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Phenytoin Sodium Side Effects

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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.

Phenytoin Sodium Side Effects Reported to FDA



Phenytoin Sodium Side Effect Report#9918832
Thrombotic Thrombocytopenic Purpura
This is a report of a 50-year-old male patient (weight: NA) from US, suffering from the following health 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): Thrombotic Thrombocytopenic Purpura 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.
Phenytoin Sodium Side Effect Report#9909099
Hypotension, Convulsion, Pyrexia, Transaminases Increased, Ileus, Hepatotoxicity
This report suggests a potential Phenytoin Sodium Injection (40042-009-02) 50 Hypotension 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. After starting Phenytoin Sodium Injection (40042-009-02) 50 the patient began experiencing various side effects, including: Hypotension, Convulsion, Pyrexia, Transaminases Increased, Ileus, HepatotoxicityAdditional 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.
Phenytoin Sodium Side Effect Report#9868538
Intentional Overdose, Ataxia, Dysarthria, Somnolence, Nystagmus, Mydriasis, Gingival Hypertrophy
This Intentional Overdose 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 using Phenytoin Sodium, the patient experienced the following unwanted symptoms/side effects: Intentional Overdose, Ataxia, Dysarthria, Somnolence, Nystagmus, Mydriasis, Gingival HypertrophyThe 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.
Phenytoin Sodium Side Effect Report#9829575
Cerebellar Atrophy
This Cerebellar Atrophy side effect was reported by a health professional from IN. A 10-year-old male patient (weight:NA) experienced the following symptoms/conditions: convulsion.The patient was prescribed Phenytoin Sodium (drug dosage: 5 Mg/kg, Od), which was initiated on NS. Concurrently used drugs: NA..After starting to take Phenytoin Sodium the consumer reported adverse symptoms, such as: Cerebellar AtrophyThese side effects may potentially be related to Phenytoin Sodium. The patient was hospitalized.
Phenytoin Sodium Side Effect Report#9822803
Sinus Tachycardia, Electrocardiogram Change
This is a report of a 52-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: status epilepticus, who was treated with Phenytoin Sodium (dosage: Unk, start time: NS), combined with:
  • Fosphenytoin Sodium (Unk)
  • Fluconazole (Unk)
  • Fluconazole
  • Vancomycin (Unk)
  • Vancomycin
  • Meropenem
  • Meropenem
and developed a serious reaction and side effect(s): Sinus Tachycardia, Electrocardiogram Change after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Phenytoin Sodium treatment in female patients, resulting in Sinus Tachycardia side effect.
Phenytoin Sodium Side Effect Report#9782977
Toxicity To Various Agents, International Normalised Ratio Increased, Ataxia, Dizziness, Lethargy, Dysarthria, Disorientation, Depression
This report suggests a potential Phenytoin Sodium Toxicity To Various Agents side effect(s) that can have serious consequences. A 87-year-old female patient (weight: NA) from ES was diagnosed with the following symptoms/conditions: epilepsy and used Phenytoin Sodium (dosage: 100 Mg, 4x/day) starting NS. After starting Phenytoin Sodium the patient began experiencing various side effects, including: Toxicity To Various Agents, International Normalised Ratio Increased, Ataxia, Dizziness, Lethargy, Dysarthria, Disorientation, DepressionAdditional drugs used concurrently:
  • Acenocoumarol (Unk)
  • Metformin Hydrochloride/sitagliptin
  • Diltiazem
  • Torasemide
  • Ramipril
  • Haloperidol
The patient was hospitalized. Although Phenytoin Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Toxicity To Various Agents, may still occur.
Phenytoin Sodium Side Effect Report#9773476
Convulsion, Pain, Product Quality Issue, Craniocerebral Injury, Fall, Excoriation, Erythema, Swelling
This Convulsion problem was reported by a health professional from US. A 74-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 2012 this consumer started treatment with Phenytoin Sodium Extended Capsules Usp 100mg (dosage: NA). The following drugs were being taken at the same time: NA. When using Phenytoin Sodium Extended Capsules Usp 100mg, the patient experienced the following unwanted symptoms/side effects: Convulsion, Pain, Product Quality Issue, Craniocerebral Injury, Fall, Excoriation, Erythema, SwellingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Convulsion, may become evident only after a product is in use by the general population.
Phenytoin Sodium Side Effect Report#9705372
Tubulointerstitial Nephritis
This Tubulointerstitial Nephritis side effect was reported by a health professional from ES. A 47-year-old male patient (weight:NA) experienced the following symptoms/conditions: partial seizures,complex partial seizures.The patient was prescribed Phenytoin Sodium (drug dosage: 100 Mg, 3x/day, Last 7 Years), which was initiated on NS. Concurrently used drugs: NA..After starting to take Phenytoin Sodium the consumer reported adverse symptoms, such as: Tubulointerstitial NephritisThese side effects may potentially be related to Phenytoin Sodium. The patient was hospitalized.
Phenytoin Sodium Side Effect Report#9700384
Epidermolysis Bullosa, Immune Thrombocytopenic Purpura
This is a report of a 3-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: epilepsy, who was treated with Phenytoin Sodium (dosage: NA, start time: NS), combined with:
  • Valproic Acid Capsules, Usp 250 Mg
and developed a serious reaction and side effect(s): Epidermolysis Bullosa, Immune Thrombocytopenic Purpura after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Phenytoin Sodium treatment in male patients, resulting in Epidermolysis Bullosa side effect. The patient was hospitalized.
Phenytoin Sodium Side Effect Report#9664425
Poisoning Deliberate, Victim Of Sexual Abuse, Hypokinesia, Fatigue, Somnolence
This report suggests a potential Phenytoin Sodium Poisoning Deliberate side effect(s) that can have serious consequences. A 14-year-old female patient (weight: NA) from TR was diagnosed with the following symptoms/conditions: NA and used Phenytoin Sodium (dosage: Unk) starting NS. After starting Phenytoin Sodium the patient began experiencing various side effects, including: Poisoning Deliberate, Victim Of Sexual Abuse, Hypokinesia, Fatigue, SomnolenceAdditional drugs used concurrently:
  • Topiramate (Unk)
  • Acetazolamide (Unk)
  • Oxcarbazepine (Unk)
Although Phenytoin Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Poisoning Deliberate, may still occur.
Phenytoin Sodium Side Effect Report#9642687
Nail Disorder
This Nail Disorder problem was reported by a consumer or non-health professional from US. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: convulsion. On 2012 this consumer started treatment with Phenytoin Sodium Extended Capsules Usp 100mg (dosage: NA). The following drugs were being taken at the same time:
  • One A Day Vitamin
  • Fish Oil
  • Vitamin D3
  • Folic Acid
When using Phenytoin Sodium Extended Capsules Usp 100mg, the patient experienced the following unwanted symptoms/side effects: Nail DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nail Disorder, may become evident only after a product is in use by the general population.
Phenytoin Sodium Side Effect Report#9633302
Face Oedema, Erythema, Pyrexia
This Face Oedema side effect was reported by a health professional from SG. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Phenytoin Sodium (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Phenytoin Sodium the consumer reported adverse symptoms, such as: Face Oedema, Erythema, PyrexiaThese side effects may potentially be related to Phenytoin Sodium.
Phenytoin Sodium Side Effect Report#9631741
Toxicity To Various Agents, Faecaloma, Lethargy, Nystagmus, Dysarthria, Ataxia, Gait Disturbance, Hypokinesia
This is a report of a 8-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: convulsion, who was treated with Phenytoin Sodium (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Toxicity To Various Agents, Faecaloma, Lethargy, Nystagmus, Dysarthria, Ataxia, Gait Disturbance, Hypokinesia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Phenytoin Sodium treatment in male patients, resulting in Toxicity To Various Agents side effect.
Phenytoin Sodium Side Effect Report#9631065
Cerebellar Atrophy, Hyperthermia, Stupor
This report suggests a potential Phenytoin Sodium Death side effect(s) that can have serious consequences. A 28-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: status epilepticus and used Phenytoin Sodium (dosage: Unk) starting NS. After starting Phenytoin Sodium the patient began experiencing various side effects, including: Cerebellar Atrophy, Hyperthermia, StuporAdditional drugs used concurrently: NA. Although Phenytoin Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Phenytoin Sodium Side Effect Report#9557884
Apnoeic Attack, Bradycardia
This Apnoeic Attack problem was reported by a health professional from US. A 11-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: convulsion. On NS this consumer started treatment with Phenytoin Sodium (dosage: Unk). The following drugs were being taken at the same time:
  • Dexamethasone Sodium Phosphate (Unk)
  • Phenobarbital (Unk)
  • Paraldehyde (6% Paraldehyde Infusion)
  • Paraldehyde (Titrated To 50 Ml/h)
When using Phenytoin Sodium, the patient experienced the following unwanted symptoms/side effects: Apnoeic Attack, BradycardiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Apnoeic Attack, may become evident only after a product is in use by the general population.
Phenytoin Sodium Side Effect Report#9524945
Compartment Syndrome
This Compartment Syndrome side effect was reported by a health professional from IN. A 16-year-old male patient (weight:NA) experienced the following symptoms/conditions: grand mal convulsion.The patient was prescribed Phenytoin Sodium (drug dosage: 1000 Mg In Normal Saline), which was initiated on NS. Concurrently used drugs: NA..After starting to take Phenytoin Sodium the consumer reported adverse symptoms, such as: Compartment SyndromeThese side effects may potentially be related to Phenytoin Sodium.
Phenytoin Sodium Side Effect Report#9517016
Electrocardiogram Qrs Complex Prolonged, Hypotension, Bradycardia, Nystagmus, Somnolence
This is a report of a 73-year-old male patient (weight: NA) from AU, suffering from the following health symptoms/conditions: NA, who was treated with Phenytoin Sodium (dosage: 15 Mg/kg, 1 G/h, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Electrocardiogram Qrs Complex Prolonged, Hypotension, Bradycardia, Nystagmus, Somnolence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Phenytoin Sodium treatment in male patients, resulting in Electrocardiogram Qrs Complex Prolonged side effect.
Phenytoin Sodium Side Effect Report#9511497
Electrocardiogram Qrs Complex Prolonged, Electrocardiogram Qt Prolonged, Status Epilepticus, Haemodialysis, Tachycardia, Toxicity To Various Agents
This report suggests a potential Phenytoin Sodium Injection (40042-009-02) 50 Electrocardiogram Qrs Complex Prolonged side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: status epilepticus and used Phenytoin Sodium Injection (40042-009-02) 50 (dosage: NA) starting NS. After starting Phenytoin Sodium Injection (40042-009-02) 50 the patient began experiencing various side effects, including: Electrocardiogram Qrs Complex Prolonged, Electrocardiogram Qt Prolonged, Status Epilepticus, Haemodialysis, Tachycardia, Toxicity To Various AgentsAdditional drugs used concurrently:
  • Fluconazole
  • Fosphenytoin Sodium Injection, Usp (025-21) (fosphenytoin Sodium)
  • Tacrolimus
  • Meropenem
  • Vancomycin
Although Phenytoin Sodium Injection (40042-009-02) 50 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Electrocardiogram Qrs Complex Prolonged, may still occur.
Phenytoin Sodium Side Effect Report#9510596
Cardiac Arrest, Bradycardia
This Cardiac Arrest problem was reported by a health professional from AU. A 68-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Feb 08, 2013 this consumer started treatment with Phenytoin Sodium (dosage: 1 G, One Time). The following drugs were being taken at the same time:
  • Adalimumab
  • Acetylsalicylic Acid
  • Folic Acid
  • Methotrexate
  • Sotalol Hydrochloride (80 Mg, 1x/day)
When using Phenytoin Sodium, the patient experienced the following unwanted symptoms/side effects: Cardiac Arrest, BradycardiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Arrest, may become evident only after a product is in use by the general population.
Phenytoin Sodium Side Effect Report#9494603
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 (drug dosage: 400mg, 1x/day At Night), which was initiated on
Aug 01, 2013. Concurrently used drugs:
  • Tegretol Retard (400mg, Long Term)
.After starting to take Phenytoin Sodium the consumer reported adverse symptoms, such as: Hypoaesthesia, Muscle Twitching, Muscle Spasms, Pruritus, Flushing, Pyrexia, Headache, Sleep Disorder, Vision BlurredThese side effects may potentially be related to Phenytoin Sodium.
Phenytoin Sodium Side Effect Report#9413225
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 health 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): Somnolence, Gait Disturbance, Constipation, Peripheral Coldness, Blood Pressure Decreased, Abdominal Discomfort, Contusion, Product Substitution Issue 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.
Phenytoin Sodium Side Effect Report#9387276
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. After starting Phenytoin Sodium the patient began experiencing various side effects, including: No Therapeutic ResponseAdditional 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.
Phenytoin Sodium Side Effect Report#9372545
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 using Phenytoin Sodium, the patient experienced the following unwanted symptoms/side effects: Urinary RetentionThe 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.
Phenytoin Sodium Side Effect Report#9370190
Gait Disturbance, Dysarthria, Cognitive Disorder
This Gait Disturbance side effect was reported by a consumer or non-health professional from US. A 84-year-old female patient (weight:NA) experienced the following symptoms/conditions: convulsion.The patient was prescribed Phenytoin Sodium (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Phenobarbital
.After starting to take Phenytoin Sodium the consumer reported adverse symptoms, such as: Gait Disturbance, Dysarthria, Cognitive DisorderThese side effects may potentially be related to Phenytoin Sodium.
Phenytoin Sodium Side Effect Report#9346013
Toxicity To Various Agents, Prescribed Overdose
This is a report of a patient (weight: NA) from US, suffering from the following health symptoms/conditions: convulsion, who was treated with Phenytoin Sodium (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Toxicity To Various Agents, Prescribed Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Phenytoin Sodium treatment in patients, resulting in Toxicity To Various Agents side effect.


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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.


What are common 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

What are common 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

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    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.

    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