Alcohol Safety Reports submitted to FDA
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More Rx Information: A B C D E F G H I J K L M N O P Q R S T U V W X Y ZTotal Alcohol reports: 24.
Alcohol FDA safety alerts: 2005 2006 2008 .
Reported deaths: 6 Reported hospitalizations: 6.
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FDA Reported Alcohol Side Effects: sleep walking, fall, amnesia, road traffic accident, somnambulism, impaired driving ability, abnormal sleep-related event, abnormal behaviour, circulatory collapse, intentional overdose, ocular hyperaemia.
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Alcohol Side Effects Report #5271370-X
Pharmacist from AUSTRALIA reported ALCOHOL problem on Feb 27, 2007. Male patient, 37 years of age, was diagnosed with insomnia and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: fall, sleep walking, trance. ALCOHOL dosage: unknown. During the same period patient was treated with ZOLPIDEM TARTRATE. Patient died on 02/01/2007.
Alcohol Side Effects Report #5286546-5
ALCOHOL problem was reported by a Consumer or non-health professional from UNITED STATES on May 25, 2006. Male patient was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: sleep walking. ALCOHOL dosage: unknown. During the same period patient was treated with AMBIEN, CLONAZEPAM. Patient recovered.
Alcohol Side Effects Report #5289826-2
Consumer or non-health professional from AUSTRALIA reported ALCOHOL problem on Mar 27, 2007. Male patient, 48 years of age, was diagnosed with alcohol use, sleep disorder and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: alcohol use, fall, foot fracture, head injury, joint injury, lower limb fracture, multiple injuries, rib fracture, sleep walking. ALCOHOL dosage: unknown. During the same period patient was treated with STILNOX. Patient was hospitalized. Patient recovered.
Alcohol Side Effects Report #5298059-5
ALCOHOL problem was reported by a Physician from AUSTRALIA on Apr 04, 2007. Female patient, 38 years of age, was diagnosed with alcoholism and was treated with ALCOHOL. ALCOHOL dosage: unknown. During the same period patient was treated with STILNOX, PROTHIADEN. Patient died on 03/27/2007.
Alcohol Side Effects Report #5300754-6
Consumer or non-health professional from UNITED STATES reported ALCOHOL problem on Mar 12, 2007. Male patient was diagnosed with insomnia and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: aggression, amnesia, anger, loss of consciousness, mental impairment, physical assault, sleep walking, suicidal ideation, thinking abnormal. ALCOHOL dosage: unknown. During the same period patient was treated with NEURONTIN, AMBIEN. Patient recovered.
Alcohol Side Effects Report #5303458-9
ALCOHOL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 12, 2007. Male patient was diagnosed with insomnia and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, amnesia, convulsion, sleep walking, weight decreased. ALCOHOL dosage: unknown. During the same period patient was treated with XANAX, EFFEXOR, AMBIEN. Patient recovered.
Alcohol Side Effects Report #5308836-X
Consumer or non-health professional from UNITED STATES reported ALCOHOL problem on Mar 12, 2007. Female patient was diagnosed with insomnia and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: amnesia, ankle fracture, anxiety, concussion, fall, injury, road traffic accident, sleep walking, weight decreased. ALCOHOL dosage: unknown. During the same period patient was treated with FOSAMAX, EFFEXOR, AMBIEN. Patient was hospitalized. Patient recovered.
Alcohol Side Effects Report #5328967-8
ALCOHOL problem was reported by a Consumer or non-health professional from UNITED STATES on May 07, 2007. Female patient was diagnosed with insomnia and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: amnesia, ankle fracture, anxiety, concussion, fall, injury, laceration, lower limb fracture, road traffic accident. ALCOHOL dosage: unknown. During the same period patient was treated with FOSAMAX, EFFEXOR, AMBIEN, PROZAC. Patient was hospitalized. Patient recovered.
Alcohol Side Effects Report #5330235-5
Health Professional from AUSTRALIA reported ALCOHOL problem on May 10, 2007. Female patient, 46 years of age, was diagnosed with anxiety disorder, sleep disorder and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: abnormal sleep-related event, amnesia, road traffic accident, sleep walking. ALCOHOL dosage: unknown. During the same period patient was treated with ANTENEX, STILNOX. Patient recovered.
Alcohol Side Effects Report #5340390-9
ALCOHOL problem was reported by a Consumer or non-health professional from AUSTRALIA on May 16, 2007. Male patient, 48 years of age, was diagnosed with alcohol use, sleep disorder and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: amnesia, fall, multiple injuries, sleep walking. ALCOHOL dosage: unknown. During the same period patient was treated with STILNOX, GLUCOSAMINE. Patient was hospitalized. Patient recovered.
Alcohol Side Effects Report #5369451-5
Health Professional from AUSTRALIA reported ALCOHOL problem on June 13, 2007. Male patient, 26 years of age, was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: face injury, fall, hallucination, sleep walking, upper limb fracture, wrist fracture. ALCOHOL dosage: unknown. During the same period patient was treated with AROPAX, ZOLPIDEM TARTRATE. Patient was hospitalized. Patient recovered.
Alcohol Side Effects Report #5369452-7
ALCOHOL problem was reported by a Consumer or non-health professional from AUSTRALIA on June 21, 2007. Male patient was diagnosed with insomnia and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: aggression, completed suicide. ALCOHOL dosage: unknown. During the same period patient was treated with ZOLPIDEM TARTRATE. Patient died on 10/15/2005.
Alcohol Side Effects Report #5370691-X
Consumer or non-health professional from UNITED STATES reported ALCOHOL problem on June 14, 2007. Male patient was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: confusional state, impaired driving ability, ocular hyperaemia, road traffic accident, sleep walking. ALCOHOL dosage: unknown. During the same period patient was treated with SONATA, LUNESTA, AMBIEN, TOPROL. Patient recovered.
Alcohol Side Effects Report #5053496-9
ALCOHOL problem was reported by a Physician from GERMANY on May 10, 2006. Male patient, weighting 198.4 lb, was diagnosed with bipolar i disorder and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage, intentional overdose, oesophagitis ulcerative, renal failure acute, toxic epidermal necrolysis. ALCOHOL dosage: unknown. During the same period patient was treated with SEROQUEL, TAVOR, STILNOX. Patient was hospitalized. Patient recovered.
Alcohol Side Effects Report #5088966-0
Consumer or non-health professional from UNITED STATES reported ALCOHOL problem on Aug 21, 2006. Female patient, 74 years of age, was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: impaired driving ability. ALCOHOL dosage: unknown. During the same period patient was treated with AMBIEN. Patient recovered.
Alcohol Side Effects Report #5127105-4
ALCOHOL problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 03, 2006. Male patient was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: alcohol use, amnesia, impaired driving ability, incorrect dose administered, overdose, road traffic accident. ALCOHOL dosage: unknown. During the same period patient was treated with AMBIEN. Patient recovered.
Alcohol Side Effects Report #5391413-2
Physician from AUSTRALIA reported ALCOHOL problem on July 09, 2007. Female patient, 38 years of age, was diagnosed with alcoholism and was treated with ALCOHOL. ALCOHOL dosage: unknown. During the same period patient was treated with ZOLPIDEM TARTRATE, PROTHIADEN. Patient died on 03/27/2007.
Alcohol Side Effects Report #5394396-4
ALCOHOL problem was reported by a Health Professional from AUSTRALIA on July 11, 2007. Male patient, 69 years of age, was diagnosed with sleep disorder, metabolic disorder, depression, diabetes mellitus and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, abnormal sleep-related event, amnesia, circulatory collapse, fall, somnambulism. ALCOHOL dosage: unknown. During the same period patient was treated with ZOLPIDEM TARTRATE, MEGAFOL, TEGRETOL, LIPITOR, FLOMAXTRA, EZETROL, EFFEXOR, DIABEX. Patient recovered.
Alcohol Side Effects Report #5400997-7
Health Professional from AUSTRALIA reported ALCOHOL problem on July 18, 2007. Female patient, 49 years of age, was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: abnormal sleep-related event, fall, poisoning, somnambulism, spinal fracture. ALCOHOL dosage: unknown. During the same period patient was treated with ZOLPIDEM TARTRATE. Patient died.
Alcohol Side Effects Report #5404411-7
ALCOHOL problem was reported by a Health Professional from AUSTRALIA on July 24, 2007. Male patient, 69 years of age, was diagnosed with sleep disorder, metabolic disorder, depression, diabetes mellitus and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, abnormal sleep-related event, amnesia, circulatory collapse, coma, fall, somnambulism. ALCOHOL dosage: unknown. During the same period patient was treated with ZOLPIDEM TARTRATE, TEGRETOL, LIPITOR, EFFEXOR, DIABEX, CARDIPRIN, AVANDIA, AMARYL. Patient recovered.
Alcohol Side Effects Report #5407275-0
Consumer or non-health professional from SWEDEN reported ALCOHOL problem on July 26, 2007. Male patient, 64 years of age, was diagnosed with anxiety, stress and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: road traffic accident. ALCOHOL dosage: unknown. During the same period patient was treated with ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE. Patient recovered.
Alcohol Side Effects Report #5422547-1
ALCOHOL problem was reported by a Pharmacist from AUSTRALIA on Aug 10, 2007. Male patient, 37 years of age, was diagnosed with insomnia and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: fall, somnambulism, trance. ALCOHOL dosage: unknown. During the same period patient was treated with STILNOX. Patient died on 02/17/2007.
Alcohol Side Effects Report #5425225-8
Consumer or non-health professional from UNITED STATES reported ALCOHOL problem on Aug 02, 2007. Male patient was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: confusional state, impaired driving ability, ocular hyperaemia, road traffic accident, somnambulism. ALCOHOL dosage: unknown. During the same period patient was treated with SONATA, LUNESTA, AMBIEN, TOPROL. Patient recovered.
Alcohol Side Effects Report #5464484-2
ALCOHOL problem was reported by a Pharmacist from AUSTRALIA on Sept 12, 2007. Male patient, 31 years of age, was diagnosed with overdose and was treated with ALCOHOL. After drug was administered, patient experienced the following problems/side effects: apnoea, convulsion, intentional overdose, joint stiffness, throat tightness. ALCOHOL dosage: unknown. During the same period patient was treated with ZOLPIDEM TARTRATE. Patient recovered.
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