PRECEDEX Side Effects

7020559-8 | Blood Pressure Systolic Decreased, Electrocardiogram St Segment Elevation
on Sep 13, 2010 Male patient from PHILIPPINES , 51 years of age, weighting 149.9 lb, was treated with Precedex (View Usage). Patient experienced the following unwanted or unexpected effects: blood pressure systolic decreased, electrocardiogram st segment elevation. Precedex dosage: See Image. During the same period patient was treated with SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ), MIDAZOLAM HYDROCHLORIDE (View Midazolam Hydrochloride Review and Midazolam Hydrochloride Label ), FENTANYL CITRATE INJ, USP CII (FENTANYL CITRATE) (View Fentanyl Citrate Inj, Usp Cii (fentanyl Citrate) Review and Fentanyl Citrate Inj, Usp Cii (fentanyl Citrate) Label ), ROCURONIUM BROMIDE (View Rocuronium Bromide Review and Rocuronium Bromide Label ).

7007734-3 | Device Computer Issue, Incorrect Dose Administered, Off Label Use, Overdose, Sedation
Patient was taking Precedex (View Usage). Patient had the following side effects: device computer issue, incorrect dose administered, off label use, overdose, sedation on Sep 08, 2010 from UNITED STATES Additional patient health information: Female patient , weighting 21.83 lb, was diagnosed with sedation and. Precedex dosage: 2 ?g/kg Microgram(s) /kilogram, Intravneous Bolus; 60 Mcg/kg/hour Intravenous Drip. During the same period patient was treated with (OXYGEN) (View (oxygen) Review and (oxygen) Label ). Patient was hospitalized.

6986345-X | Electrocardiogram St Segment Elevation
Adverse event was reported on Mar 17, 2010 by a Male patient taking Precedex (View Usage) (Dosage: 0.6 Mcg/kg/hr, 0.4 Mcg/kg/hr, , 0.2 Mcg/kg/hr,) . Location: PHILIPPINES , 51 years of age, weighting 149.9 lb, After Precedex was administered, patient had the following side effects: electrocardiogram st segment elevation. During the same period patient was treated with SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ), MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), FENTANYT CTTRATE INJ CII (FENTANYL CITRATE) (View Fentanyt Cttrate Inj Cii (fentanyl Citrate) Review and Fentanyt Cttrate Inj Cii (fentanyl Citrate) Label ), ROCURONIUM BROMIDE (View Rocuronium Bromide Review and Rocuronium Bromide Label ), (FAMOTIDINE) (View (famotidine) Review and (famotidine) Label ).

6884578-4 | Bradycardia, Electrocardiogram St Segment Depression
on Jul 15, 2010 Female patient from PHILIPPINES , 51 years of age, weighting 152.1 lb, was treated with Precedex (View Usage). Patient experienced the following unwanted or unexpected effects: bradycardia, electrocardiogram st segment depression. Precedex dosage: .2 Ug/kg Microgram(s) / Kilogram, (1 Hour). During the same period patient was treated with MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), NALBUPHINE HYDROCHLORIDE (View Nalbuphine Hydrochloride Review and Nalbuphine Hydrochloride Label ), HYDROXYZINE HYDROCHLORIDE (View Hydroxyzine Hydrochloride Review and Hydroxyzine Hydrochloride Label ), DESFLURANE (View Desflurane Review and Desflurane Label ), PROPOFOL (View Propofol Review and Propofol Label ), ROCURONIUM BROMIDE (View Rocuronium Bromide Review and Rocuronium Bromide Label ).


6874608-8 | Hypotension
on Jul 15, 2010 Male patient from PHILIPPINES , 64 years of age, weighting 18.30 lb, was diagnosed with endotracheal intubation, sedation and was treated with Precedex (View Usage). Patient had the following side effects: hypotension. Precedex dosage: See Image. During the same period patient was treated with FENTANYL CITRATE (View Fentanyl Citrate Review and Fentanyl Citrate Label ).

6863423-7 | Blister, Swelling
Patient was taking Precedex (View Usage). After Precedex was administered, patient had the following side effects: blister, swelling on Jul 08, 2010 from UNITED STATES Additional patient health information: Female patient , 46 years of age, weighting 218.3 lb, was diagnosed with alcohol withdrawal syndrome and. Precedex dosage: 0.8 Mcg/ Kg/ Hr, Intravenojs.

6843531-7 | Bradycardia, Electrocardiogram St Segment Depression
Adverse event was reported on Nov 20, 2008 by a Female patient taking Precedex (View Usage) (Dosage: .2 ?g/kg Microgram(s) /kilogram, Intravenous; .2 ?g/kg Microgram(s) /kilogram (1 Hour) Intravenous) . Location: PHILIPPINES , 51 years of age, weighting 152.1 lb, Patient experienced the following unwanted or unexpected effects: bradycardia, electrocardiogram st segment depression. During the same period patient was treated with MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), NALBUPHINE HYDROCHLORIDE (View Nalbuphine Hydrochloride Review and Nalbuphine Hydrochloride Label ), HYDROXYZINE HYDROCHLORIDE (View Hydroxyzine Hydrochloride Review and Hydroxyzine Hydrochloride Label ), DESFLURANE (View Desflurane Review and Desflurane Label ), PROPOFOL (View Propofol Review and Propofol Label ), (ROCURONIUM) (View (rocuronium) Review and (rocuronium) Label ).

6836774-X | Bradycardia, Haemothorax, Nephropathy, Presyncope, Pulse Absent
on Jun 29, 2010 Male patient from UNITED STATES , 47 years of age, weighting 186.5 lb, was diagnosed with coronary artery bypass (What is coronary artery bypass?) and was treated with Precedex (View Usage). Patient had the following side effects: bradycardia, haemothorax, nephropathy, presyncope, pulse absent. Precedex dosage: 400 Mcg/100 Ml, 0.2-0.7 Mcg/kg/hr, Intravenous. During the same period patient was treated with ASCORBIC ACID (View Ascorbic Acid Review and Ascorbic Acid Label ), MULTI VITAMINS (View Multi-vitamins Review and Multi-vitamins Label ), METFORMIN (View Metformin Review and Metformin Label ), LISINOPRIL AND HYDROCHLOROTHIAZIDE (View Lisinopril And Hydrochlorothiazide Review and Lisinopril And Hydrochlorothiazide Label ), CARVEDILOL (View Carvedilol Review and Carvedilol Label ), LANTUS (View Lantus Review and Lantus Label ), PRAVASTATIN (View Pravastatin Review and Pravastatin Label ).

6766831-8 | Atrioventricular Block Complete, Ventricular Failure
on May 31, 2010 Male patient from AUSTRALIA , 82 years of age, weighting 213.8 lb, was diagnosed with atrioventricular block complete and was treated with Precedex (View Usage). After Precedex was administered, patient had the following side effects: atrioventricular block complete, ventricular failure. Precedex dosage: 68 Ug Microgram(s), Intravenous; 19.4 Ug Microgram(s) (1 Hour). During the same period patient was treated with DIGOXIN (500 Ug Microgram(s), Intravenous) (View Digoxin Review and Digoxin Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), CHLORPROMAZINE HCL (View Chlorpromazine Hcl Review and Chlorpromazine Hcl Label ), (FRUSEMIDE /00032601/) (View (frusemide /00032601/) Review and (frusemide /00032601/) Label ), HEPARIN SODIUM (View Heparin Sodium Review and Heparin Sodium Label ), RAMIPRIL (View Ramipril Review and Ramipril Label ), RANITIDINE (View Ranitidine Review and Ranitidine Label ).

6678216-3 | Blood Creatine Phosphokinase Increased, Hyperthermia
Patient was taking Precedex (View Usage). Patient experienced the following unwanted or unexpected effects: blood creatine phosphokinase increased, hyperthermia on Apr 08, 2010 from UNITED STATES Additional patient health information: Female patient , weighting 612.9 lb, was diagnosed with sedation and. Precedex dosage: 1.5 Mcg/kg/min Continuous Infusion Iv Drip.

6654014-1 | Depressed Level Of Consciousness, Dyskinesia, Salivary Hypersecretion
Adverse event was reported on Mar 16, 2010 by a Female patient taking Precedex (View Usage) (Dosage: ) was diagnosed with mechanical ventilation, depression (What is depression?) and. Location: JAPAN , 28 years of age, Patient had the following side effects: depressed level of consciousness, dyskinesia, salivary hypersecretion. During the same period patient was treated with (ANTIPSYCHOTICS) (View (antipsychotics) Review and (antipsychotics) Label ), (PROPOFOL) (View (propofol) Review and (propofol) Label ), FENTANYL 100 (View Fentanyl-100 Review and Fentanyl-100 Label ).

6639701-3 | Depressed Level Of Consciousness, Eyelid Function Disorder, Hallucination, Auditory, Salivary Hypersecretion
on Mar 03, 2010 Female patient from JAPAN , 28 years of age, was diagnosed with mechanical ventilation and was treated with Precedex (View Usage). After Precedex was administered, patient had the following side effects: depressed level of consciousness, eyelid function disorder, hallucination, auditory, salivary hypersecretion. Precedex dosage: . During the same period patient was treated with PROPOFOL (View Propofol Review and Propofol Label ), FENTANYL 25 (View Fentanyl-25 Review and Fentanyl-25 Label ).

6590930-7 | Dyspnoea, Hypercapnia
on Nov 21, 2008 Male patient from UNITED STATES , 57 years of age, weighting 392.4 lb, was diagnosed with sedation and was treated with Precedex (View Usage). Patient experienced the following unwanted or unexpected effects: dyspnoea, hypercapnia. Precedex dosage: 1000mcg/250ml, Continuous, Intravenous. During the same period patient was treated with MORPHINE (View Morphine Review and Morphine Label ), ANTIBIOTIC (ANTIBIOTICS) (View Antibiotic (antibiotics) Review and Antibiotic (antibiotics) Label ), LACTATED RINGERS (FLEBOBAG RING LACT) (View Lactated Ringers (flebobag Ring Lact) Review and Lactated Ringers (flebobag Ring Lact) Label ).

6523849-8 | Asthma, Pco2 Increased, Unevaluable Event
Patient was taking Precedex (View Usage). Patient had the following side effects: asthma (What is asthma?), pco2 increased, unevaluable event on Dec 30, 2009 from JAPAN Additional patient health information: Female patient , 31 years of age, weighting 116.8 lb, was diagnosed with sedation and. Precedex dosage: 0.4mcg/kg/hr,continuous; .2 Ml ( 1 Day). During the same period patient was treated with (NAFAMOSTAT MESILATE) (View (nafamostat Mesilate) Review and (nafamostat Mesilate) Label ), ULINASTATIN (View Ulinastatin Review and Ulinastatin Label ), BUPRENORPHINE HYDROCHLORIDE (View Buprenorphine Hydrochloride Review and Buprenorphine Hydrochloride Label ), AMPICILLIN W/SULBACTAM (View Ampicillin W/sulbactam Review and Ampicillin W/sulbactam Label ).

6512859-2 | Bradycardia, Electromechanical Dissociation, Hypotension, Hypoxia
Adverse event was reported on Dec 09, 2009 by a Male patient taking Precedex (View Usage) (Dosage: See Image) was diagnosed with agitation and. Location: UNITED STATES , 74 years of age, weighting 163.1 lb, After Precedex was administered, patient had the following side effects: bradycardia, electromechanical dissociation, hypotension, hypoxia. During the same period patient was treated with ASPIRIN (View Aspirin Review and Aspirin Label ), METOPROLOL TARTRATE (View Metoprolol Tartrate Review and Metoprolol Tartrate Label ), (GLYCERYL TRINITRATE) (View (glyceryl Trinitrate) Review and (glyceryl Trinitrate) Label ), MOXIFLOXACIN HCL (View Moxifloxacin Hcl Review and Moxifloxacin Hcl Label ), ALBUTEROL (View Albuterol Review and Albuterol Label ), (IPRATROPIUM) (View (ipratropium) Review and (ipratropium) Label ), TERAZOSIN HCL (View Terazosin Hcl Review and Terazosin Hcl Label ).

6485761-2 |
on Nov 30, 2009 Male patient from UNITED STATES , 47 years of age, weighting 198.4 lb, was diagnosed with sedation and was treated with Precedex (View Usage). . Precedex dosage: 02. Titrated To 0.7, Intravenous. During the same period patient was treated with PROPOFOL (View Propofol Review and Propofol Label ), ATIVAN (View Ativan Review and Ativan Label ), FENTANYL (View Fentanyl Review and Fentanyl Label ).

6458765-3 | Asthma, Condition Aggravated
on Nov 11, 2009 Female patient from JAPAN , 31 years of age, weighting 116.8 lb, was diagnosed with sedation and was treated with Precedex (View Usage). Patient had the following side effects: asthma (What is asthma?), condition aggravated. Precedex dosage: 0.4mcg/kg/hr, Continuous, Intravenous; .2 Ml ( 1 Day ) Intravenous. During the same period patient was treated with BUPRENORPHINE HYDROCHLORIDE (View Buprenorphine Hydrochloride Review and Buprenorphine Hydrochloride Label ), (AMPICILLIN W/ SULBACTAM) (View (ampicillin W/ Sulbactam) Review and (ampicillin W/ Sulbactam) Label ), (NAFAMOSTAT MESILATE) (View (nafamostat Mesilate) Review and (nafamostat Mesilate) Label ), (ULINASTATIN) (View (ulinastatin) Review and (ulinastatin) Label ).

6439955-2 | Bradycardia, Obstructive Airways Disorder, Sedation
Patient was taking Precedex (View Usage). After Precedex was administered, patient had the following side effects: bradycardia, obstructive airways disorder, sedation on Nov 12, 2009 from JAPAN Additional patient health information: Female patient , 53 years of age, weighting 125.7 lb, . Precedex dosage: 2 Mcg/kg/hr, Intravenous .2 Mcg/kg/hr Intravenous. During the same period patient was treated with ANESTHETICS NOS (View Anesthetics Nos Review and Anesthetics Nos Label ), FAMOTIDINE (View Famotidine Review and Famotidine Label ), OXYGEN (View Oxygen Review and Oxygen Label ), BUPIVACAINE (View Bupivacaine Review and Bupivacaine Label ).

6425268-1 | Bradycardia, Choking, Heart Rate Decreased, Obstructive Airways Disorder, Sedation
Adverse event was reported on Oct 30, 2009 by a Female patient taking Precedex (View Usage) (Dosage: 2 Mcg/kg/hr ; .2 Mcg/kg/hr) . Location: JAPAN , 53 years of age, weighting 125.7 lb, Patient experienced the following unwanted or unexpected effects: bradycardia, choking (What is choking?), heart rate decreased, obstructive airways disorder, sedation. During the same period patient was treated with (ANESTHETICS NOS) (View (anesthetics Nos) Review and (anesthetics Nos) Label ), FAMOTIDINE (View Famotidine Review and Famotidine Label ), (OXYGEN) (View (oxygen) Review and (oxygen) Label ), BUPIVACAINE (View Bupivacaine Review and Bupivacaine Label ).

6407827-5 | Cerebral Infarction, Restlessness, Urine Output Decreased
on Oct 09, 2009 Male patient from JAPAN , child 9 years of age, was treated with Precedex (View Usage). Patient had the following side effects: cerebral infarction, restlessness, urine output decreased. Precedex dosage: 1.5 Mcg/kg/hr; .4 Mcg/kg/hr; 0.25-0.36 Mcg/kg/hr. During the same period patient was treated with PROPOFOL (View Propofol Review and Propofol Label ), (REMIFENTANIL) (View (remifentanil) Review and (remifentanil) Label ), FENTANYL 100 (View Fentanyl-100 Review and Fentanyl-100 Label ), (ROPIVACAINE) (View (ropivacaine) Review and (ropivacaine) Label ).

6407457-5 | Obstructive Airways Disorder
on Oct 05, 2009 Female patient from JAPAN , 53 years of age, was treated with Precedex (View Usage). After Precedex was administered, patient had the following side effects: obstructive airways disorder. Precedex dosage: 2 Mcg/kg/hr ; .2 Mcg/kg/hr. During the same period patient was treated with (ANESTHETICS NOS) (View (anesthetics Nos) Review and (anesthetics Nos) Label ).

6392230-7 | Cerebral Infarction, Monoplegia, Moyamoya Disease, Restlessness
Patient was taking Precedex (View Usage). Patient experienced the following unwanted or unexpected effects: cerebral infarction, monoplegia, moyamoya disease, restlessness on Sep 25, 2009 from JAPAN Additional patient health information: Male patient , child 9 years of age, . Precedex dosage: 1.5 Mcg/kg/hr, .4 Mcg/kg/hr, 0.25-0.36 Mcg/kg/hr. During the same period patient was treated with PROPOFOL (View Propofol Review and Propofol Label ), REMIFENTANIL (View Remifentanil Review and Remifentanil Label ), FENTANYL CITRATE (View Fentanyl Citrate Review and Fentanyl Citrate Label ), ROPIVACAINE HYDROCHLORIDE (View Ropivacaine Hydrochloride Review and Ropivacaine Hydrochloride Label ).

6356349-9 | Blood Pressure Abnormal
Adverse event was reported on Sep 11, 2009 by a Male patient taking Precedex (View Usage) (Dosage: 200 Mcg Continuous Iv) was diagnosed with sedation and. Location: UNITED STATES , 46 years of age, weighting 306.2 lb, Patient had the following side effects: blood pressure abnormal.

6342077-2 | Hypoalbuminaemia, Prothrombin Time Prolonged
on Aug 21, 2009 Male patient from JAPAN , 81 years of age, weighting 132.3 lb, was diagnosed with sedation and was treated with Precedex (View Usage). After Precedex was administered, patient had the following side effects: hypoalbuminaemia, prothrombin time prolonged. Precedex dosage: 0.2 Mcg/kg/hr, Intravenous. During the same period patient was treated with CARVEDILOL (View Carvedilol Review and Carvedilol Label ), CANDESARTAN CILEXETIL (View Candesartan Cilexetil Review and Candesartan Cilexetil Label ), TEMOCAPRIL HYDROCHLORIDE (View Temocapril Hydrochloride Review and Temocapril Hydrochloride Label ), NIFEDIPINE (View Nifedipine Review and Nifedipine Label ), IMIDAPRIL HYDROCHLORIDE (View Imidapril Hydrochloride Review and Imidapril Hydrochloride Label ), FUROSEMIDE (View Furosemide Review and Furosemide Label ), ALLOPURINOL (View Allopurinol Review and Allopurinol Label ), FENTANYL (View Fentanyl Review and Fentanyl Label ).

6331916-7 | Off Label Use, Upper Airway Obstruction
on Aug 18, 2009 Female patient from UNITED STATES , child 7 years of age, was treated with Precedex (View Usage). Patient experienced the following unwanted or unexpected effects: off label use, upper airway obstruction. Precedex dosage: .5 Mcg/kg. During the same period patient was treated with MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), PENTOBARBITAL SODIUM (View Pentobarbital Sodium Review and Pentobarbital Sodium Label ).

6295768-6 | Condition Aggravated, Idiopathic Pulmonary Fibrosis, Platelet Count Decreased, Vomiting, White Blood Cell Count Decreased
Patient was taking Precedex (View Usage). Patient had the following side effects: condition aggravated, idiopathic pulmonary fibrosis, platelet count decreased, vomiting, white blood cell count decreased on Jul 20, 2009 from UNITED STATES Additional patient health information: Male patient , 65 years of age, was diagnosed with idiopathic pulmonary fibrosis and. Precedex dosage: . During the same period patient was treated with CIPROXAN /00697202/) (View Ciproxan /00697202/) Review and Ciproxan /00697202/) Label ), TIENAM (View Tienam Review and Tienam Label ), ELASPOL /01588701/) (View Elaspol /01588701/) Review and Elaspol /01588701/) Label ), FRAGMIN (View Fragmin Review and Fragmin Label ), NEORAL (View Neoral Review and Neoral Label ). Patient was hospitalized.

6277879-4 | Depressed Level Of Consciousness, Respiratory Arrest
Adverse event was reported on Jul 09, 2009 by a Female patient taking Precedex (View Usage) (Dosage: 0.4 Mcg/hr, Continuous, Intravenous) was diagnosed with postoperative care, analgesia and. Location: JAPAN , 52 years of age, weighting 134.5 lb, After Precedex was administered, patient had the following side effects: depressed level of consciousness, respiratory arrest. During the same period patient was treated with (MORPHINE HYDROCHLORIDE) (40 Mcg/kg, Epidural) (View (morphine Hydrochloride) Review and (morphine Hydrochloride) Label ). Patient was hospitalized.

6249998-X | Cardiac Procedure Complication, Cardiac Tamponade
on Jun 22, 2009 Male patient from JAPAN , 46 years of age, weighting 143.3 lb, was diagnosed with sedation and was treated with Precedex (View Usage). Patient experienced the following unwanted or unexpected effects: cardiac procedure complication, cardiac tamponade. Precedex dosage: . During the same period patient was treated with CEFOPERZONE SODIUM/ SULBACTAM SODIUM (View Cefoperzone Sodium/ Sulbactam Sodium Review and Cefoperzone Sodium/ Sulbactam Sodium Label ), PROPOFOL (View Propofol Review and Propofol Label ), MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ).

6164451-X | Bronchospasm, Off Label Use, Rash, Urticaria
on Apr 14, 2009 Male patient from UNITED STATES , weighting 5.38 lb, was treated with Precedex (View Usage). Patient had the following side effects: bronchospasm, off label use, rash (What is rash?), urticaria. Precedex dosage: .2 Mcg/kg/hr, Continuous, Intravenous, .3 Mcg/kg/hr (continuious), Intravenous. During the same period patient was treated with SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ).

6154075-2 | Bronchospasm, Rash, Urticaria
Patient was taking Precedex (View Usage). After Precedex was administered, patient had the following side effects: bronchospasm, rash (What is rash?), urticaria on Mar 31, 2009 from UNITED STATES Additional patient health information: Male patient , weighting 5.38 lb, was diagnosed with sedation and. Precedex dosage: .2 Mcg/kg/hr, Continuous, Intravenous, .3 Mcg/kg/hr ( Continuous ). During the same period patient was treated with SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ).

6147139-0 | Blood Pressure Increased, Heart Rate Increased, Pruritus, Rash, Urticaria
Adverse event was reported on Mar 31, 2009 by a Male patient taking Precedex (View Usage) (Dosage: 200 Mcg, Intravenous Drip) . Location: UNITED STATES , 22 years of age, weighting 176.8 lb, Patient experienced the following unwanted or unexpected effects: blood pressure increased, heart rate increased, pruritus, rash (What is rash?), urticaria. During the same period patient was treated with FENTANYL (View Fentanyl Review and Fentanyl Label ), PROPOFOL (View Propofol Review and Propofol Label ), SODIUM CHLORIDE (View Sodium Chloride Review and Sodium Chloride Label ).

6125104-7 | Bradycardia, Hypertension, Hypoglycaemia, Off Label Use, Overdose
on Mar 09, 2009 Female patient from UNITED STATES , weighting 23.59 lb, was treated with Precedex (View Usage). Patient had the following side effects: bradycardia, hypertension, hypoglycaemia, off label use, overdose. Precedex dosage: 1 Mcg/kg/min, Intravenous Drip. During the same period patient was treated with MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), PROPOFOL (View Propofol Review and Propofol Label ), FENTANYL 25 (View Fentanyl-25 Review and Fentanyl-25 Label ).

6085435-6 | Blood Pressure Increased, Tachycardia
on May 17, 2008 Male patient from UNITED STATES , weighting 183.0 lb, was diagnosed with sedation and was treated with Precedex (View Usage). After Precedex was administered, patient had the following side effects: blood pressure increased, tachycardia. Precedex dosage: Over 10 Minutes Intravenous; 600mg, Continuous, Intravenous. During the same period patient was treated with VERSED (MIDAZOLAM HYDROCHLOTIDE) (View Versed (midazolam Hydrochlotide) Review and Versed (midazolam Hydrochlotide) Label ), FENTANYL 100 (View Fentanyl-100 Review and Fentanyl-100 Label ).

6056478-3 | Aspiration, Hypertension, Injury, Lip Swelling, Swollen Tongue
Patient was taking Precedex (View Usage). Patient experienced the following unwanted or unexpected effects: aspiration, hypertension, injury, lip swelling, swollen tongue on Jan 26, 2009 from UNITED STATES Additional patient health information: Male patient , 51 years of age, weighting 132.7 lb, was diagnosed with alcohol withdrawal syndrome and. Precedex dosage: Iv Infusion. Patient was hospitalized.

6036493-6 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Albumin Decreased, Prothrombin Time Prolonged
Adverse event was reported on Dec 08, 2008 by a Male patient taking Precedex (View Usage) (Dosage: .3 Mcg/kg/hr, Intravenous) was diagnosed with sedation and. Location: JAPAN , 71 years of age, weighting 165.3 lb, Patient had the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood albumin decreased, prothrombin time prolonged. During the same period patient was treated with PROPOFOL (View Propofol Review and Propofol Label ), FENTANYL 100 (View Fentanyl-100 Review and Fentanyl-100 Label ), VECURONIUM BROMIDE (View Vecuronium Bromide Review and Vecuronium Bromide Label ), SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ), (EPHEDRINE HYDROCHLORIDE) (View (ephedrine Hydrochloride) Review and (ephedrine Hydrochloride) Label ), DOPAMINE HYDROCHLORIDE (View Dopamine Hydrochloride Review and Dopamine Hydrochloride Label ), (FLURBIPROFEN AXETIL) (View (flurbiprofen Axetil) Review and (flurbiprofen Axetil) Label ), (NAFAMOSTAT MESILATE) (View (nafamostat Mesilate) Review and (nafamostat Mesilate) Label ).

6027912-X | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Albumin Decreased, Condition Aggravated, Prothrombin Time Prolonged
on Dec 08, 2008 Male patient from JAPAN , 71 years of age, weighting 165.3 lb, was diagnosed with sedation and was treated with Precedex (View Usage). After Precedex was administered, patient had the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood albumin decreased, condition aggravated, prothrombin time prolonged. Precedex dosage: 0.3 Mcg/kg/hr, Iv. During the same period patient was treated with PROPOFOL (View Propofol Review and Propofol Label ), FENTANYL (View Fentanyl Review and Fentanyl Label ), VECURONIUM BROMIDE (View Vecuronium Bromide Review and Vecuronium Bromide Label ), SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ), EPHEDRINE HYDROCHLORIDE (View Ephedrine Hydrochloride Review and Ephedrine Hydrochloride Label ), DOPAMINE HYDROCHLORIDE (View Dopamine Hydrochloride Review and Dopamine Hydrochloride Label ), FLURBIPROFEN AXETIL (View Flurbiprofen Axetil Review and Flurbiprofen Axetil Label ), NAFAMOSTAT MESILATE (View Nafamostat Mesilate Review and Nafamostat Mesilate Label ).

6010909-3 | Anaemia, Blood Pressure Decreased, Haemorrhage, Oliguria
on Dec 03, 2008 Female patient from UNITED STATES , 27 years of age, weighting 273.4 lb, was diagnosed with sedation and was treated with Precedex (View Usage). Patient experienced the following unwanted or unexpected effects: anaemia, blood pressure decreased, haemorrhage, oliguria. Precedex dosage: 1000mcg In 250cc Ns, Continuous, Intravenous. During the same period patient was treated with MORPHINE (View Morphine Review and Morphine Label ), NARCAN (View Narcan Review and Narcan Label ), SODIUM CHLORIDE (View Sodium Chloride Review and Sodium Chloride Label ). Patient was hospitalized.

5975233-3 | Blood Albumin Decreased, Hypotension, Post Procedural Complication, Prothrombin Time Prolonged
Patient was taking Precedex (View Usage). Patient had the following side effects: blood albumin decreased, hypotension, post procedural complication, prothrombin time prolonged on Nov 18, 2008 from JAPAN Additional patient health information: Female patient , 63 years of age, weighting 81.57 lb, was diagnosed with sedation and. Precedex dosage: 0.4mg/kg/hr, Continuous, Intravenous. During the same period patient was treated with PROPOFOL (View Propofol Review and Propofol Label ), VECURONIUM BROMIDE (View Vecuronium Bromide Review and Vecuronium Bromide Label ), EPHEDRINE HYDROCHLORIDE (EPHEDRINE) (View Ephedrine Hydrochloride (ephedrine) Review and Ephedrine Hydrochloride (ephedrine) Label ), FENTANYL CITRATE (View Fentanyl Citrate Review and Fentanyl Citrate Label ), ROPIVACAINE HYDROCHLORIDE HYDRATE (ROPIVACAINE HYDROCHLORIDE) (View Ropivacaine Hydrochloride Hydrate (ropivacaine Hydrochloride) Review and Ropivacaine Hydrochloride Hydrate (ropivacaine Hydrochloride) Label ), PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) (View Phenylephrine Hydrochloride (phenylephrine) Review and Phenylephrine Hydrochloride (phenylephrine) Label ), NAFAMOSTAT MESILATE (NAFAMOSTAT MESILATE) (View Nafamostat Mesilate (nafamostat Mesilate) Review and Nafamostat Mesilate (nafamostat Mesilate) Label ), SIVLESTAT SODIUM HYDRATE (SIVLESTAT) (View Sivlestat Sodium Hydrate (sivlestat) Review and Sivlestat Sodium Hydrate (sivlestat) Label ).

5972014-1 | Confusional State, Delirium, Pupils Unequal, Staring
Adverse event was reported on Nov 13, 2008 by a Male patient taking Precedex (View Usage) (Dosage: 0.7mcg/kg/hr, Continuous, Intravenous) was diagnosed with sedation and. Location: UNITED STATES , child 2 years of age, After Precedex was administered, patient had the following side effects: confusional state, delirium, pupils unequal, staring. During the same period patient was treated with FENTANYL (EENTANYL) (View Fentanyl (eentanyl) Review and Fentanyl (eentanyl) Label ), MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), METHADONE HCL (View Methadone Hcl Review and Methadone Hcl Label ), DIAZEPAM (View Diazepam Review and Diazepam Label ). Patient was hospitalized.

5968102-6 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Albumin Decreased, Prothrombin Time Prolonged
on Nov 11, 2008 Male patient from JAPAN , 85 years of age, weighting 119.0 lb, was diagnosed with sedation and was treated with Precedex (View Usage). Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood albumin decreased, prothrombin time prolonged. Precedex dosage: 0.3 Mcg/kg/hr, Continuous, Intravenous. During the same period patient was treated with PROPOFOL (View Propofol Review and Propofol Label ), FENTANYL CITRATE (View Fentanyl Citrate Review and Fentanyl Citrate Label ), VECURONIUM BROMIDE (View Vecuronium Bromide Review and Vecuronium Bromide Label ), SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ), EPHEDRINE HCL 1PC SOL (View Ephedrine Hcl 1pc Sol Review and Ephedrine Hcl 1pc Sol Label ), DOPAMINE HCL (View Dopamine Hcl Review and Dopamine Hcl Label ), FLURBIPROFEN AXETIL (FLURBIPROFEN AXETIL) (View Flurbiprofen Axetil (flurbiprofen Axetil) Review and Flurbiprofen Axetil (flurbiprofen Axetil) Label ), ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE HYDROCHLORIDE) (View Ropivacaine Hydrochloride (ropivacaine Hydrochloride) Review and Ropivacaine Hydrochloride (ropivacaine Hydrochloride) Label ).

5968095-1 | Aspartate Aminotransferase Increased, Blood Albumin Decreased, Condition Aggravated, Prothrombin Time Prolonged
on Nov 11, 2008 Male patient from JAPAN , 73 years of age, weighting 154.3 lb, was diagnosed with sedation and was treated with Precedex (View Usage). Patient had the following side effects: aspartate aminotransferase increased, blood albumin decreased, condition aggravated, prothrombin time prolonged. Precedex dosage: 0.3 Mcg/kg/hr, Continuous, Intravenous. During the same period patient was treated with ASPIRIN (View Aspirin Review and Aspirin Label ), CANDESARTAN CILEXETIL (View Candesartan Cilexetil Review and Candesartan Cilexetil Label ), NICORANDIL (NICORANDIL) (View Nicorandil (nicorandil) Review and Nicorandil (nicorandil) Label ), FAMOTIDINE (View Famotidine Review and Famotidine Label ), MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), FENTANYL CITRATE (View Fentanyl Citrate Review and Fentanyl Citrate Label ), REMIFENTANIL HYDROCHLORIDE (REMIFENTANIL HYDROCHLORIDE) (View Remifentanil Hydrochloride (remifentanil Hydrochloride) Review and Remifentanil Hydrochloride (remifentanil Hydrochloride) Label ), VECURONIUM BROMIDE (View Vecuronium Bromide Review and Vecuronium Bromide Label ).

5959360-2 | Blood Albumin Decreased, Blood Bilirubin Increased, Condition Aggravated
Patient was taking Precedex (View Usage). After Precedex was administered, patient had the following side effects: blood albumin decreased, blood bilirubin increased, condition aggravated on Nov 10, 2008 from JAPAN Additional patient health information: Male patient , 79 years of age, weighting 121.3 lb, was diagnosed with sedation and. Precedex dosage: 0.4 Mcg/kg/hr, Intravenous. During the same period patient was treated with ASPIRIN (View Aspirin Review and Aspirin Label ), CILASTAZOL (CILOSTAZOL) (View Cilastazol (cilostazol) Review and Cilastazol (cilostazol) Label ), AMLODIPINE BESYLATE (View Amlodipine Besylate Review and Amlodipine Besylate Label ), GLIMEPIRIDE (View Glimepiride Review and Glimepiride Label ), PROPOFOL (View Propofol Review and Propofol Label ), FENTANYL CITRATE (View Fentanyl Citrate Review and Fentanyl Citrate Label ), VECURONIUM BROMIDE (View Vecuronium Bromide Review and Vecuronium Bromide Label ), PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE) (View Phenylephrine Hydrochloride (phenylephrine Hydrochloride) Review and Phenylephrine Hydrochloride (phenylephrine Hydrochloride) Label ).

5957665-2 | Blood Albumin Decreased, Post Procedural Complication, Prothrombin Time Prolonged
Adverse event was reported on Nov 05, 2008 by a Male patient taking Precedex (View Usage) (Dosage: 0.4 Mcg/kg/hr, Not Reported, Intravenous) was diagnosed with sedation and. Location: JAPAN , 60 years of age, weighting 119.0 lb, Patient experienced the following unwanted or unexpected effects: blood albumin decreased, post procedural complication, prothrombin time prolonged. During the same period patient was treated with PROPOFOL (View Propofol Review and Propofol Label ), VECURONIUM BROMIDE (View Vecuronium Bromide Review and Vecuronium Bromide Label ), FENTANYL 100 (View Fentanyl-100 Review and Fentanyl-100 Label ), ROPIVACAINE HYDROCHLORIDE HYDATE(ROPIVACAINE HYDROCHLORIDE) (View Ropivacaine Hydrochloride Hydate(ropivacaine Hydrochloride) Review and Ropivacaine Hydrochloride Hydate(ropivacaine Hydrochloride) Label ), MORPHINE (View Morphine Review and Morphine Label ), LANSOPRAZOLE (View Lansoprazole Review and Lansoprazole Label ), CEFAZOLIN SODIUM (View Cefazolin Sodium Review and Cefazolin Sodium Label ), SIVELESTAT SODIUM HYDRATE (SIVELESTAT) (View Sivelestat Sodium Hydrate (sivelestat) Review and Sivelestat Sodium Hydrate (sivelestat) Label ).

5914932-6 | Angioedema
on Oct 01, 2008 Male patient from UNITED STATES , 45 years of age, was treated with Precedex (View Usage). Patient had the following side effects: angioedema. Precedex dosage: Intravenous. During the same period patient was treated with ATIVAN (View Ativan Review and Ativan Label ), HALDOL SOLUTAB (View Haldol Solutab Review and Haldol Solutab Label ).

5913212-2 | Post Procedural Complication, Pulmonary Oedema
on Sep 24, 2008 Female patient from UNITED STATES , child 2 years of age, weighting 37.48 lb, was diagnosed with perioperative analgesia and was treated with Precedex (View Usage). After Precedex was administered, patient had the following side effects: post procedural complication, pulmonary oedema. Precedex dosage: 2mcg/kg, Bolus, Intravenous ; 0.07mcg/kg/hr, Continuous, Intravenous. During the same period patient was treated with SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ), ROCURONIUM BROMIDE (View Rocuronium Bromide Review and Rocuronium Bromide Label ), DECADRON (View Decadron Review and Decadron Label ), ONDANSETRON HCL (View Ondansetron Hcl Review and Ondansetron Hcl Label ), NEOSTIGMINE (NEOSTIGMINE) (View Neostigmine (neostigmine) Review and Neostigmine (neostigmine) Label ), GLYCOPYRROLATE (View Glycopyrrolate Review and Glycopyrrolate Label ).

5778480-9 | Agitation, Anoxic Encephalopathy, Bradycardia, Cardiac Tamponade, Cardiogenic Shock, Hypotension, Hypoxic Encephalopathy, Myocardial Ischaemia, Pericardial Effusion
Patient was taking Precedex (View Usage). Patient experienced the following unwanted or unexpected effects: agitation, anoxic encephalopathy, bradycardia, cardiac tamponade, cardiogenic shock, hypotension, hypoxic encephalopathy, myocardial ischaemia, pericardial effusion on Jun 10, 2008 from UNITED STATES Additional patient health information: Male patient , 50 years of age, weighting 196.2 lb, . Precedex dosage: 200 Mcg, Intravenous; Continuous, Intravenous. During the same period patient was treated with FENTANYL (View Fentanyl Review and Fentanyl Label ), MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), HEPARIN (View Heparin Review and Heparin Label ), EPINEPHRINE (View Epinephrine Review and Epinephrine Label ), ATROPINE (View Atropine Review and Atropine Label ), DOPAMINE HCL (View Dopamine Hcl Review and Dopamine Hcl Label ), PROTAMINE SULFATE (View Protamine Sulfate Review and Protamine Sulfate Label ).

5775232-0 | Mental Status Changes, Speech Disorder
Adverse event was reported on Jun 16, 2008 by a Female patient taking Precedex (View Usage) (Dosage: Continuous Infusion Continuous Iv) was diagnosed with weaning failure and. Location: UNITED STATES , weighting 57.32 lb, Patient had the following side effects: mental status changes, speech disorder.

5772942-6 | Agitation, Bradycardia, Brain Herniation, Cardiac Failure, Cardiac Perforation, Cardiac Tamponade, Cardiogenic Shock, Cardiomegaly
on May 31, 2008 Male patient from UNITED STATES , 50 years of age, weighting 196.2 lb, was treated with Precedex (View Usage). After Precedex was administered, patient had the following side effects: agitation, bradycardia, brain herniation, cardiac failure, cardiac perforation, cardiac tamponade, cardiogenic shock, cardiomegaly. Precedex dosage: 200 Mcg, Intravenous. During the same period patient was treated with FENTANYL (View Fentanyl Review and Fentanyl Label ), MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), HEPARIN (View Heparin Review and Heparin Label ), EPINEPHRINE (EPINPHRINE) (View Epinephrine (epinphrine) Review and Epinephrine (epinphrine) Label ), ATROPINE (View Atropine Review and Atropine Label ), DOPAMINE HCL (View Dopamine Hcl Review and Dopamine Hcl Label ), PROTAMINE SULFATE (View Protamine Sulfate Review and Protamine Sulfate Label ).

5705439-X | Cardiac Failure, Central Venous Pressure Increased, Tachycardia
on Mar 31, 2008 Male patient from JAPAN , child 2 years of age, was diagnosed with sedation and was treated with Precedex (View Usage). Patient experienced the following unwanted or unexpected effects: cardiac failure, central venous pressure increased, tachycardia. Precedex dosage: 0.36-0.72mcg/kg/hr Iv. During the same period patient was treated with DIAZEPAM (View Diazepam Review and Diazepam Label ), ATROPINE SULFATE (View Atropine Sulfate Review and Atropine Sulfate Label ), MIOBLOCK (PANCURONIUM BROMIDE) (View Mioblock (pancuronium Bromide) Review and Mioblock (pancuronium Bromide) Label ), FENTANYL CITRATE (View Fentanyl Citrate Review and Fentanyl Citrate Label ), DORMICUM (MIDAZOLAM) (View Dormicum (midazolam) Review and Dormicum (midazolam) Label ), SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ), DOBUTREX (View Dobutrex Review and Dobutrex Label ), MILRINONE (MILRINONE) (View Milrinone (milrinone) Review and Milrinone (milrinone) Label ).

5705328-0 | Central Venous Pressure Increased, Tachycardia
Patient was taking Precedex (View Usage). Patient had the following side effects: central venous pressure increased, tachycardia on Mar 31, 2008 from JAPAN Additional patient health information: Male patient , child 2. years of age, weighting 26.46 lb, . Precedex dosage: 0.36-0.72 Mcg/kg/hr, Intravenous. During the same period patient was treated with DIAZEPAM (View Diazepam Review and Diazepam Label ), ATROPINE SULFATE (View Atropine Sulfate Review and Atropine Sulfate Label ), MIOBLOCK (PANCURONIUM BROMIDE) (View Mioblock (pancuronium Bromide) Review and Mioblock (pancuronium Bromide) Label ), FENTANYL (View Fentanyl Review and Fentanyl Label ), DORMICUM (MIDAZOLAM) (View Dormicum (midazolam) Review and Dormicum (midazolam) Label ), SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ), DOBUTREX (View Dobutrex Review and Dobutrex Label ), MILRINONE (MILRINONE) (View Milrinone (milrinone) Review and Milrinone (milrinone) Label ).