Keppra-XR Side Effects
Please note - some side effects for Keppra-XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Keppra-XR Side Effects - for the Professional
Keppra-XR
Clinical Studies 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 table, obtained when KEPPRA XR was added to concurrent AED therapy, cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. 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.
KEPPRA XR TabletsIn the well-controlled clinical study using KEPPRA XR in patients with partial onset seizures, the most frequently reported adverse reactions in patients receiving KEPPRA XR in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were irritability and somnolence.
Table 3 lists treatment-emergent adverse reactions that occurred in at least 5% of epilepsy patients treated with KEPPRA XR participating in the placebo-controlled study and were numerically more common than in patients treated with placebo. In this study, either KEPPRA XR or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.
| Body System/ Adverse Reaction |
KEPPRA XR (N=77) % |
Placebo (N=79) % |
|---|---|---|
| Gastrointestinal Disorders | ||
| Nausea | 5 | 3 |
| Infections and Infestations | ||
| Influenza | 8 | 4 |
| Nasopharyngitis | 7 | 5 |
| Nervous System Disorders | ||
| Somnolence | 8 | 3 |
| Dizziness | 5 | 3 |
| Psychiatric Disorders | ||
| Irritability | 7 | 0 |
Discontinuation Or Dose Reduction In The KEPPRA XR Well-Controlled Clinical Study
In the well-controlled clinical study using KEPPRA XR, 5.2% of patients receiving KEPPRA XR and 2.5% receiving placebo discontinued as a result of an adverse event. The adverse reactions that resulted in discontinuation and that occurred more frequently in KEPPRA XR-treated patients than in placebo-treated patients were asthenia, epilepsy, mouth ulceration, rash and respiratory failure. Each of these adverse reactions led to discontinuation in a KEPPRA XR-treated patient and no placebo-treated patients.
Comparison Of Gender, Age And Race
There are insufficient data for KEPPRA XR to support a statement regarding the distribution of adverse experience reports by gender, age and race.
Table 4 lists the adverse reactions seen in the well-controlled studies of immediate-release KEPPRA tablets in adult patients experiencing partial onset seizures. Although the pattern of adverse reactions in the KEPPRA XR study seems somewhat different from that seen in partial onset seizure well-controlled studies for immediate-release KEPPRA tablets, this is possibly due to the much smaller number of patients in this study compared to the immediate-release tablet studies. The adverse reactions for KEPPRA XR are expected to be similar to those seen with immediate-release KEPPRA tablets.
Immediate-Release KEPPRA TabletsIn well-controlled clinical studies of immediate-release KEPPRA tablets as adjunctive therapy to other AEDs in adults with partial onset seizures, the most frequently reported adverse reactions, not seen at an equivalent frequency among placebo-treated patients, were somnolence, asthenia, infection and dizziness.
Table 4 lists treatment-emergent adverse reactions that occurred in at least 1% of adult epilepsy patients treated with immediate-release KEPPRA tablets participating in placebo-controlled studies and were numerically more common than in patients treated with placebo. In these studies, either immediate-release KEPPRA tablets or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.
| Body System/ Adverse Reaction |
Immediate-release 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 addition, the following adverse reactions were seen in other well-controlled studies of immediate-release KEPPRA tablets: balance disorder, disturbance in attention, eczema, hyperkinesia, memory impairment, myalgia, personality disorders, pruritus, and vision blurred.
Postmarketing Experience
In addition to the adverse reactions listed above for immediate-release KEPPRA tablets [see Adverse Reactions (6.1)], the following adverse events have been identified during postapproval use of immediate-release KEPPRA tablets. Because these events 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, hepatic failure, hepatitis, leukopenia, neutropenia, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), thrombocytopenia and weight loss. Alopecia has been reported with immediate-release KEPPRA use; recovery was observed in majority of cases where immediate-release KEPPRA was discontinued.
TopSide Effects by Body System - for Healthcare Professionals
Nervous system
Nervous system side effects have included somnolence (up to 15%), dizziness (9%), vertigo (up to 5%), depression (4%), nervousness (4%), ataxia (3%), amnesia (2%), anxiety (2%), emotional lability (2%), hostility (2%), and paresthesia (2%). A case of levetiracetam-induced parkinsonism has also been reported.
Somnolence (8%) and dizziness (5%) have been reported with extended release tablets.
General
General side effects have included asthenia (15%), headache (14%), nasopharyngitis (14%), infection (13%), fatigue (10%), pain (7%), and influenza (5%). Several cases of considerable weight loss associated with levetiracetam use have also been reported. Levetiracetam has been associated with fatigue in pediatric patients.
Influenza (8%) has been reported with extended release tablets.
Respiratory
Respiratory side effects have included pharyngitis (up to 7%), rhinitis (4%), increased cough (2%), and sinusitis (2%).
Nasopharyngitis (7%) has been reported with extended release tablets.
Psychiatric
Slower titration should be considered in patients at a higher risk of discontinuing levetiracetam for behavioral reasons.
Psychiatric side effects such as depression (up to 5.7%) including suicidal depression (up to 0.7%), irritability (6%), and mood swings (5%) have been reported.
In some patients experiencing primary generalized tonic-clonic seizures, levetiracetam caused behavioral abnormalities. Nonpsychotic mood disorders (reported as anger, apathy, depression, altered mood, mood swings, negativism, suicidal ideation, and tearfulness) occurred in 12.7% of levetiracetam-treated patients. One patient experienced suicidal ideation. Another patient experienced delusional behavior that required the lowering of the dose of levetiracetam.
Irritability (7%) has been reported with extended release tablets.
Gastrointestinal
A multicenter, double-blind, placebo controlled trial (n=517) has reported that 10.1% of patients treated with levetiracetam had adverse psychiatric events. A significant association was reported with previous psychiatric history, history of febrile convulsions, and history of status epilepticus. Concomitant therapy with lamotrigine was reported to have had a protective effect. Psychiatric adverse events were not related to the titration schedule of levetiracetam. Certain patients seem to be more vulnerable biologically.
Gastrointestinal side effects have included anorexia (3%), pancreatitis, and diarrhea.
Nausea (5%) has been reported with extended release tablets.
Ocular
Ocular side effects have included diplopia (2%).
Hematologic
One possibly significant decreased WBC count occurred in every 3.2% of treated patients. One possibly significant decreased neutrophil count occurred in every 2.4% of treated patients.
Hematologic side effects have included leukopenia, neutropenia, pancytopenia (with bone marrow suppression identified in some of these cases), and thrombocytopenia. Minor, but statistically significant decreases in total mean RBC count (0.03 x 1,000,000/mm2), mean hemoglobin (0.09 g/dL), and mean hematocrit (0.38%) have also been reported.
Dermatologic
Recovery from alopecia was reported in the majority of the cases where levetiracetam was discontinued.
Dermatologic side effects including alopecia have been reported.
Hepatic
Hepatic side effects including abnormal liver function tests, hepatitis, and hepatic failure have been reported during postmarketing surveillance.
Musculoskeletal
Musculoskeletal side effects including neck pain (8%) have been reported.
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