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Commonly reported side effects of levetiracetam include: infection, neurosis, drowsiness, asthenia, headache, nasopharyngitis, nervousness, abnormal behavior, aggressive behavior, agitation, anxiety, apathy, depersonalization, depression, fatigue, hostility, hyperkinetic muscle activity, mental disorders, outbursts of anger, personality disorder, emotional lability, irritability, laceration, and mood changes. Other side effects include: tonic clonic epilepsy, dizziness, vertigo, decreased neutrophils, depressed mood, influenza, neck pain, and pain. See below for a comprehensive list of adverse effects.For the Consumer
Applies to levetiracetam: oral solution, oral tablet, oral tablet for suspension, oral tablet extended release
Other dosage forms:
Along with its needed effects, levetiracetam may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking levetiracetam:
Incidence not known
Some side effects of levetiracetam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
For Healthcare Professionals
Applies to levetiracetam: intravenous solution, oral solution, oral tablet, oral tablet dispersible, oral tablet extended releaseGeneral
The more commonly reported adverse reactions in adults have included somnolence, asthenia, and dizziness; in children, fatigue, aggression, nasal congestion, decreased appetite, and irritability.Nervous system
Very common (10% or more): Headache (14%), somnolence (14%)
Common (1% to 10%): Dizziness, ataxia, vertigo, paresthesia, coordination difficulties
Postmarketing reports: Choreoathetosis, dyskinesiaPsychiatric
Very Common (10% or more): Non-psychotic behavioral symptoms (up to 38%), psychotic symptoms (up to 17%)
Common (1% to 10%): Depression, nervousness, amnesia, anxiety, hostility, emotional lability, irritability, mood swings, hypersomnia, insomnia, apathy, tearfulness, negativism
Postmarketing reports: Panic attack
In studies, non-psychotic behavioral symptoms (reported as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, hyperkinesias, irritability, nervousness, neurosis, and personality disorder) were reported in 13% of adults and 38% of pediatric patients aged 4 to 16 years compared to 6% and 19%, respectively in placebo patients. In patients less than 4 years old, irritability was reported in 12% compared to 0% in placebo patients. In adult patients, behavioral symptoms resulted in dose reduction or discontinuation 0.8% and 1.7% of patients, respectively. Dose reduction or discontinuation due to behavioral symptoms occurred in 11% of pediatric patients.
In studies, psychotic symptoms were reported in 1%, 2%, and 17% of patients receiving this drug aged adult, 4 to 16 years old, and less than 4 years compared to 0.2%, 2%, and 5% in placebo patients, respectively.Hematologic
In adults, 3.2% of patients receiving this drug had at least 1 WBC of 2.8 x 10(9)/L or lower and 2.4% had at least 1 neutrophil count of 1 x 10(9)/L or lower compared to 1.8% and 1.4% of placebo patients, respectively. Of those with a low neutrophil count, only 1 patient did not have resolution with continued treatment. No patient discontinued therapy due to a low neutrophil count. In pediatric patients 4 to 16 years old, mean decreases in WBC and neutrophils were 0.4 x 10(9)/L and 0.3 x 10(9)/L, respectively, compared to small increases in placebo patients. Mean relative lymphocyte counts increased by 1.7% in patients receiving this drug (placebo=decrease of 4%).
Common (1% to 10%): Decreased white blood cell count (WBC), decreased neutrophil count, increased lymphocyte counts, higher eosinophil counts
Frequency not reported: Decreases in white blood cell, neutrophil, and red blood cell counts; decreased in hemoglobin and hematocrit; increases in eosinophil counts
Postmarketing reports: Pancytopenia (with bone marrow suppression reported in some cases), thrombocytopenia, agranulocytosisHypersensitivity
Postmarketing reports: AnaphylaxisDermatologic
Alopecia reported with this drug resolved with discontinuation of therapy in most cases.
Frequency not reported: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)
Postmarketing reports: Erythema multiforme, alopecia, angioedemaOther
Very common (10% or more): Asthenia (15%), fatigue (10%)
Common (1% to 10%): Pain, vertigoRespiratory
Common (1% to 10%): Pharyngitis, rhinitis, increased cough, sinusitisGastrointestinal
Common (1% to 10%): Diarrhea, gastroenteritis, constipation
Uncommon (0.1% to 1%): Nausea
Postmarketing reports: PancreatitisOcular
Common (1% to 10%): DiplopiaHepatic
Postmarketing reports: Abnormal liver function tests, hepatic failure, hepatitisMusculoskeletal
Common (1% to 10%): Neck pain
Postmarketing reports: Muscular weaknessImmunologic
Very common (10% or more): Infection (13%)
Common (1% to 10%): Influenza
Postmarketing reports: Drug reaction with eosinophilia and systemic symptoms (DRESS)Metabolic
Common (1% to 10%): Anorexia
Postmarketing reports: Weight loss, hyponatremiaCardiovascular
Very common (10% or more): Increased diastolic blood pressure (less than 4 years of age; 17%)
In a clinical trial in patients 1 month to less than 4 years, 17% of patients had a significantly elevated diastolic blood pressure (placebo=2%). No overall difference in mean diastolic blood pressure was observed in treated patients compared with placebo nor was this effect observed in trials with older pediatric patients or adults.Renal
Postmarketing reports: Acute kidney injury
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February 9, 2021