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: 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 31 year old male
Reported by a physician on 2012-08-07
Patient: 31 year old male
Reactions: Epilepsy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levetiracetam
Other drugs received by patient: Lamotrigine; Topiramate
Possible Levetiracetam side effects in
Reported by a physician from United Kingdom on 2012-08-07
Patient:
Reactions: Aggression
Drug(s) suspected as cause:
Levetiracetam
Possible Levetiracetam side effects in
Reported by a physician from France on 2012-08-07
Patient:
Reactions: Epilepsy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levetiracetam
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