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Review Aotal Safety Reports submitted to FDA

Total Aotal reports: 21.
Aotal FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 16.
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FDA Reported Aotal Side Effects: fall, subdural haematoma, melaena, haemoglobin decreased, blood lactic acid increased, malaise, ischaemic stroke, blood alcohol increased, vomiting, loss of consciousness, hypokalaemia.
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Aotal Side Effects Report #5635783-6
Consumer or non-health professional from FRANCE reported AOTAL problem on Feb 06, 2008. Male patient, 32 years of age, was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: cholestasis, hepatitis, hepatitis toxic, hepatosplenomegaly. AOTAL dosage: 333 MG TID PO. During the same period patient was treated with ESPERAL, NOCTRAM, OXAZEPAM, INEXIUM. Patient was hospitalized. Patient died.

Aotal Side Effects Report #5605577-6
AOTAL problem was reported by a Consumer or non-health professional from FRANCE on Jan 09, 2008. Male patient, 32 years of age, was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: cholestasis, hepatitis toxic, hepatosplenomegaly. AOTAL dosage: 333 MG TID PO. During the same period patient was treated with ESPERAL, NOCTRAM, OXAZEPAM, INEXIUM. Patient was hospitalized. Patient died.

Aotal Side Effects Report #5565035-4
Health Professional from FRANCE reported AOTAL problem on Nov 26, 2007. Male patient, 44 years of age, was diagnosed with alcohol withdrawal syndrome and was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: confusional state, hypertension, hypothermia, stress cardiomyopathy, supraventricular tachycardia. AOTAL dosage: unknown. During the same period patient was treated with METHADONE, TRANXENE. Patient was hospitalized. Patient recovered.

Aotal Side Effects Report #5521898-X
AOTAL problem was reported by a Health Professional from FRANCE on Nov 02, 2007. Male patient, 63 years of age, was diagnosed with alcoholism and was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: ageusia. AOTAL dosage: 666 MG TID PO. During the same period patient was treated with CRESTOR, EFFEXOR, ZOLPIDEM TARTRATE. Patient recovered.

Aotal Side Effects Report #5524937-5
Health Professional from FRANCE reported AOTAL problem on Nov 02, 2007. Male patient, 44 years of age, was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: cardiomyopathy, confusional state, hypothermia. AOTAL dosage: unknown. During the same period patient was treated with METHADONE, REVIA, MIDAZOLAM, TRANXENE. Patient was hospitalized. Patient recovered.

Aotal Side Effects Report #5527665-5
AOTAL problem was reported by a Consumer or non-health professional from FRANCE on Nov 16, 2007. Male patient, 63 years of age, was diagnosed with alcoholism and was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: ageusia. AOTAL dosage: 666 MG TID PO. During the same period patient was treated with CRESTPR, EFFEXOR, ZOLPIDEM TARTRATE. Patient recovered.

Aotal Side Effects Report #5415592-3
Pharmacist from FRANCE reported AOTAL problem on Aug 03, 2007. Female patient, 50 years of age, was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: blood lactic acid increased, contusion, decreased activity, fall, haemoglobin decreased, melaena, somnolence, subdural haematoma. AOTAL dosage: unknown. During the same period patient was treated with BISOPROLOL FUMARATE, MEPRONIZINE, ASPIRIN, AMLODIPINE BESYLATE, PRAVASTATIN. Patient was hospitalized. Patient recovered.

Aotal Side Effects Report #5423125-0
AOTAL problem was reported by a Health Professional from FRANCE on Aug 08, 2007. Female patient, 65 years of age, was diagnosed with alcoholism, hypercholesterolaemia and was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: focal nodular hyperplasia, hepatic failure, hepatitis fulminant. AOTAL dosage: 666 MG TID PO. During the same period patient was treated with DISULFIRAM, ATORVASTATIN CALCIUM, XANAX. Patient died on 06/28/2007.

Aotal Side Effects Report #5423126-2
Health Professional from FRANCE reported AOTAL problem on Aug 08, 2007. Male patient, 69 years of age, was diagnosed with alcoholism, anxiety and was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: alcohol use, depressed level of consciousness, disturbance in attention, malaise, repetitive speech. AOTAL dosage: 666 MG TID PO. During the same period patient was treated with DISULFIRAM, ATARAX, VALSARTAN AND HYDROCHLOROTHIAZIDE. Patient was hospitalized. Patient recovered.

Aotal Side Effects Report #5380524-3
AOTAL problem was reported by a Health Professional from FRANCE on June 22, 2007. Female patient, 50 years of age, was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: blood alcohol increased, blood lactic acid increased, cognitive disorder, fall, haemoglobin decreased, melaena, neuralgia, subdural haematoma. AOTAL dosage: unknown. During the same period patient was treated with BISOPROLOL FUMARATE, MEPRONIZINE, KARDEGIC, AMLODIPINE BESYLATE, PRAVASTATIN. Patient was hospitalized. Patient recovered.

Aotal Side Effects Report #5383612-0
Consumer or non-health professional from FRANCE reported AOTAL problem on July 04, 2007. Female patient, 50 years of age, was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: apathy, fall, haemoglobin decreased, ischaemic stroke, melaena, subarachnoid haemorrhage, subdural haematoma. AOTAL dosage: unknown. During the same period patient was treated with BISOPROLOL FUMARATE, MEPRONIZINE, ASPIRIN, AMLOR, PRAVASTATIN. Patient was hospitalized. Patient recovered.

Aotal Side Effects Report #5393041-1
AOTAL problem was reported by a Health Professional from FRANCE on July 06, 2007. Female patient, 50 years of age, was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: blood alcohol increased, blood lactic acid increased, fall, ischaemic stroke, melaena, subdural haematoma. AOTAL dosage: unknown. During the same period patient was treated with BISOPROLOL FUMARATE, MEPRONIZINE, KARDEGIC, AMLODIPINE BESYLATE, PRAVASTATIN. Patient was hospitalized. Patient recovered.

Aotal Side Effects Report #5380524-3
Health Professional from FRANCE reported AOTAL problem on June 22, 2007. Female patient, 50 years of age, was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: blood alcohol increased, blood lactic acid increased, cognitive disorder, fall, haemoglobin decreased, melaena, neuralgia, subdural haematoma. AOTAL dosage: unknown. During the same period patient was treated with BISOPROLOL FUMARATE, MEPRONIZINE, KARDEGIC, AMLODIPINE BESYLATE, PRAVASTATIN. Patient was hospitalized. Patient recovered.

Aotal Side Effects Report #5383612-0
AOTAL problem was reported by a Consumer or non-health professional from FRANCE on July 04, 2007. Female patient, 50 years of age, was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: apathy, fall, haemoglobin decreased, ischaemic stroke, melaena, subarachnoid haemorrhage, subdural haematoma. AOTAL dosage: unknown. During the same period patient was treated with BISOPROLOL FUMARATE, MEPRONIZINE, ASPIRIN, AMLOR, PRAVASTATIN. Patient was hospitalized. Patient recovered.

Aotal Side Effects Report #5393041-1
Health Professional from FRANCE reported AOTAL problem on July 06, 2007. Female patient, 50 years of age, was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: blood alcohol increased, blood lactic acid increased, fall, ischaemic stroke, melaena, subdural haematoma. AOTAL dosage: unknown. During the same period patient was treated with BISOPROLOL FUMARATE, MEPRONIZINE, KARDEGIC, AMLODIPINE BESYLATE, PRAVASTATIN. Patient was hospitalized. Patient recovered.

Aotal Side Effects Report #5766479-8
AOTAL problem was reported by a Pharmacist from FRANCE on May 23, 2008. Male patient, 57 years of age, weighting 154.3 lb, was diagnosed with alcohol abuse and was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, gamma-glutamyltransferase increased, haemoglobin decreased, platelet count decreased, purpura, rash maculo-papular, skin disorder. AOTAL dosage: unknown. During the same period patient was treated with REVIA, LEXOMIL, PROPOXYPHENE AND ACETAMINOPHEN, LAMALINE, CARDIOCALM, MIOREL. Patient was hospitalized. Patient recovered.

Aotal Side Effects Report #5748723-6
Pharmacist from FRANCE reported AOTAL problem on May 06, 2008. Male patient, 57 years of age, was diagnosed with alcohol abuse and was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: skin disorder. AOTAL dosage: unknown. During the same period patient was treated with REVIA, LEXOMIL. Patient was hospitalized. Patient recovered.

Aotal Side Effects Report #5324360-2
AOTAL problem was reported by a Health Professional from FRANCE on May 02, 2007. Male patient, 69 years of age, was diagnosed with alcoholism and was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: blood luteinising hormone increased, cushing's syndrome, dyspnoea, gynaecomastia, oestradiol increased, weight increased. AOTAL dosage: unknown. During the same period patient was treated with ALDALIX, ZOPLICLONE, CLONAZEPAM, FUROSEMIDE, XATRAL, ATARAX, EUPRESSYL. Patient recovered.

Aotal Side Effects Report #5325820-0
Health Professional from FRANCE reported AOTAL problem on Apr 27, 2007. Male patient, 34 years of age, was diagnosed with alcoholism and was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: alkalosis, fall, food intolerance, head injury, hypokalaemia, loss of consciousness, malaise, vomiting. AOTAL dosage: 999 MG BID PO. During the same period patient was treated with EQUANIL. Patient was hospitalized. Patient recovered.

Aotal Side Effects Report #5330592-X
AOTAL problem was reported by a Health Professional from FRANCE on May 11, 2007. Male patient, 34 years of age, was diagnosed with alcoholism and was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: alkalosis, fall, head injury, hypokalaemia, loss of consciousness, malaise, vomiting. AOTAL dosage: 999 MG BID PO. During the same period patient was treated with EQUANIL. Patient was hospitalized. Patient recovered.

Aotal Side Effects Report #5313477-4
Health Professional from FRANCE reported AOTAL problem on Apr 13, 2007. Male patient, 69 years of age, was diagnosed with alcoholism and was treated with AOTAL. After drug was administered, patient experienced the following problems/side effects: blood luteinising hormone increased, dyspnoea, gynaecomastia, oestradiol increased, weight increased. AOTAL dosage: unknown. During the same period patient was treated with ALDALIX, ZOPICLONE, CLONAZEPAM, FUROSEMIDE, XATRAL, ATARAX, EUPRESSYL. Patient recovered.


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