Prescription Drug Information: Levetiracetam (Page 4 of 11)

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 pediatric patients 4 to 16 years of age with partial-onset seizures. The most common adverse reactions in pediatric patients receiving levetiracetam tablets 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 levetiracetam tablets-treated patients and were numerically more common than in pediatric patients treated with placebo. In these studies, either levetiracetam tablets 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

Levetiracetam Tablets(N = 165)%

Placebo(N = 131)%

Headache

19

15

Nasopharyngitis

15

12

Vomiting

15

12

Somnolence

13

9

Fatigue

11

5

Aggression

10

5

Cough

9

5

Nasal Congestion

9

2

Upper Abdominal Pain

9

8

Decreased Appetite

8

2

Abnormal Behavior

7

4

Dizziness

7

5

Irritability

7

1

Pharyngolaryngeal Pain

7

4

Diarrhea

6

2

Lethargy

6

5

Insomnia

5

3

Agitation

4

1

Anorexia

4

3

Head Injury

4

0

Altered Mood

3

1

Constipation

3

1

Contusion

3

1

Depression

3

1

Fall

3

2

Influenza

3

1

Affect Lability

2

1

Anxiety

2

1

Arthralgia

2

0

Confusional State

2

0

Conjunctivitis

2

0

Ear Pain

2

1

Gastroenteritis

2

0

Joint Sprain

2

1

Mood Swings

2

1

Neck Pain

2

1

Rhinitis

2

0

Sedation

2

1

In the controlled pooled pediatric clinical studies in patients 4-16 years of age, 7% of patients receiving levetiracetam tablets 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 in children 1 month to less than 4 years of age with partial-onset seizures, the most common adverse reactions in patients receiving levetiracetam tablets 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 levetiracetam tablets in the placebo-controlled study and were numerically more common than in patients treated with placebo. In this study, either levetiracetam tablets 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

Levetiracetam Tablets(N = 60)%

Placebo(N = 56)%

Somnolence

13

2

Irritability

12

0

In the 7-day controlled pediatric clinical study in patients 1 month to < 4 years of age, 3% of patients receiving levetiracetam tablets 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.

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Medication Sections

Medication Information by RSS

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.