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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
This is a report of a 50-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: convulsion, who was treated with Phenytoin Sodium (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Thrombotic Thrombocytopenic Purpura
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Phenytoin Sodium treatment in male patients, resulting in thrombotic thrombocytopenic purpura side effect. The patient was hospitalized.

Hypotension, Convulsion, Pyrexia, Transaminases Increased, Ileus, Hepatotoxicity
This report suggests a potential Phenytoin Sodium Injection (40042-009-02) 50 Hypotension, Convulsion, Pyrexia, Transaminases Increased, Ileus, Hepatotoxicity side effect(s) that can have serious consequences. A 27-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: convulsion and used Phenytoin Sodium Injection (40042-009-02) 50 (dosage: Loading Dosse) starting NS. Soon after starting Phenytoin Sodium Injection (40042-009-02) 50 the patient began experiencing various side effects, including:
  • Hypotension
  • Convulsion
  • Pyrexia
  • Transaminases Increased
  • Ileus
  • Hepatotoxicity
Drugs used concurrently:
  • Phenobarbital
  • Pentobarbital (Initial Dose)
  • Levetiracetam
  • Midazolam
  • Topiramate
  • Lacosamide
  • Norepinephrine
  • Lorazepam
Although Phenytoin Sodium Injection (40042-009-02) 50 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as hypotension, may still occur.

Intentional Overdose, Ataxia, Dysarthria, Somnolence, Nystagmus, Mydriasis, Gingival Hypertrophy
This Intentional Overdose, Ataxia, Dysarthria, Somnolence, Nystagmus, Mydriasis, Gingival Hypertrophy problem was reported by a health professional from ZA. A 21-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Phenytoin Sodium (dosage: One Hundred 100mg Capsules). The following drugs were being taken at the same time: NA. When commencing Phenytoin Sodium, the patient experienced the following unwanted symptoms/side effects:
  • Intentional Overdose
  • Ataxia
  • Dysarthria
  • Somnolence
  • Nystagmus
  • Mydriasis
  • Gingival Hypertrophy
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as intentional overdose, may become evident only after a product is in use by the general population.

Cerebellar Atrophy
This is a report of a 10-year-old male patient (weight: NA) from IN. The patient developed the following symptoms/conditions: convulsion and was treated with Phenytoin Sodium (dosage: 5 Mg/kg, Od) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Cerebellar Atrophy
The patient was hospitalized. This opens a possibility that Phenytoin Sodium treatment could cause the above reactions, including cerebellar atrophy, and some male subjects may be more susceptible.


Sinus Tachycardia, Electrocardiogram Change
A 52-year-old female patient (weight: NA) from US with the following symptoms/conditions: status epilepticus started Phenytoin Sodium treatment (dosage: Unk) on NS. Soon after starting Phenytoin Sodium treatment, the subject experienced various side effects, including:
  • Sinus Tachycardia
  • Electrocardiogram Change
Concurrently used drugs:
  • Fosphenytoin Sodium (Unk)
  • Fluconazole (Unk)
  • Fluconazole
  • Vancomycin (Unk)
  • Vancomycin
  • Meropenem
  • Meropenem
This finding indicates that some female patients could be more vulnerable to Phenytoin Sodium.

Toxicity To Various Agents, International Normalised Ratio Increased, Ataxia, Dizziness, Lethargy, Dysarthria, Disorientation, Depression
A 87-year-old female patient from ES (weight: NA) experienced symptoms, such as: epilepsy and was treated with Phenytoin Sodium(dosage: 100 Mg, 4x/day). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Toxicity To Various Agents
  • International Normalised Ratio Increased
  • Ataxia
  • Dizziness
  • Lethargy
  • Dysarthria
  • Disorientation
  • Depression
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Phenytoin Sodium efficacy:
  • Acenocoumarol (Unk)
  • Metformin Hydrochloride/sitagliptin
  • Diltiazem
  • Torasemide
  • Ramipril
  • Haloperidol
The patient was hospitalized.

Convulsion, Pain, Product Quality Issue, Craniocerebral Injury, Fall, Excoriation, Erythema, Swelling
In this report, Phenytoin Sodium Extended Capsules Usp 100mg was administered for the following condition: NA.A 74-year-old male consumer from US (weight: NA) started Phenytoin Sodium Extended Capsules Usp 100mg treatment (dosage: NA) on 2012.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Convulsion
  • Pain
  • Product Quality Issue
  • Craniocerebral Injury
  • Fall
  • Excoriation
  • Erythema
  • Swelling
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Phenytoin Sodium Extended Capsules Usp 100mg treatment could be related to the listed above side effect(s).

Tubulointerstitial Nephritis
This is a report of the following Phenytoin Sodium side effect(s):
  • Tubulointerstitial Nephritis
A 47-year-old male patient from ES (weight: NA) presented with the following condition: partial seizures,complex partial seizures and received a treatment with Phenytoin Sodium (dosage: 100 Mg, 3x/day, Last 7 Years) starting: NS.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Phenytoin Sodium treatment could be associated with the listed above side effect(s).

Epidermolysis Bullosa, Immune Thrombocytopenic Purpura
This Phenytoin Sodium report was submitted by a 3-year-old male consumer from US (weight: NA). The patient was diagnosed with: epilepsy and Phenytoin Sodium was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Epidermolysis Bullosa
  • Immune Thrombocytopenic Purpura
Other drugs used simultaneously:
  • Valproic Acid Capsules, Usp 250 Mg
The patient was hospitalized.Those unexpected symptoms could be linked to a Phenytoin Sodium treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Poisoning Deliberate, Victim Of Sexual Abuse, Hypokinesia, Fatigue, Somnolence
This is a report of a possible correlation between Phenytoin Sodium use and the following symptoms/side effect(s):
  • Poisoning Deliberate
  • Victim Of Sexual Abuse
  • Hypokinesia
  • Fatigue
  • Somnolence
which could contribute to an assessment of Phenytoin Sodium risk profile.A 14-year-old female consumer from TR (weight: NA) was suffering from NA and was treated with Phenytoin Sodium (dosage: Unk) starting NS.Other concurrent medications:
  • Topiramate (Unk)
  • Acetazolamide (Unk)
  • Oxcarbazepine (Unk)


Nail Disorder
A 53-year-old female patient from US (weight: NA) presented with the following symptoms: convulsion and after a treatment with Phenytoin Sodium Extended Capsules Usp 100mg (dosage: NA) experienced the following side effect(s):
  • Nail Disorder
The treatment was started on 2012. Phenytoin Sodium Extended Capsules Usp 100mg was used in combination with the following drugs:
  • One A Day Vitamin
  • Fish Oil
  • Vitamin D3
  • Folic Acid
This report could alert potential Phenytoin Sodium Extended Capsules Usp 100mg consumers.

Face Oedema, Erythema, Pyrexia
In this report, a 63-year-old female patient from SG (weight: NA) was affected by a possible Phenytoin Sodium side effect.The patient was diagnosed with NA. After a treatment with Phenytoin Sodium (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Face Oedema
  • Erythema
  • Pyrexia
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Phenytoin Sodium treatment.

Toxicity To Various Agents, Faecaloma, Lethargy, Nystagmus, Dysarthria, Ataxia, Gait Disturbance, Hypokinesia
This is a report of a 8-year-old male patient from US (weight: NA), who used Phenytoin Sodium (dosage: Unk) for a treatment of convulsion. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Toxicity To Various Agents
  • Faecaloma
  • Lethargy
  • Nystagmus
  • Dysarthria
  • Ataxia
  • Gait Disturbance
  • Hypokinesia
The following drugs could possibly have interacted with the Phenytoin Sodium treatment NA.Taken together, these observations suggest that a Phenytoin Sodium treatment could be related to side effect(s), such as Toxicity To Various Agents, Faecaloma, Lethargy, Nystagmus, Dysarthria, Ataxia, Gait Disturbance, Hypokinesia.

Cerebellar Atrophy, Hyperthermia, Stupor
This death side effect was reported by a health professional from US. A 28-year-old female patient (weight:NA) experienced the following symptoms/conditions: status epilepticus. The patient was prescribed Phenytoin Sodium (dosage: Unk), which was started on NS. Concurrently used drugs: NA. When starting to take Phenytoin Sodium the consumer reported the following symptoms:
  • Cerebellar Atrophy
  • Hyperthermia
  • Stupor
These side effects may potentially be related to Phenytoin Sodium.

Apnoeic Attack, Bradycardia
This is a Phenytoin Sodium side effect report of a 11-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: convulsion, who was treated with Phenytoin Sodium (dosage:Unk, start time: NS), combined with:
  • Dexamethasone Sodium Phosphate (Unk)
  • Phenobarbital (Unk)
  • Paraldehyde (6% Paraldehyde Infusion)
  • Paraldehyde (Titrated To 50 Ml/h)
, and developed a serious reaction and a apnoeic attack side effect. The patient presented with:
  • Apnoeic Attack
  • Bradycardia
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Phenytoin Sodium treatment in female patients suffering from convulsion, resulting in apnoeic attack.

Compartment Syndrome
This report suggests a potential Phenytoin Sodium compartment syndrome side effect(s) that can have serious consequences. A 16-year-old male patient from IN (weight:NA) was diagnosed with the following health condition(s): grand mal convulsion and used Phenytoin Sodium (dosage: 1000 Mg In Normal Saline) starting NS. Soon after starting Phenytoin Sodium the patient began experiencing various side effects, including:
  • Compartment Syndrome
Drugs used concurrently:NA. Although Phenytoin Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as compartment syndrome, may still occur.

Electrocardiogram Qrs Complex Prolonged, Hypotension, Bradycardia, Nystagmus, Somnolence
This electrocardiogram qrs complex prolonged problem was reported by a health professional from AU. A 73-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Phenytoin Sodium (dosage: 15 Mg/kg, 1 G/h). The following drugs/medications were being taken at the same time: NA. When commencing Phenytoin Sodium, the patient experienced the following unwanted symptoms /side effects:
  • Electrocardiogram Qrs Complex Prolonged
  • Hypotension
  • Bradycardia
  • Nystagmus
  • Somnolence
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as electrocardiogram qrs complex prolonged, may become evident only after a product is in use by the general population.

Electrocardiogram Qrs Complex Prolonged, Electrocardiogram Qt Prolonged, Status Epilepticus, Haemodialysis, Tachycardia, Toxicity To Various Agents
This is a Phenytoin Sodium Injection (40042-009-02) 50 side effect report of a 52-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: status epilepticus and was treated with Phenytoin Sodium Injection (40042-009-02) 50 (dosage: NA) starting NS. Concurrently used drugs:
  • Fluconazole
  • Fosphenytoin Sodium Injection, Usp (025-21) (fosphenytoin Sodium)
  • Tacrolimus
  • Meropenem
  • Vancomycin
Soon after that, the consumer experienced the following of symptoms:
  • Electrocardiogram Qrs Complex Prolonged
  • Electrocardiogram Qt Prolonged
  • Status Epilepticus
  • Haemodialysis
  • Tachycardia
  • Toxicity To Various Agents
This opens a possibility that Phenytoin Sodium Injection (40042-009-02) 50 could cause electrocardiogram qrs complex prolonged and that some female patients may be more susceptible.

Cardiac Arrest, Bradycardia
A 68-year-old patient (weight: NA) from AU with the following symptoms: NA started Phenytoin Sodium treatment (dosage: 1 G, One Time) on Feb 08, 2013. Soon after starting Phenytoin Sodium treatment, the consumer experienced several side effects, including:
  • Cardiac Arrest
  • Bradycardia
. Concurrently used drugs:
  • Adalimumab
  • Acetylsalicylic Acid
  • Folic Acid
  • Methotrexate
  • Sotalol Hydrochloride (80 Mg, 1x/day)
This finding indicates that some patients can be more vulnerable to developing Phenytoin Sodium side effects, such as cardiac arrest.

Hypoaesthesia, Muscle Twitching, Muscle Spasms, Pruritus, Flushing, Pyrexia, Headache, Sleep Disorder, Vision Blurred
This hypoaesthesia side effect was reported by a pharmacist from GB. A 44-year-old patient (weight:NA) experienced the following symptoms/conditions: epilepsy.The patient was prescribed Phenytoin Sodium (dosage: 400mg, 1x/day At Night), which was started on Aug 01, 2013. Concurrently used drugs:
  • Tegretol Retard (400mg, Long Term)
.When starting to take Phenytoin Sodium the consumer reported symptoms, such as:
  • Hypoaesthesia
  • Muscle Twitching
  • Muscle Spasms
  • Pruritus
  • Flushing
  • Pyrexia
  • Headache
  • Sleep Disorder
  • Vision Blurred
These side effects may potentially be related to Phenytoin Sodium.

Somnolence, Gait Disturbance, Constipation, Peripheral Coldness, Blood Pressure Decreased, Abdominal Discomfort, Contusion, Product Substitution Issue
This is a report of a 72-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Phenytoin Sodium Extended Capsules Usp 100mg (dosage: NA, start time: 1993), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Somnolence
  • Gait Disturbance
  • Constipation
  • Peripheral Coldness
  • Blood Pressure Decreased
  • Abdominal Discomfort
  • Contusion
  • Product Substitution Issue
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Phenytoin Sodium Extended Capsules Usp 100mg treatment in male patients, resulting in somnolence side effect.

No Therapeutic Response
This report suggests a potential Phenytoin Sodium No Therapeutic Response side effect(s) that can have serious consequences. A 44-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: status epilepticus and used Phenytoin Sodium (dosage: 3 Am ?2 Pm?since 15y/o) starting NS. Soon after starting Phenytoin Sodium the patient began experiencing various side effects, including:
  • No Therapeutic Response
Drugs used concurrently: NA.The patient was hospitalized. Although Phenytoin Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as no therapeutic response, may still occur.

Urinary Retention
This Urinary Retention problem was reported by a physician from IL. A 8-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: convulsion. On NS this consumer started treatment with Phenytoin Sodium (dosage: 3-20 Mg/kg). The following drugs were being taken at the same time: NA. When commencing Phenytoin Sodium, the patient experienced the following unwanted symptoms/side effects:
  • Urinary Retention
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as urinary retention, may become evident only after a product is in use by the general population.

Gait Disturbance, Dysarthria, Cognitive Disorder
This is a report of a 84-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: convulsion and was treated with Phenytoin Sodium (dosage: NA) starting NS. Concurrently used drugs:
  • Phenobarbital
Soon after that, the consumer experienced the following side effects:
  • Gait Disturbance
  • Dysarthria
  • Cognitive Disorder
This opens a possibility that Phenytoin Sodium treatment could cause the above reactions, including gait disturbance, and some female subjects may be more susceptible.

Toxicity To Various Agents, Prescribed Overdose
A patient (weight: NA) from US with the following symptoms/conditions: convulsion started Phenytoin Sodium treatment (dosage: Unk) on NS. Soon after starting Phenytoin Sodium treatment, the subject experienced various side effects, including:
  • Toxicity To Various Agents
  • Prescribed Overdose
Concurrently used drugs: NA. This finding indicates that some patients could be more vulnerable to Phenytoin Sodium.

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Top 10 Phenytoin Sodium Side Effects for Women

Women Side EffectsReports
Convulsion 59
Dizziness 16
Somnolence 15
Grand Mal Convulsion 14
Pyrexia 14
Tremor 14
Balance Disorder 13
Product Substitution Issue 13
Feeling Abnormal 12
Toxicity To Various Agents 12

Top 10 Phenytoin Sodium Side Effects for Men

Men Side EffectsReports
Convulsion 62
Confusional State 18
Dizziness 18
Fall 17
Grand Mal Convulsion 16
Loss Of Consciousness 13
Somnolence 13
Dysarthria 12
Nystagmus 12
Balance Disorder 11

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

    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

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    How Effective is Phenytoin Sodium for You?

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    Phenytoin Sodium Safety Alerts, Active Ingredients, Usage Information

    NDC0143-9782
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameFosphenytoin Sodium
    NameFosphenytoin Sodium
    Dosage FormINJECTION, SOLUTION
    RouteINTRAMUSCULAR; INTRAVENOUS
    On market since20091202
    LabelerWest-Ward Pharmaceutical Corp
    Active Ingredient(s)FOSPHENYTOIN SODIUM
    Strength(s)50
    Unit(s)mg/mL
    Pharma ClassAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

    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