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What is the most frequent adverse effect of levetiracetam?: A Detailed Look

5 min read

According to U.S. FDA clinical trial data for adults, somnolence, or excessive sleepiness, was reported as the most frequent adverse effect of levetiracetam. However, identifying exactly what is the most frequent adverse effect of levetiracetam can be complex, as common side effects often differ significantly between adults and pediatric patients. This article explores the most common adverse effects associated with this widely used antiepileptic drug.

Quick Summary

The most frequent adverse effect of levetiracetam depends on the patient's age group, with somnolence and fatigue common in adults and behavioral issues prevalent in children. Dizziness, infection, and nausea are also frequently reported side effects. Many adverse effects diminish over time or can be managed with dosage adjustments and other strategies.

Key Points

  • Age-Specific Side Effects: The most common adverse effects of levetiracetam differ by age, with somnolence and fatigue most frequent in adults and behavioral issues more prevalent in children.

  • Common Adult Effects: Somnolence (drowsiness) and asthenia (weakness/fatigue) are the most frequently reported side effects in adults, often occurring within the first month of treatment.

  • Prominent Pediatric Issues: Behavioral changes, including irritability and aggression, are a key concern in children and can sometimes lead to treatment discontinuation.

  • Management is Possible: Many side effects are mild to moderate and can be managed through dosage adjustments, medication timing, or supportive care like vitamin B6 supplementation for irritability.

  • Serious Side Effects: Though rare, serious adverse effects such as severe skin reactions (SJS, TEN), blood disorders, and psychiatric symptoms like suicidal thoughts can occur and warrant immediate medical attention.

In This Article

Understanding the Most Frequent Adverse Effects of Levetiracetam

Levetiracetam, often known by the brand name Keppra, is a critical medication for managing various types of seizures in individuals with epilepsy. While effective, its therapeutic benefits must be weighed against its potential for adverse effects. For both patients and healthcare providers, understanding the most likely side effects is crucial for effective management and improving quality of life. The most frequent adverse effect varies by age, with central nervous system (CNS) effects like somnolence and asthenia being particularly common in adults, while behavioral changes are more prevalent in children.

Somnolence and Fatigue in Adult Patients

For adults, somnolence (drowsiness) and asthenia (weakness or fatigue) are consistently reported as the most frequent adverse effects of levetiracetam. In clinical trials reviewed by the FDA, somnolence was specifically noted in 15.8% of adult patients. These sedative effects typically manifest early in the course of treatment, often within the first four weeks, as the body adjusts to the medication.

Many patients describe a general feeling of tiredness or low energy that can interfere with daily activities. While these effects are often mild to moderate and may decrease over time, persistent or severe drowsiness should be discussed with a healthcare provider. Drowsiness can be exacerbated by other sedating medications and alcohol, so awareness is key for patient safety, especially concerning activities that require alertness, like driving.

Behavioral and Mood Changes in Pediatric Patients

In pediatric populations, the most prominent adverse effects of levetiracetam are frequently behavioral and psychological. These can include irritability, aggression, agitation, and mood swings. While these changes can range from mild to severe, they are a significant concern, sometimes leading to discontinuation of the drug. The mechanisms behind these behavioral effects are still being researched, but some evidence suggests it might relate to the drug's effect on neurotransmitter release.

  • Irritability and Aggression: These are among the most cited behavioral side effects in children. Parents and caregivers may notice increased frustration or aggressive outbursts.
  • Mood Swings: Emotional lability, nervousness, and depression can also be more frequently observed in children taking levetiracetam compared to adults.
  • Fatigue and Decreased Appetite: Similar to adults, fatigue is also a common complaint in pediatric patients, along with a decreased appetite.

Other Common Adverse Effects Across All Ages

While somnolence and behavioral changes may dominate, several other adverse effects are commonly reported across different age groups, often appearing in the initial stages of therapy.

  • Dizziness: A feeling of lightheadedness or vertigo is a frequent complaint, which may affect coordination and balance.
  • Infections: Pharyngitis (sore throat), rhinitis (stuffy/runny nose), and other general infections are often reported. In some cases, this can be linked to effects on certain blood cell counts.
  • Gastrointestinal Distress: Nausea, vomiting, and loss of appetite are common, especially when starting the medication. Taking the medication with food can sometimes alleviate these symptoms.
  • Headache: Headaches are also a potential side effect, though it is often difficult to distinguish whether they are caused by the medication or the underlying epilepsy condition.

Comparison of Common Side Effects: Adults vs. Children

To illustrate the age-dependent nature of levetiracetam's adverse effects, the table below provides a quick comparison of the most common issues.

Side Effect Incidence in Adults Incidence in Children Notes
Somnolence Very Common (15.8% based on FDA data) Common, but often overshadowed by behavioral issues Often improves within the first month of treatment.
Fatigue/Asthenia Very Common (often reported with somnolence) Common Can also be a symptom of underlying epilepsy or other treatments.
Behavioral Changes (Irritability, Aggression) Common, but less frequent than in children Very Common (more pronounced and frequent) Can sometimes be managed with vitamin B6 supplementation.
Dizziness Common (9.4% based on FDA data) Common Exercise caution when performing activities requiring coordination.
Infection (e.g., Pharyngitis) Reported in 7% to 15% of patients Reported in 7% to 15% of patients Often includes cold and flu-like symptoms.

Managing Levetiracetam's Adverse Effects

Effective management strategies can help minimize the impact of levetiracetam's side effects. Communication with your healthcare provider is the most important step.

  • Dose Titration: Levetiracetam is often started at a low dose and gradually increased. This allows the body to adjust and can help reduce initial side effects like dizziness and somnolence.
  • Timing of Doses: Adjusting the timing of medication doses can be helpful. For instance, a larger portion of the dose could be taken in the evening to reduce daytime sleepiness.
  • Vitamin B6 Supplementation: For behavioral side effects like irritability and aggression, especially in children, supplementation with vitamin B6 has been suggested to be beneficial in some cases. However, patients should discuss this option with their doctor before starting.
  • Lifestyle Adjustments: Limiting or avoiding alcohol can prevent increased drowsiness. For nausea, taking the medication with food can be helpful.
  • Monitor and Report: Patients and caregivers should closely monitor for changes in behavior, especially during the initial treatment phase. Any persistent or concerning symptoms should be reported to the prescribing physician.

Serious but Less Common Adverse Effects

While most adverse effects are manageable, some rare but serious reactions can occur and require immediate medical attention. These include:

  • Severe Skin Reactions: In rare instances, levetiracetam can cause life-threatening skin reactions such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). Symptoms may include a rash, fever, and swollen lymph nodes.
  • Psychiatric Symptoms: A small percentage of patients (approximately 1 in 500) may experience suicidal thoughts or behaviors. Aggression, psychosis, or hallucinations are also possible and should be reported immediately.
  • Blood Disorders: Levetiracetam can affect blood cell counts, potentially leading to anemia (low red blood cells) or thrombocytopenia (low platelets). This can cause symptoms like unusual tiredness, bleeding, or bruising.

Conclusion

Understanding the varied landscape of levetiracetam's adverse effects is vital for safe and effective treatment. While somnolence and fatigue are the most frequent adverse effect of levetiracetam in adults, healthcare providers must also be vigilant for behavioral changes, especially in pediatric patients. Many side effects can be managed with dosage adjustments and supportive care, but careful monitoring for rare, serious events is also essential. Patients and caregivers should maintain open communication with their doctors to address concerns and optimize treatment outcomes. For more detailed information on antiepileptic drugs, visit the CURE Epilepsy website.

Key Management Strategies for Levetiracetam Side Effects

  • Gradual Dosing: Start at a low dose and increase slowly to allow for body adjustment.
  • Pharmacist Consultation: Consult a pharmacist for recommendations on over-the-counter remedies for mild headaches or cold symptoms.
  • Avoid CNS Depressants: Minimize or avoid alcohol and other sedating drugs to prevent increased drowsiness.
  • Taking with Food: Consume the medication with food to help reduce gastrointestinal issues like nausea.
  • Consider B6 for Behavior: Discuss vitamin B6 supplementation with a doctor for managing irritability, particularly in pediatric patients.
  • Immediate Reporting for Serious Symptoms: Seek emergency medical attention for severe skin reactions, serious allergic reactions, or signs of suicidal ideation.
  • Avoid Abrupt Cessation: Do not stop taking levetiracetam suddenly, as this can increase seizure frequency.

Frequently Asked Questions

Many of the common initial side effects, such as drowsiness and dizziness, may lessen as the body adjusts to the medication, often within the first month of treatment. For some, side effects may be persistent, but management strategies are available.

If you or your child experience behavioral changes like irritability or aggression, it is crucial to speak with your healthcare provider. They may suggest dose adjustments or other strategies, such as vitamin B6 supplementation, especially in pediatric cases.

Yes, for gastrointestinal issues like nausea, taking levetiracetam with a meal or small snack can help settle your stomach and minimize the side effect.

No, it is not safe to stop taking levetiracetam suddenly. Abrupt cessation can increase the risk of seizures. Any changes to your medication regimen should only be made under a doctor's supervision.

Yes, levetiracetam can cause mood changes, including irritability, depression, anxiety, and aggression, particularly in children. Monitoring and discussing these changes with a doctor is important.

Risk factors for more pronounced side effects can include a history of psychiatric disorders, existing mental health conditions like depression, and potentially rapid increases in dosage.

To manage drowsiness, avoid activities requiring full alertness, such as driving, until you know how the medication affects you. Reducing alcohol consumption, which can worsen drowsiness, is also recommended. If drowsiness is persistent or severe, contact your prescriber.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.