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Phenytoin Sodium Side Effects

Common Phenytoin Sodium Side Effects


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If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Phenytoin Sodium Side Effects Reported to FDA

The following Phenytoin Sodium reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Phenytoin Sodium on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Thrombotic Thrombocytopenic Purpura
on Feb 24, 2014 Male from US , 50 years of age, was diagnosed with and was treated with Phenytoin Sodium. Directly after, patient experienced the unwanted or unexpected Phenytoin Sodium side effects: thrombotic thrombocytopenic purpura. Phenytoin Sodium dosage: N/A. Patient was hospitalized.

Hypotension, Convulsion, Pyrexia, Transaminases Increased, Ileus, Hepatotoxicity
Patient was taking Phenytoin Sodium Injection (40042-009-02) 50. Patient felt the following Phenytoin Sodium side effects: hypotension, convulsion, pyrexia, transaminases increased, ileus, hepatotoxicity on Feb 12, 2014 from US Additional patient health information: Female , 27 years of age, was diagnosed with and. Phenytoin Sodium Injection (40042-009-02) 50 dosage: Loading Dosse.
Multiple prescriptions taken:
  • Phenobarbital
  • Pentobarbital (Initial Dose)
  • Levetiracetam
  • Midazolam
  • Topiramate
  • Lacosamide
  • Norepinephrine
  • Lorazepam


Intentional Overdose, Ataxia, Dysarthria, Somnolence, Nystagmus, Mydriasis, Gingival Hypertrophy
Adverse event was reported on Feb 04, 2014 by a Female taking Phenytoin Sodium (Dosage: One Hundred 100mg Capsules) . Location: ZA , 21 years of age, After Phenytoin Sodium was administered, patient encountered several Phenytoin Sodium side effects: intentional overdose, ataxia, dysarthria, somnolence, nystagmus, mydriasis, gingival hypertrophy. Patient was hospitalized.

Cerebellar Atrophy
on Jan 20, 2014 Male from IN , child 10 years of age, was diagnosed with and was treated with Phenytoin Sodium. Directly after, patient experienced the unwanted or unexpected Phenytoin Sodium side effects: cerebellar atrophy. Phenytoin Sodium dosage: 5 Mg/kg, Od. Patient was hospitalized.


Sinus Tachycardia, Electrocardiogram Change
on Jan 16, 2014 Female from US , 52 years of age, was diagnosed with and was treated with Phenytoin Sodium. Patient felt the following Phenytoin Sodium side effects: sinus tachycardia, electrocardiogram change. Phenytoin Sodium dosage: Unk.
Multiple prescriptions taken:
  • Fosphenytoin Sodium (Unk)
  • Fluconazole (Unk)
  • Fluconazole
  • Vancomycin (Unk)
  • Vancomycin
  • Meropenem
  • Meropenem


Toxicity To Various Agents, International Normalised Ratio Increased, Ataxia, Dizziness, Lethargy, Dysarthria, Disorientation, Depression
Patient was taking Phenytoin Sodium. After Phenytoin Sodium was administered, patient encountered several Phenytoin Sodium side effects: toxicity to various agents, international normalised ratio increased, ataxia, dizziness, lethargy, dysarthria, disorientation, depression on Dec 26, 2013 from ES Additional patient health information: Female , 87 years of age, was diagnosed with and. Phenytoin Sodium dosage: 100 Mg, 4x/day.
Multiple concurrent drugs taken:
  • Acenocoumarol (Unk)
  • Metformin Hydrochloride/sitagliptin
  • Diltiazem
  • Torasemide
  • Ramipril
  • Haloperidol
Patient was hospitalized.

Convulsion, Pain, Product Quality Issue, Craniocerebral Injury, Fall, Excoriation, Erythema, Swelling
Adverse event was reported on Feb 28, 2014 by a Male taking Phenytoin Sodium Extended Capsules Usp 100mg (Dosage: N/A) . Location: US , 74 years of age, weighting 230.0 lb, Directly after, patient experienced the unwanted or unexpected Phenytoin Sodium side effects: convulsion, pain, product quality issue, craniocerebral injury, fall, excoriation, erythema, swelling.

Tubulointerstitial Nephritis
on Feb 21, 2014 Male from ES , 47 years of age, was diagnosed with and was treated with Phenytoin Sodium. Patient felt the following Phenytoin Sodium side effects: tubulointerstitial nephritis. Phenytoin Sodium dosage: 100 Mg, 3x/day, Last 7 Years. Patient was hospitalized.

Epidermolysis Bullosa, Immune Thrombocytopenic Purpura
on Nov 21, 2013 Male from US , child 3 years of age, was diagnosed with and was treated with Phenytoin Sodium. After Phenytoin Sodium was administered, patient encountered several Phenytoin Sodium side effects: epidermolysis bullosa, immune thrombocytopenic purpura. Phenytoin Sodium dosage: N/A.
Multiple concurrent drugs taken:
  • Valproic Acid Capsules, Usp 250 Mg
Patient was hospitalized.

Poisoning Deliberate, Victim Of Sexual Abuse, Hypokinesia, Fatigue, Somnolence
Patient was taking Phenytoin Sodium. Directly after, patient experienced the unwanted or unexpected Phenytoin Sodium side effects: poisoning deliberate, victim of sexual abuse, hypokinesia, fatigue, somnolence on Nov 01, 2013 from TR Additional patient health information: Female , 14 years of age, . Phenytoin Sodium dosage: Unk.
Associated medications used:
  • Topiramate (Unk)
  • Acetazolamide (Unk)
  • Oxcarbazepine (Unk)


Nail Disorder
Adverse event was reported on Oct 24, 2013 by a Female taking Phenytoin Sodium Extended Capsules Usp 100mg (Dosage: N/A) was diagnosed with and. Location: US , 53 years of age, weighting 120.0 lb, Patient felt the following Phenytoin Sodium side effects: nail disorder.
Multiple prescriptions taken:
  • One A Day Vitamin
  • Fish Oil
  • Vitamin D3
  • Folic Acid


Face Oedema, Erythema, Pyrexia
on Oct 21, 2013 Female from SG , 63 years of age, was treated with Phenytoin Sodium. After Phenytoin Sodium was administered, patient encountered several Phenytoin Sodium side effects: face oedema, erythema, pyrexia. Phenytoin Sodium dosage: N/A.

Toxicity To Various Agents, Faecaloma, Lethargy, Nystagmus, Dysarthria, Ataxia, Gait Disturbance, Hypokinesia
on Oct 18, 2013 Male from US , child 8 years of age, was diagnosed with and was treated with Phenytoin Sodium. Directly after, patient experienced the unwanted or unexpected Phenytoin Sodium side effects: toxicity to various agents, faecaloma, lethargy, nystagmus, dysarthria, ataxia, gait disturbance, hypokinesia. Phenytoin Sodium dosage: Unk.

Cerebellar Atrophy, Hyperthermia, Stupor
Patient was taking Phenytoin Sodium. Patient felt the following Phenytoin Sodium side effects: cerebellar atrophy, hyperthermia, stupor on Oct 18, 2013 from US Additional patient health information: Female , 28 years of age, was diagnosed with and. Phenytoin Sodium dosage: Unk.

Apnoeic Attack, Bradycardia
Adverse event was reported on Oct 16, 2013 by a Female taking Phenytoin Sodium (Dosage: Unk) was diagnosed with and. Location: US , child 11 years of age, After Phenytoin Sodium was administered, patient encountered several Phenytoin Sodium side effects: apnoeic attack, bradycardia.
Multiple concurrent drugs taken:
  • Dexamethasone Sodium Phosphate (Unk)
  • Phenobarbital (Unk)
  • Paraldehyde (6% Paraldehyde Infusion)
  • Paraldehyde (Titrated To 50 Ml/h)


Compartment Syndrome
on Sep 16, 2013 Male from IN , 16 years of age, was diagnosed with and was treated with Phenytoin Sodium. Directly after, patient experienced the unwanted or unexpected Phenytoin Sodium side effects: compartment syndrome. Phenytoin Sodium dosage: 1000 Mg In Normal Saline.

Electrocardiogram Qrs Complex Prolonged, Hypotension, Bradycardia, Nystagmus, Somnolence
on Sep 11, 2013 Male from AU , 73 years of age, was treated with Phenytoin Sodium. Patient felt the following Phenytoin Sodium side effects: electrocardiogram qrs complex prolonged, hypotension, bradycardia, nystagmus, somnolence. Phenytoin Sodium dosage: 15 Mg/kg, 1 G/h.

Electrocardiogram Qrs Complex Prolonged, Electrocardiogram Qt Prolonged, Status Epilepticus, Haemodialysis, Tachycardia, Toxicity To Various Agents
Patient was taking Phenytoin Sodium Injection (40042-009-02) 50. After Phenytoin Sodium was administered, patient encountered several Phenytoin Sodium side effects: electrocardiogram qrs complex prolonged, electrocardiogram qt prolonged, status epilepticus, haemodialysis, tachycardia, toxicity to various agents on Sep 06, 2013 from US Additional patient health information: Female , 52 years of age, was diagnosed with and. Phenytoin Sodium Injection (40042-009-02) 50 dosage: N/A.
Multiple concurrent drugs taken:
  • Fluconazole
  • Fosphenytoin Sodium Injection, Usp (025-21) (fosphenytoin Sodium)
  • Tacrolimus
  • Meropenem
  • Vancomycin


Cardiac Arrest, Bradycardia
Adverse event was reported on Sep 23, 2013 by a Patient taking Phenytoin Sodium (Dosage: 1 G, One Time) . Location: AU , 68 years of age, Directly after, patient experienced the unwanted or unexpected Phenytoin Sodium side effects: cardiac arrest, bradycardia.
Associated medications used:
  • Adalimumab
  • Acetylsalicylic Acid
  • Folic Acid
  • Methotrexate
  • Sotalol Hydrochloride (80 Mg, 1x/day)


Hypoaesthesia, Muscle Twitching, Muscle Spasms, Pruritus, Flushing, Pyrexia, Headache, Sleep Disorder, Vision Blurred
on Sep 12, 2013 Patient from GB , 44 years of age, was diagnosed with and was treated with Phenytoin Sodium. Patient felt the following Phenytoin Sodium side effects: hypoaesthesia, muscle twitching, muscle spasms, pruritus, flushing, pyrexia, headache, sleep disorder, vision blurred. Phenytoin Sodium dosage: 400mg, 1x/day At Night.
Multiple prescriptions taken:
  • Tegretol Retard (400mg, Long Term)


Somnolence, Gait Disturbance, Constipation, Peripheral Coldness, Blood Pressure Decreased, Abdominal Discomfort, Contusion, Product Substitution Issue
on Jul 22, 2013 Male from US , 72 years of age, weighting 170.0 lb, was treated with Phenytoin Sodium Extended Capsules Usp 100mg. After Phenytoin Sodium was administered, patient encountered several Phenytoin Sodium side effects: somnolence, gait disturbance, constipation, peripheral coldness, blood pressure decreased, abdominal discomfort, contusion, product substitution issue. Phenytoin Sodium Extended Capsules Usp 100mg dosage: N/A.

No Therapeutic Response
Patient was taking Phenytoin Sodium. Directly after, patient experienced the unwanted or unexpected Phenytoin Sodium side effects: no therapeutic response on Jul 03, 2013 from US Additional patient health information: Female , 44 years of age, weighting 180.0 lb, was diagnosed with and. Phenytoin Sodium dosage: 3 Am ?2 Pm?since 15y/o. Patient was hospitalized.

Urinary Retention
Adverse event was reported on Jun 27, 2013 by a Female taking Phenytoin Sodium (Dosage: 3-20 Mg/kg) was diagnosed with and. Location: IL , child 8 years of age, weighting 23.81 lb, Patient felt the following Phenytoin Sodium side effects: urinary retention. Patient was hospitalized.

Gait Disturbance, Dysarthria, Cognitive Disorder
on Jun 24, 2013 Female from US , 84 years of age, was diagnosed with and was treated with Phenytoin Sodium. After Phenytoin Sodium was administered, patient encountered several Phenytoin Sodium side effects: gait disturbance, dysarthria, cognitive disorder. Phenytoin Sodium dosage: N/A.
Multiple concurrent drugs taken:
  • Phenobarbital


Toxicity To Various Agents, Prescribed Overdose
on Jun 13, 2013 Patient from US , weighting 27.56 lb, was diagnosed with and was treated with Phenytoin Sodium. Directly after, patient experienced the unwanted or unexpected Phenytoin Sodium side effects: toxicity to various agents, prescribed overdose. Phenytoin Sodium dosage: Unk.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Phenytoin Sodium Side Effects

    Did You Have a Phenytoin Sodium Side Effect?

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    How Effective is Phenytoin Sodium for You?

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    Safety Alerts, Active Ingredients, Usage Information

    Alternative PHENYTOIN SODIUM Names:EXTENDED FOSPHENYT PHENYTOIN

    Active Ingredient: FOSPHENYT PHENYTOIN

    More About Phenytoin sodium

    Side Effects reported to FDA: 541

    Phenytoin Sodium safety alerts: 2008

    Reported deaths: 40

    Reported hospitalizations: 193

    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]

    Latest Phenytoin Sodium clinical trials