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Precedex Side Effects

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Common Precedex Side Effects


The most commonly reported Precedex side effects (click to view or check a box to report):

Bradycardia (21)
Cardiac Arrest (18)
Prothrombin Time Prolonged (11)
Hypotension (11)
Blood Albumin Decreased (10)
Aspartate Aminotransferase Increased (10)
Procedural Complication (9)
Blood Pressure Decreased (8)
Alanine Aminotransferase Increased (8)
Post Procedural Complication (7)
Blood Pressure Increased (7)
Cardiac Tamponade (7)
Condition Aggravated (6)
Heart Rate Increased (6)
Salivary Hypersecretion (6)
Oxygen Saturation Decreased (5)
Obstructive Airways Disorder (5)
Central Venous Pressure Increased (5)
Glossoptosis (5)
Hypertension (5)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Precedex Side Effects Reported to FDA



Precedex Side Effect Report#9722998
Pneumonia, Pyrexia
This is a report of a 32-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Precedex (dosage: NA, start time:
Nov 23, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pneumonia, Pyrexia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Precedex treatment in female patients, resulting in Pneumonia side effect.
Precedex Side Effect Report#9547725
Extravasation, Purulence
This report suggests a potential Precedex Extravasation side effect(s) that can have serious consequences. A 20-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Precedex (dosage: 1 Mcg/kg/hr) starting NS. After starting Precedex the patient began experiencing various side effects, including: Extravasation, PurulenceAdditional drugs used concurrently:
  • Potassium Chl In 5% Dex + 0.9% Sod. Chl Inj., Usp., In Pvc Fc (dextrose And Potassium Chloride And S
Although Precedex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Extravasation, may still occur.
Precedex Side Effect Report#9504136
Torsade De Pointes
This Torsade De Pointes problem was reported by a physician from US. A 29-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: delirium,toxicity to various agents,alcohol use. On
Sep 03, 2013 this consumer started treatment with Precedex (dosage: NA). The following drugs were being taken at the same time: NA. When using Precedex, the patient experienced the following unwanted symptoms/side effects: Torsade De PointesAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Torsade De Pointes, may become evident only after a product is in use by the general population.
Precedex Side Effect Report#9319366
Neuroleptic Malignant Syndrome
This Neuroleptic Malignant Syndrome side effect was reported by a physician from US. A 45-year-old male patient (weight:NA) experienced the following symptoms/conditions: sedation.The patient was prescribed Precedex (drug dosage: NA), which was initiated on
Apr 16, 2013. Concurrently used drugs:
  • Cefazolin
  • Propofol
  • Morphine
  • Pantoprazole
  • Midazolam
.After starting to take Precedex the consumer reported adverse symptoms, such as: Neuroleptic Malignant SyndromeThese side effects may potentially be related to Precedex.
Precedex Side Effect Report#9173515
Dyspnoea, Heart Rate Increased, Blood Pressure Increased, Agitation, Vomiting, Tremor
This is a report of a 72-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Precedex (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Dyspnoea, Heart Rate Increased, Blood Pressure Increased, Agitation, Vomiting, Tremor after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Precedex treatment in male patients, resulting in Dyspnoea side effect.
Precedex Side Effect Report#9159449
Pyrexia
This report suggests a potential Precedex Pyrexia side effect(s) that can have serious consequences. A 56-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Precedex (dosage: NA) starting NS. After starting Precedex the patient began experiencing various side effects, including: PyrexiaAdditional drugs used concurrently: NA. Although Precedex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pyrexia, may still occur.
Precedex Side Effect Report#8914027
Anaphylactic Reaction
This Anaphylactic Reaction problem was reported by a pharmacist from US. A 54-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Precedex (dosage: NA). The following drugs were being taken at the same time: NA. When using Precedex, the patient experienced the following unwanted symptoms/side effects: Anaphylactic ReactionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anaphylactic Reaction, may become evident only after a product is in use by the general population.
Precedex Side Effect Report#8817080
Pyrexia, White Blood Cell Count Increased, Pneumonia Aspiration, Klebsiella Test Positive, Escherichia Test Positive, Clostridium Test Positive
This Pyrexia side effect was reported by a health professional from US. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Precedex (drug dosage: NA), which was initiated on
Aug 29, 2012. Concurrently used drugs:
  • Zosyn
  • Bupropion Xl
  • Clonazepam
  • Duuloxetine
  • Metoprolol Tartrate
  • Pranipexole
  • Chlorhexidine
  • Heparin
.After starting to take Precedex the consumer reported adverse symptoms, such as: Pyrexia, White Blood Cell Count Increased, Pneumonia Aspiration, Klebsiella Test Positive, Escherichia Test Positive, Clostridium Test PositiveThese side effects may potentially be related to Precedex.
Precedex Side Effect Report#8764119
Cardiac Arrest
This is a report of a 46-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: alcohol withdrawal syndrome, who was treated with Precedex (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Cardiac Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Precedex treatment in male patients, resulting in Cardiac Arrest side effect.
Precedex Side Effect Report#8718282
Epilepsy, Dyskinesia Neonatal, Blood Pressure Increased, Oxygen Saturation Decreased
This report suggests a potential Precedex Epilepsy side effect(s) that can have serious consequences. A male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: sedation and used Precedex (dosage: Intravenous Drip) starting NS. After starting Precedex the patient began experiencing various side effects, including: Epilepsy, Dyskinesia Neonatal, Blood Pressure Increased, Oxygen Saturation DecreasedAdditional drugs used concurrently:
  • Midazolam
Although Precedex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Epilepsy, may still occur.
Precedex Side Effect Report#8545353
Cardiac Arrest, Bradycardia, Procedural Complication
This Cardiac Arrest problem was reported by a physician from CA. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: obstructive sleep apnea syndrome. On
Feb 09, 2012 this consumer started treatment with Precedex (dosage: 60 Mcg, Continuous, Intravenous). The following drugs were being taken at the same time:
  • Fentanyl Citrate
  • Remifentanil
  • Nexium
When using Precedex, the patient experienced the following unwanted symptoms/side effects: Cardiac Arrest, Bradycardia, Procedural ComplicationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Arrest, may become evident only after a product is in use by the general population.
Precedex Side Effect Report#8541770
Cardiac Arrest
This Cardiac Arrest side effect was reported by a physician from CA. A 49-year-old female patient (weight:NA) experienced the following symptoms/conditions: anaesthesia.The patient was prescribed Precedex (drug dosage: 100mcg, Continuous, Intravenous (not Otherwise Specified)), which was initiated on
Mar 23, 2012. Concurrently used drugs:
  • Versed
  • Propofol
  • Remifentanil
  • Rocuronium Bromide
  • Quelicin
  • Decadron
  • Morphine
.After starting to take Precedex the consumer reported adverse symptoms, such as: Cardiac ArrestThese side effects may potentially be related to Precedex.
Precedex Side Effect Report#8541751
Cardiac Arrest, Blood Pressure Decreased, Procedural Complication
This is a report of a 34-year-old male patient (weight: NA) from CA, suffering from the following health symptoms/conditions: obesity surgery, who was treated with Precedex (dosage: 100mcg, Once, Intravenous (not Otherwise Specified), start time:
Nov 15, 2011), combined with:
  • Remifentanil
  • Fentanyl
  • Celebrex
and developed a serious reaction and side effect(s): Cardiac Arrest, Blood Pressure Decreased, Procedural Complication after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Precedex treatment in male patients, resulting in Cardiac Arrest side effect.
Precedex Side Effect Report#8488801-4
Respiratory Arrest, Atelectasis
This report suggests a potential Precedex Respiratory Arrest side effect(s) that can have serious consequences. A 82-year-old male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: sedation and used Precedex (dosage: See Image) starting
Apr 30, 2012. After starting Precedex the patient began experiencing various side effects, including: Respiratory Arrest, AtelectasisAdditional drugs used concurrently: NA. Although Precedex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Respiratory Arrest, may still occur.
Precedex Side Effect Report#8483053-3
Glossoptosis
This Glossoptosis problem was reported by a health professional from Japan. A 83-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: sedation. On NS this consumer started treatment with Precedex (dosage: NA). The following drugs were being taken at the same time:
  • Lidocaine Hydrochloride/epinephrine)
  • Oxygen
When using Precedex, the patient experienced the following unwanted symptoms/side effects: GlossoptosisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Glossoptosis, may become evident only after a product is in use by the general population.
Precedex Side Effect Report#8342775-5
Cardiac Arrest, Procedural Complication, Bradycardia
This Cardiac Arrest side effect was reported by a physician from Canada. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: sleep apnoea syndrome.The patient was prescribed Precedex (drug dosage: 60 Mcg, Continuous, Intravenous), which was initiated on
Feb 09, 2012. Concurrently used drugs:
  • Remifentanil
  • Nexium
  • Fentanyl Citrate
.After starting to take Precedex the consumer reported adverse symptoms, such as: Cardiac Arrest, Procedural Complication, BradycardiaThese side effects may potentially be related to Precedex.
Precedex Side Effect Report#8322003-7
Cardiac Arrest, Procedural Complication, Blood Pressure Decreased
This is a report of a 34-year-old male patient (weight: NA) from Canada, suffering from the following health symptoms/conditions: obesity surgery, who was treated with Precedex (dosage: 100mcg, Once, Intravenous (not Otherwise Specified), start time:
Nov 15, 2011), combined with:
  • Celebrex
  • (remifentanil)
  • Fentanyl Citrate
and developed a serious reaction and side effect(s): Cardiac Arrest, Procedural Complication, Blood Pressure Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Precedex treatment in male patients, resulting in Cardiac Arrest side effect.
Precedex Side Effect Report#8321948-1
Bradycardia, Procedural Complication, Cardiac Arrest
This report suggests a potential Precedex Bradycardia side effect(s) that can have serious consequences. A 44-year-old female patient (weight: NA) from Canada was diagnosed with the following symptoms/conditions: sleep apnoea syndrome and used Precedex (dosage: 60mcg, Continuous, Intravenous (not Otherwise Specified)) starting
Feb 09, 2012. After starting Precedex the patient began experiencing various side effects, including: Bradycardia, Procedural Complication, Cardiac ArrestAdditional drugs used concurrently:
  • Nexium
  • Fentanyl Citrate
  • (remifentanil)
Although Precedex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bradycardia, may still occur.
Precedex Side Effect Report#8313145-0
Cardiac Arrest
This Cardiac Arrest problem was reported by a physician from Canada. A 49-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: anaesthesia. On
Mar 23, 2012 this consumer started treatment with Precedex (dosage: 100mcg, Continuous, Intravenous (not Otherwise Specified)). The following drugs were being taken at the same time:
  • Propofol
  • Morphine
  • (remifentanil)
  • Rocuronium Bromide
  • Quelicin
  • Versed
  • Decadron
When using Precedex, the patient experienced the following unwanted symptoms/side effects: Cardiac ArrestAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Arrest, may become evident only after a product is in use by the general population.
Precedex Side Effect Report#8313123-1
Cardiac Arrest, Procedural Complication, Blood Pressure Decreased
This Cardiac Arrest side effect was reported by a physician from Canada. A 34-year-old male patient (weight:NA) experienced the following symptoms/conditions: obesity surgery.The patient was prescribed Precedex (drug dosage: 100mcg, Once, Intravenous (not Otherwise Specified)), which was initiated on
Nov 15, 2011. Concurrently used drugs:
  • (remifentanil)
  • (fentanyl)
  • Celebrex
.After starting to take Precedex the consumer reported adverse symptoms, such as: Cardiac Arrest, Procedural Complication, Blood Pressure DecreasedThese side effects may potentially be related to Precedex.
Precedex Side Effect Report#8288144-8
Renal Impairment, Renal Failure, Multi-organ Failure, Respiratory Failure, Pleural Effusion, Infection
This is a report of a 49-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Precedex (dosage: 0.6 Micrograms/ Kilograms/hour, start time:
Feb 08, 2007), combined with:
  • Fresh Frozen Plasma (4 U, Unk)
  • Etomidate (8 Mg, Unk)
  • Versed (10 Mg, Unk)
  • Ancef (1 G, Unk)
  • Bumex
  • Trasylol (3 Ml, Test Dose)
  • Protamine Sulfate (470 Mg, Unk)
  • Uncodeable ^unclassifiable^ (1350 Ml, Bypass)
and developed a serious reaction and side effect(s): Renal Impairment, Renal Failure, Multi-organ Failure, Respiratory Failure, Pleural Effusion, Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Precedex treatment in male patients, resulting in Renal Impairment side effect. The patient was hospitalized.
Precedex Side Effect Report#8274252-4
Product Outer Packaging Issue
This report suggests a potential Precedex Product Outer Packaging Issue side effect(s) that can have serious consequences. A male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: hypotension and used Precedex (dosage: 200mcg) starting
Apr 03, 2012. After starting Precedex the patient began experiencing various side effects, including: Product Outer Packaging IssueAdditional drugs used concurrently:
  • Ddavp (20mcg)
Although Precedex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Product Outer Packaging Issue, may still occur.
Precedex Side Effect Report#8237591-9
Fall, Subdural Haematoma, Anaemia, Convulsion
This Fall problem was reported by a physician from United States. A 77-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Dec 12, 2011 this consumer started treatment with Precedex (dosage: NA). The following drugs were being taken at the same time:
  • Vimpat
  • Sabril (500 Mg Milligram(s), 2 In 1 D, Oral ; 1500 Mg Milligram(s), 2 In 1 D, Oral)
  • Sabril (500 Mg Milligram(s), 2 In 1 D, Oral ; 1500 Mg Milligram(s), 2 In 1 D, Oral)
  • Xanax
  • Keppra
When using Precedex, the patient experienced the following unwanted symptoms/side effects: Fall, Subdural Haematoma, Anaemia, ConvulsionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Fall, may become evident only after a product is in use by the general population.
Precedex Side Effect Report#8186519-9
Bradyarrhythmia
This Bradyarrhythmia side effect was reported by a pharmacist from United States. A 23-year-old male patient (weight:NA) experienced the following symptoms/conditions: sedation.The patient was prescribed Precedex (drug dosage: 0.3 Mcg/kg/hr Iv), which was initiated on
Feb 28, 2012. Concurrently used drugs: NA..After starting to take Precedex the consumer reported adverse symptoms, such as: BradyarrhythmiaThese side effects may potentially be related to Precedex.
Precedex Side Effect Report#8174498-X
Peripheral Circulatory Failure, Hyperthermia, Blood Creatine Phosphokinase Increased, Musculoskeletal Stiffness, Acidosis
This is a report of a male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: sedation,blood pressure management, who was treated with Precedex (dosage: 0.3-0.4 Microg/kg/hr X 1, Drip Infusion, start time:
Jan 16, 2012), combined with:
  • Dobutamine Hcl (3-5 Microg/kg/min X 1)
  • Sevoflurane (1-3% X 1)
  • Diazepam
  • Fentanyl (20-60 Microg/hr X 1)
  • Dopamine Hcl (3-5 Microg/kg/min X 1)
  • Rocuronium Bromide
and developed a serious reaction and side effect(s): Peripheral Circulatory Failure, Hyperthermia, Blood Creatine Phosphokinase Increased, Musculoskeletal Stiffness, Acidosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Precedex treatment in male patients, resulting in Peripheral Circulatory Failure side effect.


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The appearance of Precedex on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Precedex reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Precedex Safety Alerts, Active Ingredients, Usage Information

    NDC0409-1638
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NamePrecedex
    NameDEXMEDETOMIDINE HYDROCHLORIDE
    Dosage FormINJECTION, SOLUTION, CONCENTRATE
    RouteINTRAVENOUS
    On market since19991217
    LabelerHospira, Inc.
    Active Ingredient(s)DEXMEDETOMIDINE HYDROCHLORIDE
    Strength(s)100
    Unit(s)ug/mL
    Pharma ClassAdrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE]

    Precedex Dosage, Warnings, Usage.

    Side Effects reported to FDA: 161

    Precedex safety alerts: No

    Reported deaths: 20

    Reported hospitalizations: 24

    Latest Precedex clinical trials