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Side Effects > Keppra

Keppra Side Effects

Generic Name: Levetiracetam

Please note - some side effects for Keppra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).


For the consumer

For the professional

Side Effects of Keppra - for the consumer


Keppra

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Keppra:

Dizziness; drowsiness; loss of appetite; runny nose; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Keppra:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavioral changes (eg, aggression; agitation; anger; apathy; irritability); changes in vision; decreased coordination; depression; fever, chills, or sore throat; hallucinations; memory loss; mental or mood changes; new or worsening seizures; suicidal thoughts or attempts; unusual bruising or bleeding; yellowing of the skin or eyes.


Keppra Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Keppra Solution:

Dizziness; drowsiness; loss of appetite; runny nose; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Keppra Solution:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavioral changes (eg, aggression; agitation; anger; apathy; irritability); changes in vision; decreased coordination; depression; fever, chills, or sore throat; hallucinations; memory loss; mental or mood changes; new or worsening seizures; suicidal thoughts or attempts; unusual bruising or bleeding; yellowing of the skin or eyes.

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For the professional


Keppra

The prescriber should be aware that the adverse event incidence figures in the following tables, obtained when Keppra was added to concurrent AED therapy, cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. 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 event incidences in the population studied.

Partial Onset Seizures

In well-controlled clinical studies in adults with partial onset seizures, the most frequently reported adverse events associated with the use of Keppra in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, asthenia, infection and dizziness. In the well-controlled pediatric clinical study in children 4 to 16 years of age with partial onset seizures, the adverse events most frequently reported with the use of Keppra in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, accidental injury, hostility, nervousness, and asthenia.

Table 7 lists treatment-emergent adverse events 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. Table 8 lists treatment-emergent adverse events that occurred in at least 2% of pediatric epilepsy patients (ages 4-16 years) treated with Keppra participating in the placebo-controlled study 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 events were usually mild to moderate in intensity.

Table 7: Incidence (%) Of Treatment-Emergent Adverse Events In Placebo-Controlled, Add-On Studies In Adults Experiencing Partial Onset Seizures By Body System (Adverse Events Occurred In At Least 1% Of Keppra-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)
Body System/
        Adverse Event
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

Other events reported by at least 1% of adult Keppra-treated patients but as or more frequent in the placebo group were the following: abdominal pain, accidental injury, amblyopia, arthralgia, back pain, bronchitis, chest pain, confusion, constipation, convulsion, diarrhea, drug level increased, dyspepsia, ecchymosis, fever, flu syndrome, fungal infection, gastroenteritis, gingivitis, grand mal convulsion, insomnia, nausea, otitis media, rash, thinking abnormal, tremor, urinary tract infection, vomiting and weight gain.

Table 8: Incidence (%) Of Treatment-Emergent Adverse Events In A Placebo-Controlled, Add-On Study In Pediatric Patients Ages 4-16 Years Experiencing Partial Onset Seizures By Body System (Adverse Events Occurred In At Least 2% Of Keppra-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)
Body System/
        Adverse Event
Keppra
(N=101)
%
Placebo
(N=97)
%
Body as a Whole
      Accidental Injury 17 10
      Asthenia 9 3
      Pain 6 3
      Flu Syndrome 3 2
      Face Edema 2 1
      Neck Pain 2 1
      Viral Infection 2 1
Digestive System
      Vomiting 15 13
      Anorexia 13 8
      Diarrhea 8 7
      Gastroenteritis 4 2
      Constipation 3 1
Hemic and Lymphatic System
      Ecchymosis 4 1
Metabolic and Nutritional
      Dehydration 2 1
Nervous System
      Somnolence 23 11
      Hostility 12 6
      Nervousness 10 2
      Personality Disorder 8 7
      Dizziness 7 2
      Emotional Lability 6 4
      Agitation 6 1
      Depression 3 1
      Vertigo 3 1
      Reflexes Increased 2 1
      Confusion 2 0
Respiratory System
      Rhinitis 13 8
      Cough Increased 11 7
      Pharyngitis 10 8
      Asthma 2 1
Skin and Appendages
      Pruritus 2 0
      Skin Discoloration 2 0
      Vesiculobullous Rash 2 0
Special Senses
      Conjunctivitis 3 2
      Amblyopia 2 0
      Ear Pain 2 0
Urogenital System
      Albuminuria 4 0
      Urine Abnormality 2 1

Other events occurring in at least 2% of pediatric Keppra-treated patients but as or more frequent in the placebo group were the following: abdominal pain, allergic reaction, ataxia, convulsion, epistaxis, fever, headache, hyperkinesia, infection, insomnia, nausea, otitis media, rash, sinusitis, status epilepticus (not otherwise specified), thinking abnormal, tremor, and urinary incontinence.

Myoclonic Seizures

Although the pattern of adverse events 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 event 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 events associated with the use of Keppra in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, neck pain, and pharyngitis.

Table 9 lists treatment-emergent adverse events 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 events were usually mild to moderate in intensity.

Table 9: Incidence (%) Of Treatment-Emergent Adverse Events In A Placebo-Controlled, Add-On Study In Patients 12 Years Of Age And Older With Myoclonic Seizures By Body System (Adverse Events Occurred In At Least 5% Of Keppra-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)
Body System /
    MedDRA preferred term
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

Other events occurring in at least 5% of Keppra-treated patients with myoclonic seizures but as or more frequent in the placebo group were the following: fatigue and headache.

Primary Generalized Tonic-Clonic Seizures

Although the pattern of adverse events 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 event pattern for patients with PGTC seizures is expected to be essentially the same as for patients with partial seizures.

In the well-controlled clinical study that included patients 4 years of age and older with primary generalized tonic-clonic (PGTC) seizures, the most frequently reported adverse event associated with the use of Keppra in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, was nasopharyngitis.

Table 10 lists treatment-emergent adverse events 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 events were usually mild to moderate in intensity.

Table 10: Incidence (%) Of Treatment-Emergent Adverse Events In A Placebo-Controlled, Add-On Study In Patients 4 Years Of Age And Older With PGTC Seizures By MedDRA System Organ Class (Adverse Events Occurred In At Least 5% Of Keppra-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)
MedDRA System Organ Class/
     Preferred Term
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

Other events occurring in at least 5% of Keppra-treated patients with PGTC seizures but as or more frequent in the placebo group were the following: dizziness, headache, influenza, and somnolence.

Time Course Of Onset Of Adverse Events For Partial Onset Seizures

Of the most frequently reported adverse events in adults experiencing partial onset seizures, asthenia, somnolence and dizziness appeared to occur predominantly during the first 4 weeks of treatment with Keppra.

Discontinuation Or Dose Reduction In Well-Controlled Clinical Studies

Partial Onset Seizures

In well-controlled adult clinical studies, 15.0% of patients receiving Keppra and 11.6% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. Table 11 lists the most common (>1%) adverse events that resulted in discontinuation or dose reduction.

Table 11: Adverse Events That Most Commonly Resulted In Discontinuation Or Dose Reduction In Placebo-Controlled Studies In Adult Patients Experiencing Partial Onset Seizures
Number (%)
Keppra
(N=769)
Placebo
(N=439)
Asthenia 10 (1.3%) 3 (0.7%)
Convulsion 23 (3.0%) 15 (3.4%)
Dizziness 11 (1.4%) 0
Rash 0 5 (1.1%)
Somnolence 34 (4.4%) 7 (1.6%)

In the well-controlled pediatric clinical study, 16.8% of patients receiving Keppra and 20.6% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. The adverse events most commonly associated (≥3% in patients receiving Keppra) with discontinuation or dose reduction in the well-controlled study are presented in Table 12.

Table 12: Adverse Events Most Commonly Associated With Discontinuation Or Dose Reduction In The Placebo-Controlled Study In Pediatric Patients Ages 4-16 Years Experiencing Partial Onset Seizures
Number (%)
Keppra
(N=101)
Placebo
(N=97)
Asthenia 3 (3.0%) 0
Hostility 7 (6.9%) 2 (2.1%)
Somnolence 3 (3.0%) 3 (3.1%)

Myoclonic Seizures

In the placebo-controlled study, 8.3% of patients receiving Keppra and 1.7% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. The adverse events that led to discontinuation or dose reduction in the well-controlled study are presented in Table 13.

Table 13: Adverse Events That Resulted In Discontinuation Or Dose Reduction In The Placebo-Controlled Study In Patients With Juvenile Myoclonic Epilepsy
Body System/
   MedDRA preferred term
Keppra
(N=60)
n (%)
Placebo
(N=60)
n (%)
    Anxiety 2 (3.3%) 1 (1.7%)
    Depressed mood 1 (1.7%) 0
    Depression 1 (1.7%) 0
    Diplopia 1 (1.7%) 0
    Hypersomnia 1 (1.7%) 0
    Insomnia 1 (1.7%) 0
    Irritability 1 (1.7%) 0
    Nervousness 1 (1.7%) 0
    Somnolence 1 (1.7%) 0

Primary Generalized Tonic-Clonic Seizures

In the placebo-controlled study, 5.1% of patients receiving Keppra and 8.3% receiving placebo either discontinued or had a dose reduction during the treatment period as a result of a treatment-emergent adverse event.

This study was too small to adequately characterize the adverse events leading to discontinuation. It is expected that the adverse events that would lead to discontinuation in this population would be similar to those resulting in discontinuation in other epilepsy trials.

Comparison Of Gender, Age And Race

The overall adverse experience 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

In addition to the adverse experiences listed above, the following have been reported in patients receiving marketed Keppra worldwide. The listing is alphabetized: abnormal liver function test, hepatic failure, hepatitis, leukopenia, neutropenia, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), thrombocytopenia, and weight loss. Alopecia has been reported with Keppra use; recovery was observed in majority of cases where Keppra was discontinued. There have been reports of suicidal behavior (including completed suicide) with marketed Keppra. These adverse experiences have not been listed above, and data are insufficient to support an estimate of their incidence or to establish causation.

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More resources:

Drugs.com Keppra

PDR Keppra

MedFacts Keppra

Micromedex Keppra - Includes detailed dosage instructions.

FDA Keppra

Facts & Comparisons Levetiracetam

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