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Levetiracetam (Levetiracetam) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Levetiracetam 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 (852)
Death (70)
Life Threatening Events (27)
Disability (29)

Reports by Reaction Type

Convulsion (165)Product Substitution Issue (61)Drug Ineffective (60)Condition Aggravated (59)Pregnancy (53)Grand MAL Convulsion (46)Aggression (44)Petit MAL Epilepsy (40)Somnolence (39)Maternal Exposure During Pregnancy (39)Drug Rash With Eosinophilia and Systemic Symptoms (39)Abortion Spontaneous (37)

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

Possible Levetiracetam side effects in 6 year old female

Reported by a physician from Spain on 2012-08-27

Patient: 6 year old female

Reactions: Vomiting, Autism, Headache

Drug(s) suspected as cause:
Levetiracetam
    Dosage: 53 mg/kg/day

Levetiracetam
    Dosage: 15 mg/kg/day; progressively increased to 53 mg/kg/day over 9mo
    Indication: Convulsion



Possible Levetiracetam side effects in 6 year old female

Reported by a physician from Spain on 2012-08-27

Patient: 6 year old female

Reactions: Autism, Vomiting, Headache

Drug(s) suspected as cause:
Levetiracetam
    Dosage: 53 mg/kg/day

Levetiracetam
    Dosage: 15 mg/kg/day; progressively increased to 53 mg/kg/day over 9mo
    Indication: Convulsion



Possible Levetiracetam side effects in 46 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 46 year old female, weighing 40.0 kg (88.0 pounds)

Reactions: Drug Interaction, Hypothyroidism, Concomitant Disease Progression

Drug(s) suspected as cause:
Levetiracetam

Other drugs received by patient possibly interacting with the suspect drug:
Phenobarbital TAB
    Indication: Convulsion

Phenytoin
    Indication: Convulsion



Possible Levetiracetam side effects in 65 year old male

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

Patient: 65 year old male

Reactions: Speech Disorder, Fatigue, Bone Pain, Chills, Vision Blurred, Condition Aggravated, Asthenia, Muscle Spasms

Drug(s) suspected as cause:
Amlodipine Besylate

Levetiracetam

Pravastatin

Symbicort
    Dosage: 160 mcg, frequency unknown



Possible Levetiracetam side effects in 22 year old male

Reported by a physician from Italy on 2012-08-23

Patient: 22 year old male

Reactions: Anhedonia, Loss of Libido, Erectile Dysfunction

Drug(s) suspected as cause:
Levetiracetam



Possible Levetiracetam side effects in 30 year old male

Reported by a physician from Italy on 2012-08-23

Patient: 30 year old male

Reactions: Anhedonia, Loss of Libido

Drug(s) suspected as cause:
Levetiracetam



Possible Levetiracetam side effects in 9 month old female

Reported by a physician from United Kingdom on 2012-08-23

Patient: 9 month old female

Reactions: Lower Respiratory Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levetiracetam

Other drugs received by patient: Amoxicillin and Clavulanate Potassium; Leucovorin Calcium; Nitrazepam; Ranitidine; Clarithromycin; Domperidone



Possible Levetiracetam side effects in 88 year old female

Reported by a individual with unspecified qualification from Spain on 2012-08-23

Patient: 88 year old female

Reactions: Long QT Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levetiracetam

Other drugs received by patient: Acetylsalicylic Acid SRT; Hydrochlorothiazide (Hidrosaluretil R)



Possible Levetiracetam side effects in 9 month old female

Reported by a physician from United Kingdom on 2012-08-17

Patient: 9 month old female

Reactions: Lower Respiratory Tract Infection, Infantile Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levetiracetam

Other drugs received by patient: Domperidone; Ranitidine; Nitrazepam; Amoxicillin and Clavulanate Potassium; Clarithromycin; Leucovorin Calcium



Possible Levetiracetam side effects in 17 year old female

Reported by a pharmacist from United States on 2012-08-17

Patient: 17 year old female

Reactions: Anticonvulsant Drug Level Decreased, Treatment Noncompliance, Convulsion

Drug(s) suspected as cause:
Levetiracetam



Possible Levetiracetam side effects in 24 year old male

Reported by a physician from Japan on 2012-08-16

Patient: 24 year old male

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Carbamazepine
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Levetiracetam
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Nitrazepam; Corticotropin; Zonisamide; Ethosuximide; Vitamin B6



Possible Levetiracetam side effects in 17 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 17 year old female

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Carbamazepine
    Indication: Infantile Spasms

Clobazam
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Gabapentin
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Levetiracetam
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Vitamin B6; Corticotropin; Zonisamide; Nitrazepam; Potassium Bromide; Benzodiazepine Derivatives



Possible Levetiracetam side effects in 33 year old female

Reported by a health professional (non-physician/pharmacist) from Saudi Arabia on 2012-08-15

Patient: 33 year old female

Reactions: Angioedema

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Levetiracetam



Possible Levetiracetam side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: 30 year old female

Reactions: Drug Effect Decreased, Status Epilepticus, Rash, Thrombocytopenia

Drug(s) suspected as cause:
Acetazolamide
    Dosage: max 500 mg twice daily
    Indication: Convulsion

Corticotropin
    Indication: Convulsion

Fosphenytoin
    Indication: Product Used FOR Unknown Indication

Immune Globulin NOS
    Dosage: 0.4 mg/kg/day
    Indication: Convulsion

Levetiracetam
    Dosage: max 2500 mg twice daily
    Indication: Convulsion

Midazolam
    Dosage: continuous drip
    Indication: Product Used FOR Unknown Indication

Neurontin
    Dosage: max 1200 mg three times daily
    Indication: Convulsion

Oxcarbazepine
    Dosage: max 1200 mg twice daily
    Indication: Convulsion

Pentobarbital CAP
    Dosage: 4-5 mg/kg/hr
    Indication: Convulsion

Phenobarbital TAB
    Indication: Convulsion

Propofol
    Dosage: drip
    Indication: Product Used FOR Unknown Indication

Topiramate
    Dosage: max dose 400 mg daily
    Indication: Convulsion

Valproate Sodium
    Indication: Convulsion

Other drugs received by patient: Magnesium; Ketamine HCL; Vancomycin; Acyclovir; Ceftriaxone; Benzodiazepine Related Drugs



Possible Levetiracetam side effects in 87 year old female

Reported by a physician from Denmark on 2012-08-14

Patient: 87 year old female

Reactions: Abdominal Pain, Dyspnoea, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levetiracetam
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2009-10-01
    End date: 2012-07-25

Valproate Sodium
    Dosage: styrke: 300 mg
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2009-10-01
    End date: 2012-07-25

Other drugs received by patient: Acetaminophen; Simvastatin; Selexid; Spiriva; Clopidogrel; Serevent; Potassium Chloride; Cetirizine HCL; Boniva; Pantoprazole; Trimopan



Possible Levetiracetam side effects in 65 year old male

Reported by a physician from United States on 2012-08-14

Patient: 65 year old male

Reactions: Confusional State, Fatigue, Condition Aggravated, Convulsion

Drug(s) suspected as cause:
Levetiracetam
    Dosage: maximal dosing
    Indication: Product Used FOR Unknown Indication

Mistletoe
    Dosage: every 3 days
    Indication: Small Cell Lung Cancer Stage Unspecified

Valproate Sodium
    Dosage: maximal dosing
    Indication: Product Used FOR Unknown Indication

Vitamin C / 00008001 /
    Dosage: biweekly
    Indication: Small Cell Lung Cancer Stage Unspecified



Possible Levetiracetam side effects in 79 year old female

Reported by a physician from United States on 2012-08-13

Patient: 79 year old female, weighing 87.0 kg (191.4 pounds)

Reactions: Fatigue, Hallucination, Auditory, Rash, Somnolence, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levetiracetam

Levetiracetam
    Dosage: 500 mg tablet, 1/2 tablet for 2 weeks
    Administration route: Oral
    Start date: 2012-01-01
    End date: 2012-01-01

Levetiracetam
    Start date: 2012-01-01
    End date: 2012-06-01

Levetiracetam
    Dosage: 500 mg tablet, 1/2 each night for 2 weeks
    Administration route: Oral
    Start date: 2012-01-01
    End date: 2012-01-01

Vimpat
    Dosage: 100 mg
    Administration route: Oral
    End date: 2012-01-01

Vimpat
    Administration route: Oral
    Indication: Convulsion
    Start date: 2012-01-01
    End date: 2012-06-01



Possible Levetiracetam side effects in 31 year old male

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

Patient: 31 year old male

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levetiracetam

Other drugs received by patient: Dexamethasone Sodium Phosphate



Possible Levetiracetam side effects in 25 year old female

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

Patient: 25 year old female

Reactions: Myoclonus, Condition Aggravated

Drug(s) suspected as cause:
Levetiracetam



Possible Levetiracetam side effects in 31 year old female

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

Patient: 31 year old female

Reactions: Partial Seizures, Drug Ineffective, General Physical Health Deterioration, Gait Disturbance

Drug(s) suspected as cause:
Lacsoamide (Lacosamide) 150mg
    Dosage: 150 mg, bid
    Indication: Product Used FOR Unknown Indication

Levetiracetam
    Indication: Product Used FOR Unknown Indication

Piracetam (Piracetam)

Other drugs received by patient: Lamotrigine; Clonazepam; Phenobarbital TAB; Zonisamide; Midazolam HCL; Valproate (Valproate); Vigabatrin (Vigabatrin); Phenobaritone (Phenobarbital + Phenobarbitone); Clobazam; Phenytoin (Phenytoin); Topirmate (Topirmate)



Possible Levetiracetam side effects in 22 year old female

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

Patient: 22 year old female

Reactions: Myoclonus, Condition Aggravated

Drug(s) suspected as cause:
Levetiracetam



Possible Levetiracetam side effects in 24 year old male

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

Patient: 24 year old male

Reactions: Drug Ineffective, Fall, Convulsion

Drug(s) suspected as cause:
Carbamazepine
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Levetiracetam
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Nitrazepam; Vitamin B6; Corticotropin; Zonisamide; Ethosuximide



Possible Levetiracetam side effects in 17 year old female

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

Patient: 17 year old female

Reactions: Drug Ineffective, Fall, Convulsion

Drug(s) suspected as cause:
Carbamazepine
    Indication: Infantile Spasms

Clobazam
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Gabapentin
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Levetiracetam
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Other drugs received by patient: Nitrazepam; Benzodiazepine Derivatives; Zonisamide; Corticotropin; Vitamin B6; Potassium Bromide



Possible Levetiracetam side effects in 25 year old female

Reported by a physician from Saudi Arabia on 2012-08-08

Patient: 25 year old female

Reactions: Epilepsy

Drug(s) suspected as cause:
Levetiracetam

Other drugs received by patient: Valproate Sodium



Possible Levetiracetam side effects in 22 year old female

Reported by a physician from Saudi Arabia on 2012-08-08

Patient: 22 year old female

Reactions: Epilepsy

Drug(s) suspected as cause:
Levetiracetam

Other drugs received by patient: Valproate Sodium



Possible Levetiracetam side effects in female

Reported by a pharmacist from United States on 2012-08-08

Patient: female, weighing 58.6 kg (128.9 pounds)

Reactions: Pancreatitis Acute, Hypophagia, Posture Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levetiracetam



Possible Levetiracetam side effects in 65 year old male

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

Patient: 65 year old male

Reactions: Confusional State, Fatigue, Oedema, Convulsive Threshold Lowered, Hemiparesis, Convulsion, Cerebral Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ascorbic Acid
    Dosage: (2 in 1 wk), unknown
    Indication: Small Cell Lung Cancer Metastatic

Levetiracetam
    Indication: Product Used FOR Unknown Indication

Mistletoe (Viscum Album)
    Dosage: (1 in 3 d), unknown
    Indication: Small Cell Lung Cancer Metastatic

Valproic Acid



Possible Levetiracetam side effects in 33 year old female

Reported by a health professional (non-physician/pharmacist) from Saudi Arabia on 2012-08-07

Patient: 33 year old female

Reactions: Rash Generalised, Angioedema, Rash Maculo-Papular

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levetiracetam

Other drugs received by patient: Phenytoin



Possible Levetiracetam side effects in 31 year old male

Reported by a physician from Spain on 2012-08-07

Patient: 31 year old male

Reactions: Dyspnoea, Pyrexia, Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levetiracetam

Other drugs received by patient: Dexamethasone



Possible Levetiracetam side effects in 31 year old male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-07

Patient: 31 year old male

Reactions: Epilepsy

Drug(s) suspected as cause:
Levetiracetam

Other drugs received by patient: Topiramate; Lamotrigine

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