Levetiracetam (Page 5 of 14)

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.

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