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Keppra XR

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Keppra XR

Keppra XR Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Keppra XR (levetiracetam) Extended-Release Tablets is 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. It is an anti-epileptic drug. This medication is available in generic form. Common side effects include drowsiness, dizziness, and weakness. Effects are more common during the first 4 weeks and usually lessen as your body adjusts to the medication. 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 breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Keppra XR in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Keppra XR Overview - Patient Information: Side Effects

SIDE EFFECTS: Drowsiness, dizziness, and weakness may occur. These side effects are more common during the first 4 weeks and usually lessen as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these serious side effects occur: loss of coordination (such as difficulty walking and controlling muscles), mental/mood changes (such as irritability, aggression, agitation, anger, anxiety).

A small number of people who take anticonvulsants for any condition (such as seizures, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Levetiracetam can cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Keppra XR (Levetiracetam Extended-Release Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Keppra XR FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 (Study 1), 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 (Study 1) 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

Adults

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

Pediatric Patients 4 Years to < 16 Years

In a pooled analysis of two controlled pediatric clinical studies in children 4 to 16 years of age with partial onset seizures, the adverse reactions most frequently reported with the use of immediate-release KEPPRA in combination with other AEDs, and with greater frequency than in patients on placebo, were fatigue, aggression, nasal congestion, decreased appetite, and irritability.

Table 5 lists adverse reactions that occurred in at least 2% of pediatric patients treated with immediate-release KEPPRA and were more common than in pediatric patients on placebo. In these studies, either immediate-release KEPPRA or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 5: Incidence (%) Of Adverse Reactions In Pooled Placebo-Controlled, Add-On Studies In Pediatric Patients Ages 4 to 16 Years Experiencing Partial Onset Seizures By Body System (Adverse Reactions Occurred In At Least 2% Of Patients Treated With Immediate-Release KEPPRA And Occurred More Frequently Than Patients on Placebo)

Body System/ Adverse Reaction Immediate- Release KEPPRA
(N=165) %
Placebo
(N=131) %
Ear and Labyrinth Disorders
  Ear Pain 2 1
  Eye Disorders
  Conjunctivitis 2 0
Gastrointestinal Disorders
  Vomiting 15 12
  Abdominal Pain Upper 9 8
  Diarrhea 6 5
  Constipation 3 1
General Disorders and Administration Site Conditions
  Fatigue 11 5
Infections and Infestations
  Nasopharyngitis 15 12
  Influenza 3 1
  Gastroenteritis 2 0
  Rhinitis 2 0
Injury, Poisoning and Procedural Complications
  Head Injury 4 0
  Contusion 3 1
  Fall 3 2
  Joint Sprain 2 1
Metabolism and Nutrition Disorders
  Decreased Appetite 8 2
  Anorexia 4 3
Musculoskeletal and Connective Tissue Disorders
  Arthralgia 2 0
  Neck Pain 2 1
Nervous System
  Headache 19 15
  Somnolence 13 9
  Dizziness 7 5
  Lethargy 6 2
  Sedation 2 1
Psychiatric Disorders
  Aggression 10 5
  Abnormal Behavior 7 4
  Irritability 7 1
  Insomnia 5 3
  Agitation 4 1
  Depression 3 1
  Mood Altered 3 1
  Affect Lability 2 1
  Anxiety 2 1
  Confusional State 2 0
  Mood Swings 2 1
Respiratory, Thoracic and Mediastinal Disorders
  Cough 9 5
  Nasal Congestion 9 2
  Pharyngolaryngeal Pain 7 4

In controlled pediatric clinical studies in patients 4-16 years of age, 7% of patients treated with immediate-release KEPPRA tablets and 9% of patients on placebo discontinued as a result of an adverse event.

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 [see Clinical Trials Experience], the following adverse reactions have been identified during post-approval 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, muscular weakness, neutropenia, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), panic attack, 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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Keppra XR - User Reviews

Keppra XR User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Keppra XR sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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