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Review Precedex Safety Reports submitted to FDA

Total Precedex reports: 38.
Precedex FDA safety alerts: No.
Reported deaths: 9    Reported hospitalizations: 8.
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FDA Reported Precedex Side Effects: hypotension, aspartate aminotransferase increased, atelectasis, mediastinitis, bradycardia, foaming at mouth, cardio-respiratory arrest, post procedural complication, cardiac output decreased, clonic convulsion, erythema.
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Precedex Side Effects Report #5652071-2
Pharmacist from JAPAN reported PRECEDEX problem on Feb 26, 2008. Female patient, child 1 years of age, weighting 21.16 lb, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: bradycardia, loss of consciousness, pallor, sinoatrial block, sinus arrest. PRECEDEX dosage: unknown. During the same period patient was treated with KETALAR, DORMICUM, SEVOFLURANE, MORPHINE, PANCURONIUM BROMIDE, ULTIVA, MILLISROL, OPYSTAN. Patient recovered.

Precedex Side Effects Report #5671632-8
PRECEDEX problem was reported by a Consumer or non-health professional from JAPAN on Feb 27, 2008. Male patient, child 2 years of age, was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: central venous pressure increased, heart rate increased. PRECEDEX dosage: unknown. Patient recovered.

Precedex Side Effects Report #5691944-1
Physician from JAPAN reported PRECEDEX problem on Mar 20, 2008. Male patient, child 2. years of age, was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: central venous pressure increased, heart rate increased. PRECEDEX dosage: unknown. Patient recovered.

Precedex Side Effects Report #5616732-3
PRECEDEX problem was reported by a Physician from JAPAN on Jan 22, 2008. Male patient, 57 years of age, weighting 152.1 lb, was diagnosed with sedation, schizophrenia, depression, procedural hypotension and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: hypotension. PRECEDEX dosage: unknown. During the same period patient was treated with CLOCAPRAMINE HYDROCHLORIDE, LEVOMEPROMAZINE MALEATE, DOSULEPIN HYDROCHLORIDE, DOPAMINE, EPHEDRINE, NITRAZEPAM, FLUNITRAZEPAM. Patient recovered.


Precedex Side Effects Report #5627654-6
Consumer or non-health professional from UNITED STATES reported PRECEDEX problem on Feb 14, 2008. Male patient, 66 years of age, weighting 155.0 lb, was diagnosed with blood pressure management, pain and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, chest pain, dyspnoea, feeling abnormal, oxygen saturation decreased, therapeutic response unexpected, vascular graft complication. PRECEDEX dosage: 100 MGS. 4 TIMES IV. Patient recovered.

Precedex Side Effects Report #5639754-5
PRECEDEX problem was reported by a Health Professional from UNITED STATES on Feb 12, 2008. Female patient, 39 years of age, weighting 250.0 lb, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: brain stem infarction, cardiac arrest, cerebrovascular accident, depressed level of consciousness, dysarthria. PRECEDEX dosage: unknown. During the same period patient was treated with BENADRYL, MIDAZOLAM, PROPOFOL, SUCCINYLCHOLINE CHLORIDE, KETAMINE, ZEMURON, SEVOFLUORANE, ENLON PLUS. Patient was hospitalized. Patient died on 01/31/2007.

Precedex Side Effects Report #5647928-2
Physician from UNITED STATES reported PRECEDEX problem on Feb 14, 2008. Female patient, 76 years of age, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: arteriosclerosis, cardio-respiratory arrest, cardiomegaly, coronary artery stenosis, foaming at mouth, pulmonary embolism, pulmonary oedema, ventricular fibrillation. PRECEDEX dosage: unknown. During the same period patient was treated with VANCOMYCIN, ACTIVASE. Patient died on 01/01/2006.

Precedex Side Effects Report #5611076-8
PRECEDEX problem was reported by a Health Professional from UNITED STATES on Jan 18, 2008. Male patient was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: bradycardia, hypotension, restlessness, ventricular extrasystoles, ventricular tachycardia. PRECEDEX dosage: CONTINUOUS, INTRAVENOUS; CONTINUOUS, 1MG/MIN., INTRAVENOUS. Patient recovered.

Precedex Side Effects Report #5565834-9
Pharmacist from JAPAN reported PRECEDEX problem on Dec 04, 2007. Male patient, 63 years of age, was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: bradycardia, cardiac arrest. PRECEDEX dosage: unknown. Patient died on 11/30/2007.


Precedex Side Effects Report #5574128-7
PRECEDEX problem was reported by a Pharmacist from JAPAN on Dec 11, 2007. Male patient, 63 years of age, was diagnosed with sedation, delirium, insomnia, hypertension and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: aggression, av dissociation, blood pressure increased, blood pressure systolic decreased, bradycardia, cardiac arrest, heart rate decreased, phlebitis. PRECEDEX dosage: unknown. During the same period patient was treated with HALOPERIDOL, RILMAZAFONE HYDROCHLORIDE, VALSARTAN, DIAZEPAM, DILTIAZEM HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE. Patient died on 11/30/2007.

Precedex Side Effects Report #5532194-9
Consumer or non-health professional from AUSTRALIA reported PRECEDEX problem on Nov 14, 2007. Female patient, 58 years of age, was diagnosed with autonomic nervous system imbalance and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: autonomic nervous system imbalance, blood pressure fluctuation, heart rate abnormal. PRECEDEX dosage: unknown. During the same period patient was treated with ANTIBIOTICS, METRONIDAZOLE, ERYTHROMYCIN, GENTAMICIN SULPHATE, TETANUS IMMUNOGLOBULIN, CEFTRIAXONE, MIDAZOLAM, DIAZEPAM. Patient recovered.

Precedex Side Effects Report #5482176-0
PRECEDEX problem was reported by a Health Professional from AUSTRALIA on Sept 25, 2007. Female patient, child 7 years of age, was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: convulsion, head injury. PRECEDEX dosage: unknown. During the same period patient was treated with DEXAMETHASONE, GENTAMICIN SULPHATE. Patient was hospitalized. Patient recovered.

Precedex Side Effects Report #5482177-2
Health Professional from AUSTRALIA reported PRECEDEX problem on Sept 25, 2007. Male patient, child 7 years of age, was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: convulsion. PRECEDEX dosage: unknown. During the same period patient was treated with POTASSIUM CHLORIDE, MIDAZOLAM, TOPIRAMATE, ENOXAPARIN, METHYLPREDNISOLONE, ERYTHROMYCIN. Patient recovered.

Precedex Side Effects Report #5451908-X
PRECEDEX problem was reported by a Physician from JAPAN on Sept 04, 2007. Male patient, 60 years of age, weighting 119.0 lb, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: blood albumin decreased, prothrombin time prolonged. PRECEDEX dosage: unknown. During the same period patient was treated with PROPOFOL, VECURONIUM BROMIDE, FENTANYL, ROPIVACAINE HYDROCHLORIDE HYDRATE, MORPHINE, LANSOPRAZOLE, CEFAZOLIN, SIVELESTAT HYDRATE. Patient recovered.


Precedex Side Effects Report #5455733-5
Physician from UNITED STATES reported PRECEDEX problem on Aug 30, 2007. Female patient, 76 years of age, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: arteriosclerosis, cardio-respiratory arrest, cardiomegaly, coronary artery stenosis, erythema, foaming at mouth, hypoxia, loss of consciousness, procedural complication. PRECEDEX dosage: unknown. During the same period patient was treated with VANCOMYCIN, ACTIVASE. Patient died on 01/01/2006.

Precedex Side Effects Report #5404715-8
PRECEDEX problem was reported by a Pharmacist from JAPAN on July 24, 2007. Female patient, 52 years of age, weighting 130.1 lb, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: hepatic function abnormal, liver disorder, staphylococcal infection, transplant rejection. PRECEDEX dosage: unknown. During the same period patient was treated with PROGRAF, DOPAMINE, SULTAMICILLIN TOSILATE, SULBACTAM, ISOFLURANE. Patient died on 04/16/2007.

Precedex Side Effects Report #5409638-6
Physician from UNITED STATES reported PRECEDEX problem on Aug 07, 2007. Male patient, 40 years of age, weighting 149.3 lb, was diagnosed with agitation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: metabolic acidosis. PRECEDEX dosage: unknown. Patient recovered.

Precedex Side Effects Report #5415332-8
PRECEDEX problem was reported by a Physician from JAPAN on Aug 02, 2007. Male patient, weighting 116.0 lb, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: mediastinitis. PRECEDEX dosage: unknown. During the same period patient was treated with SERUM ALBUMIN, CEFOTIAM HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE, NAFAMOSTAT MESILATE, BROMHEXINE HYDROCHLORIDE, PENTAZOCINE HYDROCHLORIDE, HYDROXYZINE. Patient was hospitalized. Patient recovered.

Precedex Side Effects Report #5379440-2
Physician from UNITED STATES reported PRECEDEX problem on June 25, 2007. Female patient, weighting 6.61 lb, was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: bradycardia, hypothermia. PRECEDEX dosage: unknown. During the same period patient was treated with FENTANYL CITRATE, SEVOFLURANE, NITROUS OXIDE. Patient recovered.


Precedex Side Effects Report #5385099-0
PRECEDEX problem was reported by a Physician from JAPAN on June 27, 2007. Male patient, 57 years of age, was diagnosed with schizophrenia and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: hypotension. PRECEDEX dosage: unknown. During the same period patient was treated with CLOCAPRAMINE HYDROCHLORIDE, LEVOMEPROMAZINE, TRYCYCLIC ANTIDEPRESSANT, BENZODIAZEPINE, EPHEDRINE HYDROCHLORIDE, DOPAMINE, PHENYLEPHRINE HYDROCHLORIDE. Patient recovered.

Precedex Side Effects Report #5388705-X
Physician from JAPAN reported PRECEDEX problem on July 02, 2007. Male patient, weighting 116.0 lb, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: mediastinitis, post procedural complication. PRECEDEX dosage: unknown. During the same period patient was treated with SERUM ALBUMIN, CEFOTIAM HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE, NAFAMOSTAT MESILATE, BROMHEXINE HYDROCHLORIDE, PENTAZOCINE HYDROCHLIRDE, HYDROXYZINE. Patient was hospitalized. Patient recovered.

Precedex Side Effects Report #5390850-X
PRECEDEX problem was reported by a Pharmacist from JAPAN on July 06, 2007. Male patient, 61 years of age, weighting 114.6 lb, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased. PRECEDEX dosage: unknown. During the same period patient was treated with VANCOMYCIN, BIAPENEM, INSULIN, CIMETADINE, CARBAZOCHROME SULFONATE, SERUM ALBUMIN, PANCURONIUM BROMIDE. Patient was hospitalized. Patient recovered.

Precedex Side Effects Report #5398789-0
Physician from JAPAN reported PRECEDEX problem on July 12, 2007. Male patient, 57 years of age, weighting 152.1 lb, was diagnosed with sedation, schizophrenia, depression, procedural hypotension and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: hypotension. PRECEDEX dosage: unknown. During the same period patient was treated with CLOCAPRAMINE HYDROCHLORIDE, LEVOMEPROMAZINE MALEATE, DOSULEPIN HYDROCHLORIDE, DOPAMINE, EPHEDRINE, NITRAZEPAM, FLUNITRAZEPAM. Patient recovered.

Precedex Side Effects Report #5379440-2
PRECEDEX problem was reported by a Physician from UNITED STATES on June 25, 2007. Female patient, weighting 6.61 lb, was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: bradycardia, hypothermia. PRECEDEX dosage: unknown. During the same period patient was treated with FENTANYL CITRATE, SEVOFLURANE, NITROUS OXIDE. Patient recovered.

Precedex Side Effects Report #5385099-0
Physician from JAPAN reported PRECEDEX problem on June 27, 2007. Male patient, 57 years of age, was diagnosed with schizophrenia and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: hypotension. PRECEDEX dosage: unknown. During the same period patient was treated with CLOCAPRAMINE HYDROCHLORIDE, LEVOMEPROMAZINE, TRYCYCLIC ANTIDEPRESSANT, BENZODIAZEPINE, EPHEDRINE HYDROCHLORIDE, DOPAMINE, PHENYLEPHRINE HYDROCHLORIDE. Patient recovered.

Precedex Side Effects Report #5388705-X
PRECEDEX problem was reported by a Physician from JAPAN on July 02, 2007. Male patient, weighting 116.0 lb, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: mediastinitis, post procedural complication. PRECEDEX dosage: unknown. During the same period patient was treated with SERUM ALBUMIN, CEFOTIAM HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE, NAFAMOSTAT MESILATE, BROMHEXINE HYDROCHLORIDE, PENTAZOCINE HYDROCHLIRDE, HYDROXYZINE. Patient was hospitalized. Patient recovered.

Precedex Side Effects Report #5390850-X
Pharmacist from JAPAN reported PRECEDEX problem on July 06, 2007. Male patient, 61 years of age, weighting 114.6 lb, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased. PRECEDEX dosage: unknown. During the same period patient was treated with VANCOMYCIN, BIAPENEM, INSULIN, CIMETADINE, CARBAZOCHROME SULFONATE, SERUM ALBUMIN, PANCURONIUM BROMIDE. Patient was hospitalized. Patient recovered.

Precedex Side Effects Report #5398789-0
PRECEDEX problem was reported by a Physician from JAPAN on July 12, 2007. Male patient, 57 years of age, weighting 152.1 lb, was diagnosed with sedation, schizophrenia, depression, procedural hypotension and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: hypotension. PRECEDEX dosage: unknown. During the same period patient was treated with CLOCAPRAMINE HYDROCHLORIDE, LEVOMEPROMAZINE MALEATE, DOSULEPIN HYDROCHLORIDE, DOPAMINE, EPHEDRINE, NITRAZEPAM, FLUNITRAZEPAM. Patient recovered.

Precedex Side Effects Report #5772942-6
Physician from UNITED STATES reported PRECEDEX problem on May 31, 2008. Male patient, 50 years of age, weighting 196.2 lb, was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: agitation, bradycardia, brain herniation, cardiac failure, cardiac perforation, cardiac tamponade, cardiogenic shock, cardiomegaly. PRECEDEX dosage: unknown. During the same period patient was treated with FENTANYL, MIDAZOLAM, HEPARIN, EPINEPHRINE, ATROPINE, DOPAMINE, PROTAMINE SULPHATE. Patient died on 09/01/2006.

Precedex Side Effects Report #5775232-0
PRECEDEX problem was reported by a Pharmacist from UNITED STATES on June 16, 2008. Female patient, weighting 57.32 lb, was diagnosed with weaning failure and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: mental status changes, speech disorder. PRECEDEX dosage: unknown. Patient recovered.

Precedex Side Effects Report #5778480-9
Physician from UNITED STATES reported PRECEDEX problem on June 10, 2008. Male patient, 50 years of age, weighting 196.2 lb, was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: agitation, anoxic encephalopathy, bradycardia, cardiac tamponade, cardiogenic shock, hypotension, hypoxic encephalopathy, myocardial ischaemia, pericardial effusion. PRECEDEX dosage: unknown. During the same period patient was treated with FENTANYL, MIDAZOLAM, HEPARIN, EPINEPHRINE, ATROPINE, DOPAMINE, PROTAMINE SULPHATE. Patient died on 09/01/2006.

Precedex Side Effects Report #5691944-1
PRECEDEX problem was reported by a Physician from JAPAN on Mar 20, 2008. Male patient, child 2. years of age, was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: central venous pressure increased, heart rate increased. PRECEDEX dosage: unknown. Patient recovered.

Precedex Side Effects Report #5705328-0
Physician from JAPAN reported PRECEDEX problem on Mar 31, 2008. Male patient, child 2. years of age, weighting 26.46 lb, was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: central venous pressure increased, tachycardia. PRECEDEX dosage: unknown. During the same period patient was treated with DIAZEPAM, ATROPINE SULPHATE, MIOBLOCK, FENTANYL, DORMICUM, SEVOFLURANE, DOBUTREX, MILRINONE. Patient recovered.

Precedex Side Effects Report #5705439-X
PRECEDEX problem was reported by a Consumer or non-health professional from JAPAN on Mar 31, 2008. Male patient, child 2 years of age, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: cardiac failure, central venous pressure increased, tachycardia. PRECEDEX dosage: unknown. During the same period patient was treated with DIAZEPAM, ATROPINE SULPHATE, MIOBLOCK, FENTANYL CITRATE, DORMICUM, SEVOFLURANE, DOBUTREX, MILRINONE. Patient recovered.

Precedex Side Effects Report #5299722-2
Health Professional from FINLAND reported PRECEDEX problem on Apr 03, 2007. Female patient, 65 years of age, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: cardiac index decreased, cardiovascular insufficiency, hypotension, multi-organ failure, renal failure, respiratory failure, sepsis. PRECEDEX dosage: unknown. During the same period patient was treated with ACTRAPID, DOBUJECT INFUSION, FENTANYL INFUSION, FURESIS, MERONEM, METRONIDAZOLE BRAUN, NORADRENALINA. Patient recovered.

Precedex Side Effects Report #5316482-7
PRECEDEX problem was reported by a Pharmacist from JAPAN on Apr 19, 2007. Male patient, 57 years of age, weighting 114.6 lb, was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: hyperbilirubinaemia. PRECEDEX dosage: unknown. During the same period patient was treated with CEFTAZIDIME, DIPRIVAN, FENTANYL, VECURONIUM BROMIDE, NICARDIPINE HYDROCHLORIDE, ETILEFRINE HYDROCHLORIDE, SEVOFLURANE, MIDAZOLAM. Patient was hospitalized. Patient recovered.

Precedex Side Effects Report #5321014-3
Pharmacist from UNITED STATES reported PRECEDEX problem on Jan 04, 2006. Female patient, 71 years of age, weighting 127.9 lb, was diagnosed with sedation and was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, erythema, heart rate increased. PRECEDEX dosage: unknown. During the same period patient was treated with ATIVAN, DIPRIVAN, ANTIBIOTICS. Patient recovered.

Precedex Side Effects Report #5273296-4
PRECEDEX problem was reported by a Health Professional from FINLAND on Mar 09, 2007. Female patient, 65 years of age, was treated with PRECEDEX. After drug was administered, patient experienced the following problems/side effects: cardiac index decreased, hypotension. PRECEDEX dosage: unknown. During the same period patient was treated with ACTRAPID, DIFLUCAN INFUSION, DOBUJECT INFUSION, FENTANYL INFUSION, FRAGMIN INFUSION, FURESIS, MERONEM. Patient recovered.


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