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Levetiracetam

Last reviewed on RxList: 11/17/2020
Levetiracetam Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Levetiracetam?

Levetiracetam (levetiracetam injection) is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy; as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy; as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy; and for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. Levetiracetam is available in generic form.

What Are Side Effects of Levetiracetam?

Common side effects of levetiracetam include:

Dosage for Levetiracetam

Dosing of levetiracetam depends on the type of seizures being treated, the patient's age, and in some cases, the patient's body weight.

What Drugs, Substances, or Supplements Interact with Levetiracetam?

Levetiracetam may interact with other drugs. Tell your doctor all medications and supplements you use.

Levetiracetam During Pregnancy and Breastfeeding

During pregnancy, levetiracetam should be used only if prescribed. Pregnant patients taking levetiracetam are advised to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry. Levetiracetam passes into breast milk. Breastfeeding while taking levetiracetam is not recommended. Withdrawal seizures may occur if you suddenly stop taking levetiracetam.

Additional Information

Our Levetiracetam (levetiracetam injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
Levetiracetam Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel agitated, hostile, irritable, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • unusual changes in mood or behavior (unusual risk-taking behavior, being irritable or talkative);
  • confusion, hallucinations, loss of balance or coordination;
  • extreme drowsiness, feeling very weak or tired;
  • problems with walking or movement;
  • the first sign of any skin rash, no matter how mild;
  • easy bruising, unusual bleeding; or
  • fever, chills, weakness, or other signs of infection.

Common side effects may include:

  • dizziness, drowsiness, tiredness;
  • weakness;
  • feeling aggressive or irritable;
  • loss of appetite;
  • stuffy nose; or
  • infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Levetiracetam (Levetiracetam Injection, Solution, and Concentrate)

SLIDESHOW

What Is Epilepsy? Symptoms, Causes, and Treatments See Slideshow
Levetiracetam Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in more details in other sections of labeling:

  • Psychiatric Reactions [see WARNINGS AND PRECAUTIONS]
  • Somnolence and Fatigue [see WARNINGS AND PRECAUTIONS]
  • Anaphylaxis and Angioedema [see WARNINGS AND PRECAUTIONS]
  • Serious Dermatological Reactions [see WARNINGS AND PRECAUTIONS]
  • Coordination Difficulties [see WARNINGS AND PRECAUTIONS]
  • Withdrawal Seizures [see WARNINGS AND PRECAUTIONS]
  • Hematologic Abnormalities [see WARNINGS AND PRECAUTIONS]
  • Seizure Control During Pregnancy [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The adverse reactions that result from levetiracetam injection use include all of those reported for levetiracetam tablets and oral solution. Equivalent doses of intravenous (IV) levetiracetam and oral levetiracetam result in equivalent Cmax, Cmin, and total systemic exposure to levetiracetam when the IV Levetiracetam is administered as a 15 minute infusion.

The prescriber should be aware that the adverse reaction incidence figures in the following tables, obtained when levetiracetam was added to concurrent AED therapy, cannot be used to predict the frequency of adverse reactions in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical trials. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and non-drug factors to the adverse reaction incidences in the population studied.

Partial Onset Seizures

In controlled clinical studies using levetiracetam tablets in adults with partial onset seizures, the most common adverse reactions in adult patients receiving levetiracetam in combination with other AEDs, for events with rates greater than placebo, were somnolence, asthenia, infection and dizziness.

Of the most common reported adverse reactions in adults experiencing partial onset seizures, asthenia, somnolence and dizziness occurred predominantly during the first 4 weeks of treatment with levetiracetam.

Table 2 lists adverse reactions that occurred in at least 1% of adult epilepsy patients receiving levetiracetam tablets in placebo-controlled studies and were numerically more common than in patients treated with placebo. In these studies, either levetiracetam or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 2: Incidence (%) of Adverse Reactions in Placebo-Controlled, Add-On Studies in Adults Experiencing Partial Onset Seizures by Body System (Adverse Reactions Occurred in at Least 1% Of Levetiracetam-Treated Patients and Occurred More Frequently Than Placebo-Treated Patients)

Body System/ Adverse ReactionLevetiracetam
(N=769) %
Placebo
(N=439) %
Body as a Whole
Asthenia159
Headache1413
Infection138
Pain76
Digestive System
Anorexia32
Nervous System
Somnolence158
Dizziness94
Depression42
Nervousness42
Ataxia31
Vertigo31
Amnesia21
Anxiety21
Hostility21
Paresthesia21
Emotional Lability20
Respiratory System
Pharyngitis64
Rhinitis43
Cough Increased21
Sinusitis21
Special Senses
Diplopia21

In controlled adult clinical studies using levetiracetam tablets, 15% of patients receiving levetiracetam and 12% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. Table 3 lists the most common (>1%) adverse reactions that resulted in discontinuation or dose reduction and that occurred more frequently in levetiracetam-treated patients than in placebo-treated patients.In controlled adult clinical studies using levetiracetam tablets, 15% of patients receiving levetiracetam and 12% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. Table 3 lists the most common (>1%) adverse reactions that resulted in discontinuation or dose reduction and that occurred more frequently in levetiracetam-treated patients than in placebo-treated patients.

Table 3: Adverse Reactions that Most Commonly Resulted in Discontinuation or Dose Reduction That Occurred More Frequently in Levetiracetam-Treated Patients in Placebo- Controlled Studies in Adult Patients Experiencing Partial Onset Seizures

Adverse ReactionLevetiracetam
(N=769) %
Placebo
(N=439)%
Somnolence42
Dizziness10

Myoclonic Seizures

Although the pattern of adverse reactions in this study seems somewhat different from that seen in patients with partial seizures, this is likely due to the much smaller number of patients in this study compared to partial seizure studies. The adverse reaction pattern for patients with JME is expected to be essentially the same as for patients with partial seizures. In the controlled clinical study using levetiracetam tablets in patients with myoclonic seizures, the most common adverse reactions in patients using levetiracetam in combination with other AEDs, for events with rates greater than placebo, were somnolence, neck pain, and pharyngitis.

Table 4 lists adverse reactions that occurred in at least 5% of juvenile myoclonic epilepsy patients experiencing myoclonic seizures treated with levetiracetam tablets and were numerically more common than in patients treated with placebo. In this study, either levetiracetam or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 4: Incidence (%) of Adverse Reactions in a Placebo-Controlled, Add-On Study in Patients with Myoclonic Seizures by Body System (Adverse Reactions Occurred in at Least 5% of Levetiracetam-Treated Patients and Occurred More Frequently than Placebo-Treated Patients)

Body System/ Adverse ReactionLevetiracetam
(N=60) %
Placebo
(N=60) %
Ear and labyrinth disorders
Vertigo53
Infections and infestations
Pharyngitis70
Influenza52
Musculoskeletal and connective tissue disorders
Neck pain82
Nervous system disorders
Somnolence122
Psychiatric disorders
Depression52

In the placebo-controlled study using levetiracetam tablets in patients with JME, 8% of patients receiving levetiracetam and 2% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. The adverse reactions that led to discontinuation or dose reduction and that occurred more frequently in levetiracetam-treated patients than in placebo-treated patients are presented in Table 5.

Table 5: Adverse Reactions that Re sulted in Discontinuation or Dose Reduction That Occurred More Frequently In Levetiracetam-Treated Patients In The Placebo-Controlled Study In Patients with Juvenile Myoclonic Epilepsy

Adverse ReactionLevetiracetam
(N=60)%
Placebo
(N=60)%
Anxiety32
Depressed mood20
Depression20
Diplopia20
Hypersomnia20
Insomnia20
Irritability20
Nervousness20
Somnolence20

Primary Generalized Tonic-Clonic Seizures

Although the pattern of adverse reactions in this study seems somewhat different from that seen in patients with partial seizures, this is likely due to the much smaller number of patients in this study compared to partial seizure studies. The adverse reaction pattern for patients with primary generalized tonic-clonic (PGTC) seizures is expected to be essentially the same as for patients with partial seizures.

In the controlled clinical study that included patients with PGTC seizures, the most common adverse reaction in patients receiving levetiracetam oral formulation in combination with other AEDs, for events with rates greater than placebo was nasopharyngitis.

Table 6 lists adverse reactions that occurred in at least 5% of idiopathic generalized epilepsy patients experiencing PGTC seizures treated with levetiracetam and were numerically more common than in patients treated with placebo. In this study, either levetiracetam or placebo was added to concurrent AED therapy.

Table 6: Incidence (%) of Adverse Reactions in a Placebo-Controlled, Add-On Study in Patients with PGTC Seizures by MedDRA System Organ Class (Adverse Reactions Occurred in at Least 5% of Levetiracetam-Treated Patients and Occurred More Frequently than Placebo-Treated Patients)

Body System/ Adverse ReactionLevetiracetam
(N=79) %
Placebo
(N=84) %
Gastrointestinal disorders
Diarrhea87
General disorders and administration site conditions
Fatigue108
Infections and infestations
Nasopharyngitis145
Psychiatric disorders
Irritability62
Mood swings51

In the placebo-controlled study, 5% of patients receiving levetiracetam and 8% receiving placebo either discontinued or had a dose reduction during the treatment period as a result of an adverse reaction.

This study was too small to adequately characterize the adverse reactions that could be expected to result in discontinuation of treatment in this population. It is expected that the adverse reactions that would lead to discontinuation in this population would be similar to those resulting in discontinuation in other epilepsy trials (see Tables 3 and 5).

In addition, the following adverse reactions were seen in other controlled adult studies of levetiracetam: balance disorder, disturbance in attention, eczema, memory impairment, myalgia, and blurred vision.

Comparison Of Gender, Age And Race

The overall adverse reaction profile of levetiracetam was similar between females and males. There are insufficient data to support a statement regarding the distribution of adverse reactions by age and race.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of levetiracetam. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In addition to the adverse reactions listed above [see ADVERSE REACTIONS], the following adverse reactions have been reported in patients receiving marketed levetiracetam worldwide. The listing is alphabetized: abnormal liver function test, acute kidney injury, anaphylaxis, angioedema, choreoathetosis, drug reaction with eosinophilia and systemic symptoms (DRESS), dyskinesia, erythema multiforme, hepatic failure, hepatitis, hyponatremia, muscular weakness, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), panic attack, thrombocytopenia, and weight loss. Alopecia has been reported with levetiracetam use; recovery was observed in majority of cases where levetiracetam was discontinued.

Read the entire FDA prescribing information for Levetiracetam (Levetiracetam Injection, Solution, and Concentrate)

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© Levetiracetam Patient Information is supplied by Cerner Multum, Inc. and Levetiracetam Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer

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