Keppra Side Effects

Generic name: levetiracetam

Generic Name: Levetiracetam

Please note - some side effects for Keppra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Keppra - for the consumer

Keppra

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Keppra:

Dizziness; drowsiness; irritability; sore throat; tiredness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; behavioral changes (eg, aggression, agitation, anger, anxiety, apathy, depression, hostility); dark urine; decreased coordination; extreme dizziness, drowsiness, tiredness, or weakness; fever, chills, or persistent sore throat; hallucinations; memory loss; mental or mood changes, muscle or neck pain; new or worsening seizures; suicidal thoughts or attempts; unusual bruising or bleeding; vision changes; yellowing of the skin or eyes.

Keppra XR Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Keppra XR Extended-Release Tablets:

Dizziness; drowsiness; irritability; nausea; sore throat; tiredness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; behavioral changes (eg, aggression, agitation, anger, anxiety, apathy, depression, hostility); dark urine; decreased coordination; extreme drowsiness, dizziness, tiredness, or weakness; fever, chills, or persistent sore throat; hallucinations; memory loss; mental or mood changes; new or worsening seizures; suicidal thoughts or attempts; unusual bruising or bleeding; vision changes; yellowing of the skin or eyes.

Keppra Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Keppra Solution:

Dizziness; drowsiness; irritability; runny nose; sore throat; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; behavioral changes (eg, aggression, agitation, anger, anxiety, apathy, depression, hostility); dark urine; decreased coordination; extreme dizziness, drowsiness, tiredness, or weakness; fever, chills, or persistent sore throat; hallucinations; memory loss; mental or mood changes; new or worsening seizures; suicidal thoughts or attempts; unusual bruising or bleeding; vision changes; yellowing of the skin or eyes.

Keppra Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Keppra Tablets:

Dizziness; drowsiness; irritability; runny nose; sore throat; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; behavioral changes (eg, aggression, agitation, anger, anxiety, apathy, depression, hostility); dark urine; decreased coordination; extreme drowsiness, dizziness, tiredness, or weakness; fever, chills, or persistent sore throat; hallucinations; memory loss; mental or mood changes; new or worsening seizures; suicidal thoughts or attempts; unusual bruising or bleeding; vision changes; yellowing of the skin or eyes.

By body system

Nervous system side effects

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 side effects

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 use have also been reported. Levetiracetam has been associated with fatigue in pediatric patients.

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

Respiratory side effects

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 side effects

Slower titration should be considered in patients at a higher risk of discontinuing levetiracetam 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 side effects

A multicenter, double-blind, placebo controlled trial (n=517) has reported that 10.1% of patients treated with levetiracetam 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 side effects

Ocular side effects have included diplopia (2%).

Hematologic side effects

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 side effects

Dermatologic side effects including alopecia have been reported.

Recovery from alopecia was reported in the majority of the cases where levetiracetam was discontinued.

Hepatic side effects

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

Musculoskeletal side effects

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

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