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Dextrose Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 166 

Pyrexia, Tremor (7905376-6)
on Nov 01, 2011 Male from BRAZIL , child 10 years of age, weighting 85.98 lb, was diagnosed with
  • fluid replacement
  • intravenous catheter management
and was treated with Dextrose 5%. Directly after, patient experienced the unwanted or unexpected Dextrose side effects: pyrexia, tremor. Dextrose 5% dosage: N/A. Patient was hospitalized.

Tremor, Pyrexia (7905375-4)
Patient was taking Dextrose 5%. Patient felt the following Dextrose side effects: tremor, pyrexia on Nov 01, 2011 from BRAZIL Additional patient health information: Female , child 4 years of age, weighting 26.46 lb, was diagnosed with
  • intravenous catheter management
  • fluid replacement
and. Dextrose 5% dosage: N/A. Patient was hospitalized.

Overdose, Cardiogenic Shock, Tachycardia, Disseminated Intravascular Coagulation, Hypotension, Hypoglycaemia (7900555-6)
Adverse event was reported on Oct 25, 2011 by a Female taking Dextrose (Dosage: Total Dose According To Table: 2082g) . Location: UNITED STATES , 37 years of age, After Dextrose was administered, patient encountered several Dextrose side effects: overdose, cardiogenic shock, tachycardia, disseminated intravascular coagulation, hypotension, hypoglycaemia.
Multiple concurrent drugs taken:
  • Norepinephrine Bitartrate (40 Mcg/min)
  • Vasopressin
  • Amlodipine
  • Insulin
  • Loxapine
  • Warfarin Sodium
  • Carbamazepine
  • Tramadol Hcl
Patient was hospitalized.

Hypotension, Hypokalaemia, Overdose, Cardiogenic Shock, Hypoglycaemia (7900518-0)
on Oct 25, 2011 Male from UNITED STATES , 36 years of age, was treated with Dextrose. Directly after, patient experienced the unwanted or unexpected Dextrose side effects: hypotension, hypokalaemia, overdose, cardiogenic shock, hypoglycaemia. Dextrose dosage: Total Dose According To Table: 289g.
Associated medications used:
  • Carvedilol
  • Insulin
  • Insulin (10-70 Iu/h)
  • Furosemide
  • Lisinopril
Patient was hospitalized.


Cardiogenic Shock, Hypokalaemia, Overdose, Hypotension, Hypoglycaemia (7898890-3)
on Oct 25, 2011 Female from UNITED STATES , 58 years of age, was treated with Dextrose. Patient felt the following Dextrose side effects: cardiogenic shock, hypokalaemia, overdose, hypotension, hypoglycaemia. Dextrose dosage: Total Dose According To Table: 587g.
Multiple prescriptions taken:
  • Verapamil
  • Insulin (82-84 Iu/h)
  • Insulin
Patient was hospitalized.

(7898379-1)
Patient was taking Dextrose 5%. on Oct 28, 2011 from SPAIN Additional patient health information: Male , 68 years of age, . Dextrose 5% dosage: N/A.
Multiple concurrent drugs taken:
  • Morphine


(7787021-6)
Adverse event was reported on Sep 20, 2011 by a Male taking Dextrose 10% (Dosage: N/A) was diagnosed with
  • medical diet
and. Location: NEW ZEALAND , 28 years of age, .
Associated medications used:
  • Travasol 10% W/ Electrolytes
  • Clinoleic 20%


Family Stress, Aphasia, Dysphagia, Renal Cyst, Balance Disorder, Dyskinesia, Activities Of Daily Living Impaired, Depression, Anxiety (7768819-7)
on Sep 09, 2011 Female from UNITED STATES , weighting 208.0 lb, was treated with Dextrose. Patient felt the following Dextrose side effects: family stress, aphasia, dysphagia, renal cyst, balance disorder, dyskinesia, activities of daily living impaired, depression, anxiety. Dextrose dosage: N/A.
Multiple prescriptions taken:
  • Atenolol
  • Quinapril Hcl
  • Lexapro
  • Vicodin
  • Veramyst
  • Cephalexin
  • Xalatan
  • Novolog


Torsade De Pointes, Circulatory Collapse, Syncope, Electrocardiogram Qt Prolonged (7753353-0)
on Sep 01, 2011 Female from FRANCE , 63 years of age, was treated with Dextrose. After Dextrose was administered, patient encountered several Dextrose side effects: torsade de pointes, circulatory collapse, syncope, electrocardiogram qt prolonged. Dextrose dosage: N/A.
Multiple concurrent drugs taken:
  • Cetirizine Hcl
  • Cetirizine Hcl
  • Antihypertensives
  • Ketoconazole (Daily Dose Text: 400 Mg)
Patient was hospitalized.

Skin Exfoliation, Blister (7730447-7)
Patient was taking Dextrose. Directly after, patient experienced the unwanted or unexpected Dextrose side effects: skin exfoliation, blister on Aug 31, 2011 from JAPAN Additional patient health information: Male , 77 years of age, . Dextrose dosage: N/A.
Associated medications used:
  • Meropenem


Chest Pain, Pyrexia, Back Pain, Chills, Hypotension (7717513-7)
Adverse event was reported on Aug 15, 2008 by a Male taking Dextrose (Dosage: N/A) . Location: UNITED STATES , 54 years of age, weighting 249.1 lb, Patient felt the following Dextrose side effects: chest pain, pyrexia, back pain, chills, hypotension.
Multiple prescriptions taken:
  • Docusate (docusate)
  • Insulin (insulin)
  • Prednisone
  • Tramadol Hcl
  • Tubersol
  • Dexamethasone
  • Zolpidem
  • Cimetidine


Mental Disorder (7716480-X)
on Aug 18, 2011 Male from CHINA , 71 years of age, was treated with Dextrose. After Dextrose was administered, patient encountered several Dextrose side effects: mental disorder. Dextrose dosage: N/A.
Multiple concurrent drugs taken:
  • Lidocaine


Lethargy, Pain, Poor Quality Sleep, Agitation, Dyskinesia, Convulsion, Mood Altered (7654385-3)
on Jul 31, 2011 Male from UNITED STATES , weighting 149.9 lb, was treated with Dextrose. Directly after, patient experienced the unwanted or unexpected Dextrose side effects: lethargy, pain, poor quality sleep, agitation, dyskinesia, convulsion, mood altered. Dextrose dosage: Unk.
Associated medications used:
  • Lyrica (150 Mg, 1x/day)
  • Lyrica (Unk)
  • Tetrabenazine (Unk)
  • Norvasc (10 Mg, Unk)
  • Lyrica (50 Mg, 3x/day)
  • Lyrica (50 Mg, 3x/day)
  • Levothyroxine (50 Mg, Unk)
  • Lithium (450 Iu, Unk)


Cardiac Output Decreased (7646560-9)
Patient was taking Dextrose 5%. Patient felt the following Dextrose side effects: cardiac output decreased on Jul 07, 2011 from UNITED STATES Additional patient health information: Male , 50 years of age, . Dextrose 5% dosage: N/A.
Multiple prescriptions taken:
  • Isoflurane
  • Dopamine Hcl
  • Lasix
  • Vecuroniium (vecuronium)
  • Neostigmine (neostigmine Metilsulfate)
  • Ephedrine (ephedrine Hydrochloride)
  • Bicarbonate (sodium Bicarbonate)
  • Insulin


(7642713-4)
Adverse event was reported on Jul 19, 2011 by a Male taking Dextrose 10% (Dosage: N/A) was diagnosed with
  • parenteral nutrition
  • medical diet
and. Location: AUSTRALIA , 29 years of age, .
Multiple concurrent drugs taken:
  • Travasol 10% W/ Electrolytes
  • Clinoleic 20%


Chills, Pyrexia, Maternal Exposure During Pregnancy (7625993-0)
on Jun 29, 2010 Female from INDIA , 25 years of age, was diagnosed with
  • caesarean section
and was treated with Dextrose 5% And Sodium Chloride 0.9% In Plastic Container. Directly after, patient experienced the unwanted or unexpected Dextrose side effects: chills, pyrexia, maternal exposure during pregnancy. Dextrose 5% And Sodium Chloride 0.9% In Plastic Container dosage: N/A.

Incorrect Dose Administered (7617249-7)
on Jul 08, 2011 Female from UNITED STATES , 95 years of age, was treated with Dextrose Normal Saline. Patient felt the following Dextrose side effects: incorrect dose administered. Dextrose Normal Saline dosage: N/A.
Multiple prescriptions taken:
  • Ceftriaxone
  • Dopamine Hcl
  • Nitroglycerin
  • Morphine
  • Dextrose 50%
  • Risperdal Consta
  • Artificial Tears Nos
  • Levothyroxine Sodium
Patient was hospitalized.

Gastritis Erosive, Leukopenia, Anaemia, Hyponatraemia, Varices Oesophageal, Thrombocytopenia, Dehydration, Haemorrhoidal Haemorrhage (7594707-5)
Patient was taking Dextrose. After Dextrose was administered, patient encountered several Dextrose side effects: gastritis erosive, leukopenia, anaemia, hyponatraemia, varices oesophageal, thrombocytopenia, dehydration, haemorrhoidal haemorrhage on Jun 23, 2011 from PERU Additional patient health information: Male , weighting 138.9 lb, . Dextrose dosage: Unk.
Multiple concurrent drugs taken:
  • Erlotinib Hydrochloride
  • Erlotinib Hydrochloride (100 Mg, Uid/qd)
  • Sorafenib (800 Mg, Uid/qd)
  • Potassium Chloride (Unk)
  • Lactulose (Unk)
  • Sodium Chloride (Unk)
Patient was hospitalized.

Supraventricular Tachycardia, Odynophagia, Mucosal Inflammation (7581582-8)
Adverse event was reported on Jun 16, 2011 by a Male taking Dextrose (Dosage: 25 Gram) . Location: UNITED STATES , 73 years of age, Directly after, patient experienced the unwanted or unexpected Dextrose side effects: supraventricular tachycardia, odynophagia, mucosal inflammation.
Associated medications used:
  • Polyvinylpyrolidone/sodium Hyaluronate (1 Packet)
  • Scopolamine (1 Milligram)
  • Sodium Phosphate (15 Millimole)
  • Reglan (10 Milligram)
  • Cetuximab (250 Milligram/sq. Meter)
  • Plavix (75 Milligram)
  • Silvadene
  • Triamcinolone
Patient was hospitalized.

Respiratory Arrest, Cyanosis, Loss Of Consciousness, Pulse Absent (7579760-7)
on Jun 13, 2011 Female from UNITED STATES , 54 years of age, was treated with Dextrose 10%. Patient felt the following Dextrose side effects: respiratory arrest, cyanosis, loss of consciousness, pulse absent. Dextrose 10% dosage: N/A. Patient was hospitalized.

(7530443-9)
on May 31, 2011 Female from AUSTRALIA , 74 years of age, was diagnosed with
  • parenteral nutrition
and was treated with Dextrose 10%. . Dextrose 10% dosage: N/A.
Multiple concurrent drugs taken:
  • Travasol 10% W/ Electrolytes
  • Clinoleic 20%


Convulsion, Adrenal Suppression, Blood Cortisol Decreased, Hypoglycaemia (7525916-9)
Patient was taking Dextrose. Directly after, patient experienced the unwanted or unexpected Dextrose side effects: convulsion, adrenal suppression, blood cortisol decreased, hypoglycaemia on May 27, 2011 from CANADA Additional patient health information: Female , child 5 years of age, . Dextrose dosage: N/A.
Associated medications used:
  • Ciclesonide
  • Fluticasone Propionate


Renal Injury, Anxiety, Fear, Pain, Multi-organ Failure, Cerebrovascular Accident, Renal Failure, Stress (7488585-2)
Adverse event was reported on Oct 31, 2009 by a Female taking Dextrose 5% (Dosage: N/A) . Location: UNITED STATES , 70 years of age, weighting 97.00 lb, Patient felt the following Dextrose side effects: renal injury, anxiety, fear, pain, multi-organ failure, cerebrovascular accident, renal failure, stress.
Multiple prescriptions taken:
  • Lanoxin (0.125 Mg, Qd)
  • Potassium Chloride
  • Normal Saline
  • Trasylol (100 Ml Loading Dose)
  • Toprol-xl (50 Mg, Qd)
  • Trasylol (1 Ml Initial (test) Dose)
  • Trasylol (Unk)
  • Epinephrine


Hypotension (7413857-7)
on Apr 04, 2011 Male from UNITED STATES , 70 years of age, weighting 154.3 lb, was diagnosed with
  • fatigue
and was treated with Dextrose. After Dextrose was administered, patient encountered several Dextrose side effects: hypotension. Dextrose dosage: 1df=20.unit Not Specified.
Multiple concurrent drugs taken:
  • Sodium Chloride
  • Phenergan Hcl
Patient was hospitalized.

Dehydration, Stomatitis, Pallor, Sepsis, Bronchopneumonia, Lymphocytosis, Productive Cough, Malaise, Hepatitis (7375048-8)
on Mar 01, 2011 Male from UGANDA , 32 years of age, was treated with Dextrose (+) Electrolytes. Directly after, patient experienced the unwanted or unexpected Dextrose side effects: dehydration, stomatitis, pallor, sepsis, bronchopneumonia, lymphocytosis, productive cough, malaise, hepatitis. Dextrose (+) Electrolytes dosage: N/A.
Associated medications used:
  • Acetaminophen
  • Ciprofloxacin
  • Ibuprofen
  • Tab Raltegravir Potassium
  • Aluvia (lopinavir + Ritonavir)
Patient was hospitalized.

Showing 1-25 of 166 

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Dextrose Information

DEXTRAN 4 SODIUM LA

Active Ingredient: ADENINE; ANHYDROUS CALCIUM C DEXTRAN 4 DEXTROSE DEXTROSE;

Dextrose Dosage, Warnings, Usage.

Side Effects reported to FDA: 166. View Dextrose Adverse Reports

Dextrose safety alerts: 2013 2012 2008

Reported deaths: 8

Reported hospitalizations: 31

Lactated Ringers and 5 Percent Dextrose Injection, USP, 1000 ML, Flexible Containers: Recall - Due to Non-Sterility

[Posted 01/28/2013]

AUDIENCE: Pharmacy, Patient, Health Professional

ISSUE: Hospira, Inc. is initiating a voluntary nationwide user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09. This action is due to one confirmed customer report where a spore-like structured particulate, consistent with mold, was noted in the solution. Hospira has not received reports of any adverse events associated with this issue for this lot, and has not identified any quality issues with retention samples for this lot. If contaminated solution is used on a patient, this may cause thrombosis, phlebitis, bacteremia, sepsis, septic shock and/or endocarditis, or result in a fatal infection in a broad array of patients.

BACKGROUND: The product is used as a source of water, electrolytes and calories or as an alkalizing agent and is packaged in a 1000 mL flexible container, lot number 05-019-JT, with an expiration date of May 1, 2013. The affected lot was distributed nationwide between June 2011 and January 2012 to wholesalers/distributors, hospitals and pharmacies.

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-965-5798 between the hours of 8am to 5pm EST, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[01/25/2013 - Firm Press Release - Hospira, Inc]

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