Index of reports
> Life Threatening Events (8)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Precedex (Dexmedetomidine) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Precedex side effects in 5 month old female
Reported by a physician from Japan on 2012-05-31
Patient: 5 month old female
Reactions: Hepatitis Fulminant
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Aspirin
Dosage: daily dose 20 mg
Administration route: Oral
Indication: Thrombosis Prophylaxis
Start date: 2011-12-06
End date: 2011-12-07
Dopamine HCL
Dosage: unk
Indication: Cardiac Failure
Start date: 2011-12-05
End date: 2011-12-07
Precedex
Dosage: unk
Indication: Sedation
Start date: 2011-12-05
Aldactone
Dosage: daily dose 15 mg
Administration route: Oral
Indication: Cardiac Failure
Start date: 2011-12-06
Midazolam HCL
Dosage: unk
Indication: Sedation
Start date: 2011-12-05
Lasix
Administration route: Oral
Indication: Cardiac Failure
Start date: 2011-12-06
Herbal Preparation
Dosage: unk
Administration route: Oral
Heparin
Dosage: unk
Indication: Thrombosis Prophylaxis
Start date: 2011-12-05
Acetaminophen
Dosage: unk
Administration route: Oral
Possible Precedex side effects in 44 year old female
Reported by a physician from Canada on 2012-05-03
Patient: 44 year old female, weighing 121.0 kg (266.2 pounds)
Reactions: Procedural Complication, Bradycardia, Cardiac Arrest
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Precedex
Other drugs received by patient: Remifentanil; Nexium; Fentanyl Citrate
Possible Precedex side effects in 44 year old female
Reported by a physician from Canada on 2012-04-26
Patient: 44 year old female, weighing 121.0 kg (266.2 pounds)
Reactions: Procedural Complication, Bradycardia, Cardiac Arrest
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Precedex
Other drugs received by patient: Nexium; Fentanyl Citrate; (Remifentanil)
Possible Precedex side effects in 34 year old male
Reported by a physician from Canada on 2012-04-26
Patient: 34 year old male, weighing 181.0 kg (398.2 pounds)
Reactions: Procedural Complication, Blood Pressure Decreased, Cardiac Arrest
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Precedex
Other drugs received by patient: Celebrex; (Remifentanil); Fentanyl Citrate
Possible Precedex side effects in 49 year old female
Reported by a physician from Canada on 2012-04-24
Patient: 49 year old female, weighing 152.0 kg (334.4 pounds)
Reactions: Cardiac Arrest
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Precedex
Other drugs received by patient: Propofol; Morphine; (Remifentanil); Rocuronium Bromide; Quelicin; Versed; Decadron
Possible Precedex side effects in 34 year old male
Reported by a physician from Canada on 2012-04-24
Patient: 34 year old male, weighing 181.0 kg (398.2 pounds)
Reactions: Procedural Complication, Blood Pressure Decreased, Cardiac Arrest
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Precedex
Other drugs received by patient: (Remifentanil); (Fentanyl); Celebrex
Possible Precedex side effects in 5 month old female
Reported by a physician from Japan on 2012-04-18
Patient: 5 month old female
Reactions: Hepatitis Fulminant
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Dopamine HCL
Dosage: unk
Aldactone
Dosage: unk
Administration route: Oral
Midazolam HCL
Dosage: unk
Acetaminophen
Dosage: unk
Administration route: Oral
Herbal Preparation
Dosage: unk
Administration route: Oral
Unfractionated Heparin
Aspirin
Dosage: unk
Administration route: Oral
Indication: Thrombosis Prophylaxis
Start date: 2011-12-06
End date: 2011-12-07
Lasix
Administration route: Oral
Precedex
Dosage: unk
Possible Precedex side effects in 57 year old male
Reported by a pharmacist from United States on 2012-03-15
Patient: 57 year old male, weighing 143.0 kg (314.6 pounds)
Reactions: Agitation, Hypoxic-Ischaemic Encephalopathy, Pulse Absent, Bradycardia, Cardiac Arrest, Pulseless Electrical Activity
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Precedex
Other drugs received by patient: Albutetol / Ipratropium MDI; Clonidine; Famotidine; Amiodarone Hydrochloride; Valproic Acid; Diltiazem HCL; Dexmedetomodine Hydrochloride; Furosemide; Heparin
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