Levetiracetam Side Effects

Brand Names: Keppra XR, Keppra

Please note - some side effects for Levetiracetam 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).

Side Effects of Levetiracetam - for the Consumer

Levetiracetam

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 Levetiracetam:

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

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

Levetiracetam 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 Levetiracetam Extended-Release Tablets:

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

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

Levetiracetam 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 Levetiracetam Solution:

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

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

Levetiracetam 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 Levetiracetam Tablets:

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

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

Levetiracetam Side Effects - for the Professional

Levetiracetam

The prescriber should be aware that the adverse event incidence figures in the following tables, obtained when Levetiracetam 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 Levetiracetam 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 Levetiracetam in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, accidental injury, hostility, nervousness, and asthenia.

Table 5 lists treatment-emergent adverse events that occurred in at least 1% of adult epilepsy patients treated with Levetiracetam participating in placebo-controlled studies and were numerically more common than in patients treated with placebo. Table 6 lists treatment-emergent adverse events that occurred in at least 2% of pediatric epilepsy patients (ages 4-16 years) treated with Levetiracetam participating in the placebo-controlled study and were numerically more common than in pediatric patients treated with placebo. In these studies, either Levetiracetam or placebo was added to concurrent AED therapy. Adverse events were usually mild to moderate in intensity.

Other events reported by at least 1% of adult Levetiracetam-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.

Other events occurring in at least 2% of pediatric Levetiracetam-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.

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 Levetiracetam.

Discontinuation Or Dose Reduction In Well-Controlled Clinical Studies

Partial Onset Seizures

In well-controlled adult clinical studies, 15.0% of patients receiving Levetiracetam and 11.6% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. Table 7 lists the most common (>1%) adverse events that resulted in discontinuation or dose reduction.

In the well-controlled pediatric clinical study, 16.8% of patients receiving Levetiracetam 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 Levetiracetam) with discontinuation or dose reduction in the well-controlled study are presented in Table 8.

Comparison Of Gender, Age And Race

The overall adverse experience profile of Levetiracetam 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 events have been identified during postapproval use of Levetiracetam. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.

In addition to the adverse experiences listed above, the following have been reported in patients receiving marketed Levetiracetam 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 Levetiracetam use; recovery was observed in majority of cases where Levetiracetam was discontinued. There have been reports of suicidal behavior (including completed suicide, suicide attempt and suicidal ideation) with marketed Levetiracetam. These adverse experiences have not been listed above, and data are insufficient to support an estimate of their incidence or to establish causation.

Side Effects by Body System

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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