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Review Fosphenytoin Safety Reports submitted to FDA

Total Fosphenytoin reports: 8.
Fosphenytoin FDA safety alerts: No.
   Reported hospitalizations: 5.
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FDA Reported Fosphenytoin Side Effects: hypotension, bradycardia, overdose, hyperthermia, choreoathetosis, convulsion, thrombocytopenia, leukopenia, haemoglobin decreased, unresponsive to stimuli, sensory loss.
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Fosphenytoin Side Effects Report #5648419-5
Pharmacist from UNITED STATES reported FOSPHENYTOIN problem on Mar 03, 2008. Male patient, 59 years of age, was diagnosed with convulsion and was treated with FOSPHENYTOIN. After drug was administered, patient experienced the following problems/side effects: confusional state, lethargy, mental status changes, nystagmus, sedation. FOSPHENYTOIN dosage: unknown. Patient was hospitalized. Patient recovered.

Fosphenytoin Side Effects Report #5680733-X
FOSPHENYTOIN problem was reported by a Pharmacist from UNITED STATES on Mar 26, 2008. Male patient, 48 years of age, weighting 210.1 lb, was diagnosed with convulsion and was treated with FOSPHENYTOIN. After drug was administered, patient experienced the following problems/side effects: hypotension. FOSPHENYTOIN dosage: 1600MG ONCE IV. Patient was hospitalized. Patient recovered.

Fosphenytoin Side Effects Report #5637894-8
Health Professional from UNITED STATES reported FOSPHENYTOIN problem on Feb 21, 2008. Female patient, 48 years of age, weighting 264.6 lb, was treated with FOSPHENYTOIN. After drug was administered, patient experienced the following problems/side effects: erythema multiforme, stevens-johnson syndrome. FOSPHENYTOIN dosage: unknown. During the same period patient was treated with PHENOBARBITAL, INSULIN, FUROSEMIDE, LEVETIRACETAM, LANSOPRAZOLE, ACYCLOVIR, LORAZEPAM, PIPERACILLIN. Patient was hospitalized. Patient recovered.

Fosphenytoin Side Effects Report #5509745-3
FOSPHENYTOIN problem was reported by a Pharmacist from UNITED STATES on Nov 07, 2007. Female patient, child 10 years of age, weighting 59.97 lb, was diagnosed with convulsion prophylaxis and was treated with FOSPHENYTOIN. After drug was administered, patient experienced the following problems/side effects: hepatic enzyme increased, hepatic function abnormal. FOSPHENYTOIN dosage: 544 MG PE ONCE IV BOLUS 136,108.8, 81.6, 68 MG PE ONCE IV BOLUS. Patient was hospitalized. Patient recovered.

Fosphenytoin Side Effects Report #5520833-8
Pharmacist from UNITED STATES reported FOSPHENYTOIN problem on Nov 16, 2007. Female patient, weighting 242.5 lb, was diagnosed with convulsion and was treated with FOSPHENYTOIN. After drug was administered, patient experienced the following problems/side effects: rash maculo-papular. FOSPHENYTOIN dosage: unknown. During the same period patient was treated with ASPIRIN, LORAZEPAM, ETOMIDATE, PROPOFOL, SUCCINYLCHOLINE CHLORIDE, LIDOCAINE, NITROPRUSSIDE, LABETOLOL. Patient recovered.

Fosphenytoin Side Effects Report #5448220-1
FOSPHENYTOIN problem was reported by a Pharmacist from UNITED STATES on Sept 06, 2007. Female patient, 80 years of age, was diagnosed with convulsion and was treated with FOSPHENYTOIN. After drug was administered, patient experienced the following problems/side effects: hepatitis. FOSPHENYTOIN dosage: unknown. Patient was hospitalized and became disabled. Patient recovered.

Fosphenytoin Side Effects Report #5455656-1
Pharmacist from UNITED STATES reported FOSPHENYTOIN problem on Sept 13, 2007. Female patient, 60 years of age, weighting 159.8 lb, was diagnosed with convulsion and was treated with FOSPHENYTOIN. After drug was administered, patient experienced the following problems/side effects: convulsion, infusion related reaction, no therapeutic response, sensory loss, unresponsive to stimuli. FOSPHENYTOIN dosage: 1000MG ONCE IV BOLUS. During the same period patient was treated with MORPHINE, HYDRALAZINE, NIMOTOP, CEFAZOLIN, PANTOPRAZOLE, DEXAMETHASONE, NS WITH KCL. Patient recovered.

Fosphenytoin Side Effects Report #5427416-9
FOSPHENYTOIN problem was reported by a Pharmacist from UNITED STATES on Aug 24, 2007. Female patient, 79 years of age, weighting 172.0 lb, was diagnosed with altered state of consciousness, convulsion and was treated with FOSPHENYTOIN. After drug was administered, patient experienced the following problems/side effects: blood pressure systolic decreased, cardio-respiratory arrest, electromechanical dissociation. FOSPHENYTOIN dosage: 1000MG 1X ONLY 1V BOLUS. Patient recovered.


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confusional state, lethargy, mental status changes, nystagmus, sedation, hypotension, erythema multiforme, stevens-johnson syndrome, , was diagnosed with convulsion and was diagnosed with convulsion and was diagnosed with convulsion prophylaxis and