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Dexmedetomidine adverse events reported to FDA.

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Summary

FDA Adverse Reports: 12. View All

Dexmedetomidine FDA safety alerts: No

Reported deaths: 2

Reported hospitalizations: 3

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Often additional risks of using a medication, such as Dexmedetomidine, become known after product is used by a larger number of patients, for a longer period of time, and by patients with different health characteristics from those studied before drug approval. This page allows You to Find answers and discuss health symptoms with other Dexmedetomidine users, Learn more about unwanted side effects & find ways to reduce them. Browse Dexmedetomidine Adverse Reports reported to FDA and participate in Dexmedetomidine discussion, find alternative treatments and find ways to avoid or reduce risks associated with using Dexmedetomidine. You can also Post a question to users community or Ask a Doctor. PatientsVille.com is Your Complete Guide to all common, undocumented and undisclosed side effects associated with drugs and vaccines. Browse More Drug Reports Here: A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

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Dexmedetomidine Adverse Effect Reports (FDA)

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6381456-4 | Dyskinesia
on Sep 14, 2009 Female patient from SOUTH AFRICA , 59 years of age, was diagnosed with sedation and was treated with Dexmedetomidine (View Usage). Patient experienced the following unwanted or unexpected effects: dyskinesia. Dexmedetomidine dosage: .7 Mcg/kg/hr, Intravenous. During the same period patient was treated with NAROPIN (20 Ml, Intravenous) (View Naropin Review and Naropin Label ), DORMICUM /00036201/ (7.5 Mg, Oral) (View Dormicum /00036201/ Review and Dormicum /00036201/ Label ), FOSAMAX (View Fosamax Review and Fosamax Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ), PREDNISONE (View Prednisone Review and Prednisone Label ).

6328996-1 | Anxiety, Convulsion, Hyperhidrosis, Tachycardia
Patient was taking Dexmedetomidine (View Usage). Patient had the following side effects: anxiety (What is anxiety?), convulsion, hyperhidrosis, tachycardia on Aug 24, 2009 from UNITED STATES Additional patient health information: Male patient , weighting 268.3 lb, was diagnosed with sedation and. Dexmedetomidine dosage: .

6173820-3 | Atrial Fibrillation, Atrioventricular Block, Bradyarrhythmia, Cardiac Arrest, Hypertension, Hypotension, Supraventricular Tachycardia, Ventricular Dysfunction
Adverse event was reported on Apr 29, 2009 by a Female patient taking Dexmedetomidine (View Usage) (Dosage: ) . Location: UNITED STATES , weighting 22.71 lb, After Dexmedetomidine was administered, patient had the following side effects: atrial fibrillation (What is atrial fibrillation?), atrioventricular block, bradyarrhythmia, cardiac arrest (What is cardiac arrest?), hypertension, hypotension, supraventricular tachycardia, ventricular dysfunction.

6143015-8 | Blood Pressure Fluctuation, Blood Pressure Increased, Feeling Abnormal, Insomnia, Respiratory Acidosis, Respiratory Arrest, Respiratory Depression, Sedation
on Apr 01, 2009 Female patient from JAPAN , 74 years of age, weighting 83.78 lb, was diagnosed with induction of anaesthesia and was treated with Dexmedetomidine (View Usage). Patient experienced the following unwanted or unexpected effects: blood pressure fluctuation, blood pressure increased, feeling abnormal, insomnia, respiratory acidosis, respiratory arrest, respiratory depression, sedation. Dexmedetomidine dosage: See Image. During the same period patient was treated with FENTANYL (200 Mcg Intervenous Drip) (View Fentanyl Review and Fentanyl Label ), DORMICUM (View Dormicum Review and Dormicum Label ), SEVOFRANE (View Sevofrane Review and Sevofrane Label ), ULTIVA (View Ultiva Review and Ultiva Label ), PROPOFOL (View Propofol Review and Propofol Label ), MUSCULAX (View Musculax Review and Musculax Label ), HUMULIN R (View Humulin R Review and Humulin R Label ), SOLITA T (View Solita T Review and Solita T Label ).


6141159-8 | Angina Pectoris, Anxiety, Blood Pressure Increased, Bradycardia, Dyspnoea, Ill-defined Disorder, Troponin Increased
on Apr 01, 2009 Male patient from UNITED STATES , 62 years of age, weighting 227.7 lb, was diagnosed with surgery (What is surgery?) and was treated with Dexmedetomidine (View Usage). Patient had the following side effects: angina pectoris, anxiety (What is anxiety?), blood pressure increased, bradycardia, dyspnoea, ill-defined disorder, troponin increased. Dexmedetomidine dosage: 100 Mcg Qweek Iv. Patient was hospitalized.

6128777-8 | Anxiety Postoperative, Blood Pressure Fluctuation, Blood Pressure Increased, Insomnia, Respiratory Acidosis, Respiratory Arrest, Respiratory Depression, Sedation
Patient was taking Dexmedetomidine (View Usage). After Dexmedetomidine was administered, patient had the following side effects: anxiety postoperative, blood pressure fluctuation, blood pressure increased, insomnia, respiratory acidosis, respiratory arrest, respiratory depression, sedation on Mar 12, 2009 from JAPAN Additional patient health information: Female patient , 74 years of age, was diagnosed with induction of anaesthesia, maintenance of anaesthesia and. Dexmedetomidine dosage: . During the same period patient was treated with FENTANYL 25 (View Fentanyl-25 Review and Fentanyl-25 Label ), FENTANYL 25 (View Fentanyl-25 Review and Fentanyl-25 Label ), DORMICUM (View Dormicum Review and Dormicum Label ), SEVOFRANE (View Sevofrane Review and Sevofrane Label ), ULTIVA (View Ultiva Review and Ultiva Label ), PROPOFOL (View Propofol Review and Propofol Label ), MUSCULAX (View Musculax Review and Musculax Label ), HUMULIN R (View Humulin R Review and Humulin R Label ).

6093756-6 | Hypotension
Adverse event was reported on Feb 23, 2009 by a Male patient taking Dexmedetomidine (View Usage) (Dosage: 0.3 Microgram/kg/hr Iv Drip) . Location: UNITED STATES , 77 years of age, weighting 206.1 lb, Patient experienced the following unwanted or unexpected effects: hypotension. During the same period patient was treated with FENTANYL (View Fentanyl Review and Fentanyl Label ), HEPARIN (View Heparin Review and Heparin Label ), INSULIN (View Insulin Review and Insulin Label ), ALBUMIN (HUMAN) (View Albumin (human) Review and Albumin (human) Label ).

5445731-X | Feeling Jittery, Grand Mal Convulsion, Metabolic Acidosis, Nervousness
on Aug 24, 2007 Female patient from UNITED STATES , 34 years of age, weighting 150.4 lb, was diagnosed with sedation and was treated with Dexmedetomidine (View Usage). Patient had the following side effects: feeling jittery, grand mal convulsion, metabolic acidosis, nervousness. Dexmedetomidine dosage: 10 Ml, 1 In 1 Hr, Intravenous. During the same period patient was treated with ALBUTEROL (View Albuterol Review and Albuterol Label ), ATROVENT (View Atrovent Review and Atrovent Label ), AMBIEN (View Ambien Review and Ambien Label ), PROTONIX (View Protonix Review and Protonix Label ), ZOSYN (View Zosyn Review and Zosyn Label ), SYNTHROID (View Synthroid Review and Synthroid Label ), POTASSIUM CHLORIDE (View Potassium Chloride Review and Potassium Chloride Label ), NEXIUM (View Nexium Review and Nexium Label ). Patient was hospitalized.

5168698-0 | Cardiac Arrest, Procedural Hypotension, Pulmonary Oedema
on Dec 04, 2006 Female patient from UNITED STATES , 76 years of age, weighting 224.0 lb, was diagnosed with sedation and was treated with Dexmedetomidine (View Usage). After Dexmedetomidine was administered, patient had the following side effects: cardiac arrest (What is cardiac arrest?), procedural hypotension, pulmonary oedema. Dexmedetomidine dosage: 50mcg Continuous Iv Drip.

5166993-2 | Cardiac Arrest, Hypotension, Ill-defined Disorder, Post Procedural Complication
Patient was taking Dexmedetomidine (View Usage). Patient experienced the following unwanted or unexpected effects: cardiac arrest (What is cardiac arrest?), hypotension, ill-defined disorder, post procedural complication on Dec 01, 2006 from UNITED STATES Additional patient health information: Male patient , 51 years of age, weighting 196.2 lb, was diagnosed with sedation and. Dexmedetomidine dosage: 200mcg Continuos Iv Drip. During the same period patient was treated with MIDAZOLAM HYDROCHLORIDE (View Midazolam Hydrochloride Review and Midazolam Hydrochloride Label ), FENTANYL (View Fentanyl Review and Fentanyl Label ).

5109699-8 | Convulsion
Adverse event was reported on Sep 05, 2006 by a Female patient taking Dexmedetomidine (View Usage) (Dosage: 0.7 Mcg/kg/hr, Infusion) was diagnosed with maintenance of anaesthesia and. Location: TURKEY , child 6 years of age, Patient had the following side effects: convulsion. During the same period patient was treated with D5 0.3% (SODIUM CHLORIDE) (View D5 0.3% (sodium Chloride) Review and D5 0.3% (sodium Chloride) Label ), ANESTHETIC CREAM (ANAESTHETICS FOR TOPICAL USE) (View Anesthetic Cream (anaesthetics For Topical Use) Review and Anesthetic Cream (anaesthetics For Topical Use) Label ), MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), KETAMINE (KETAMINE) (View Ketamine (ketamine) Review and Ketamine (ketamine) Label ).

4897541-X | Blood Pressure Diastolic Decreased
on Jan 30, 2006 Male patient from UNITED STATES , 77 years of age, weighting 280.6 lb, was diagnosed with agitation, intubation, sedation and was treated with Dexmedetomidine (View Usage). After Dexmedetomidine was administered, patient had the following side effects: blood pressure diastolic decreased. Dexmedetomidine dosage: 0.1 0.4 Mcg/kg/hr. Patient was hospitalized.


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To find out about documented side effects or safety concerns read either the drug label or the drug's package insert. You may also want to speak with your pharmacist or healthcare provider. All medicines have benefits and risks. The risks are the chances that something unwanted or unexpected could happen to you when you use them. You can protect yourself by searching summaries of recent safety alerts, adverse reports. Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.

Be aware of the following potential Dexmedetomidine risks to be aware of: 1. Watch for any Serious adverse events, such as life-threatening situation, which can require an admission to hospital or longer-than-expected hospital stay, permanent disability, birth defect, miscarriage, stillbirth, or birth with serious disease requires medical care to prevent permanent damage
2. Any potential Dexmedetomidine quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Dexmedetomidine use error: mixing up products with similar drug names or packaging, taking wrong dose of a drug because of confusing dosing instructions on label
4. When applicable, Problems with different manufacturer of same medicine: not getting same results from a generic drug as a brand name drug, or from another generic

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Dexmedetomidine Reactions
Angina Pectoris
AnxietyWhat is Anxiety?
Anxiety Postoperative
Atrial FibrillationWhat is Atrial fibrillation?
Atrioventricular Block
Blood Pressure Diastolic Decreased
Blood Pressure Fluctuation
Blood Pressure Increased
Bradyarrhythmia
Bradycardia
Cardiac ArrestWhat is Cardiac arrest?
Convulsion
Dyskinesia
Dyspnoea
Feeling Abnormal
Feeling Jittery
Grand Mal Convulsion
Hyperhidrosis
Hypertension
Hypotension
Ill-defined Disorder
Insomnia
Metabolic Acidosis
Nervousness
Post Procedural Complication
Respiratory Acidosis
Respiratory Arrest
Respiratory Depression
Sedation
Tachycardia
Dexmedetomidine Side Effects Notice - The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. PatientsVille.com does not provide medical advice, diagnosis or treatment. The information regarding Dexmedetomidine adverse reports, reviews and polls contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments. Thank you for visiting Patientsville.com!