Summary

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. Continue reading for a comprehensive list of adverse effects.

Applies to levetiracetam: oral solution, oral tablet, oral tablet for suspension, oral tablet extended release. Other dosage forms:

• intravenous solution

Serious side effects of Levetiracetam

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:

More common

• Aggressive or angry
• anxiety
• change in personality
• chills
• cough
• crying
• deep or fast breathing with dizziness
• delusions of persecution, mistrust, suspiciousness, or combativeness
• diarrhea
• dry mouth
• false or unusual sense of well-being
• feeling of unreality
• fever
• general feeling of discomfort or illness
• headache
• hoarseness
• irregular heartbeat
• irritability
• joint pain
• loss of appetite
• lower back or side pain
• mental depression
• muscle aches and pains
• nausea
• numbness of the feet, hands, and around the mouth
• painful or difficult urination
• quick to react or overreact emotionally
• rapidly changing moods
• restlessness
• sense of detachment from self or body
• shaking
• shivering
• sleepiness or unusual drowsiness
• sore throat
• stuffy or runny nose
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Less common

• Bloody nose
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• clumsiness or unsteadiness
• discouragement
• dizziness or lightheadedness
• double vision
• earache
• feeling of constant movement of self or surroundings
• feeling sad or empty
• increase in body movements
• loss of bladder control
• loss of memory
• mood or mental changes
• outburst of anger
• pain or tenderness around the eyes and cheekbones
• problems with memory
• redness or swelling in the ear
• seizures
• sensation of spinning
• shakiness and unsteady walk
• shakiness in the legs, arms, hands, or feet
• tightness of the chest
• trembling or shaking of the hands or feet
• trouble concentrating
• unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

• Attempts at killing oneself
• being forgetful
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• bloody, black, or tarry stools
• blurred vision
• changes in vision
• chest pain
• coma
• confusion
• constipation
• dark urine
• difficulty with moving
• fast heartbeat
• fever with or without chills
• general feeling of tiredness or weakness
• high fever
• increased thirst
• indigestion
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• muscle pains or stiffness
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• skin rash, encrusted, scaly, and oozing
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain, continuing
• swelling of the face, ankles, or hands
• swollen glands
• swollen joints
• thoughts or attempts at killing oneself
• trouble with balance
• twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• uncontrolled jerking or twisting movements of the hands, arms, or legs
• uncontrolled movements of the lips, tongue, or cheeks
• unexplained bleeding or bruising
• unusual bleeding or bruising
• upper right abdominal or stomach pain
• weight loss
• yellow eyes or skin

Other side effects of Levetiracetam

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:

More common

• Loss of strength or energy
• muscle pain or weakness
• pain
• tender, swollen glands in the neck
• trouble swallowing
• unusual weak feeling
• voice changes

Less common

• Body aches or pain
• burning, dry, or itching eyes
• change in the color of the skin
• congestion
• cough increased
• sneezing

Incidence not known

• Hair loss or thinning of the hair

For Healthcare Professionals

Applies to levetiracetam: intravenous solution, oral solution, oral tablet, oral tablet dispersible, oral tablet extended release.

General

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, dyskinesia^[Ref]

Psychiatric

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.^[Ref]

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^[Ref]

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%).^[Ref]

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, agranulocytosis^[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis

Dermatologic

Frequency not reported: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)

Postmarketing reports: Erythema multiforme, alopecia, angioedema^[Ref]

Alopecia reported with this drug resolved with discontinuation of therapy in most cases.^[Ref]

Other

Very common (10% or more): Asthenia (15%), fatigue (10%)

Common (1% to 10%): Pain, vertigo^[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, rhinitis, increased cough, sinusitis^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, gastroenteritis, constipation

Uncommon (0.1% to 1%): Nausea

Postmarketing reports: Pancreatitis^[Ref]

Ocular

Common (1% to 10%): Diplopia^[Ref]

Hepatic

Postmarketing reports: Abnormal liver function tests, hepatic failure, hepatitis^[Ref]

Musculoskeletal

Common (1% to 10%): Neck pain

Postmarketing reports: Muscular weakness^[Ref]

Immunologic

Very common (10% or more): Infection (13%)

Common (1% to 10%): Influenza

Postmarketing reports: Drug reaction with eosinophilia and systemic symptoms (DRESS)^[Ref]

Metabolic

Common (1% to 10%): Anorexia

Postmarketing reports: Weight loss, hyponatremia^[Ref]

Cardiovascular

Very common (10% or more): Increased diastolic blood pressure (less than 4 years of age; 17%)^[Ref]

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.^[Ref]

Renal

Postmarketing reports: Acute kidney injury