Spritam

Last reviewed on RxList: 1/27/2021
Spritam Side Effects Center

What Is Spritam?

Spritam (levetiracetam) is an epilepsy medicine indicated for adjunctive therapy in the treatment of partial onset seizures in patients with epilepsy 4 years of age and older weighing more than 20 kg; myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy; and primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.

What Are Side Effects of Spritam?

Common side effects of Spritam in adults include sleepiness, weakness, and infection. Common side effects of Spritam in children include:

Dosage for Spritam

The Spritam dosing regimen depends on the indication, age group, and renal function.

What Drugs, Substances, or Supplements Interact with Spritam?

Spritam may interact with other drugs. Tell your doctor all medications and supplements you use.

Spritam During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Spritam; it may harm a fetus. It is recommended that patients be monitored carefully during pregnancy. Spritam passes into breast milk. Breastfeeding while using Spritam is not recommended. Withdrawal seizures may occur if you suddenly stop taking Spritam.

Spritam must be gradually withdrawn.

Additional Information

Our Spritam (levetiracetam) 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.

IMAGES

See Images
Spritam Consumer Information

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 Spritam (Levetiracetam Tablets)

QUESTION

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

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

  • Behavioral Abnormalities and Psychotic Symptoms [see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior and Ideation [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.

Partial Onset Seizures

Adults

In controlled clinical studies in adults with partial onset seizures, the most common adverse reactions in patients receiving levetiracetam 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 levetiracetam.

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

Table 3: Adverse Reactions in Pooled Placebo-Controlled, Add-On Studies in Adults with Partial Onset Seizures

Adverse ReactionLevetiracetam
(N=769) %
Placebo
(N=439) %
Asthenia159
Somnolence158
Headache1413
Infection138
Dizziness94
Pain76
Pharyngitis64
Depression42
Nervousness42
Rhinitis43
Anorexia32
Ataxia31
Vertigo31
Amnesia21
Anxiety21
Cough Increased21
Diplopia21
Emotional Lability20
Hostility21
Paresthesia21
Sinusitis21

In controlled adult clinical studies, 15% of patients receiving levetiracetam 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 levetiracetam-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 with Partial Onset Seizures

Adverse ReactionLevetiracetam
(n=769) %
Placebo
(N=439) %
Somnolence42
Dizziness10

Pediatric Patients 4 Years To Less Than 16 Years Of Age

The adverse reaction data presented below was obtained from a pooled analysis of two controlled clinical studies in pediatric patients 4 to less than 16 years of age with partial onset seizures. The most common adverse reactions in pediatric patients 4 to less than 16 years of age receiving levetiracetam 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 less than 16 years of age) that occurred in at least 2% of pediatric levetiracetam-treated patients and were numerically more common than in pediatric patients treated with placebo. In these studies, either levetiracetam or placebo was added to concurrent AED therapy.

Table 5: Adverse Reactions in Pooled Placebo-Controlled, Add-On Studies in Pediatric Patients 4 to 16 Years of Age with Partial Onset Seizures

Adverse ReactionLevetiracetam
(N=165) %
Placebo
(N=131) %
Headache1915
Nasopharyngitis1512
Vomiting1512
Somnolence139
Fatigue115
Aggression105
Cough95
Nasal Congestion92
Upper Abdominal Pain98
Decreased Appetite82
Abnormal Behavior74
Dizziness75
Irritability71
Pharyngolaryngeal Pain74
Diarrhea62
Lethargy65
Insomnia53
Agitation41
Anorexia43
Head Injury40
Altered Mood31
Constipation31
Contusion31
Depression31
Fall32
Influenza31
Affect Lability21
Anxiety21
Arthralgia20
Confusional State20
Conjunctivitis20
Ear Pain21
Gastroenteritis20
Joint Sprain21
Mood Swings21
Neck Pain21
Rhinitis20
Sedation21

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

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 controlled clinical study in patients 12 years of age and older with myoclonic seizures, the most common adverse reactions in patients receiving levetiracetam in combination with other AEDs, for events with rates greater than placebo, were somnolence, neck pain, and pharyngitis.

Table 6 lists adverse reactions that occurred in at least 5% of juvenile myoclonic epilepsy patients experiencing myoclonic seizures treated with levetiracetam and were numerically more common than in patients treated with placebo. In this study, either levetiracetam or placebo was added to concurrent AED therapy.

Table 6: Adverse Reactions in a Placebo-Controlled, Add-On Study in Patients 12 Years of Age and Older with Myoclonic Seizures

Adverse ReactionLevetiracetam
(N=60) %
Placebo
(N=60) %
Somnolence122
Neck pain82
Pharyngitis70
Depression52
Influenza52
Vertigo53

In the placebo-controlled study, 8% of patients receiving levetiracetam 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 levetiracetam-treated patients than in placebo-treated patients are presented in Table 7.

Table 7: Adverse Reactions that Resulted in Discontinuation or Dose Reduction in a Placebo- Controlled Study in Patients with Juvenile Myoclonic Epilepsy

Adverse ReactionLevetiracetam
(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 trial in patients with PGTC seizures, the most common adverse reaction in patients receiving levetiracetam in combination with other AEDs, for events with rates greater than placebo, was nasopharyngitis.

Table 8 lists adverse reactions that occurred in at least 5% of idiopathic generalized epilepsy patients experiencing PGTC seizures treated with levetiracetam and were numerically more common than in patients treated with placebo. In this study, either levetiracetam or placebo was added to concurrent AED therapy.

Table 8: Adverse Reactions in a Placebo-Controlled, Add-On Study in Patients 4 Years of Age and Older with PGTC Seizures

Adverse ReactionLevetiracetam
(N=79) %
Placebo
(N=84) %
Nasopharyngitis145
Fatigue108
Diarrhea87
Irritability62
Mood swings51

In the placebo-controlled study, 5% of patients receiving levetiracetam 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 Table 4 and Table 7).

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

Comparison Of Gender, Age, And Race

The overall adverse reaction profile of levetiracetam 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 levetiracetam. 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, acute kidney injury, agranulocytosis, anaphylaxis, angioedema, 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, and weight loss. Alopecia has been reported with levetiracetam use; recovery was observed in majority of cases where levetiracetam was discontinued.

Read the entire FDA prescribing information for Spritam (Levetiracetam Tablets)

SLIDESHOW

What Is Epilepsy? Symptoms, Causes, and Treatments See Slideshow

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

Health Solutions From Our Sponsors