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Index of reports
> Cases with Agitation ()
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Zofran (Ondansetron) where reactions include agitation. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Zofran side effects in 48 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-23
Patient: 48 year old female, weighing 86.2 kg (189.6 pounds)
Reactions: Agitation, Restlessness, Drug Ineffective, Dyskinesia, Sneezing, Muscle Spasms
Drug(s) suspected as cause:
Zofran
Dosage: 4 mg q 8 hours p.o.; 8 mg once p.o.
Administration route: Oral
Indication: Nausea
Start date: 2012-01-21
Zofran
Dosage: 4 mg q 8 hours p.o.; 8 mg once p.o.
Administration route: Oral
Indication: Weight Decreased
Start date: 2012-01-21
Zofran
Dosage: 4 mg q 8 hours p.o.; 8 mg once p.o.
Administration route: Oral
Indication: Nausea
Start date: 2012-01-20
End date: 2012-01-21
Zofran
Dosage: 4 mg q 8 hours p.o.; 8 mg once p.o.
Administration route: Oral
Indication: Weight Decreased
Start date: 2012-01-20
End date: 2012-01-21
Other drugs received by patient: Seroquel; Diazepam; Tamoxifen Citrate; Lithium Carbonate ER; Tramadol HCL; Prilosec; Propranolol; Bismuth Subsalicylate
Possible Zofran side effects in 58 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-02-22
Patient: 58 year old female
Reactions: Agitation, Disseminated Intravascular Coagulation, Disorientation, Lactic Acidosis, Multi-Organ Failure, Incontinence, Left Ventricular Dysfunction, Anuria, Acute Pulmonary Oedema, Back Pain, Metabolic Acidosis, Vomiting, Hypothermia, Respiratory Distress, Cardiogenic Shock, Respiratory Failure, Coombs Positive Haemolytic Anaemia, Hypoalbuminaemia, Cardiac Arrest, Shock
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Levoleucovorin Calcium
Dosage: 330 mg, cyclic
Indication: Colorectal Cancer Metastatic
Start date: 2009-04-01
End date: 2009-10-09
Zofran
Dosage: single
Indication: Premedication
Start date: 2009-10-09
End date: 2009-10-09
Solu-Medrol
Dosage: single
Indication: Premedication
Start date: 2009-10-09
End date: 2009-10-09
Oxaliplatin
Dosage: 105 mg, cyclic
Indication: Colorectal Cancer Metastatic
Start date: 2009-04-01
End date: 2009-10-09
Other drugs received by patient: Fluorouracil; Fluorouracil
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