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Keppra

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Keppra

Keppra

Keppra Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Keppra (levetiracetam) is an anti-epileptic drug (AED) often used in conjunction with other drugs to treat types of seizures in people with epilepsy. Keppra (levetiracetam) belongs to a class of medications known as anticonvulsants. Reported side effects of Keppra (levetiracetam) in adults include somnolence, asthenia, infection, and dizziness. Reported side effects in children include somnolence, accidental injury, hostility, nervousness, and asthenia.

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

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.

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 in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • hallucinations;
  • fever, chills, body aches, flu symptoms;
  • weakness, lack of coordination;
  • increasing or worsening seizures; or
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • dizziness, spinning sensation;
  • drowsiness;
  • feeling irritable;
  • headache;
  • runny nose, sore throat; or
  • neck pain.

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 (Levetiracetam) »

What is Patient Information Overview?

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

Keppra 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 (Levetiracetam)»

What is Prescribing information?

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

Keppra 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 tables, obtained when KEPPRA 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.

Partial Onset Seizures

Adults

In controlled clinical studies in adults with partial onset seizures, the most frequently reported adverse reactions in patients receiving KEPPRA in combination with other AEDs, for events with rates greater than placebo, were somnolence, asthenia, infection and dizziness. Of the most frequently reported adverse reactions in adults experiencing partial onset seizures, asthenia, somnolence and dizziness appeared to occur 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 treated with KEPPRA participating 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. Adverse reactions were usually mild to moderate in intensity.

Table 3: 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 KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/ Adverse Reaction 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 controlled adult clinical studies, 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 Most Commonly Resulted In Discontinuation Or Dose Reduction That Occurred More Frequently In KEPPRA-Treated Patients In Placebo-Controlled Studies In Adult Patients Experiencing Partial Onset Seizures

Adverse Reaction KEPPRA
(N=769) %
Placebo
(N=439) %
Dizziness 1 0
Somnolence 4 2

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 in children 4 to 16 years of age with partial onset seizures. The adverse reactions most frequently reported with the use of 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. 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 KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/ Adverse Reaction 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 the well 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 event.

Pediatric Patients 1 Month to < 4 Years

In the 7-day, controlled pediatric clinical study in children 1 month to less than 4 years of age with partial onset seizures, the adverse reactions most frequently reported with the use of 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 participating 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. Adverse reactions were usually mild to moderate in intensity.

Table 6: Incidence (%) Of Adverse Reactions In A Placebo-Controlled, Add-On Study In Pediatric Patients Ages 1 Month to < 4 Years Experiencing Partial Onset Seizures By Body System (Adverse Reactions Occurred In At Least 5% Of KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/ Adverse Reaction KEPPRA
(N=60) %
Placebo
(N=56) %
Nervous System
  Somnolence 13 2
Psychiatric Disorders
  Irritability 12 0

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 event. There was no adverse event 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 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 well-controlled clinical study that included both adolescent (12 to 16 years of age) and adult patients with myoclonic seizures, the most frequently reported adverse reactions in patients using 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 and were numerically more common than in patients treated with placebo. In this study, either KEPPRA or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 7: Incidence (%) Of Adverse Reactions In A Placebo-Controlled, Add-On Study In Patients 12 Years Of Age And Older With Myoclonic Seizures By Body System (Adverse Reactions Occurred In At Least 5% Of KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/ Adverse Reaction KEPPRA
(N=60) %
Placebo
(N=60) %
Ear and labyrinth disorders
  Vertigo 5 3
Infections and infestations
  Pharyngitis 7 0
  Influenza 5 2
Musculoskeletal and connective tissue disorders
  Neck pain 8 2
Nervous system disorders
  Somnolence 12 2
Psychiatric disorders
  Depression 5 2

In the placebo-controlled study, 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 That Occurred More Frequently in KEPPRA-Treated Patients In The Placebo-Controlled Study In Patients With Juvenile Myoclonic Epilepsy

Adverse Reaction KEPPRA
(N=60) %
Placebo
(N=60) %
Anxiety 3 2
Depressed mood 2 0
Depression 2 0
Diplopia 2 0
Hypersomnia 2 0
Insomnia 2 0
Irritability 2 0
Nervousness 2 0
Somnolence 2 0

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 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 primary generalized tonicclonic (PGTC) seizures, the most frequently reported adverse reaction in patients using KEPPRA 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. Adverse reactions were usually mild to moderate in intensity.

Table 9: Incidence (%) Of Adverse Reactions In A Placebo-Controlled, Add-On Study In Patients 4 Years Of Age And Older With PGTC Seizures By MedDRA System Organ Class (Adverse Reactions Occurred In At Least 5% Of KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/ Adverse Reaction KEPPRA
(N=79) %
Placebo
(N=84) %
Gastrointestinal disorders
  Diarrhea 8 7
General disorders and administration site conditions
  Fatigue 10 8
Infections and infestations
  Nasopharyngitis 14 5
Psychiatric disorders
  Irritability 6 2
  Mood Swings 5 1

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 well-controlled adult studies of KEPPRA: balance disorder, disturbance in attention, eczema, memory impairment, myalgia, and vision blurred.

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 experience reports 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.

In addition to the adverse reactions listed above, the following adverse events have been reported in patients receiving marketed KEPPRA worldwide. The listing is alphabetized: abnormal liver function test, choreoathetosis, dyskinesia, erythema multiforme, hepatic failure, hepatitis, leukopenia, muscle 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 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 - User Reviews

Keppra 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 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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