYMBYAX problem on Aug 29, 2007. Male patient, 30 years of age, was treated with SYMBYAX. SYMBYAX dosage: unknown. During the same period patient was treated with AMPHETAMINE AND DEXTROAMPHETAMINE SALTS. Patient died on 08/01/2007.

Symbyax Side Effects Report #5673917-8
SYMBYAX problem was reported by a Physician from UNITED STATES on Jan 22, 2007. Male patient, 45 years of age, weighting 274.9 lb, was diagnosed with bipolar i disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood glucose increased, diabetes mellitus, fatigue, hyperlipidaemia, obesity, polydipsia, polyuria. SYMBYAX dosage: unknown. During the same period patient was treated with XANAX, CLONAZEPAM, METHADONE. Patient recovered.

Symbyax Side Effects Report #5673919-1
Physician from UNITED STATES reported SYMBYAX problem on Nov 08, 2007. Male patient, 42 years of age, was diagnosed with bipolar i disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: grand mal convulsion, tongue haematoma. SYMBYAX dosage: unknown. Patient recovered.

Symbyax Side Effects Report #5673920-8
SYMBYAX problem was reported by a Physician from UNITED STATES on Nov 27, 2007. Male patient, 20 years of age, was diagnosed with bipolar disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: convulsion. SYMBYAX dosage: unknown. Patient recovered.


Symbyax Side Effects Report #5673921-X
Health Professional from UNITED STATES reported SYMBYAX problem on Nov 27, 2007. Female patient was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: erythema multiforme. SYMBYAX dosage: unknown. During the same period patient was treated with LUNESTA. Patient recovered.

Symbyax Side Effects Report #5673922-1
SYMBYAX problem was reported by a Physician from UNITED STATES on Oct 22, 2007. Male patient, 30 years of age, was diagnosed with bipolar i disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: blood triglycerides increased. SYMBYAX dosage: unknown. Patient recovered.

Symbyax Side Effects Report #5673923-3
Physician from UNITED STATES reported SYMBYAX problem on Oct 08, 2007. Female patient, 42 years of age, was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: convulsion. SYMBYAX dosage: unknown. During the same period patient was treated with ATIVAN. Patient recovered.

Symbyax Side Effects Report #5673924-5
SYMBYAX problem was reported by a Consumer or non-health professional from UNITED STATES on June 15, 2007. Male patient, 21 years of age, weighting 215.0 lb, was diagnosed with bipolar disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: libido decreased, overdose, weight increased. SYMBYAX dosage: unknown. During the same period patient was treated with KLONOPIN, ADDERALL. Patient recovered.

Symbyax Side Effects Report #5673925-7
Physician from UNITED STATES reported SYMBYAX problem on May 17, 2007. Female patient, 31 years of age, was diagnosed with borderline personality disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: suicide attempt. SYMBYAX dosage: unknown. During the same period patient was treated with LAMICTAL, TRILEPTAL. Patient was hospitalized. Patient recovered.


Symbyax Side Effects Report #5673927-0
SYMBYAX problem was reported by a Physician from UNITED STATES on June 08, 2007. Female patient, 27 years of age, was diagnosed with bipolar i disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: intentional overdose. SYMBYAX dosage: unknown. During the same period patient was treated with DARVOCET, XANAX, PONSTEL. Patient died on 04/22/2007.

Symbyax Side Effects Report #5673928-2
Physician from UNITED STATES reported SYMBYAX problem on Mar 28, 2007. Male patient, 17 years of age, was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: weight increased. SYMBYAX dosage: unknown. Patient recovered.

Symbyax Side Effects Report #5673929-4
SYMBYAX problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 03, 2007. Female patient, 27 years of age, was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: gingival bleeding. SYMBYAX dosage: unknown. Patient recovered.

Symbyax Side Effects Report #5673930-0
Physician from UNITED STATES reported SYMBYAX problem on Jan 17, 2007. Male patient, 51 years of age, was diagnosed with bipolar i disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, overdose. SYMBYAX dosage: unknown. During the same period patient was treated with PREGABALIN, XANAX, LORCET, FOLIC ACID. Patient died on 01/01/2007.

Symbyax Side Effects Report #5673931-2
SYMBYAX problem was reported by a Physician from UNITED STATES on Jan 30, 2007. Female patient, 53 years of age, weighting 239.4 lb, was diagnosed with bipolar i disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: blood glucose increased. SYMBYAX dosage: unknown. During the same period patient was treated with BUPROPION, CALTRATE, COLACE, LISINOPRIL, FLONASE, LORTAB, NEXIUM, TOPAMAX. Patient recovered.

Symbyax Side Effects Report #5703862-0
Physician from UNITED STATES reported SYMBYAX problem on Apr 02, 2008. Male patient, 55 years of age, was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. SYMBYAX dosage: unknown. Patient died.

Symbyax Side Effects Report #5703869-3
SYMBYAX problem was reported by a Physician from UNITED STATES on Apr 03, 2008. Female patient, 47 years of age, was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: completed suicide. SYMBYAX dosage: unknown. During the same period patient was treated with AMBIEN. Patient died on 01/01/2008.

Symbyax Side Effects Report #5712214-9
Physician from UNITED STATES reported SYMBYAX problem on Apr 09, 2008. Male patient, 65 years of age, was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: hallucination, hospitalisation. SYMBYAX dosage: unknown. During the same period patient was treated with DILAUDID. Patient was hospitalized. Patient recovered.

Symbyax Side Effects Report #5335933-5
SYMBYAX problem was reported by a Physician from UNITED STATES on Oct 12, 2006. Female patient, 24 years of age, weighting 300.0 lb, was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: prescribed overdose, suicide attempt. SYMBYAX dosage: unknown. Patient was hospitalized. Patient recovered.

Symbyax Side Effects Report #5335934-7
Physician from UNITED STATES reported SYMBYAX problem on Oct 20, 2006. Female patient, 22 years of age, was diagnosed with bipolar i disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: convulsion, faecal incontinence. SYMBYAX dosage: unknown. Patient recovered.

Symbyax Side Effects Report #5335935-9
SYMBYAX problem was reported by a Health Professional from UNITED STATES on Oct 25, 2006. Male patient, 45 years of age, was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: weight increased. SYMBYAX dosage: unknown. Patient recovered.

Symbyax Side Effects Report #5335936-0
Health Professional from UNITED STATES reported SYMBYAX problem on Oct 31, 2006. Female patient, 30 years of age, was diagnosed with bipolar disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: hepatic enzyme increased, oedema, weight increased. SYMBYAX dosage: 625 MG. Patient recovered.

Symbyax Side Effects Report #5335937-2
SYMBYAX problem was reported by a Physician from UNITED STATES on Nov 15, 2006. Female patient, 27 years of age, was diagnosed with bipolar disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: intentional overdose. SYMBYAX dosage: unknown. During the same period patient was treated with METAMFETAMINE HYDROCHLORIDE. Patient was hospitalized. Patient recovered.

Symbyax Side Effects Report #5335938-4
Physician from UNITED STATES reported SYMBYAX problem on Dec 08, 2006. Male patient, 25 years of age, was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: intentional overdose. SYMBYAX dosage: unknown. Patient was hospitalized. Patient recovered.

Symbyax Side Effects Report #5335939-6
SYMBYAX problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 15, 2006. Female patient, 25 years of age, was diagnosed with stress and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: anxiety, chest pain, dizziness, insomnia, stress, tremor. SYMBYAX dosage: unknown. Patient recovered.

Symbyax Side Effects Report #5340748-8
Health Professional from UNITED STATES reported SYMBYAX problem on Jan 05, 2007. Female patient, 20 years of age, was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: oedema peripheral. SYMBYAX dosage: unknown. During the same period patient was treated with CYMBALTA. Patient recovered.

Symbyax Side Effects Report #5340896-2
SYMBYAX problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 02, 2006. Female patient, 32 years of age, was diagnosed with bipolar disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: memory impairment, migraine. SYMBYAX dosage: EACH EVENING (6MG/25MG). During the same period patient was treated with CYMBALTA, DARVOCET, XANAX. Patient recovered.

Symbyax Side Effects Report #5216711-4
Consumer or non-health professional from UNITED STATES reported SYMBYAX problem on May 09, 2006. Male patient was diagnosed with bipolar disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: weight increased. SYMBYAX dosage: 12/50MG. During the same period patient was treated with ZYPREXA, ZYPREXA ZYDIS. Patient recovered.

Symbyax Side Effects Report #5268126-0
SYMBYAX problem was reported by a Physician from UNITED STATES on Mar 13, 2007. Male patient was diagnosed with bipolar i disorder and was treated with SYMBYAX. After drug was administered, patient experienced the following problems/side effects: hiv infection. SYMBYAX dosage: unknown. Patient died.


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