Index of reports
> All Cases (21)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Precedex (Dexmedetomidine) all cases. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Precedex side effects in 63 year old female
Reported by a pharmacist from United States on 2012-07-27
Patient: 63 year old female, weighing 96.0 kg (211.2 pounds)
Reactions: Bradycardia
Drug(s) suspected as cause:
Precedex
Possible Precedex side effects in male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-26
Patient: male, weighing 3.0 kg (6.6 pounds)
Reactions: Dyskinesia, Epilepsy
Drug(s) suspected as cause:
Precedex
Other drugs received by patient: Midazolam
Possible Precedex side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-13
Patient: female
Reactions: Confusional State, Agitation, Respiratory Rate Increased, Anaemia, Mental Status Changes, Bradycardia, Oxygen Saturation Decreased
Adverse event resulted in: death
Drug(s) suspected as cause:
Precedex
Other drugs received by patient: Versed; Fentanyl Citrate; (Oxygen)
Possible Precedex side effects in 83 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-13
Patient: 83 year old male, weighing 54.0 kg (118.8 pounds)
Reactions: Glossoptosis
Drug(s) suspected as cause:
Precedex
Dosage: 1 mcg/kg, intravenous drip, 0.2-0.4 mcg/kg/h, intravenous drip
Indication: Sedation
Start date: 2009-07-14
End date: 2009-07-14
Precedex
Dosage: 1 mcg/kg, intravenous drip, 0.2-0.4 mcg/kg/h, intravenous drip
Indication: Sedation
Start date: 2009-07-14
End date: 2009-07-14
Other drugs received by patient: (Oxygen); (Lidocaine Hydrochloride / Epinephrine)
Possible Precedex side effects in 82 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-26
Patient: 82 year old male
Reactions: Atelectasis, Respiratory Arrest
Drug(s) suspected as cause:
Precedex
Dosage: see image
Indication: Sedation
Start date: 2012-05-03
End date: 2012-05-04
Precedex
Dosage: see image
Indication: Sedation
Start date: 2012-05-05
End date: 2012-05-06
Precedex
Dosage: see image
Indication: Sedation
Start date: 2012-04-30
End date: 2012-04-30
Precedex
Dosage: see image
Indication: Sedation
Start date: 2012-05-01
End date: 2012-05-01
Precedex
Dosage: see image
Indication: Sedation
Start date: 2012-05-02
End date: 2012-05-02
Ramelteon
Dosage: 8 mg (8 mg,1 in 1 d) gastrostomy tube
Indication: Passive Smoking
Start date: 2012-04-30
End date: 2012-05-02
Other drugs received by patient: Olmesartan Medoxomil; Propofol; Teicoplanin; Erythrocin (Erythromycin Lactobionate); Pazufloxacin
Possible Precedex side effects in 83 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-25
Patient: 83 year old male, weighing 54.0 kg (118.8 pounds)
Reactions: Glossoptosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Precedex
Other drugs received by patient: Lidocaine Hydrochloride / Epinephrine); Oxygen
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 2 year old male
Reported by a pharmacist from United States on 2012-04-27
Patient: 2 year old male, weighing 12.0 kg (26.4 pounds)
Reactions: Agitation, Off Label Use, Communication Disorder, Staring, Drug Withdrawal Syndrome
Drug(s) suspected as cause:
Precedex
Other drugs received by patient: Fentanyl Citrate; Vecuronium Bromide; Methadone HCL; Diazepam; Midazolam
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 male
Reported by a pharmacist from United States on 2012-04-11
Patient: male, weighing 56.7 kg (124.7 pounds)
Reactions: Wrong Drug Administered, Product Outer Packaging Issue, Drug Dispensing Error
Drug(s) suspected as cause:
Precedex
Other drugs received by patient: Ddavp
Possible Precedex side effects in male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-03-20
Patient: male, weighing 48.0 kg (105.6 pounds)
Reactions: Blood Creatine Phosphokinase Increased, Hyperthermia, Peripheral Circulatory Failure, Musculoskeletal Stiffness, Acidosis
Drug(s) suspected as cause:
Sevoflurane
Dosage: 1-3% x 1
Indication: General Anaesthesia
Start date: 2012-01-16
End date: 2012-01-16
Precedex
Dosage: infusion
Indication: Sedation
Start date: 2012-01-16
End date: 2012-01-17
Other drugs received by patient: Dopamine HCL; Diazepam; Dobutamine HCL; Fentanyl; Rocuronium Bromide
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
Possible Precedex side effects in
Reported by a pharmacist from United States on 2012-03-07
Patient:
Reactions: Cough
Drug(s) suspected as cause:
Precedex
Possible Precedex side effects in 23 year old male
Reported by a pharmacist from United States on 2012-03-02
Patient: 23 year old male, weighing 131.0 kg (288.2 pounds)
Reactions: Bradyarrhythmia
Drug(s) suspected as cause:
Precedex
Possible Precedex side effects in male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-02-29
Patient: male, weighing 48.0 kg (105.6 pounds)
Reactions: Blood Creatine Phosphokinase Increased, Hyperthermia, Peripheral Circulatory Failure, Musculoskeletal Stiffness, Acidosis
Drug(s) suspected as cause:
Precedex
Dosage: 0.3-0.4 microg/kg/hr x 1, drip infusion
Indication: Sedation
Start date: 2012-01-16
End date: 2012-01-17
Sevoflurane
Dosage: 1-3% x 1
Indication: General Anaesthesia
Start date: 2012-01-16
End date: 2012-01-16
Other drugs received by patient: Dobutamine HCL; Diazepam; Fentanyl; Dopamine HCL; Rocuronium Bromide
Possible Precedex side effects in male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-02-20
Patient: male, weighing 48.0 kg (105.6 pounds)
Reactions: Hyperthermia, Musculoskeletal Stiffness
Drug(s) suspected as cause:
Sevoflurane
Dosage: 1-3% x 1
Indication: General Anaesthesia
Start date: 2012-01-16
End date: 2012-01-16
Precedex
Dosage: 0.3-0.4 microg/kg/hr x 1, drip infusion
Indication: Sedation
Start date: 2012-01-16
End date: 2012-01-17
Other drugs received by patient: Dobutamine Hydrochloride; Dopamine HCL; Fentanyl
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