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Keppra XR (Levetiracetam) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Keppra XR (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 (87)
Death (10)

Reports by Reaction Type

Convulsion (23)Foetal Exposure During Pregnancy (19)Pregnancy (16)Upper Respiratory Tract Infection (10)Premature Baby (10)Death (6)Dyspepsia (6)Inappropriate Schedule of Drug Administration (6)Rash (6)Cerebrovascular Accident (6)Haemangioma (6)Headache (5)

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

Possible Keppra XR side effects in 35 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 35 year old male

Reactions: Convulsion

Adverse event resulted in: death

Drug(s) suspected as cause:
Keppra XR



Possible Keppra XR side effects in male

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

Patient: male, weighing 109.7 kg (241.3 pounds)

Reactions: Dyspnoea, Glossodynia, Fatigue, Throat Cancer, Laceration, Pharyngitis Streptococcal, Swollen Tongue, Back Injury, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Keppra XR
    Dosage: in am
    Administration route: Oral
    Indication: Grand MAL Convulsion
    End date: 2012-08-07

Keppra XR
    Dosage: increased to 2 pills in the am
    Administration route: Oral
    Start date: 2012-08-08

Other drugs received by patient: Cephalexin; Diltiazem; Listerine; Digoxin; Saline; Cephalexin; Hydrocodone Bitartrate; Coumadin



Possible Keppra XR side effects in male

Reported by a physician from United States on 2012-08-22

Patient: male

Reactions: Psychomotor Hyperactivity, Speech Disorder Developmental, Exposure During Breast Feeding, Restlessness, Foetal Exposure During Pregnancy, Abnormal Behaviour, Constipation, Aggression, Poor Quality Sleep, Choking, Coordination Abnormal

Drug(s) suspected as cause:
Keppra
    Indication: Epilepsy
    End date: 2009-02-03

Keppra XR
    Start date: 2009-02-03

Keppra XR
    Indication: Epilepsy
    Start date: 2009-02-03
    End date: 2009-07-16



Possible Keppra XR side effects in 37 year old male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 37 year old male

Reactions: Road Traffic Accident, Convulsion

Drug(s) suspected as cause:
Keppra XR



Possible Keppra XR side effects in 20 year old male

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

Patient: 20 year old male, weighing 90.7 kg (199.6 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Suture Insertion, JAW Fracture, Fall, Convulsion

Drug(s) suspected as cause:
Keppra
    Dosage: 5 cc or 100 mg/ml is equal to 500 mg or 1000 mg, 5 ml 2 times a day which was 100 mg/ml
    Administration route: Oral
    Indication: Convulsion
    Start date: 2012-04-01
    End date: 2012-01-01

Keppra XR
    Administration route: Oral
    Start date: 2012-06-13

Keppra XR
    Administration route: Oral
    Indication: Convulsion
    End date: 2012-06-12

Other drugs received by patient: Xanax



Possible Keppra XR side effects in 43 year old female

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

Patient: 43 year old female, weighing 85.7 kg (188.6 pounds)

Reactions: Convulsion

Drug(s) suspected as cause:
Keppra XR

Other drugs received by patient: Levothroid



Possible Keppra XR side effects in 46 year old male

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

Patient: 46 year old male, weighing 83.9 kg (184.6 pounds)

Reactions: HIP Fracture, Fall, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Keppra XR

Other drugs received by patient: Dilantin



Possible Keppra XR side effects in male

Reported by a physician from United States on 2012-08-07

Patient: male, weighing 2.1 kg (4.7 pounds)

Reactions: Trisomy 21, Dysmorphism, Premature Baby, Foetal Exposure During Pregnancy, Hypotonia, Abnormal Palmar / Plantar Creases

Drug(s) suspected as cause:
Keppra XR
    Dosage: total daily dose : 3000 mg
    Indication: Convulsion
    End date: 2011-06-15

Keppra XR
    Dosage: total daily dose : 3000 mg
    Indication: Epilepsy
    End date: 2011-06-15

Other drugs received by patient: Folic Acid; Ferrous Sulfate TAB; Pepcid AC; Tylenol; Prenatal Complete; Trazodone Hydrochloride



Possible Keppra XR side effects in male

Reported by a physician from United States on 2012-08-07

Patient: male, weighing 3.0 kg (6.6 pounds)

Reactions: Dysmorphism, Premature Baby, Foetal Exposure During Pregnancy, Abnormal Palmar / Plantar Creases

Drug(s) suspected as cause:
Keppra XR
    Dosage: total daily dose : 3000 mg
    Indication: Epilepsy
    Start date: 2010-10-01
    End date: 2011-06-15

Keppra XR
    Dosage: total daily dose : 3000 mg
    Indication: Convulsion
    Start date: 2010-10-01
    End date: 2011-06-15

Other drugs received by patient: Trazodone Hydrochloride; Folic Acid; Tylenol; Prenatal Complete; Pepcid AC; Ferrous Sulfate TAB



Possible Keppra XR side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 53 year old female, weighing 61.2 kg (134.7 pounds)

Reactions: Humerus Fracture, Inappropriate Schedule of Drug Administration

Drug(s) suspected as cause:
Keppra XR

Other drugs received by patient: Tegretol



Possible Keppra XR side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient: male

Reactions: Myocardial Infarction, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Keppra XR



Possible Keppra XR side effects in male

Reported by a physician from United States on 2012-07-26

Patient: male, weighing 2.1 kg (4.7 pounds)

Reactions: Trisomy 21, Maternal Drugs Affecting Foetus, Dysmorphism, Premature Baby, Hypotonia, Foetal Exposure During Pregnancy, Abnormal Palmar / Plantar Creases

Drug(s) suspected as cause:
Keppra XR
    Dosage: total daily dose : 3000 mg
    Indication: Epilepsy
    End date: 2011-06-15

Keppra XR
    Dosage: total daily dose : 3000 mg
    Indication: Convulsion
    End date: 2011-06-15

Other drugs received by patient: Prenatal Complete; Folic Acid; Trazodone Hydrochloride; Tylenol; Pepcid AC; Ferrous Sulfate TAB



Possible Keppra XR side effects in male

Reported by a physician from United States on 2012-07-26

Patient: male, weighing 3.0 kg (6.6 pounds)

Reactions: Dysmorphism, Premature Baby, Foetal Exposure During Pregnancy, Abnormal Palmar / Plantar Creases

Drug(s) suspected as cause:
Keppra XR
    Dosage: total daily dose : 3000 mg
    Indication: Convulsion
    Start date: 2010-10-01
    End date: 2011-06-15

Keppra XR
    Dosage: total daily dose : 3000 mg
    Indication: Epilepsy
    Start date: 2010-10-01
    End date: 2011-06-15

Other drugs received by patient: Tylenol; Ferrous Sulfate TAB; Trazodone Hydrochloride; Prenatal Complete; Pepcid AC; Folic Acid



Possible Keppra XR side effects in female

Reported by a physician from United States on 2012-07-25

Patient: female, weighing 3.1 kg (6.9 pounds)

Reactions: Foetal Exposure During Pregnancy, Pleural Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Keppra
    Indication: Epilepsy

Keppra XR
    Indication: Epilepsy
    End date: 2009-06-15

Lacosamide
    Indication: Epilepsy
    Start date: 2009-06-15
    End date: 2010-06-22

Other drugs received by patient: Claritin; Lantus; Repliva; Glyburide; Advair Diskus 100 / 50; Albuterol; Multi-Vitamins



Possible Keppra XR side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: male

Reactions: Myocardial Infarction, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Keppra XR



Possible Keppra XR side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-12

Patient: female

Reactions: Lung Neoplasm Malignant, Brain Neoplasm, Convulsion

Drug(s) suspected as cause:
Keppra XR



Possible Keppra XR side effects in female

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

Patient: female

Reactions: Cerebrovascular Accident

Drug(s) suspected as cause:
Keppra XR



Possible Keppra XR side effects in female

Reported by a physician from United States on 2012-07-02

Patient: female, weighing 3.1 kg (6.8 pounds)

Reactions: Jaundice, Bradycardia Foetal, Foetal Exposure During Pregnancy, Haemangioma

Drug(s) suspected as cause:
Keppra
    Dosage: 1000 daily dose
    Indication: Epilepsy
    End date: 2009-11-01

Keppra XR
    Start date: 2009-11-01
    End date: 2010-05-31

Other drugs received by patient: Folic Acid; Multi-Vitamins; Ferrous Sulfate TAB



Possible Keppra XR side effects in 33 year old female

Reported by a physician from United States on 2012-06-28

Patient: 33 year old female

Reactions: Road Traffic Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Keppra XR



Possible Keppra XR side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient: female, weighing 73.5 kg (161.7 pounds)

Reactions: Dysarthria, Thinking Abnormal, Incorrect Dose Administered, Mental Disorder, Convulsion, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Keppra XR
    Dosage: 6 pills a day was suggested

Keppra XR
    Dosage: 4 times a day or equally a total of 2000 mg
    Administration route: Oral
    Indication: Epilepsy



Possible Keppra XR side effects in 20 year old female

Reported by a physician from United States on 2012-06-20

Patient: 20 year old female

Reactions: Inappropriate Schedule of Drug Administration, Abdominal Pain, Nausea, Headache, Muscle Twitching, Constipation, Convulsion, Vaginal Haemorrhage, Upper Respiratory Tract Infection, Insomnia, Pregnancy

Drug(s) suspected as cause:
Keppra XR
    Indication: Epilepsy
    Start date: 2009-12-01

Keppra XR
    End date: 2009-11-30

Levetiracetam
    Indication: Epilepsy
    Start date: 2009-11-01

Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP



Possible Keppra XR side effects in 20 year old male

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient: 20 year old male, weighing 90.7 kg (199.6 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Suture Insertion, JAW Fracture, Fall, Convulsion

Drug(s) suspected as cause:
Keppra
    Dosage: 5 cc or 100 mg/ml is equal to 500 mg or 1000 mg, 5 ml 2 times a day which was 100 mg/ml
    Administration route: Oral
    Indication: Convulsion
    Start date: 2012-04-01

Keppra XR
    Administration route: Oral
    Indication: Convulsion
    End date: 2012-06-12

Keppra XR
    Administration route: Oral
    Start date: 2012-06-13

Other drugs received by patient: Xanax



Possible Keppra XR side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: 53 year old female

Reactions: Upper Limb Fracture

Drug(s) suspected as cause:
Keppra XR



Possible Keppra XR side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-14

Patient: female

Reactions: Abortion Spontaneous, Pregnancy

Drug(s) suspected as cause:
Keppra XR



Possible Keppra XR side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-14

Patient: female

Reactions: Maternal Exposure Before Pregnancy, Abortion Spontaneous, Pregnancy

Drug(s) suspected as cause:
Keppra XR



Possible Keppra XR side effects in male

Reported by a physician from United States on 2012-06-11

Patient: male

Reactions: Convulsion

Drug(s) suspected as cause:
Keppra XR
    Indication: Convulsion

Vimpat
    Indication: Convulsion

Other drugs received by patient: Keppra



Possible Keppra XR side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-04

Patient: male

Reactions: Lower Limb Fracture, Convulsion

Drug(s) suspected as cause:
Keppra XR



Possible Keppra XR side effects in 30 year old female

Reported by a physician from United States on 2012-05-31

Patient: 30 year old female

Reactions: Unintended Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Keppra XR
    Dosage: dose: 3000 mg
    Indication: Epilepsy

Topamax
    Dosage: dose: 400 mg
    Indication: Epilepsy



Possible Keppra XR side effects in 39 year old male

Reported by a consumer/non-health professional from United States on 2012-05-30

Patient: 39 year old male

Reactions: Skin Exfoliation, Hypoaesthesia, Muscle Twitching, Amnesia, Paraesthesia, Medication Error, Insomnia, Oedema Peripheral, Vision Blurred, Brain Operation

Drug(s) suspected as cause:
Keppra XR



Possible Keppra XR side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-05-30

Patient: 64 year old male, weighing 95.2 kg (209.6 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Grand MAL Convulsion, Gingivitis, Feeling Abnormal, Somnolence

Drug(s) suspected as cause:
Keppra
    Dosage: strenght 500 mg
    Administration route: Oral

Keppra
    Dosage: form strength: 500 mg; 1500mg in am, 1500mg in pm
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2005-01-01
    End date: 2010-12-01

Keppra
    Dosage: form strength: 500 mg; 1500mg in am, 1500mg in pm
    Administration route: Oral
    Indication: Convulsion
    Start date: 2005-01-01
    End date: 2010-12-01

Keppra
    Dosage: strenght 500 mg
    Administration route: Oral

Keppra XR
    Dosage: 1500mg in am, 1500 mg in pm
    Administration route: Oral
    Indication: Convulsion
    Start date: 2005-01-01
    End date: 2005-01-01

Levetiracetam
    Dosage: 1500mg in am, 1500mg in pm-generic levetiracetam
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2010-12-01

Levetiracetam
    Dosage: 1500mg in am, 1500mg in pm-generic levetiracetam
    Administration route: Oral
    Indication: Convulsion
    Start date: 2010-12-01

Other drugs received by patient: Atenolol; Clonazepam; Cholesterol Pill; Dilantain; Sleeping Pill; Triamterene and Hydrochlorothiazide; Reflux Pill; Lorazepam

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