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Review Fosphenytoin View Fosphenytoin Adverse Event Reports: patient, 70 years of age, took Fosphenytoin 750 Mg, 1x/day

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Showing 1-25 of 88 

(8479561-1)
on Jun 21, 2012 Female patient from JAPAN , 70 years of age, was treated with Fosphenytoin Sodium(View Usage). . Fosphenytoin Sodium dosage: 750 Mg, 1x/day.

Rhabdomyolysis (8479543-X)
Patient was taking Fosphenytoin Sodium (View Usage). Patient had the following side effects: rhabdomyolysis on Jun 21, 2012 from JAPAN Additional patient health information: Female patient , 24 years of age, weighting 110.2 lb, was diagnosed with and. Fosphenytoin Sodium dosage: 1125 Mg, 1x/day. Patient was hospitalized.

Intestinal Ischaemia (8464251-1)
Adverse event was reported on Jun 19, 2012 by a Male patient taking Fosphenytoin Sodium (View Usage) (Dosage: 15 Mg/kg, Unk) was diagnosed with
  • status epilepticus
and. Location: FRANCE , weighting 6.93 lb, After Fosphenytoin was administered, patient had the following side effects: intestinal ischaemia.
Patient was taking other medications: Patient was hospitalized.

Mental Status Changes, Unresponsive To Stimuli, Toxicity To Various Agents, Encephalopathy, Hyporeflexia (8414885-5)
on Jun 01, 2012 Male patient from UNITED STATES , 68 years of age, was diagnosed with
  • convulsion
and was treated with Fosphenytoin (View Usage). Patient experienced the following unwanted or unexpected effects: mental status changes, unresponsive to stimuli, toxicity to various agents, encephalopathy, hyporeflexia. Fosphenytoin dosage: 200 Mg Tid Iv. Patient was hospitalized.


Cardio-respiratory Arrest, Pulse Absent (8397526-5)
on May 29, 2012 Male patient from UNITED STATES , weighting 231.9 lb, was treated with Fosphenytoin(View Usage). Patient had the following side effects: cardio-respiratory arrest, pulse absent. Fosphenytoin dosage: 2000mg Iv.

Product Quality Issue, Pruritus, Product Contamination Physical (8394740-X)
Patient was taking Fosphenytoin (View Usage). After Fosphenytoin was administered, patient had the following side effects: product quality issue, pruritus, product contamination physical on May 25, 2012 from UNITED STATES Additional patient health information: Male patient , child 8 years of age, weighting 79.37 lb, was diagnosed with
  • grand mal convulsion
and. Fosphenytoin dosage: 725 Mg In 100 Ml Ns Iv One Time Iv Bolus One Partial Dose. Patient was hospitalized.

Blood Pressure Decreased, Respiratory Arrest (8275190-3)
Adverse event was reported on Apr 05, 2012 by a Female patient taking Fosphenytoin Sodium (View Usage) (Dosage: 750 Mg X 1/30 Min) was diagnosed with and. Location: JAPAN , 40 years of age, weighting 101.4 lb, Patient experienced the following unwanted or unexpected effects: blood pressure decreased, respiratory arrest.

Intentional Overdose, Ataxia, Agitation, Neurotoxicity, Dysarthria, Grand Mal Convulsion (8265688-6)
on Mar 26, 2012 Male patient from , 15 years of age, was diagnosed with
  • partial seizures
and was treated with Fosphenytoin Sodium (View Usage). Patient had the following side effects: intentional overdose, ataxia (ataxia Questions), agitation, neurotoxicity, dysarthria, grand mal convulsion. Fosphenytoin Sodium dosage: 3750 Mg (45 Mg/kg) Over 1 Hour Iv Infusion. Patient was hospitalized.

Respiratory Arrest (8209422-4)
on Mar 08, 2012 Female patient from JAPAN , 49 years of age, weighting 101.4 lb, was diagnosed with
  • convulsion prophylaxis
and was treated with Fosphenytoin Sodium(View Usage). After Fosphenytoin was administered, patient had the following side effects: respiratory arrest. Fosphenytoin Sodium dosage: 750 Mg X 1/30 Min.

Bradycardia, Atrioventricular Block Second Degree, Hypotension (8202845-9)
Patient was taking Fosphenytoin (View Usage). Patient experienced the following unwanted or unexpected effects: bradycardia, atrioventricular block second degree, hypotension on Mar 12, 2012 from UNITED STATES Additional patient health information: Female patient , 73 years of age, weighting 209.0 lb, was diagnosed with
  • status epilepticus
and. Fosphenytoin dosage: 1275mg.

Accidental Overdose, Poisoning, Altered State Of Consciousness, Nystagmus, Vestibular Disorder, Dyspnoea (8057113-5)
Adverse event was reported on Jan 13, 2012 by a Female patient taking Fosphenytoin Sodium (View Usage) (Dosage: 3750 Mg (45 Mg/kg)) was diagnosed with
  • convulsion prophylaxis
and. Location: TUNISIA , 39 years of age, Patient had the following side effects: accidental overdose, poisoning (poisoning Questions), altered state of consciousness, nystagmus, vestibular disorder, dyspnoea.

Renal Failure Acute, Erythema, Pruritus (7880187-9)
on Oct 19, 2011 Female patient from FRANCE , 25 years of age, was treated with Fosphenytoin Sodium (View Usage). After Fosphenytoin was administered, patient had the following side effects: renal failure acute, erythema, pruritus. Fosphenytoin Sodium dosage: Unk.
Patient was taking other medications:

Renal Failure Acute, Haemodialysis, Tubulointerstitial Nephritis, Swelling, Eosinophilia, Pulseless Electrical Activity, Toxicity To Various Agents, Asthenia, Rash Erythematous (7585583-5)
on Jun 28, 2011 Male patient from UNITED STATES , weighting 265.4 lb, was diagnosed with
  • convulsion
and was treated with Fosphenytoin(View Usage). Patient experienced the following unwanted or unexpected effects: renal failure acute, haemodialysis, tubulointerstitial nephritis, swelling, eosinophilia, pulseless electrical activity, toxicity to various agents, asthenia, rash erythematous. Fosphenytoin dosage: 400mg Q 12h Iv Bolus. Patient was hospitalized.

Status Epilepticus, Respiratory Distress, Pneumonia Aspiration, Accidental Overdose, Hypotension (7500962-X)
Patient was taking Fosphenytoin Sodium (View Usage). Patient had the following side effects: status epilepticus, respiratory distress, pneumonia aspiration, accidental overdose, hypotension on May 19, 2011 from FRANCE Additional patient health information: Female patient , weighting 17.64 lb, was diagnosed with
  • convulsion
and. Fosphenytoin Sodium dosage: 100 Mg/kg, Unk.
Patient was taking other medications:

Skin Discolouration, Hypotension (7366920-3)
Adverse event was reported on Mar 17, 2011 by a Male patient taking Fosphenytoin (View Usage) (Dosage: 1200 Mg Once Iv Bolus) was diagnosed with
  • convulsion
and. Location: UNITED STATES , 71 years of age, weighting 170.0 lb, After Fosphenytoin was administered, patient had the following side effects: skin discolouration, hypotension.

Infusion Related Reaction, Convulsion, Hypotension, Heart Rate Irregular (7366851-9)
on Mar 17, 2011 Male patient from UNITED STATES , 71 years of age, weighting 170.0 lb, was diagnosed with
  • convulsion
and was treated with Fosphenytoin (View Usage). Patient experienced the following unwanted or unexpected effects: infusion related reaction, convulsion, hypotension, heart rate irregular. Fosphenytoin dosage: 800 Mg Once Iv Bolus.

Agitation, Delirium (7272511-5)
on Jan 31, 2011 Male patient from UNITED STATES , 59 years of age, weighting 114.6 lb, was diagnosed with
  • convulsion
and was treated with Fosphenytoin(View Usage). Patient had the following side effects: agitation, delirium. Fosphenytoin dosage: 1000 Mg Once Iv. Patient was hospitalized.

Hepatic Adenoma, Tumour Haemorrhage (7003953-0)
Patient was taking Fosphenytoin Sodium (View Usage). After Fosphenytoin was administered, patient had the following side effects: hepatic adenoma, tumour haemorrhage on Sep 06, 2010 from UNITED STATES Additional patient health information: Female patient , 46 years of age, was diagnosed with
  • convulsion
and. Fosphenytoin Sodium dosage: N/A.

Hepatic Adenoma, Tumour Haemorrhage (6985055-2)
Adverse event was reported on Aug 28, 2010 by a Female patient taking Fosphenytoin Sodium (View Usage) (Dosage: N/A) was diagnosed with
  • convulsion
and. Location: UNITED STATES , 46 years of age, Patient experienced the following unwanted or unexpected effects: hepatic adenoma, tumour haemorrhage.

Body Temperature Increased, Hypotension, Ischaemic Hepatitis, Lung Infiltration, Platelet Toxicity, Renal Failure Acute, Thrombocytopenia (6983212-2)
on Aug 27, 2010 Male patient from UNITED STATES , 55 years of age, was diagnosed with
  • convulsion prophylaxis
and was treated with Fosphenytoin Sodium (View Usage). Patient had the following side effects: body temperature increased, hypotension, ischaemic hepatitis, lung infiltration, platelet toxicity, renal failure acute, thrombocytopenia. Fosphenytoin Sodium dosage: 1 Gm. Patient was hospitalized.

Basal Ganglia Haemorrhage, Cerebral Haemorrhage, Hepatic Ischaemia, Hypotension, Pneumonia, Renal Failure Acute, Thrombocytopenia (6959512-9)
on Aug 11, 2010 Male patient from UNITED STATES , 55 years of age, was diagnosed with
  • convulsion prophylaxis
and was treated with Fosphenytoin Sodium(View Usage). After Fosphenytoin was administered, patient had the following side effects: basal ganglia haemorrhage, cerebral haemorrhage, hepatic ischaemia, hypotension, pneumonia (pneumonia Questions), renal failure acute, thrombocytopenia. Fosphenytoin Sodium dosage: 1 G Loading Dose Intravenous Drip. Patient was hospitalized.

Apnoea, Bacteria Urine Identified, Blood Glucose Increased, Blood Urea Increased, Cardiac Arrest, Intracardiac Thrombus, Intussusception, Mental Status Changes, Pco2 Decreased (6333306-X)
Patient was taking Fosphenytoin Sodium Injection, 75 Mg/ml, 2 Ml + 10 Ml Vials (View Usage). Patient experienced the following unwanted or unexpected effects: apnoea, bacteria urine identified, blood glucose increased, blood urea increased, cardiac arrest (cardiac arrest Questions), intracardiac thrombus, intussusception, mental status changes, pco2 decreased on Aug 17, 2009 from UNITED STATES Additional patient health information: Female patient , weighting 17.90 lb, was diagnosed with
  • convulsion
and. Fosphenytoin Sodium Injection, 75 Mg/ml, 2 Ml + 10 Ml Vials dosage: 160 Mg Over 10 Minutes, Intravenous.
Patient was taking other medications: Patient was hospitalized.

Apnoea, Cardiac Arrest, Intussusception, Unresponsive To Stimuli, Viral Myocarditis (6304020-1)
Adverse event was reported on Jul 31, 2009 by a Female patient taking Fosphenytoin (View Usage) (Dosage: 160 Mg, Unk) was diagnosed with
  • convulsion
and. Location: UNITED STATES , weighting 8.12 lb, Patient had the following side effects: apnoea, cardiac arrest (cardiac arrest Questions), intussusception, unresponsive to stimuli, viral myocarditis.

Acute Respiratory Failure, Agranulocytosis, Coma, Convulsion, Disturbance In Attention, Encephalitis, Escherichia Bacteraemia, Haemoglobin Decreased, Hyperammonaemia (6288845-7)
on Jul 23, 2009 Female patient from FRANCE , 17 years of age, was diagnosed with and was treated with Fosphenytoin Sodium (View Usage). After Fosphenytoin was administered, patient had the following side effects: acute respiratory failure, agranulocytosis, coma, convulsion, disturbance in attention, encephalitis (encephalitis Questions), escherichia bacteraemia, haemoglobin decreased, hyperammonaemia. Fosphenytoin Sodium dosage: Unk.
Patient was taking other medications: Patient was hospitalized.

Blood Glucose Increased, Convulsion, Cough, Dyspnoea, Feeding Disorder, Rhinorrhoea, Vomiting (6265108-7)
on Jul 09, 2009 Female patient from UNITED STATES , weighting 17.90 lb, was diagnosed with
  • convulsion
and was treated with Fosphenytoin Sodium(View Usage). Patient experienced the following unwanted or unexpected effects: blood glucose increased, convulsion, cough, dyspnoea, feeding disorder, rhinorrhoea, vomiting. Fosphenytoin Sodium dosage: 160mg Iv Over 10min On Pump.

Showing 1-25 of 88 


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Alternative FOSPHENYTOIN Names:FOSPHENYT

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Side Effects reported to FDA: 88. View FDA Adverse Reports

Fosphenytoin safety alerts: 2008

Reported deaths: 12

Reported hospitalizations: 33

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Fosphenytoin Sodium (marketed as Cerebyx and generics)

Phenytoin (marketed as Dilantin, Phenytek and generics) and Fosphenytoin Sodium (marketed as Cerebyx and generics)

Audience: Neurological healthcare professionals 
[Posted 11/24/2008] FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais. Until the FDA evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the risks and benefits described in the current prescribing information for this drug. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502. A summary of the data currently being analyzed by FDA, and information for patients and healthcare professionals to consider, can be found in the links provided below.

[November 24, 2008 - Drug Information Page - FDA]
[November 24, 2008 - Information for Healthcare Professionals - FDA]

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Fosphenytoin Adverse Reactions
Hypotension ( 20 Reports)
Thrombocytopenia ( 11 Reports)
Bradycardia ( 8 Reports)
Convulsion ( 8 Reports)
Renal Failure Acute ( 7 Reports)
Cardiac Arrest ( 6 Reports) Cardiac arrest Questions
Haemoglobin Decreased ( 6 Reports)
Accidental Overdose ( 5 Reports)
Mental Status Changes ( 4 Reports)
Apnoea ( 3 Reports)
Blood Glucose Increased ( 3 Reports)
Condition Aggravated ( 3 Reports)
Convulsion Neonatal ( 3 Reports)
Dizziness ( 3 Reports) Dizziness Questions
Dyspnoea ( 3 Reports)
Encephalitis ( 3 Reports) Encephalitis Questions
Haemodialysis ( 3 Reports)
Hepatic Failure ( 3 Reports)
Infusion Related Reaction ( 3 Reports)
Ischaemic Hepatitis ( 3 Reports)
Lethargy ( 3 Reports)
Nystagmus ( 3 Reports)
Overdose ( 3 Reports)
Platelet Toxicity ( 3 Reports)
Pulse Absent ( 3 Reports)
Rash ( 3 Reports) Rash Questions
Rhabdomyolysis ( 3 Reports)
Unresponsive To Stimuli ( 3 Reports)
Agitation ( 2 Reports)
Altered State Of Consciousness ( 2 Reports)

side effects
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