Common Epanutin Side Effects


The most commonly reported Epanutin side effects (click to view or check a box to report):

Convulsion (18)
Epilepsy (9)
Dizziness (8)
Somnolence (5)
Gait Disturbance (5)
Disorientation (4)
Balance Disorder (4)
Anxiety (4)
Dysphagia (4)
Malaise (4)
Toxicity To Various Agents (4)
Tremor (4)
Overdose (4)
Vitamin D Deficiency (3)
Gamma-glutamyltransferase Increased (3)
Renal Failure (3)
Insomnia (3)
Hallucination (3)
Osteomalacia (3)
Rash (3)

➢ More



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.

Epanutin Side Effects Reported to FDA



Epanutin Side Effect Report#9852643
Gingival Inflammation
This is a report of a 31-year-old female patient (weight: NA) from ES, suffering from the following health symptoms/conditions: epilepsy, who was treated with Epanutin (dosage: 100 Mg, 2x/day (in The Morning And At Night), start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Gingival Inflammation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epanutin treatment in female patients, resulting in Gingival Inflammation side effect. The patient was hospitalized.
Epanutin Side Effect Report#9819363
Hallucination, Poor Quality Sleep, Agitation, Headache, Dizziness, Confusional State
This report suggests a potential Epanutin Hallucination side effect(s) that can have serious consequences. A 85-year-old male patient (weight: NA) from GR was diagnosed with the following symptoms/conditions: epilepsy,hypertension and used Epanutin (dosage: 17 Ml, 3x/day) starting 201401. After starting Epanutin the patient began experiencing various side effects, including: Hallucination, Poor Quality Sleep, Agitation, Headache, Dizziness, Confusional StateAdditional drugs used concurrently:
  • Vascase Plus
Although Epanutin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hallucination, may still occur.
Epanutin Side Effect Report#9768039
Suspected Counterfeit Product, Product Quality Issue
This Suspected Counterfeit Product problem was reported by a physician from GB. A 27-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: convulsion. On
Jul 30, 2013 this consumer started treatment with Epanutin (dosage: 100 Mg, 1x/day). The following drugs were being taken at the same time:
  • Phenytoin Sodium (300 Mg, 1x/day)
  • Phenytoin Sodium (100 Mg, 1x/day)
  • Co-codamol (8/500. 1-2 Every Six Hours When Required.)
  • Vitamin D3 (1000 Iu, 1x/day)
When using Epanutin, the patient experienced the following unwanted symptoms/side effects: Suspected Counterfeit Product, Product Quality IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Suspected Counterfeit Product, may become evident only after a product is in use by the general population.
Epanutin Side Effect Report#9619501
Toxicity To Various Agents, Athetosis, Ballismus
This Toxicity To Various Agents side effect was reported by a physician from US. A 23-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Epanutin (drug dosage: 250 Mg, 2x/day), which was initiated on
Nov 23, 1966. Concurrently used drugs: NA..After starting to take Epanutin the consumer reported adverse symptoms, such as: Toxicity To Various Agents, Athetosis, BallismusThese side effects may potentially be related to Epanutin.
Epanutin Side Effect Report#9618135
Toxicity To Various Agents, Cerebellar Atrophy, Cerebellar Ataxia, Dysarthria, Balance Disorder, Somnolence, Nystagmus
This is a report of a 32-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: prophylaxis, who was treated with Epanutin (dosage: 40 Mg, Daily, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Toxicity To Various Agents, Cerebellar Atrophy, Cerebellar Ataxia, Dysarthria, Balance Disorder, Somnolence, Nystagmus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epanutin treatment in male patients, resulting in Toxicity To Various Agents side effect. The patient was hospitalized.
Epanutin Side Effect Report#9419507
Overdose, Somnolence, Hypertonia, Constipation, Grand Mal Convulsion, Vomiting
This report suggests a potential Epanutin Overdose side effect(s) that can have serious consequences. A male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: convulsion and used Epanutin (dosage: 8 Mg, 2x/day) starting 201304. After starting Epanutin the patient began experiencing various side effects, including: Overdose, Somnolence, Hypertonia, Constipation, Grand Mal Convulsion, VomitingAdditional drugs used concurrently: NA.The patient was hospitalized. Although Epanutin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Overdose, may still occur.
Epanutin Side Effect Report#9394913
Dysphagia
This Dysphagia problem was reported by a pharmacist from GB. A 89-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: epilepsy. On NS this consumer started treatment with Epanutin (dosage: 100 Mg, 2x/day). The following drugs were being taken at the same time: NA. When using Epanutin, the patient experienced the following unwanted symptoms/side effects: DysphagiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dysphagia, may become evident only after a product is in use by the general population.
Epanutin Side Effect Report#9368529
Aggression, Head Banging
This Aggression side effect was reported by a consumer or non-health professional from GB. A 15-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Epanutin (drug dosage: 9 Mg, Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Epanutin the consumer reported adverse symptoms, such as: Aggression, Head BangingThese side effects may potentially be related to Epanutin.
Epanutin Side Effect Report#9162828
Overdose, Somnolence, Gait Disturbance, Disorientation
This is a report of a 90-year-old female patient (weight: NA) from ES, suffering from the following health symptoms/conditions: epilepsy, who was treated with Epanutin (dosage: 100 Mg, 3x/day, start time: 201210), combined with: NA. and developed a serious reaction and side effect(s): Overdose, Somnolence, Gait Disturbance, Disorientation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epanutin treatment in female patients, resulting in Overdose side effect. The patient was hospitalized.
Epanutin Side Effect Report#9140295
Overdose, Suicide Attempt, Toxicity To Various Agents, Circulatory Collapse, Depressed Level Of Consciousness, Restlessness, Strabismus, Hyporeflexia
This report suggests a potential Epanutin Overdose side effect(s) that can have serious consequences. A 20-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: epilepsy and used Epanutin (dosage: 12 G, Unk) starting NS. After starting Epanutin the patient began experiencing various side effects, including: Overdose, Suicide Attempt, Toxicity To Various Agents, Circulatory Collapse, Depressed Level Of Consciousness, Restlessness, Strabismus, HyporeflexiaAdditional drugs used concurrently:
  • Primidone (15 G, Unk)
The patient was hospitalized. Although Epanutin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Overdose, may still occur.
Epanutin Side Effect Report#9105013
Somnolence, Disorientation
This Somnolence problem was reported by a pharmacist from ES. A 79-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Apr 28, 2012 this consumer started treatment with Epanutin (dosage: Unk). The following drugs were being taken at the same time: NA. When using Epanutin, the patient experienced the following unwanted symptoms/side effects: Somnolence, DisorientationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Somnolence, may become evident only after a product is in use by the general population.
Epanutin Side Effect Report#9017280
Grand Mal Convulsion
This Grand Mal Convulsion side effect was reported by a pharmacist from ES. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: epilepsy.The patient was prescribed Epanutin (drug dosage: 100 Mg, 3x/day), which was initiated on
Mar 10, 2009. Concurrently used drugs: NA..After starting to take Epanutin the consumer reported adverse symptoms, such as: Grand Mal ConvulsionThese side effects may potentially be related to Epanutin. The patient was hospitalized.
Epanutin Side Effect Report#8985226
Deep Vein Thrombosis
This is a report of a 71-year-old male patient (weight: NA) from CZ, suffering from the following health symptoms/conditions: status epilepticus, who was treated with Epanutin (dosage: 1500 Mg, Unk, start time:
Dec 14, 2012), combined with:
  • Valproat (500 Mg, 2x/day)
  • Letrox
  • Seduxen
  • Zinnat
  • Apaurin
and developed a serious reaction and side effect(s): Deep Vein Thrombosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epanutin treatment in male patients, resulting in Deep Vein Thrombosis side effect. The patient was hospitalized.
Epanutin Side Effect Report#8985201
Deep Vein Thrombosis
This report suggests a potential Epanutin Deep Vein Thrombosis side effect(s) that can have serious consequences. A 68-year-old male patient (weight: NA) from CZ was diagnosed with the following symptoms/conditions: status epilepticus and used Epanutin (dosage: 1250 Mg, 16mg/kg, 50mg/min) starting
Dec 11, 2012. After starting Epanutin the patient began experiencing various side effects, including: Deep Vein ThrombosisAdditional drugs used concurrently:
  • Keppra (Unk)
  • Warfarin (7.5 Mg, 1x/day)
  • Kalnormin
  • Helicid
  • Digoxin
  • Aktiferrin
  • Concor
The patient was hospitalized. Although Epanutin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Deep Vein Thrombosis, may still occur.
Epanutin Side Effect Report#8051904-2
Alcohol Use, Respiratory Arrest, Epilepsy, Fatigue, Toxicity To Various Agents
This Alcohol Use problem was reported by a health professional from United Kingdom. A 32-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 17, 2006 this consumer started treatment with Epanutin (phenytoin) (dosage: NA). The following drugs were being taken at the same time:
  • Zanaflex
  • Onfi (clobazam) (clobazam) (20 Mg) (20 Mg, Milligram (s), 2 In 1 D)
  • Morphine Sulfate (80 Mg, Milligram(s))
  • Temazepam
  • Morphine Sulfate (Oral)
  • Prozac
  • Trileptal
  • Benzodiazepine Derivatives (benzodiazepine Derivatives)
When using Epanutin (phenytoin), the patient experienced the following unwanted symptoms/side effects: Alcohol Use, Respiratory Arrest, Epilepsy, Fatigue, Toxicity To Various AgentsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Alcohol Use, may become evident only after a product is in use by the general population.
Epanutin Side Effect Report#7495415-1
Disorientation, Muscular Weakness, Hepatitis, Metastases To Liver
This Disorientation side effect was reported by a consumer or non-health professional from Spain. A 75-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Epanutin Unk (phenytoin Sodium) (drug dosage: NA), which was initiated on
Oct 30, 2009. Concurrently used drugs:
  • Samsca (15 Mg Milligram(s), Qd Oral, 30 Mg Milligram(s) ; Oral)
  • Omeprazole
  • Lisinopril
.After starting to take Epanutin Unk (phenytoin Sodium) the consumer reported adverse symptoms, such as: Disorientation, Muscular Weakness, Hepatitis, Metastases To LiverThese side effects may potentially be related to Epanutin Unk (phenytoin Sodium).
Epanutin Side Effect Report#7475810-7
Agitation, Mood Swings, Paranoia, Anxiety, Aggression, Feeling Guilty, Personality Change, Delusion
This is a report of a 41-year-old male patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: NA, who was treated with Epanutin /00017402/ (dosage: NA, start time:
Jun 16, 2009), combined with:
  • Keppra (250 Mg Qd Oral, 500 Mg Bid Oral)
  • Keppra (250 Mg Qd Oral, 500 Mg Bid Oral)
and developed a serious reaction and side effect(s): Agitation, Mood Swings, Paranoia, Anxiety, Aggression, Feeling Guilty, Personality Change, Delusion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epanutin /00017402/ treatment in male patients, resulting in Agitation side effect.
Epanutin Side Effect Report#7347162-4
Pyrexia, Malaise, Wheezing, Tremor, Pruritus, Breathing-related Sleep Disorder, Fatigue
This report suggests a potential Epanutin Pyrexia side effect(s) that can have serious consequences. A 57-year-old male patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: NA and used Epanutin (dosage: 100 Mg, 2x/day) starting
Jan 01, 1971. After starting Epanutin the patient began experiencing various side effects, including: Pyrexia, Malaise, Wheezing, Tremor, Pruritus, Breathing-related Sleep Disorder, FatigueAdditional drugs used concurrently: NA. Although Epanutin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pyrexia, may still occur.
Epanutin Side Effect Report#7331801-8
Dizziness, Somnolence, Feeling Abnormal, Malaise, Insomnia
This Dizziness problem was reported by a consumer or non-health professional from United States. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: grand mal convulsion. On
Jul 01, 2009 this consumer started treatment with Epanutin (dosage: 300 Mg/day). The following drugs were being taken at the same time:
  • Dilantin (Unk)
  • Multi-vitamins (Unk)
  • Zocor (Unk)
When using Epanutin, the patient experienced the following unwanted symptoms/side effects: Dizziness, Somnolence, Feeling Abnormal, Malaise, InsomniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dizziness, may become evident only after a product is in use by the general population.
Epanutin Side Effect Report#7325656-5
Ataxia, Dysarthria
This Ataxia side effect was reported by a pharmacist from Spain. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: partial seizures.The patient was prescribed Epanutin (drug dosage: 200 Mg, 2x/day), which was initiated on
Jan 01, 2010. Concurrently used drugs: NA..After starting to take Epanutin the consumer reported adverse symptoms, such as: Ataxia, DysarthriaThese side effects may potentially be related to Epanutin. The patient was hospitalized.
Epanutin Side Effect Report#7302296-5
Priapism
This is a report of a 32-year-old male patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: NA, who was treated with Epanutin (dosage: 300 Mg, 1x/day Every Night, start time: NS), combined with:
  • Perborate (Unk)
and developed a serious reaction and side effect(s): Priapism after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epanutin treatment in male patients, resulting in Priapism side effect.
Epanutin Side Effect Report#7293893-4
Anxiety, Blood Disorder, Folate Deficiency, Deafness Unilateral, Allergy To Chemicals, Food Intolerance, Depression, Vitamin B6 Deficiency, Osteoporosis
This report suggests a potential Epanutin Anxiety side effect(s) that can have serious consequences. A 65-year-old female patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: epilepsy and used Epanutin (dosage: 150 Mg, 2x/day) starting NS. After starting Epanutin the patient began experiencing various side effects, including: Anxiety, Blood Disorder, Folate Deficiency, Deafness Unilateral, Allergy To Chemicals, Food Intolerance, Depression, Vitamin B6 Deficiency, OsteoporosisAdditional drugs used concurrently: NA. Although Epanutin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anxiety, may still occur.
Epanutin Side Effect Report#7289387-2
This Death problem was reported by a health professional from United Kingdom. A 29-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 04, 2002 this consumer started treatment with Epanutin (dosage: 86.25 Ml, 1x/day). The following drugs were being taken at the same time:
  • Clobazam (10 Mg, 2x/day)
  • Epilim Chrono (1500 Mg, 2x/day)
When using Epanutin, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Epanutin Side Effect Report#7288328-1
Product Colour Issue, Pruritus, Product Size Issue, Wheezing
This Product Colour Issue side effect was reported by a consumer or non-health professional from United Kingdom. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Epanutin (drug dosage: 100 Mg, 2x/day), which was initiated on
Jan 01, 1971. Concurrently used drugs: NA..After starting to take Epanutin the consumer reported adverse symptoms, such as: Product Colour Issue, Pruritus, Product Size Issue, WheezingThese side effects may potentially be related to Epanutin.
Epanutin Side Effect Report#7279759-4
Gastrostomy, Withdrawal Syndrome
This is a report of a 16-year-old male patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: NA, who was treated with Epanutin (dosage: 160 Mg, 2x/day, start time: NS), combined with:
  • Clonazepam
  • Phenytoin
and developed a serious reaction and side effect(s): Gastrostomy, Withdrawal Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epanutin treatment in male patients, resulting in Gastrostomy side effect. The patient was hospitalized.


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The appearance of Epanutin 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 Epanutin Side Effects for Women?

Women Side Effects Reports
Convulsion 8
Gait Disturbance 4
Dizziness 3
Dysgeusia 3
Fall 3
Osteomalacia 3
Rash 3
Vitamin D Deficiency 3
Anxiety 2
Balance Disorder 2

What are common Epanutin Side Effects for Men?

Men Side Effects Reports
Convulsion 10
Epilepsy 7
Dizziness 5
Somnolence 4
Toxicity To Various Agents 4
Tremor 4
Agitation 3
Confusional State 3
Dysphagia 3
Dyspnoea 3

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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.

    Epanutin 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.

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