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Ethanol Side Effects submitted to FDA

Total Ethanol reports: 6.
Ethanol FDA safety alerts: No.
Reported deaths: 5    Reported hospitalizations: 1.
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FDA Reported Ethanol Side Effects: completed suicide, body temperature increased, nausea, mental status changes, lethargy, hepatotoxicity, depressed mood, confusional state, blood ethanol increased, electrocardiogram qrs complex shortened, depressed level of consciousness,
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Ethanol Side Effects Report #5600974-7
Physician from UNITED STATES reported ETHANOL problem on Jan 04, 2008. Male patient, 34 years of age, was diagnosed with suicide attempt and was treated with ETHANOL. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, cardiac arrest, completed suicide. ETHANOL dosage: unknown. During the same period patient was treated with AMPHETAMINE SULPHATE, BUPROPION, ACETAMINOPHEN W, BENZODIAZEPINE DERIVATIVES. Patient died.



Ethanol Side Effects Report #5600975-9
ETHANOL problem was reported by a Physician from UNITED STATES on Jan 04, 2008. Female patient, 49 years of age, was diagnosed with suicide attempt and was treated with ETHANOL. After drug was administered, patient experienced the following problems/side effects: completed suicide. ETHANOL dosage: unknown. During the same period patient was treated with HYDROCODONE BITARTRATE, BENZODIAZEPINE DERIVATIVES. Patient died.



Ethanol Side Effects Report #5601014-6
Physician from UNITED STATES reported ETHANOL problem on Jan 04, 2008. Female patient, 66 years of age, was treated with ETHANOL. After drug was administered, patient experienced the following problems/side effects: completed suicide. ETHANOL dosage: unknown. Patient died.



Ethanol Side Effects Report #5612168-X
ETHANOL problem was reported by a Health Professional from UNITED STATES on Jan 31, 2008. Male patient, weighting 44.09 lb, was diagnosed with central line infection and was treated with ETHANOL. After drug was administered, patient experienced the following problems/side effects: bone pain, lymphadenitis, neck pain, pain in extremity. ETHANOL dosage: 2 ML OF 70% DAILY IV. Patient recovered.




Ethanol Side Effects Report #5506486-3
Consumer or non-health professional from CANADA reported ETHANOL problem on Sept 25, 2007. Male patient was treated with ETHANOL. After drug was administered, patient experienced the following problems/side effects: cyanosis neonatal, lung disorder, neonatal aspiration, neonatal disorder, oxygen saturation decreased. ETHANOL dosage: unknown. Patient was hospitalized. Patient recovered.



Ethanol Side Effects Report #5163783-1
ETHANOL problem was reported by a Physician from UNITED STATES on Nov 09, 2006. Female patient, 66 years of age, was diagnosed with suicide attempt and was treated with ETHANOL. After drug was administered, patient experienced the following problems/side effects: completed suicide. ETHANOL dosage: unknown. During the same period patient was treated with ACETAMINOPHEN. Patient died.




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