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side effects patient, 21 years of age, weighting 110.2 lb, took Phenytoin sodium Daily Dose: 250 Mg . View more Serious Adverse Events reported to FDA.

List of Phenytoin Sodium Adverse Effects reported to US Food and Drug Administration (FDA)

Showing 1-25 of 467 

Pancreatic Enzymes Increased (8228205-2)
on Mar 15, 2012 Female patient from JAPAN , 21 years of age, weighting 110.2 lb, was treated with Phenytoin Sodium. Patient experienced the following unwanted or unexpected effects: pancreatic enzymes increased. Phenytoin Sodium dosage: Daily Dose: 250 Mg.
Patient also using the following medications:
  • Keppra
  • Diprivan (Daily Dose: 500 Ml)


Cardiac Arrest (8219406-8)
Patient was taking Phenytoin Sodium. Patient had the following side effects: cardiac arrest on Mar 18, 2012 from EGYPT Additional patient health information: Female patient , 68 years of age, was diagnosed with
  • postoperative care
and. Phenytoin Sodium dosage: 150 Mg, 3x/day.

Convulsion, Amnesia, Product Substitution Issue, Communication Disorder, Vomiting (8216100-4)
Adverse event was reported on Feb 23, 2012 by a Female patient taking Phenytoin Sodium (Dosage: 200 Mg;qd) was diagnosed with
  • convulsion
and. Location: UNITED STATES , 66 years of age, weighting 150.0 lb, After Phenytoin Sodium was administered, patient had the following side effects: convulsion, amnesia, product substitution issue, communication disorder, vomiting.
Patient also using the following medications:
  • Vitamin D


(8202630-8)
on Mar 08, 2012 Female patient from EGYPT , 68 years of age, was diagnosed with
  • postoperative care
and was treated with Phenytoin Sodium. . Phenytoin Sodium dosage: 150 Mg, 3x/day.


Dry Mouth, Pollakiuria (8200251-4)
on Mar 09, 2012 Male patient from UNITED STATES , weighting 173.0 lb, was diagnosed with
  • epilepsy
  • convulsion
  • brain injury
and was treated with Phenytoin Sodium. Patient had the following side effects: dry mouth, pollakiuria. Phenytoin Sodium dosage: 100 Mg Ext Cap. 3 - B/f Bed -} 300mg Total.

Pancreatic Enzymes Increased (8193795-5)
Patient was taking Phenytoin Sodium. After Phenytoin Sodium was administered, patient had the following side effects: pancreatic enzymes increased on Feb 29, 2012 from JAPAN Additional patient health information: Female patient , 21 years of age, weighting 110.2 lb, . Phenytoin Sodium dosage: Daily Dose: 250 Mg.
Patient also using the following medications:
  • Keppra
  • Diprivan (Daily Dose: 500 Ml)


Balance Disorder, Diplopia, Tremor, Toxicity To Various Agents, Vomiting (8179108-3)
Adverse event was reported on Feb 17, 2012 by a Female patient taking Phenytoin Sodium (Dosage: 400 Mg (400 Mg, 1 In 1 D), Oral) was diagnosed with
  • epilepsy
  • depression
  • prophylaxis against gastrointestinal ulcer
and. Location: DENMARK , 67 years of age, Patient experienced the following unwanted or unexpected effects: balance disorder, diplopia, tremor, toxicity to various agents, vomiting.
Patient also using the following medications:
  • Citalopram Hydrobromide (20 Mg (20 Mg, 1 In 1 D), Oral)
  • Omeprazole (20 Mg (10 Mg, 1 In 1 D), Oral)
Patient was hospitalized.

Hypotension, Heart Rate Decreased (8177312-1)
on Feb 26, 2012 Female patient from ITALY , 73 years of age, was diagnosed with
  • convulsion
and was treated with Phenytoin Sodium. Patient had the following side effects: hypotension, heart rate decreased. Phenytoin Sodium dosage: 250 Mg, Total Dose.
Patient also using the following medications:
  • Valium


Respiratory Disorder, Somnolence (8174431-0)
on Feb 28, 2012 Female patient from UNITED KINGDOM , weighting 22.05 lb, was treated with Phenytoin Sodium. After Phenytoin Sodium was administered, patient had the following side effects: respiratory disorder, somnolence. Phenytoin Sodium dosage: N/A.
Patient also using the following medications:
  • Zonegran (60 Mg)
Patient was hospitalized and became disabled.

Nephritis, Hepatitis Acute, Erythema Multiforme (8170874-X)
Patient was taking Phenytoin Sodium Cap. Patient experienced the following unwanted or unexpected effects: nephritis, hepatitis acute, erythema multiforme on Feb 16, 2012 from JAPAN Additional patient health information: Male patient , 30 years of age, was diagnosed with
  • epilepsy
and. Phenytoin Sodium Cap dosage: Daily Dose: 200 Mg.
Patient also using the following medications:
  • Tegretol (Daily Dose: 400 Mg)
  • Keppra
Patient was hospitalized.

Epilepsy, Toxicity To Various Agents, Diplopia, Vomiting, Balance Disorder, Tremor (8164147-9)
Adverse event was reported on Feb 03, 2012 by a Female patient taking Phenytoin Sodium (Dosage: 400 Mg (400 Mg, 1 In 1 D), Oral, 5 Tablets,oral) was diagnosed with
  • epilepsy
and. Location: DENMARK , 67 years of age, Patient had the following side effects: epilepsy, toxicity to various agents, diplopia, vomiting, balance disorder, tremor.
Patient also using the following medications:
  • Telmisartan (telmisartan) (telmisartan)
  • Omeprazole (20 Mg (20 Mg, 1 In 1 D),oral)
  • Citalopram Hydrobromide (20 Mg (20 Mg, 1 In 1 D),oral )
Patient was hospitalized.

Convulsion (8158940-6)
on Feb 06, 2012 Male patient from UNITED KINGDOM , 66 years of age, was treated with Phenytoin Sodium. After Phenytoin Sodium was administered, patient had the following side effects: convulsion. Phenytoin Sodium dosage: 475 Mg Milligram(s),.

Encephalitis, Disease Progression, Purpura, Pallor, Epilepsy, Erythema, Cerebral Atrophy, Status Epilepticus (8158018-1)
on Feb 14, 2012 Female patient from JAPAN , 59 years of age, was diagnosed with
  • epilepsy
  • simple partial seizures
and was treated with Phenytoin Sodium Cap. Patient experienced the following unwanted or unexpected effects: encephalitis, disease progression, purpura, pallor, epilepsy, erythema, cerebral atrophy, status epilepticus. Phenytoin Sodium Cap dosage: Unk Ukn, Unk.
Patient also using the following medications:
  • Valproic Acid (Unk Ukn, Unk)
  • Tegretol (Unk Ukn, Unk)
  • Tegretol (600 Mg, Daily)
Patient was hospitalized.

Electroencephalogram Abnormal, Toxicity To Various Agents, Diplopia, Balance Disorder, Tremor, Vomiting (8155412-X)
Patient was taking Phenytoin Sodium. Patient had the following side effects: electroencephalogram abnormal, toxicity to various agents, diplopia, balance disorder, tremor, vomiting on Feb 02, 2012 from DENMARK Additional patient health information: Female patient , 67 years of age, was diagnosed with
  • epilepsy
  • prophylaxis against gastrointestinal ulcer
and. Phenytoin Sodium dosage: 500 Mg (500 Mg, 1 In 1 D),oral.
Patient also using the following medications:
  • Omeprazole (20 Mg (20 Mg, 1 In 1 D), Oral)
  • Telmisartan (telmisartan) (telmisartan)
  • Citalopram Hydrobromide (20 Mg (20 Mg, 1 In 1 D), Oral)
Patient was hospitalized.

Vomiting, Convulsion (8153596-0)
Adverse event was reported on Jan 31, 2012 by a Female patient taking Phenytoin Sodium (Dosage: 200 Mg; Qd) was diagnosed with
  • convulsion
and. Location: UNITED STATES , 66 years of age, weighting 150.0 lb, After Phenytoin Sodium was administered, patient had the following side effects: vomiting, convulsion.
Patient also using the following medications:
  • Vitamin D


Acute Respiratory Distress Syndrome, Pneumonia Aspiration (8129539-2)
on Feb 06, 2012 Male patient from JAPAN , 72 years of age, weighting 110.2 lb, was diagnosed with
  • grand mal convulsion
and was treated with Phenytoin Sodium Cap. Patient experienced the following unwanted or unexpected effects: acute respiratory distress syndrome, pneumonia aspiration. Phenytoin Sodium Cap dosage: Total Daily Dose : 2.4 Gm.
Patient also using the following medications:
  • Keppra


Vomiting, Diplopia, Balance Disorder, Tremor (8125658-5)
on Jan 24, 2012 Female patient from DENMARK , 67 years of age, was diagnosed with
  • epilepsy
  • depression
and was treated with Phenytoin Sodium. Patient had the following side effects: vomiting, diplopia, balance disorder, tremor. Phenytoin Sodium dosage: 5 Tablets, Oral.
Patient also using the following medications:
  • Citalopram Hydrobromide (20 Mg (20 Mg, 1 In 1 D), Oral)
  • Telmisartan (telmisartan) (telmisartan)
Patient was hospitalized.

Grand Mal Convulsion (8123134-7)
Patient was taking Phenytoin Sodium Cap. After Phenytoin Sodium was administered, patient had the following side effects: grand mal convulsion on Jan 31, 2012 from UNITED STATES Additional patient health information: Male patient , weighting 178.0 lb, was diagnosed with
  • brain injury
and. Phenytoin Sodium Cap dosage: N/A.

Neuroendocrine Carcinoma Of The Skin, Lymphadenopathy (8122456-3)
Adverse event was reported on Jan 20, 2012 by a Female patient taking Phenytoin Sodium (Dosage: 1 Caps 2x/day; Oral) was diagnosed with
  • epilepsy
and. Location: UNITED STATES , 74 years of age, weighting 145.0 lb, Patient experienced the following unwanted or unexpected effects: neuroendocrine carcinoma of the skin, lymphadenopathy.
Patient also using the following medications:
  • Glucosamine


Affective Disorder, Depression, Agitation, Anxiety, Irritability, Restlessness, Insomnia, Aggression, Abnormal Behaviour (8119810-2)
on Feb 06, 2012 Male patient from UNITED STATES , weighting 211.0 lb, was diagnosed with
  • convulsion
and was treated with Phenytoin Sodium. Patient had the following side effects: affective disorder, depression, agitation, anxiety, irritability, restlessness, insomnia, aggression, abnormal behaviour. Phenytoin Sodium dosage: 2 In Morning 3 At Night Morning + Night.

Tremor, Diplopia, Vomiting, Balance Disorder, Electroencephalogram Abnormal (8118568-0)
on Jan 19, 2012 Female patient from DENMARK , 67 years of age, was diagnosed with
  • epilepsy
  • depression
  • prophylaxis against gastrointestinal ulcer
and was treated with Phenytoin Sodium. After Phenytoin Sodium was administered, patient had the following side effects: tremor, diplopia, vomiting, balance disorder, electroencephalogram abnormal. Phenytoin Sodium dosage: 500 Mg (500 Mg,1 In 1 D),oral.
Patient also using the following medications:
  • Citalopram Hydrobromide (20 Mg (20 Mg,1 In 1 D),oral)
  • Omeprazole (20 Mg (20 Mg,1 In 1 D),oral)
Patient was hospitalized.

Gingival Hyperplasia (8074311-5)
Patient was taking Phenytoin Sodium Cap. Patient experienced the following unwanted or unexpected effects: gingival hyperplasia on Jan 17, 2012 from UNITED STATES Additional patient health information: Female patient , 26 years of age, was diagnosed with
  • convulsion
and. Phenytoin Sodium Cap dosage: N/A. Patient was hospitalized.

Hypersensitivity, Cholestasis, Eosinophilia, Rash, Pruritus (8072472-5)
Adverse event was reported on Jan 18, 2012 by a Female patient taking Phenytoin Sodium (Dosage: Unk) . Location: FRANCE , 80 years of age, Patient had the following side effects: hypersensitivity, cholestasis, eosinophilia, rash, pruritus.
Patient also using the following medications:
  • Cordarone (Unk)
  • Keppra (Unk)
Patient was hospitalized.

Lymphadenopathy, Product Substitution Issue, Neuroendocrine Carcinoma Of The Skin (8053072-X)
on Dec 28, 2011 Female patient from UNITED STATES , 74 years of age, weighting 145.0 lb, was diagnosed with
  • epilepsy
and was treated with Phenytoin Sodium. After Phenytoin Sodium was administered, patient had the following side effects: lymphadenopathy, product substitution issue, neuroendocrine carcinoma of the skin. Phenytoin Sodium dosage: 1 Caps 2x/day; Oral.

Constipation, Somnolence, Confusional State (8053057-3)
on Jan 07, 2012 Female patient from UNITED STATES , 51 years of age, weighting 145.0 lb, was diagnosed with
  • convulsion
and was treated with Phenytoin Sodium. Patient experienced the following unwanted or unexpected effects: constipation, somnolence, confusional state. Phenytoin Sodium dosage: 2 To 5 Caps Daily; Oral.
Patient also using the following medications:
  • Levothyroxine Sodium
  • Vitamin E + Calcium


Showing 1-25 of 467 

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Phenytoin Sodium Information

Alternative PHENYTOIN SODIUM Names:EXTENDED FOSPHENYT PHENYTOIN

Substance:FOSPHENYT PHENYTOIN

More About Phenytoin sodium

Side Effects reported to FDA: 467. View FDA Adverse Reports

Phenytoin Sodium safety alerts: 2008

Reported deaths: 33

Reported hospitalizations: 135

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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Phenytoin Sodium Adverse Reactions

Convulsion ( 116 Reports)

Dizziness ( 30 Reports)

Grand Mal Convulsion ( 30 Reports)

Fall ( 25 Reports)

Balance Disorder ( 24 Reports)

Product Substitution Issue ( 23 Reports)

Confusional State ( 22 Reports)

Stevens-johnson Syndrome ( 22 Reports)

Somnolence ( 20 Reports)

Tremor ( 20 Reports)

Pyrexia ( 18 Reports)

Loss Of Consciousness ( 17 Reports)

Condition Aggravated ( 16 Reports)

Epilepsy ( 16 Reports)

Vision Blurred ( 16 Reports)

Feeling Abnormal ( 15 Reports)

Fatigue ( 14 Reports)

Ataxia ( 13 Reports)

Diplopia ( 12 Reports)

Headache ( 12 Reports)

Nystagmus ( 12 Reports)

Dysarthria ( 11 Reports)

Rash ( 11 Reports)

Vomiting ( 11 Reports)

Coordination Abnormal ( 10 Reports)

Overdose ( 10 Reports)

Toxicity To Various Agents ( 10 Reports)

Asthenia ( 9 Reports)

Malaise ( 9 Reports)

Treatment Noncompliance ( 9 Reports)

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