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Review Temesta Safety Reports submitted to FDA

Total Temesta reports: 18.
Temesta FDA safety alerts: No.
Reported deaths: 6    Reported hospitalizations: 14.
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FDA Reported Temesta Side Effects: fall, hallucination, visual, sedation, abortion induced, altered state of consciousness, oxygen saturation decreased, dehydration, oligohydramnios, orthostatic hypotension, respiratory depression, renal failure acute.
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Temesta Side Effects Report #5673076-1
Health Professional from SWITZERLAND reported TEMESTA problem on Feb 29, 2008. Female patient was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: alcohol use, coma, depression, eyelid oedema, loss of consciousness, mydriasis, overdose, suicide attempt. TEMESTA dosage: (50 MG 1X ORAL). During the same period patient was treated with ETHANOL. Patient was hospitalized. Patient recovered.

Temesta Side Effects Report #5635910-0
TEMESTA problem was reported by a Health Professional from FRANCE on Jan 31, 2008. Female patient was diagnosed with ischaemic cardiomyopathy and was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: hypothyroidism, pulmonary fibrosis. TEMESTA dosage: unknown. During the same period patient was treated with CORDARONE, ADANCOR, BURINEX, CELECTOL, DISCOTRINE, LANZOR, NOCTRAN, OROCAL. Patient was hospitalized. Patient recovered.

Temesta Side Effects Report #5648317-7
Health Professional from SWITZERLAND reported TEMESTA problem on Feb 14, 2008. Male patient was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: hypospadias. TEMESTA dosage: 1 MG QD TRANSPLACENTAL. During the same period patient was treated with EFFEXOR. Patient recovered.

Temesta Side Effects Report #5603334-8
TEMESTA problem was reported by a Health Professional from SWITZERLAND on Jan 03, 2008. Female patient was diagnosed with depression and was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: daydreaming, hallucination, visual, hypotension, intentional overdose, movement disorder, nausea, speech disorder, suicide attempt. TEMESTA dosage: unknown. During the same period patient was treated with SOMNIUM, EFFEXOR, ZYPREXA, SEROQUEL, ATARAX. Patient was hospitalized. Patient recovered.

Temesta Side Effects Report #5613344-2
Physician from SWITZERLAND reported TEMESTA problem on Jan 11, 2008. Male patient was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: agitation, depression, insomnia, logorrhoea, mania, restlessness. TEMESTA dosage: (2 MG QD ORAL). During the same period patient was treated with SINEMET, SIRDALUD, PANTOZOL, ALDACTONE, REMERON. Patient was hospitalized. Patient recovered.

Temesta Side Effects Report #5508554-9
TEMESTA problem was reported by a Pharmacist from SWEDEN on Oct 19, 2007. Female patient was diagnosed with sleep disorder and was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: nausea, palpitations. TEMESTA dosage: (0.5 MG QD ORAL, (0.5 MG QD DIFFERENT LOT ORAL). Patient was hospitalized. Patient recovered.

Temesta Side Effects Report #5519105-7
Health Professional from SWEDEN reported TEMESTA problem on Oct 29, 2007. Female patient was diagnosed with sleep disorder and was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: nausea, palpitations. TEMESTA dosage: (0.5 MG QD ORAL), (0.5 MG QD ORAL). Patient was hospitalized. Patient recovered.

Temesta Side Effects Report #5483229-3
TEMESTA problem was reported by a Physician from SWITZERLAND on Sept 20, 2007. Male patient was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: aortic stenosis, cardiac arrest, cyanosis, fear, hyperventilation, panic attack, respiratory distress, sleep disorder, unresponsive to stimuli. TEMESTA dosage: (1 MG QD ORAL), (2 MG QD ORAL). During the same period patient was treated with HALDOL, DIPIPERON, FLUIMUCIL, DEANXIT, SEROPRAM. Patient was hospitalized. Patient died on 06/20/2007.

Temesta Side Effects Report #5483879-4
Health Professional from SWITZERLAND reported TEMESTA problem on Sept 20, 2007. Female patient was diagnosed with ill-defined disorder and was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: completed suicide. TEMESTA dosage: 4 MG QD ORAL, 6MG QD ORAL, 5 MG QD ORAL, 2 MG QD ORAL. During the same period patient was treated with EFFEXOR, REMERON, STILNOX. Patient died on 10/02/2006.

Temesta Side Effects Report #5484875-3
TEMESTA problem was reported by a Physician from SWITZERLAND on Sept 24, 2007. Male patient was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: aggression, delusion, restlessness, sleep disorder, treatment noncompliance. TEMESTA dosage: unknown. During the same period patient was treated with EFFEXOR, AXURA, REMINYL, TORSEMIDE, REMERON, ASPIRIN, PRAVASTATIN. Patient was hospitalized. Patient recovered.

Temesta Side Effects Report #5388554-2
Health Professional from FRANCE reported TEMESTA problem on June 25, 2007. Male patient, 66 years of age, was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: akinesia, blood glucose increased, coordination abnormal, fall, hypertonia, parkinsonism. TEMESTA dosage: ( 1 MG TID ORAL). During the same period patient was treated with AVLOCARDYL, FLUOXETINE, STILNOX, TERCIAN. Patient was hospitalized. Patient recovered.

Temesta Side Effects Report #5389857-8
TEMESTA problem was reported by a Consumer or non-health professional from SWITZERLAND on June 27, 2007. Female patient, 34 years of age, was diagnosed with anxiety and was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: asthmatic crisis. TEMESTA dosage: (3.5 MG QD ORAL), (1 DF QD). During the same period patient was treated with AXOTIDE, TOPAMAX, CETIRIZINE, FLUOXETINE, SEREVENT. Patient recovered.

Temesta Side Effects Report #5390819-5
Health Professional from SWITZERLAND reported TEMESTA problem on June 29, 2007. Male patient was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, cyanosis, hyperglycaemia, ketoacidosis, pneumonia, renal failure acute, respiratory depression, rhabdomyolysis. TEMESTA dosage: 2.5 MG TID ORAL. During the same period patient was treated with DORMICUM, STILNOX, TRANXILIUM, ATORVASTATIN CALCIUM, ACETAMINOPHEN, NORVASC, BELOC, PLAVIX. Patient was hospitalized. Patient died on 05/06/2007.

Temesta Side Effects Report #5403529-2
TEMESTA problem was reported by a Health Professional from SWITZERLAND on July 13, 2007. Male patient was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, altered state of consciousness, aspartate aminotransferase increased, cyanosis, diabetic ketoacidosis, hyperglycaemia, pneumonia, renal failure acute, respiratory depression. TEMESTA dosage: 2.5 MG TID, ORAL. During the same period patient was treated with DORMICUM, STILNOX, TRANXILIUM, SORTIS, ACETAMINOPHEN, NORVASC, BELOC, TOREM. Patient was hospitalized. Patient died on 05/06/2007.

Temesta Side Effects Report #5388554-2
Health Professional from FRANCE reported TEMESTA problem on June 25, 2007. Male patient, 66 years of age, was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: akinesia, blood glucose increased, coordination abnormal, fall, hypertonia, parkinsonism. TEMESTA dosage: ( 1 MG TID ORAL). During the same period patient was treated with AVLOCARDYL, FLUOXETINE, STILNOX, TERCIAN. Patient was hospitalized. Patient recovered.

Temesta Side Effects Report #5389857-8
TEMESTA problem was reported by a Consumer or non-health professional from SWITZERLAND on June 27, 2007. Female patient, 34 years of age, was diagnosed with anxiety and was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: asthmatic crisis. TEMESTA dosage: (3.5 MG QD ORAL), (1 DF QD). During the same period patient was treated with AXOTIDE, TOPAMAX, CETIRIZINE, FLUOXETINE, SEREVENT. Patient recovered.

Temesta Side Effects Report #5390819-5
Health Professional from SWITZERLAND reported TEMESTA problem on June 29, 2007. Male patient was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, cyanosis, hyperglycaemia, ketoacidosis, pneumonia, renal failure acute, respiratory depression, rhabdomyolysis. TEMESTA dosage: 2.5 MG TID ORAL. During the same period patient was treated with DORMICUM, STILNOX, TRANXILIUM, ATORVASTATIN CALCIUM, ACETAMINOPHEN, NORVASC, BELOC, PLAVIX. Patient was hospitalized. Patient died on 05/06/2007.

Temesta Side Effects Report #5403529-2
TEMESTA problem was reported by a Health Professional from SWITZERLAND on July 13, 2007. Male patient was treated with TEMESTA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, altered state of consciousness, aspartate aminotransferase increased, cyanosis, diabetic ketoacidosis, hyperglycaemia, pneumonia, renal failure acute, respiratory depression. TEMESTA dosage: 2.5 MG TID, ORAL. During the same period patient was treated with DORMICUM, STILNOX, TRANXILIUM, SORTIS, ACETAMINOPHEN, NORVASC, BELOC, TOREM. Patient was hospitalized. Patient died on 05/06/2007.


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alcohol use, coma, depression, eyelid oedema, loss of consciousness, mydriasis, overdose, suicide attempt, , was diagnosed with ischaemic cardiomyopathy and was diagnosed with depression and was diagnosed with sleep disorder and