Keppra XR Side Effects

Generic name: levetiracetam

Note: This document contains side effect information about levetiracetam. Some of the dosage forms listed on this page may not apply to the brand name Keppra XR.

Some side effects of Keppra XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to levetiracetam: oral solution, oral tablet, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking levetiracetam (the active ingredient contained in Keppra XR) 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 of levetiracetam 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.

For Healthcare Professionals

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

Nervous system

Nervous system side effects have included somnolence (up to 15%), dizziness (9%), vertigo (up to 5%), depression (4%), nervousness (4%), ataxia (3%), amnesia (2%), anxiety (2%), emotional lability (2%), hostility (2%), and paresthesia (2%). A case of levetiracetam-induced parkinsonism has also been reported.

Somnolence (8%) and dizziness (5%) have been reported with extended release tablets.

General

General side effects have included asthenia (15%), headache (14%), nasopharyngitis (14%), infection (13%), fatigue (10%), pain (7%), and influenza (5%). Several cases of considerable weight loss associated with levetiracetam (the active ingredient contained in Keppra XR) use have also been reported. Levetiracetam has been associated with fatigue in pediatric patients.

Influenza (8%) has been reported with extended release tablets.

Respiratory

Respiratory side effects have included pharyngitis (up to 7%), rhinitis (4%), increased cough (2%), and sinusitis (2%).

Nasopharyngitis (7%) has been reported with extended release tablets.

Psychiatric

Slower titration should be considered in patients at a higher risk of discontinuing levetiracetam (the active ingredient contained in Keppra XR) for behavioral reasons.

Psychiatric side effects such as depression (up to 5.7%) including suicidal depression (up to 0.7%), irritability (6%), and mood swings (5%) have been reported.

In some patients experiencing primary generalized tonic-clonic seizures, levetiracetam caused behavioral abnormalities. Nonpsychotic mood disorders (reported as anger, apathy, depression, altered mood, mood swings, negativism, suicidal ideation, and tearfulness) occurred in 12.7% of levetiracetam-treated patients. One patient experienced suicidal ideation. Another patient experienced delusional behavior that required the lowering of the dose of levetiracetam.

Irritability (7%) has been reported with extended release tablets.

Gastrointestinal

A multicenter, double-blind, placebo controlled trial (n=517) has reported that 10.1% of patients treated with levetiracetam (the active ingredient contained in Keppra XR) had adverse psychiatric events. A significant association was reported with previous psychiatric history, history of febrile convulsions, and history of status epilepticus. Concomitant therapy with lamotrigine was reported to have had a protective effect. Psychiatric adverse events were not related to the titration schedule of levetiracetam. Certain patients seem to be more vulnerable biologically.

Gastrointestinal side effects have included anorexia (3%), pancreatitis, and diarrhea.

Nausea (5%) has been reported with extended release tablets.

Ocular

Ocular side effects have included diplopia (2%).

Hematologic

One possibly significant decreased WBC count occurred in every 3.2% of treated patients. One possibly significant decreased neutrophil count occurred in every 2.4% of treated patients.

Hematologic side effects have included leukopenia, neutropenia, pancytopenia (with bone marrow suppression identified in some of these cases), and thrombocytopenia. Minor, but statistically significant decreases in total mean RBC count (0.03 x 1,000,000/mm2), mean hemoglobin (0.09 g/dL), and mean hematocrit (0.38%) have also been reported.

Dermatologic

Recovery from alopecia was reported in the majority of the cases where levetiracetam (the active ingredient contained in Keppra XR) was discontinued.

Dermatologic side effects have included Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in both children and adults and alopecia.

Hepatic

Hepatic side effects including abnormal liver function tests, hepatitis, and hepatic failure have been reported during postmarketing surveillance.

Musculoskeletal

Musculoskeletal side effects including neck pain (8%) have been reported.

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