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Spritam Side Effects

Generic name: levetiracetam

Medically reviewed by Drugs.com. Last updated on Jan 24, 2024.

Note: This document contains side effect information about levetiracetam. Some dosage forms listed on this page may not apply to the brand name Spritam.

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

Serious side effects of Spritam

Along with its needed effects, levetiracetam (the active ingredient contained in Spritam) 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

Less common

Incidence not known

Other side effects of Spritam

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

Less common

Incidence not known

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

Frequently asked questions

References

1. Product Information. Keppra (levetiracetam). UCB Pharma Inc. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Pharmaceutical Society of Australia. APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp 2006.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.