Keppra - Side Effects levetiracetam

Side Effects for KEPPRA (levetiracetam tablet, film coated) are also known as adverse reactions. Below is a summary of known side effects for Keppra. If you experience side effects when taking Keppra, be sure to tell your doctor.

Adverse Reactions

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.

Partial Onset Seizures

Adults

In controlled clinical studies in adults with partial onset seizures, the most common 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 common adverse reactions in adults experiencing partial onset seizures, asthenia, somnolence, and dizziness occurred 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 receiving KEPPRA 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.

Table 3: Adverse Reactions in Pooled Placebo-Controlled, Add-On Studies in Adults Experiencing Partial Onset Seizures
KEPPRA
(N=769)
%
Placebo
(N=439)
%
Asthenia 15 9
Somnolence 15 8
Headache 14 13
Infection 13 8
Dizziness 9 4
Pain 7 6
Pharyngitis 6 4
Depression 4 2
Nervousness 4 2
Rhinitis 4 3
Anorexia 3 2
Ataxia 3 1
Vertigo 3 1
Amnesia 2 1
Anxiety 2 1
Cough Increased 2 1
Diplopia 2 1
Emotional Lability 2 0
Hostility 2 1
Paresthesia 2 1
Sinusitis 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 Resulted in Discontinuation or Dose Reduction in Placebo-Controlled Studies in Adult Patients Experiencing Partial Onset Seizures
Adverse Reaction KEPPRA
(N=769)
%
Placebo
(N=439)
%
Somnolence 4 2
Dizziness 1 0

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 pediatric patients 4 to 16 years of age with partial onset seizures. The most common adverse reactions in pediatric patients receiving 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.

Table 5: Adverse Reactions in Pooled Placebo-Controlled, Add-On Studies in Pediatric Patients Ages 4 to 16 Years Experiencing Partial Onset Seizures
KEPPRA
(N=165)
%
Placebo
(N=131)
%
Headache 19 15
Nasopharyngitis 15 12
Vomiting 15 12
Somnolence 13 9
Fatigue 11 5
Aggression 10 5
Cough 9 5
Nasal Congestion 9 2
Upper Abdominal Pain 9 8
Decreased Appetite 8 2
Abnormal Behavior 7 4
Dizziness 7 5
Irritability 7 1
Pharyngolaryngeal Pain 7 4
Diarrhea 6 2
Lethargy 6 5
Insomnia 5 3
Agitation 4 1
Anorexia 4 3
Head Injury 4 0
Altered Mood 3 1
Constipation 3 1
Contusion 3 1
Depression 3 1
Fall 3 2
Influenza 3 1
Affect Lability 2 1
Anxiety 2 1
Arthralgia 2 0
Confusional State 2 0
Conjunctivitis 2 0
Ear Pain 2 1
Gastroenteritis 2 0
Joint Sprain 2 1
Mood Swings 2 1
Neck Pain 2 1
Rhinitis 2 0
Sedation 2 1

In the 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 reaction.

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 most common adverse reactions in patients receiving 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 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.

Table 6: Adverse Reactions in a Placebo-Controlled, Add-On Study in Pediatric Patients Ages 1 Month to < 4 Years Experiencing Partial Onset Seizures
KEPPRA
(N=60)
%
Placebo
(N=56)
%
Somnolence 13 2
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 reaction. There was no adverse reaction 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 controlled clinical study in patients 12 years of age and older with myoclonic seizures, the most common adverse reactions in patients receiving 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.

Table 7: Adverse Reactions in a Placebo-Controlled, Add-On Study in Patients 12 Years of Age and Older with Myoclonic Seizures
KEPPRA
(N=60)
%
Placebo
(N=60)
%
Somnolence 12 2
Neck pain 8 2
Pharyngitis 7 0
Depression 5 2
Influenza 5 2
Vertigo 5 3

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 in a 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 primary generalized tonic-clonic (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 PGTC seizures, the most common adverse reaction in patients receiving 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.

Table 9: Adverse Reactions in a Placebo-Controlled, Add-On Study in Patients 4 Years of Age and Older with PGTC Seizures
KEPPRA
(N=79)
%
Placebo
(N=84)
%
Nasopharyngitis 14 5
Fatigue 10 8
Diarrhea 8 7
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 controlled adult studies of KEPPRA: balance disorder, disturbance in attention, eczema, memory impairment, myalgia, and blurred vision.

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 reactions 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.

The following adverse reactions have been reported in patients receiving marketed KEPPRA worldwide. The listing is alphabetized: abnormal liver function test, acute kidney injury, anaphylaxis, angioedema, agranulocytosis, choreoathetosis, drug reaction with eosinophilia and systemic symptoms (DRESS), dyskinesia, erythema multiforme, hepatic failure, hepatitis, hyponatremia, muscular weakness, 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.

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. 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.
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