Recommended Topic Related To:

Keppra

"The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.

Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain"...

Keppra

Keppra

SIDE EFFECTS

The following adverse reactions are discussed in more details in other sections of labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The prescriber should be aware that the adverse reaction incidence figures in the following tables, obtained when KEPPRA was added to concurrent AED therapy, cannot be used to predict the frequency of adverse reactions in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical trials. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and non-drug factors to the adverse reaction incidences in the population studied.

Partial Onset Seizures

Adults

In controlled clinical studies in adults with partial onset seizures, the most frequently reported adverse reactions in patients receiving KEPPRA in combination with other AEDs, for events with rates greater than placebo, were somnolence, asthenia, infection and dizziness. Of the most frequently reported adverse reactions in adults experiencing partial onset seizures, asthenia, somnolence and dizziness appeared to occur predominantly during the first 4 weeks of treatment with KEPPRA.

Table 3 lists adverse reactions that occurred in at least 1% of adult epilepsy patients treated with KEPPRA participating in placebo-controlled studies and were numerically more common than in patients treated with placebo. In these studies, either KEPPRA or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 3: Incidence (%) Of Adverse Reactions In Placebo-Controlled, Add-On Studies In Adults Experiencing Partial Onset Seizures By Body System (Adverse Reactions Occurred In At Least 1% Of KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/ Adverse Reaction KEPPRA
(N=769) %
Placebo
(N=439) %
Body as a Whole
  Asthenia 15 9
  Headache 14 13
  Infection 13 8
  Pain 7 6
Digestive System
  Anorexia 3 2
Nervous System
  Somnolence 15 8
  Dizziness 9 4
  Depression 4 2
  Nervousness 4 2
  Ataxia 3 1
  Vertigo 3 1
  Amnesia 2 1
  Anxiety 2 1
  Hostility 2 1
  Paresthesia 2 1
  Emotional Lability 2 0
Respiratory System
  Pharyngitis 6 4
  Rhinitis 4 3
  Cough Increased 2 1
  Sinusitis 2 1
Special Senses
  Diplopia 2 1

In controlled adult clinical studies, 15% of patients receiving KEPPRA and 12% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. Table 4 lists the most common ( > 1%) adverse reactions that resulted in discontinuation or dose reduction and that occurred more frequently in KEPPRA-treated patients than in placebo-treated patients.

Table 4: Adverse Reactions That Most Commonly Resulted In Discontinuation Or Dose Reduction That Occurred More Frequently In KEPPRA-Treated Patients In Placebo-Controlled Studies In Adult Patients Experiencing Partial Onset Seizures

Adverse Reaction KEPPRA
(N=769) %
Placebo
(N=439) %
Dizziness 1 0
Somnolence 4 2

Pediatric Patients 4 Years to < 16 Years

The adverse reaction data presented below was obtained from a pooled analysis of two controlled pediatric clinical studies in children 4 to 16 years of age with partial onset seizures. The adverse reactions most frequently reported with the use of KEPPRA in combination with other AEDs, for events with rates greater than placebo, were fatigue, aggression, nasal congestion, decreased appetite, and irritability.

Table 5 lists adverse reactions from the pooled pediatric controlled studies (4 to 16 years of age) that occurred in at least 2% of pediatric KEPPRA-treated patients and were numerically more common than in pediatric patients treated with placebo. In these studies, either KEPPRA or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 5: Incidence (%) Of Adverse Reactions In Pooled Placebo-Controlled, Add-On Studies In Pediatric Patients Ages 4 to 16 Years Experiencing Partial Onset Seizures By Body System (Adverse Reactions Occurred In At Least 2% Of KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/ Adverse Reaction KEPPRA
(N=165) %
Placebo
(N=131) %
Ear and Labyrinth Disorders
  Ear Pain 2 1
Eye Disorders
  Conjunctivitis 2 0
Gastrointestinal Disorders
  Vomiting 15 12
  Abdominal Pain Upper 9 8
  Diarrhea    6 5
  Constipation 3 1
General Disorders and Administration Site Conditions
  Fatigue 11 5
Infections and Infestations
  Nasopharyngitis 15 12
  Influenza 3 1
  Gastroenteritis 2 0
  Rhinitis 2 0
Injury, Poisoning and Procedural Complications
  Head Injury 4 0
  Contusion 3 1
  Fall 3 2
  Joint Sprain 2 1
Metabolism and Nutrition Disorders
  Decreased Appetite 8 2
  Anorexia 4 3
Musculoskeletal and Connective Tissue Disorders
  Arthralgia   2 0
  Neck Pain 2 1
Nervous System
  Headache 19 15
  Somnolence 13 9
  Dizziness 7 5
  Lethargy 6 2
  Sedation 2 1
Psychiatric Disorders
  Aggression 10 5
  Abnormal Behavior 7 4
  Irritability 7 1
  Insomnia 5 3
  Agitation 4 1
  Depression 3 1
  Mood Altered 3 1
  Affect Lability 2 1
  Anxiety 2 1
  Confusional State 2 0
  Mood Swings 2 1
Respiratory, Thoracic and Mediastinal Disorders
  Cough 9 5
  Nasal Congestion 9 2
  Pharyngolaryngeal Pain 7 4

In the well controlled pooled pediatric clinical studies in patients 4-16 years of age, 7% of patients receiving KEPPRA and 9% receiving placebo discontinued as a result of an adverse event.

Pediatric Patients 1 Month to < 4 Years

In the 7-day, controlled pediatric clinical study in children 1 month to less than 4 years of age with partial onset seizures, the adverse reactions most frequently reported with the use of KEPPRA in combination with other AEDs, for events with rates greater than placebo, were somnolence and irritability. Because of the shorter exposure period, incidences of adverse reactions are expected to be lower than in other pediatric studies in older patients. Therefore, other controlled pediatric data, presented above, should also be considered to apply to this age group.

Table 6 lists adverse reactions that occurred in at least 5% of pediatric epilepsy patients (ages 1 month to < 4 years) treated with KEPPRA participating in the placebo-controlled study and were numerically more common than in patients treated with placebo. In this study, either KEPPRA or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 6: Incidence (%) Of Adverse Reactions In A Placebo-Controlled, Add-On Study In Pediatric Patients Ages 1 Month to < 4 Years Experiencing Partial Onset Seizures By Body System (Adverse Reactions Occurred In At Least 5% Of KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/ Adverse Reaction KEPPRA
(N=60) %
Placebo
(N=56) %
Nervous System
  Somnolence 13 2
Psychiatric Disorders
  Irritability 12 0

In the 7-day controlled pediatric clinical study in patients 1 month to < 4 years of age, 3% of patients receiving KEPPRA and 2% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. There was no adverse event that resulted in discontinuation for more than one patient.

Myoclonic Seizures

Although the pattern of adverse reactions in this study seems somewhat different from that seen in patients with partial seizures, this is likely due to the much smaller number of patients in this study compared to partial seizure studies. The adverse reaction pattern for patients with JME is expected to be essentially the same as for patients with partial seizures.

In the well-controlled clinical study that included both adolescent (12 to 16 years of age) and adult patients with myoclonic seizures, the most frequently reported adverse reactions in patients using KEPPRA in combination with other AEDs, for events with rates greater than placebo, were somnolence, neck pain, and pharyngitis.

Table 7 lists adverse reactions that occurred in at least 5% of juvenile myoclonic epilepsy patients experiencing myoclonic seizures treated with KEPPRA and were numerically more common than in patients treated with placebo. In this study, either KEPPRA or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 7: Incidence (%) Of Adverse Reactions In A Placebo-Controlled, Add-On Study In Patients 12 Years Of Age And Older With Myoclonic Seizures By Body System (Adverse Reactions Occurred In At Least 5% Of KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/ Adverse Reaction KEPPRA
(N=60) %
Placebo
(N=60) %
Ear and labyrinth disorders
  Vertigo 5 3
Infections and infestations
  Pharyngitis 7 0
  Influenza 5 2
Musculoskeletal and connective tissue disorders
  Neck pain 8 2
Nervous system disorders
  Somnolence 12 2
Psychiatric disorders
  Depression 5 2

In the placebo-controlled study, 8% of patients receiving KEPPRA and 2% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. The adverse reactions that led to discontinuation or dose reduction and that occurred more frequently in KEPPRA-treated patients than in placebo-treated patients are presented in Table 8.

Table 8: Adverse Reactions That Resulted In Discontinuation Or Dose Reduction That Occurred More Frequently in KEPPRA-Treated Patients In The Placebo-Controlled Study In Patients With Juvenile Myoclonic Epilepsy

Adverse Reaction KEPPRA
(N=60) %
Placebo
(N=60) %
Anxiety 3 2
Depressed mood 2 0
Depression 2 0
Diplopia 2 0
Hypersomnia 2 0
Insomnia 2 0
Irritability 2 0
Nervousness 2 0
Somnolence 2 0

Primary Generalized Tonic-Clonic Seizures

Although the pattern of adverse reactions in this study seems somewhat different from that seen in patients with partial seizures, this is likely due to the much smaller number of patients in this study compared to partial seizure studies. The adverse reaction pattern for patients with PGTC seizures is expected to be essentially the same as for patients with partial seizures.

In the controlled clinical study that included patients 4 years of age and older with primary generalized tonicclonic (PGTC) seizures, the most frequently reported adverse reaction in patients using KEPPRA in combination with other AEDs, for events with rates greater than placebo, was nasopharyngitis.

Table 9 lists adverse reactions that occurred in at least 5% of idiopathic generalized epilepsy patients experiencing PGTC seizures treated with KEPPRA and were numerically more common than in patients treated with placebo. In this study, either KEPPRA or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 9: Incidence (%) Of Adverse Reactions In A Placebo-Controlled, Add-On Study In Patients 4 Years Of Age And Older With PGTC Seizures By MedDRA System Organ Class (Adverse Reactions Occurred In At Least 5% Of KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/ Adverse Reaction KEPPRA
(N=79) %
Placebo
(N=84) %
Gastrointestinal disorders
  Diarrhea 8 7
General disorders and administration site conditions
  Fatigue 10 8
Infections and infestations
  Nasopharyngitis 14 5
Psychiatric disorders
  Irritability 6 2
  Mood Swings 5 1

In the placebo-controlled study, 5% of patients receiving KEPPRA and 8% receiving placebo either discontinued or had a dose reduction during the treatment period as a result of an adverse reaction.

This study was too small to adequately characterize the adverse reactions that could be expected to result in discontinuation of treatment in this population. It is expected that the adverse reactions that would lead to discontinuation in this population would be similar to those resulting in discontinuation in other epilepsy trials (see tables 4 and 8).

In addition, the following adverse reactions were seen in other well-controlled adult studies of KEPPRA: balance disorder, disturbance in attention, eczema, memory impairment, myalgia, and vision blurred.

Comparison of Gender, Age and Race

The overall adverse reaction profile of KEPPRA was similar between females and males. There are insufficient data to support a statement regarding the distribution of adverse experience reports by age and race.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of KEPPRA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In addition to the adverse reactions listed above, the following adverse events have been reported in patients receiving marketed KEPPRA worldwide. The listing is alphabetized: abnormal liver function test, choreoathetosis, dyskinesia, erythema multiforme, hepatic failure, hepatitis, leukopenia, muscle weakness, neutropenia, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), panic attack, thrombocytopenia, and weight loss. Alopecia has been reported with KEPPRA use; recovery was observed in majority of cases where KEPPRA was discontinued.

Read the Keppra (levetiracetam) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No significant pharmacokinetic interactions were observed between levetiracetam or its major metabolite and concomitant medications via human liver cytochrome P450 isoforms, epoxide hydrolase, UDP-glucuronidation enzymes, P-glycoprotein, or renal tubular secretion [see CLINICAL PHARMACOLOGY].

Read the Keppra Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 3/19/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

Keppra - User Reviews

Keppra User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Keppra sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

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.


Epilepsy

Find tips and treatments to control seizures.

Related Supplements
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations