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.

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; irritability; sore throat; tiredness; 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); abnormal thoughts; dark urine; decreased coordination; extreme dizziness, drowsiness, tiredness, or weakness; fever, chills, or persistent sore throat; hallucinations; memory loss; mouth sores; muscle or neck pain; new or worsening mental, mood, or behavior changes (eg, aggression, agitation, anger, anxiety, apathy, depression, hostility, irritability, panic attacks, restlessness); new or worsening seizures; pain, itching, or redness at the injection site; suicidal thoughts or attempts; unusual bruising or bleeding; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Keppra XR Extended-Release Tablets

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 XR Extended-Release Tablets:

Dizziness; drowsiness; irritability; nausea; sore throat; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Keppra XR Extended-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; dark urine; decreased coordination; extreme drowsiness, dizziness, tiredness, or weakness; fever, chills, or persistent sore throat; hallucinations; memory loss; mouth sores; new or worsening mental, mood, or behavior changes (eg, aggression, agitation, anger, anxiety, apathy, depression, hostility, irritability, panic attacks, restlessness); new or worsening seizures; suicidal thoughts or attempts; trouble sleeping; unusual bruising or bleeding; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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; irritability; runny nose; sore throat; 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); abnormal thoughts; dark urine; decreased coordination; extreme drowsiness, dizziness, tiredness, or weakness; fever, chills, or persistent sore throat; hallucinations; memory loss; mouth sores; new or worsening mental, mood, or behavior changes (eg, aggression, agitation, anger, anxiety, apathy, depression, hostility, irritability, panic attacks, restlessness); new or worsening seizures; suicidal thoughts or attempts; trouble sleeping; unusual bruising or bleeding; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Keppra Tablets

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 Tablets:

Dizziness; drowsiness; irritability; runny nose; sore throat; tiredness; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; dark urine; decreased coordination; extreme drowsiness, dizziness, tiredness, or weakness; fever, chills, or persistent sore throat; hallucinations; memory loss; mouth sores; new or worsening mental, mood, or behavior changes (eg, aggression, agitation, anger, anxiety, apathy, depression, hostility, irritability, panic attacks, restlessness); new or worsening seizures; suicidal thoughts or attempts; trouble sleeping; unusual bruising or bleeding; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Keppra Side Effects - 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 8 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 9 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 8: 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 9: 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 10 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 10: 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 11 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 11: 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 12 lists the most common (>1%) adverse events that resulted in discontinuation or dose reduction.

Table 12: 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 13.

Table 13: 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 14.

Table 14: 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. 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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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects have included somnolence (up to 15%), dizziness (9%), vertigo (up to 5%), depression (4%), nervousness (4%), ataxia (3%), amnesia (2%), anxiety (2%), emotional lability (2%), hostility (2%), and paresthesia (2%). A case of levetiracetam-induced parkinsonism has also been reported.

Somnolence (8%) and dizziness (5%) have been reported with extended release tablets.

General

General side effects have included asthenia (15%), headache (14%), nasopharyngitis (14%), infection (13%), fatigue (10%), pain (7%), and influenza (5%). Several cases of considerable weight loss associated with levetiracetam use have also been reported. Levetiracetam has been associated with fatigue in pediatric patients.

Influenza (8%) has been reported with extended release tablets.

Respiratory

Respiratory side effects have included pharyngitis (up to 7%), rhinitis (4%), increased cough (2%), and sinusitis (2%).

Nasopharyngitis (7%) has been reported with extended release tablets.

Psychiatric

Slower titration should be considered in patients at a higher risk of discontinuing levetiracetam for behavioral reasons.

Psychiatric side effects such as depression (up to 5.7%) including suicidal depression (up to 0.7%), irritability (6%), and mood swings (5%) have been reported.

In some patients experiencing primary generalized tonic-clonic seizures, levetiracetam caused behavioral abnormalities. Nonpsychotic mood disorders (reported as anger, apathy, depression, altered mood, mood swings, negativism, suicidal ideation, and tearfulness) occurred in 12.7% of levetiracetam-treated patients. One patient experienced suicidal ideation. Another patient experienced delusional behavior that required the lowering of the dose of levetiracetam.

Irritability (7%) has been reported with extended release tablets.

Gastrointestinal

A multicenter, double-blind, placebo controlled trial (n=517) has reported that 10.1% of patients treated with levetiracetam had adverse psychiatric events. A significant association was reported with previous psychiatric history, history of febrile convulsions, and history of status epilepticus. Concomitant therapy with lamotrigine was reported to have had a protective effect. Psychiatric adverse events were not related to the titration schedule of levetiracetam. Certain patients seem to be more vulnerable biologically.

Gastrointestinal side effects have included anorexia (3%), pancreatitis, and diarrhea.

Nausea (5%) has been reported with extended release tablets.

Ocular

Ocular side effects have included diplopia (2%).

Hematologic

One possibly significant decreased WBC count occurred in every 3.2% of treated patients. One possibly significant decreased neutrophil count occurred in every 2.4% of treated patients.

Hematologic side effects have included leukopenia, neutropenia, pancytopenia (with bone marrow suppression identified in some of these cases), and thrombocytopenia. Minor, but statistically significant decreases in total mean RBC count (0.03 x 1,000,000/mm2), mean hemoglobin (0.09 g/dL), and mean hematocrit (0.38%) have also been reported.

Dermatologic

Recovery from alopecia was reported in the majority of the cases where levetiracetam was discontinued.

Dermatologic side effects including alopecia have been reported.

Hepatic

Hepatic side effects including abnormal liver function tests, hepatitis, and hepatic failure have been reported during postmarketing surveillance.

Musculoskeletal

Musculoskeletal side effects including neck pain (8%) have been reported.

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