Adverse drug reactions to levetiracetam: A case series and clinical insights

Levetiracetam (LEV) is a widely used antiepileptic drug with a generally favourable safety profile. However, rare but clinically significant adverse drug reactions (ADRs) may occur and remain underreported. We report three patients who developed uncommon ADRs following LEV therapy: psychosis, drug-induced Parkinsonism and hyponatraemia. All cases demonstrated a clear temporal association with LEV initiation and improvement after drug withdrawal. Causality assessment using the Naranjo Scale yielded probable scores for all cases (Case 1: 7; Case 2: 6; Case 3: 7). The World Health Organization–Uppsala Monitoring Centre causality assessment categorised all reactions as Probable/Likely. Severity was graded as moderate (Hartwig Level 3), and preventability as probably preventable using the Modified Schumock and Thornton scale. Although LEV is generally safe, clinicians should remain vigilant for rare neuropsychiatric and metabolic ADRs, especially in elderly patients and those with polypharmacy. Early recognition, prompt withdrawal and strict pharmacovigilance are essential to prevent morbidity and mortality.

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Journal
Indian Journal of Physiology and Pharmacology
Published
2026-10-19
DOI
https://doi.org/10.25259/ijpp_676_2025
Primary Topic
Pharmacovigilance and Adverse Drug Reactions
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article
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article

Adverse drug reactions to levetiracetam: A case series and clinical insights

S. Priyanka, N. Hamsini
Indian Journal of Physiology and Pharmacology
Pharmacovigilance and Adverse Drug Reactions
article

Adverse drug reactions to levetiracetam: A case series and clinical insights

S. Priyanka, N. Hamsini
article en

Abstract

Levetiracetam (LEV) is a widely used antiepileptic drug with a generally favourable safety profile. However, rare but clinically significant adverse drug reactions (ADRs) may occur and remain underreported. We report three patients who developed uncommon ADRs following LEV therapy: psychosis, drug-induced Parkinsonism and hyponatraemia. All cases demonstrated a clear temporal association with LEV initiation and improvement after drug withdrawal. Causality assessment using the Naranjo Scale yielded probable scores for all cases (Case 1: 7; Case 2: 6; Case 3: 7). The World Health Organization–Uppsala Monitoring Centre causality assessment categorised all reactions as Probable/Likely. Severity was graded as moderate (Hartwig Level 3), and preventability as probably preventable using the Modified Schumock and Thornton scale. Although LEV is generally safe, clinicians should remain vigilant for rare neuropsychiatric and metabolic ADRs, especially in elderly patients and those with polypharmacy. Early recognition, prompt withdrawal and strict pharmacovigilance are essential to prevent morbidity and mortality.

Indian Journal of Physiology and PharmacologyVol. 0
Kempegowda Institute of Medical Sciences (IN)
Openalex Percentile: Top 11%
Pharmacovigilance and Adverse Drug Reactions
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