The adverse effects profile of levetiracetam in epilepsy: a more detailed look

Abstract

The adverse effects profile of levetiracetam in epilepsy is still being fully described. We recently published a Cochrane Review evaluating the effectiveness of levetiracetam, added on to usual care, in treating drug-resistant focal epilepsy. The five most common adverse effects were reported and analysed with no scope for reporting any less common adverse effects than those. Here, we report and analyse the remaining adverse effects (including the five most common). These were (in decreasing order of frequency) somnolence; headache; asthenia; accidental injury; dizziness; infection; pharyngitis; pain; rhinitis; abdominal pain; flu syndrome; vomiting; diarrhoea; convulsion; nausea; increased cough; anorexia; upper respiratory tract infection; hostility; personality disorder; urinary tract infection; nervousness; depression; aggression; back pain; agitation; emotional liability; psychomotor hyperactivity; pyrexia; rash; ECG abnormalities; decreased appetite; nasal congestion; irritability; abnormal behaviour; epistaxis; insomnia; altered mood; anxiety; bloody urine; diplopia; dissociation; memory impairment; pruritis; increased appetite; acne; and stomach discomfort. Only somnolence and infection were significantly associated with levetiracetam. When adverse effects pertaining to infection were combined, these affected 19.7% and 15.1% of participants on levetiracetam and placebo (relative risk 1.16, CI 0.89-1.50, Chi(2) heterogeneity p = 0.13). Somnolence and infection further retained significance in adults while no single adverse effect was significant in children. This review updates the adverse effects profile data on levetiracetam use by empirically reporting its common and uncommon adverse effects and analysing their relative importance statistically using data from a group of trials that possess low Risk of Bias and high Quality of Evidence GRADE scores.

Specific adverse effects of antiepileptic drugs — A true-to-life monotherapy study

“…Sleep disturbances so far have been reported only occasionally [21,25] and probably are not in the focus of physicians' attention. In the regulatory monotherapy trial, however, insomnia was reported by patients treated with levetiracetam more than twice as often as by patients on CR carbamazepine [26].…”

Do antiepileptic drugs increase the risk of infectious diseases? A meta‐analysis of placebo‐controlled studies

“…Even though previous clinical observations suggested an increased risk of upper respiratory infections with levetiracetam , our subanalysis failed to show a specific effect on these infections, thus suggesting that this facilitating effect concerns all infectious disease and is not specific of any particular infectious disease.…”

“…These effects may increase the risk of developing infectious diseases and some clinical data suggest a higher frequency of upper respiratory infectious diseases in subjects under treatment with specific drugs .…”

Spectrum of Cutaneous Adverse Reactions to Levetiracetam and Human Leukocyte Antigen Typing in North-Indian Patients

“…2–4,10–15 In a systematic review of ten randomised controlled trials by Mbizvo et al, adverse effect profile of LEV in patients of drug-resistant epilepsy was studied, and rash due to LEV was reported in only two studies. It was noted that only symptoms affecting more than 5 or 10% of participants of the groups were published in these ten trials 16. In the study by Cheung et al, out of 55 patients of cADR due to various AEDs identified over 16.5 years, there was only one patient with rashes due to LEV, though one of the reasons maybe that being a newly introduced AED it may not have been prescribed much in the initial few years 17.…”