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Potiga (Ezogabine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Potiga (Ezogabine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (84)
Death (6)
Life Threatening Events (3)

Reports by Reaction Type

Convulsion (20)Epilepsy (16)Somnolence (7)Dizziness (7)Urinary Retention (7)Diarrhoea (7)Aphasia (6)Confusional State (5)Drug Ineffective (5)Loss of Consciousness (5)Dysarthria (5)Agitation (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Potiga (Ezogabine). For a complete list or a specific selection of reports, please use the links above.

Possible Potiga side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-24

Patient: male

Reactions: Product Quality Issue, Urethral Discharge, Urinary Tract Infection Bacterial, Haematuria, Urinary Retention

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Naproxen; Oxycontin; Lacosamide; Beconase; Loratadine; Mebeverine; Laxido; Amitriptyline Hydrochloride; Lamictal; Oxycodone Hydrochloride



Possible Potiga side effects in male

Reported by a physician from Ireland on 2012-08-22

Patient: male

Reactions: Sudden Unexplained Death in Epilepsy

Adverse event resulted in: death

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Phenytoin; Tegretol



Possible Potiga side effects in male

Reported by a health professional (non-physician/pharmacist) from Latvia on 2012-08-21

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Anxiety, Choking Sensation, Dizziness, Disorientation, Somnolence, Loss of Consciousness, Tremor

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Clonazepam; Lamictal; Depakene



Possible Potiga side effects in male

Reported by a health professional (non-physician/pharmacist) from Latvia on 2012-08-20

Patient: male, weighing 90.0 kg (198.0 pounds)

Reactions: Epilepsy

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Phenaemal; Valproic Acid; Carbamazepine; Diazepam



Possible Potiga side effects in 29 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 29 year old female

Reactions: Catheter Placement, Urinary Tract Infection, Sepsis, Urinary Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Depakote ER; Topamax



Possible Potiga side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-16

Patient: male

Reactions: Product Quality Issue, Haematuria, Urinary Tract Infection Bacterial, Urethral Discharge, Urinary Retention

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Oxycodone Hydrochloride; Mebeverine; Oxycontin; Amitriptyline HCL; Naproxen; Lacosamide; Beconase; Loratadine; Laxido; Lamictal



Possible Potiga side effects in 18 year old female

Reported by a physician from Switzerland on 2012-08-13

Patient: 18 year old female

Reactions: Major Depression, Somnolence, Hallucination, Suicidal Ideation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamictal
    Dosage: 500 mg, daily
    Administration route: Oral

Potiga
    Dosage: 400 mg, unk
    Administration route: Oral
    Start date: 2011-09-14
    End date: 2011-10-10

Trileptal
    Dosage: 900 mg, daily
    Administration route: Oral



Possible Potiga side effects in 20 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-08-10

Patient: 20 year old female

Reactions: Convulsion

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Keppra; Clonazepam; Midazolam



Possible Potiga side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-09

Patient: female

Reactions: Convulsion

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Pizotifen; Topiramate; Lamotrigine



Possible Potiga side effects in 64 year old male

Reported by a physician from Spain on 2012-08-09

Patient: 64 year old male

Reactions: Agitation, Unresponsive To Stimuli, Urinary Retention, Emotional Disorder, Pneumonia, Benign Prostatic Hyperplasia, Catatonia, Ill-Defined Disorder, Apathy, Hypotonia, Disturbance in Social Behaviour, Dehydration, Metabolic Encephalopathy, Atelectasis, Confusional State, Hyperthermia, Fear, Drug Interaction, Constipation, Somnolence, Suicidal Ideation, Protein Total Increased, Depression, Acute Respiratory Failure, Decreased Appetite, Akinesia, Stupor, Diarrhoea, Pseudomembranous Colitis, Gait Disturbance, Bradyphrenia, Asthenia, Depressed Mood

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Potiga
    Dosage: 50mg per day
    Administration route: Oral
    Indication: Post-Traumatic Epilepsy
    Start date: 2012-05-15
    End date: 2012-07-07

Topiramate
    Dosage: 150mg per day
    Administration route: Oral
    Indication: Post-Traumatic Epilepsy
    End date: 2012-06-29

Other drugs received by patient: Clobazam; Zebinix; Phenobarbital TAB



Possible Potiga side effects in male

Reported by a physician from Slovenia on 2012-08-08

Patient: male

Reactions: Dysarthria, Gait Disturbance, Convulsion, Dysphemia

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Tegretol; Depakene; Lyrica



Possible Potiga side effects in female

Reported by a physician from Poland on 2012-08-06

Patient: female, weighing 55.0 kg (121.0 pounds)

Reactions: Epilepsy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Potiga



Possible Potiga side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-03

Patient: male

Reactions: Urinary Retention, Respiratory Tract Infection

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Valproate Sodium; Clobazam



Possible Potiga side effects in female

Reported by a physician from Mexico on 2012-08-02

Patient: female, weighing 57.0 kg (125.4 pounds)

Reactions: Somatisation Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Clonazepam; Carbamazepine



Possible Potiga side effects in 64 year old male

Reported by a physician from Spain on 2012-08-02

Patient: 64 year old male

Reactions: Agitation, Confusional State, Fear, Unresponsive To Stimuli, Drug Interaction, Suicidal Ideation, Protein Total Increased, Urinary Retention, Emotional Disorder, Depression, Decreased Appetite, Pneumonia, Catatonia, Akinesia, Ill-Defined Disorder, Disturbance in Social Behaviour, Hypotonia, Pseudomembranous Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Potiga
    Administration route: Oral
    Indication: Post-Traumatic Epilepsy
    Start date: 2012-05-15
    End date: 2012-07-07

Topiramate
    Dosage: 150mg per day
    Administration route: Oral
    Indication: Post-Traumatic Epilepsy
    End date: 2012-06-29

Other drugs received by patient: Phenobarbital TAB; Clobazam; Zebinix



Possible Potiga side effects in male

Reported by a physician from Germany on 2012-08-01

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Mechanical Ventilation, Cardioversion, Electrocardiogram QT Prolonged, Pneumonia Aspiration, Drug Ineffective, Joint Hyperextension, Cognitive Disorder, Pyrexia, Hyperkinesia, Partial Seizures, Drug Tolerance, Cyanosis, Hypoxia, Withdrawal Syndrome, Ventricular Fibrillation, Cardiac Arrest, Muscle Spasms

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Valdoxan; Haldol; Oxcarbazepine; Lamotrigine; Keppra; Chloralhydrat; Akineton



Possible Potiga side effects in

Reported by a consumer/non-health professional from United Kingdom on 2012-07-19

Patient:

Reactions: Bladder Disorder, Convulsion

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Unknown Medication



Possible Potiga side effects in 48 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-18

Patient: 48 year old male

Reactions: Emotional Distress, Hallucination, Visual, Hallucination, Auditory

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Zonegran; Keppra



Possible Potiga side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-18

Patient: male

Reactions: Confusional State, Suicidal Behaviour, Dysphonia, Abnormal Behaviour, Aggression, Psychotic Behaviour, Delusion

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Clonazepam; Valproate Sodium



Possible Potiga side effects in 49 year old female

Reported by a physician from United Kingdom on 2012-07-17

Patient: 49 year old female

Reactions: Convulsion

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Lamotrigine; Topiramate; Pizotifen



Possible Potiga side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-17

Patient: male

Reactions: Drug Ineffective, Condition Aggravated, Convulsion

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Vimpat; Multiple Drugs



Possible Potiga side effects in 24 year old female

Reported by a physician from Lithuania on 2012-07-13

Patient: 24 year old female

Reactions: Somnolence, Epilepsy

Drug(s) suspected as cause:
Potiga



Possible Potiga side effects in male

Reported by a physician from Slovenia on 2012-07-12

Patient: male, weighing 90.0 kg (198.0 pounds)

Reactions: Weight Decreased, Psychotic Disorder, Diarrhoea, Hypoproteinaemia, Oedema Peripheral, Faecal Incontinence

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Akineton; Haldol; Depakene; Tegretol; Diazepam



Possible Potiga side effects in male

Reported by a physician from Slovenia on 2012-07-10

Patient: male

Reactions: Contusion, Epilepsy

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Lacosamide; Difetoin; Carbamazepine; Levetiracetam



Possible Potiga side effects in 45 year old male

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: 45 year old male

Reactions: Contusion, Injury, Multiple Fractures, Fall, Loss of Consciousness

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Trileptal; Keppra



Possible Potiga side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-05

Patient: male

Reactions: Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Trimipramine Maleate; Levetiracetam; Valproic Acid; Vimpat; Tamsulosin HCL



Possible Potiga side effects in female

Reported by a physician from Poland on 2012-07-05

Patient: female, weighing 55.0 kg (121.0 pounds)

Reactions: Epilepsy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine
    Dosage: 200mg twice per day
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2012-05-19
    End date: 2012-05-25

Potiga
    Administration route: Oral
    Indication: Partial Seizures
    Start date: 2012-04-12
    End date: 2012-05-19



Possible Potiga side effects in male

Reported by a physician from Ireland on 2012-07-05

Patient: male

Reactions: Sudden Unexplained Death in Epilepsy

Adverse event resulted in: death

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Phenytoin; Tegretol



Possible Potiga side effects in female

Reported by a physician from Poland on 2012-07-05

Patient: female, weighing 55.0 kg (121.0 pounds)

Reactions: Epilepsy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Potiga



Possible Potiga side effects in female

Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-07-05

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Nausea, Lymphatic Disorder, Aphasia, Ataxia, Amnesia, Somnolence, Myoclonus, Dysarthria, Balance Disorder, TIC, Visual Impairment, Disturbance in Attention, Memory Impairment, Coordination Abnormal, Hallucination

Drug(s) suspected as cause:
Potiga

Other drugs received by patient: Lamictal; Topamax; Depakene

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