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Esertia Side Effects submitted to FDA

Total Esertia reports: 3.
Esertia FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 2.
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FDA Reported Esertia Side Effects: restlessness, inappropriate antidiuretic hormone secretion, agitation,
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Esertia Side Effects Report #5587153-7
Health Professional from SPAIN reported ESERTIA problem on Dec 21, 2007. Male patient, 52 years of age, was diagnosed with depressed mood and was treated with ESERTIA. After drug was administered, patient experienced the following problems/side effects: candidiasis, opportunistic infection, pseudomonas infection, septic shock, subarachnoid haemorrhage, thrombocytopenia, ulcer. ESERTIA dosage: 10 MG QD PO. During the same period patient was treated with MENOREM, FENITOIN, AMBISOME, VANCOMICIN, ENOXAPARIN, LEVOTHYROXINE, CANCIDAS. Patient died on 10/05/2007.



Esertia Side Effects Report #5491407-2
ESERTIA problem was reported by a Health Professional from SPAIN on Oct 04, 2007. Female patient, 75 years of age, was diagnosed with depression and was treated with ESERTIA. After drug was administered, patient experienced the following problems/side effects: agitation, blood cortisol increased, inappropriate antidiuretic hormone secretion, restlessness. ESERTIA dosage: 10 MG BID PO. During the same period patient was treated with RISPERIDONE, DURPHALAC. Patient was hospitalized. Patient recovered.



Esertia Side Effects Report #5458000-9
Consumer or non-health professional from DENMARK reported ESERTIA problem on Aug 31, 2007. Female patient, 75 years of age, was diagnosed with depression, personality disorder and was treated with ESERTIA. After drug was administered, patient experienced the following problems/side effects: agitation, inappropriate antidiuretic hormone secretion, restlessness. ESERTIA dosage: 10 MG BID PO. During the same period patient was treated with RISPERIDONE, TEGRETOL, DEPRAX, DUPHALAC, COAPROVEL. Patient was hospitalized. Patient recovered.




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, Esertia was diagnosed with depressed mood and Esertia was diagnosed with depression and Esertia was diagnosed with depression, personality disorder and