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Precedex (Dexmedetomidine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Precedex (Dexmedetomidine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (21)
Death (1)
Life Threatening Events (8)

Reports by Reaction Type

Cardiac Arrest (6)Bradycardia (5)Procedural Complication (4)Agitation (3)Hyperthermia (3)Musculoskeletal Stiffness (3)Blood Creatine Phosphokinase Increased (2)Acidosis (2)Hepatitis Fulminant (2)Glossoptosis (2)Peripheral Circulatory Failure (2)Blood Pressure Decreased (2)

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 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 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 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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