Keppra

Last updated on RxList: 10/20/2020
Keppra Side Effects Center

What Is Keppra

Keppra (levetiracetam) is an anti-epileptic drug (AED) (antoconvulsant) often used in conjunction with other drugs to treat types of seizures in people with epilepsy.

What Are Side Effects of Keppra?

Side effects of Keppra in adults include:

What Are Side Effects of Keppra In Children?

Side effects of Keppra in children include

  • sleepiness,
  • accidental injury,
  • hostility,
  • nervousness, and
  • weakness.

Anti-epileptic drugs (AEDs), including Keppra, increase the risk of suicidal thoughts or behavior. Patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual mood or behavior changes.

Dosage for Keppra

Keppra (levetiracetam) is available in pills in the following dosages and colors: 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1,000 mg (white). Keppra (levetiracetam) is also available as a clear, colorless grape-flavored liquid at a concentration of 100 mg/mL.

What Drugs, Substances, or Supplements Interact with Keppra

Drug interactions include phenytoin, valproate, oral contraceptives, digoxin, warfarin, and probenecid.

Keppra and Pregnancy

Keppra (levetiracetam) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Keppra (levetiracetam) is excreted in breast milk. Women must talk to their doctors to decide whether to discontinue nursing or the drug.

Additional Information

Our Keppra 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.

SLIDESHOW

What Is Epilepsy? Symptoms, Causes, and Treatments See Slideshow
Keppra Consumer Information

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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, extreme drowsiness, feeling very weak or tired;
  • loss of balance or coordination, problems with walking or movement;
  • a 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 Keppra (Levetiracetam)

QUESTION

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

SIDE EFFECTS

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

  • Behavioral Abnormalities and Psychotic Symptoms [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]
  • Hematologic Abnormalities [see WARNINGS AND PRECAUTIONS]
  • Increase in Blood Pressure [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 KEPPRA injection use include all of those reported for KEPPRA 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.

Partial-Onset Seizures

Adults

In controlled clinical studies using KEPPRA tablets in adults with partial-onset seizures [see Clinical Studies], the most common adverse reactions in adult patients receiving KEPPRA in combination with other AEDs, for events with rates greater than placebo, were somnolence, asthenia, infection, and dizziness. Of the most common adverse reactions in adults experiencing partial-onset seizures, asthenia, somnolence, and dizziness occurred predominantly during the first 4 weeks of treatment with KEPPRA.

Table 3 lists adverse reactions that occurred in at least 1% of adult epilepsy patients receiving KEPPRA tablets in placebo-controlled studies and were numerically more common than in patients treated with placebo. In these studies, either KEPPRA or placebo was added to concurrent AED therapy.

Table 3: Adverse Reactions* in Pooled Placebo-Controlled, Adjunctive Studies in Adults Experiencing Partial-Onset Seizures

KEPPRA
(N=769) %
Placebo
(N=439) %
Asthenia159
Somnolence158
Headache1413
Infection138
Dizziness94
Pain76
Pharyngitis64
Depression42
Nervousness42
Rhinitis43
Anorexia32
Ataxia31
Vertigo31
Amnesia21
Anxiety21
Cough Increased21
Diplopia21
Emotional Lability2
Hostility21
Paresthesia21
Sinusitis21
* Adverse reactions occurred in at least 1% of KEPPRA-treated patients and occurred more frequently than placebo-treated patients

In controlled adult clinical studies using KEPPRA tablets, 15% of patients receiving KEPPRA and 12% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. Table 4 lists the most common (>1%) adverse reactions that resulted in discontinuation or dose reduction and that occurred more frequently in KEPPRA-treated patients than in placebo-treated patients.

Table 4: Adverse Reactions that Resulted in Discontinuation or Dose Reduction in Pooled Placebo-Controlled Studies in Adults Experiencing Partial-Onset Seizures

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

Pediatric Patients 4 Years To <16 Years

The adverse reaction data presented below was obtained from a pooled analysis of two controlled pediatric clinical studies using an oral formulation in pediatric patients 4 to 16 years of age with partial-onset seizures. The most common adverse reactions in pediatric patients receiving KEPPRA in combination with other AEDs, for events with rates greater than placebo, were fatigue, aggression, nasal congestion, decreased appetite, and irritability.

Table 5 lists adverse reactions from the pooled pediatric controlled studies (4 to 16 years of age) that occurred in at least 2% of pediatric KEPPRA-treated patients and were numerically more common than in pediatric patients treated with placebo. In these studies, either KEPPRA or placebo was added to concurrent AED therapy.

Table 5: Adverse Reactions* in Pooled Placebo-Controlled, Adjunctive Studies in Pediatric Patients Ages 4 to 16 Years Experiencing Partial-Onset Seizures

KEPPRA
(N=165) %
Placebo
(N=131) %
Headache1915
Nasopharyngitis1512
Vomiting1512
Somnolence139
Fatigue115
Aggression105
Upper Abdominal Pain98
Cough95
Nasal Congestion92
Decreased Appetite82
Abnormal Behavior74
Dizziness75
Irritability71
Pharyngolaryngeal Pain74
Diarrhea62
Lethargy65
Insomnia53
Agitation41
Anorexia43
Head Injury40
Constipation31
Contusion31
Depression31
Fall32
Influenza31
Mood Altered31
Affect Lability21
Anxiety21
Arthralgia20
Confusional State20
Conjunctivitis20
Ear Pain21
Gastroenteritis20
Joint Sprain21
Mood Swings21
Neck Pain21
Rhinitis20
Sedation21
* Adverse reactions occurred in at least 2% of pediatric KEPPRA-treated patients and occurred more frequently than placebo-treated patients

In the controlled pooled pediatric clinical studies in patients 4-16 years of age, 7% of patients receiving KEPPRA and 9% receiving placebo discontinued as a result of an adverse reaction.

Pediatric Patients 1 Month To < 4 Years

In the 7-day controlled pediatric clinical study using an oral formulation of KEPPRA in children 1 month to less than 4 years of age with partial-onset seizures, the most common adverse reactions in patients receiving KEPPRA in combination with other AEDs, for events with rates greater than placebo, were somnolence and irritability. Because of the shorter exposure period, incidences of adverse reactions are expected to be lower than in other pediatric studies in older patients. Therefore, other controlled pediatric data, presented above, should also be considered to apply to this age group.

Table 6 lists adverse reactions that occurred in at least 5% of pediatric epilepsy patients (ages 1 month to < 4 years) treated with KEPPRA in the placebo-controlled study and were numerically more common than in patients treated with placebo. In this study, either KEPPRA or placebo was added to concurrent AED therapy.

Table 6: Adverse Reactions* in a Placebo-Controlled, Adjunctive Study in Pediatric Patients Ages 1 Month to < 4 Years Experiencing Partial-Onset Seizures

KEPPRA
(N=60) %
Placebo
(N=56) %
Somnolence132
Irritability120
* Adverse reactions occurred in at least 5% of KEPPRA-treated patients and occurred more frequently than placebo-treated patients

In the 7-day controlled pediatric clinical study in patients 1 month to < 4 years of age, 3% of patients receiving KEPPRA and 2% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. There was no adverse reaction that resulted in discontinuation for more than one patient.

Myoclonic Seizures

Although the pattern of adverse reactions in this study seems somewhat different from that seen in patients with partial-onset 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 KEPPRA tablets in patients with myoclonic seizures [see Clinical Studies], the most common adverse reactions in patients receiving KEPPRA in combination with other AEDs, for events with rates greater than placebo, were somnolence, neck pain, and pharyngitis.

Table 7 lists adverse reactions that occurred in at least 5% of juvenile myoclonic epilepsy patients experiencing myoclonic seizures treated with KEPPRA tablets and were numerically more common than in patients treated with placebo. In this study, either KEPPRA or placebo was added to concurrent AED therapy.

Table 7: Adverse Reactions* in a Placebo-Controlled, Adjunctive Study in Patients 12 Years of Age and Older with Myoclonic Seizures

KEPPRA
(N=60) %
Placebo
(N=60) %
Somnolence122
Neck pain82
Pharyngitis70
Depression52
Influenza52
Vertigo53
* Adverse reactions occurred in at least 5% of KEPPRA-treated patients and occurred more frequently than placebo-treated patients

In the placebo-controlled study using KEPPRA tablets in patients with JME, 8% of patients receiving KEPPRA 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 KEPPRA-treated patients than in placebo-treated patients are presented in Table 8.

Table 8: Adverse Reactions that Resulted in Discontinuation or Dose Reduction in Patients with Juvenile Myoclonic Epilepsy

Adverse ReactionKEPPRA
(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 4 years of age and older with PGTC seizures, the most common adverse reaction in patients receiving KEPPRA oral formulation in combination with other AEDs, for events with rates greater than placebo was nasopharyngitis.

Table 9 lists adverse reactions that occurred in at least 5% of idiopathic generalized epilepsy patients experiencing PGTC seizures treated with KEPPRA and were numerically more common than in patients treated with placebo. In this study, either KEPPRA or placebo was added to concurrent AED therapy.

Table 9: Adverse Reactions* in a Placebo-Controlled, Adjunctive Study in Patients 4 Years of Age and Older with PGTC Seizures

KEPPRA
(N=79) %
Placebo
(N=84) %
Nasopharyngitis145
Fatigue108
Diarrhea87
Irritability62
Mood swings51
* Adverse reactions occurred in at least 5% of KEPPRA-treated patients and occurred more frequently than placebo-treated patients

In the placebo-controlled study, 5% of patients receiving KEPPRA 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 4 and 8).

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

Comparison Of Gender, Age And Race

The overall adverse reaction profile of KEPPRA 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 postapproval use of KEPPRA. 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 following adverse reactions have been reported in patients receiving KEPPRA worldwide. The listing is alphabetized: abnormal liver function test, acute kidney injury, anaphylaxis, angioedema, agranulocytosis, 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, weight loss, and worsening of seizures. Alopecia has been reported with KEPPRA use; recovery was observed in majority of cases where KEPPRA was discontinued.

Read the entire FDA prescribing information for Keppra (Levetiracetam)

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

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