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Keppra XR

Last reviewed on RxList: 4/19/2016
Keppra XR Side Effects Center

Last reviewed on RxList 12/29/2016

Keppra XR (levetiracetam) Extended-Release Tablets is an anti-epileptic drug used to treat partial onset seizures in adults and children who are at least 4 years old, and is also used to treat tonic-clonic seizures in adults and children who are at least 6 years old, and myoclonic seizures in adults and children who are at least 12 years old. Keppra XR is available in generic form. Common side effects of Keppra XR include:

Side effects are more common during the first 4 weeks and usually lessen as your body adjusts to Keppra XR. Tell your doctor if you have serious side effects of Keppra XR including:

  • loss of coordination (such as difficulty walking and controlling muscles), or
  • mental/mood changes (such as irritability, aggression, agitation, anger, or anxiety).

The starting dose of Keppra XR is 1000 mg once daily. The daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum daily dose of 3000 mg. Other drugs may interact with Keppra XR. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Keppra XR should be used only when prescribed. It may harm a fetus. Since untreated seizures are a serious condition that can harm both a pregnant woman and her fetus, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, talk to your doctor about using this medication during pregnancy. This medication passes into breast milk. Consult your doctor before breastfeeding.

Our Keppra XR (levetiracetam) Extended-Release Tablets 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.

Keppra XR Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, 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 a serious side effect such as:

  • hallucinations, unusual thoughts or behavior;
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • feeling very weak or tired;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • problems with walking or movement;
  • the first sign of any skin rash, no matter how mild; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • mild dizziness or drowsiness;
  • mild tired feeling;
  • loss of appetite; or
  • stuffy nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Keppra XR (Levetiracetam Extended-Release Tablets)

Keppra XR Professional Information

SIDE EFFECTS

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

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 prescriber should be aware that the adverse reaction incidence figures in the following table, obtained when KEPPRA XR 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.

KEPPRA XR Tablets

In the controlled clinical study using KEPPRA XR in patients with partial onset seizures, the most frequently reported adverse reactions in patients receiving KEPPRA XR in combination with other AEDs, for events with rates greater than placebo, were irritability and somnolence.

Table 3 lists adverse reactions that occurred in at least 5% of epilepsy patients treated with KEPPRA XR participating in the placebo-controlled study and were numerically more common than in patients treated with placebo. In this study, either KEPPRA XR or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 3: Incidence (%) Of Adverse Reactions In The Placebo-Controlled, Add-On Study By Body System (Adverse Reactions Occurred In At Least 5% Of KEPPRA XR-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/ Adverse Reaction KEPPRA XR
(N=77)
%
Placebo
(N=79)
%
Gastrointestinal Disorders
  Nausea 5 3
Infections and Infestations
  Influenza 8 4
  Nasopharyngitis 7 5
Nervous System Disorders
  Somnolence 8 3
  Dizziness 5 3
Psychiatric Disorders
  Irritability 7 0

Discontinuation or Dose Reduction in the KEPPRA XR Controlled Clinical Study

In the controlled clinical study using KEPPRA XR, 5.2% of patients receiving KEPPRA XR and 2.5% receiving placebo discontinued as a result of an adverse reaction. The adverse reactions that resulted in discontinuation and that occurred more frequently in KEPPRA XR-treated patients than in placebo-treated patients were asthenia, epilepsy, mouth ulceration, rash and respiratory failure. Each of these adverse reactions led to discontinuation in a KEPPRA XR-treated patient and no placebo-treated patients.

Table 4 lists the adverse reactions seen in the controlled studies of immediate-release KEPPRA tablets in adult patients experiencing partial onset seizures. Although the pattern of adverse reactions in the KEPPRA XR study seems somewhat different from that seen in partial onset seizure controlled studies for immediate-release KEPPRA tablets, this is possibly due to the much smaller number of patients in this study compared to the immediate-release tablet studies. The adverse reactions for KEPPRA XR are expected to be similar to those seen with immediate-release KEPPRA tablets.

Immediate-Release KEPPRA Tablets

In controlled clinical studies of immediate-release KEPPRA tablets as adjunctive therapy to other AEDs in adults with partial onset seizures, the most frequently reported adverse reactions, for events with rates greater than placebo, were somnolence, asthenia, infection and dizziness.

Table 4 lists adverse reactions that occurred in at least 1% of adult epilepsy patients treated with immediate-release KEPPRA tablets participating in placebo-controlled studies and were numerically more common than in patients treated with placebo. In these studies, either immediate-release KEPPRA tablets or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 4: 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 Immediate-Release KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/ Adverse Reaction Immediate-release KEPPRA
(N=769)
%
Placebo
(N=439)
%
Body as a Whole
  Asthenia 15 9
  Headache 14 13
  Infection 13 8
  Pain 7 6
Digestive System
  Anorexia 3 2
Nervous System
  Somnolence 15 8
  Dizziness 9 4
  Depression 4 2
  Nervousness 4 2
  Ataxia 3 1
  Vertigo 3 1
  Amnesia 2 1
  Anxiety 2 1
  Hostility 2 1
  Paresthesia 2 1
  Emotional Lability 2 0
Respiratory System
  Pharyngitis 6 4
  Rhinitis 4 3
  Cough Increased 2 1
  Sinusitis 2 1
Special Senses
  Diplopia 2 1

In addition, the following adverse reactions were seen in other well-controlled studies of immediate-release KEPPRA tablets: balance disorder, disturbance in attention, eczema, hyperkinesia, memory impairment, myalgia, personality disorders, pruritus, and vision blurred.

Comparison of Gender, Age and Race

There are insufficient data for KEPPRA XR to support a statement regarding the distribution of adverse experience reports by gender, age and race.

Postmarketing Experience

In addition to the adverse reactions listed above for immediate-release KEPPRA tablets, the following adverse events have been identified during postapproval use of immediate-release KEPPRA tablets. 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. The listing is alphabetized: abnormal liver function test, choreoathetosis, dyskinesia, erythema multiforme, hepatic failure, hepatitis, leukopenia, neutropenia, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), thrombocytopenia, and weight loss. Alopecia has been reported with immediate-release KEPPRA use; recovery was observed in majority of cases where immediate-release KEPPRA was discontinued.

Read the entire FDA prescribing information for Keppra XR (Levetiracetam Extended-Release Tablets)

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