Spritam Side Effects

Generic name: levetiracetam

Medically reviewed by Drugs.com. Last updated on Apr 27, 2024.

Note: This document provides detailed information about Spritam Side Effects associated with levetiracetam. Some dosage forms listed on this page may not apply specifically to the brand name Spritam.

Applies to levetiracetam: intravenous solution.

Other dosage forms:

• oral solution, oral tablet, oral tablet for suspension, oral tablet extended release

Precautions

It is very important that your doctor check your progress closely while you or your child is receiving this medicine. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

Levetiracetam may cause changes in mood or behavior, problems with coordination, or unusual tiredness or weakness. Tell your doctor right away if you or your child starts to feel depressed, anxious, or angry, getting upset easily, restless, or if you have thoughts about hurting yourself. Report any unusual thoughts or behavior that trouble you or your child, especially if they are new or getting worse quickly.

This medicine may cause some people to become dizzy, drowsy, tired, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Do not interrupt or stop receiving this medicine without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely.

This medicine may cause an increase in blood pressure in children 1 month to 4 years of age. If you notice any changes to your child's normal blood pressure, tell your child's doctor right away.

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 or nurse immediately if any of the following side effects occur while taking levetiracetam:

Get emergency help immediately if any of the following symptoms of overdose occur while taking levetiracetam:

Symptoms of overdose

• anxiety
• attack, assault, or force
• decrease, loss, or change in consciousness
• difficult or troubled breathing
• dry mouth
• hyperventilation
• irregular, fast or slow, or shallow breathing
• irregular heartbeats
• irritability
• pale or blue lips, fingernails, or skin
• restlessness
• shaking
• sleepiness or unusual drowsiness
• trouble sleeping

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:

See also:

For healthcare professionals

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

General adverse events

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

• 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]

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]

Hematologic

• 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]

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]

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

• How is the drug Spritam made?

Further information

Spritam side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer