Pregabalin ADRs: WHO-VigiAccess Flags CNS and Misuse Signals

Key Takeaways

• In a worldwide World Health Organization-VigiAccess snapshot, among the 164,223 identified pregabalin-associated adverse drug reactions, general disorders and administration-site conditions accounted for 21% and nervous system disorders for 18%.
• Psychiatric disorders accounted for 9% of reported adverse drug reactions, and common neuropsychiatric reactions included dizziness, somnolence, ataxia, euphoria, and aggression.
• About 1% of reports filed under social circumstances used explicit misuse- and dependence-related terms.
• Functional impairment in the reporting stream extended to reduced driving and work ability.

Pregabalin is used widely in neuropathic pain, epilepsy, and anxiety disorders, but concern about sedation, behavioral effects, and nonmedical use continues to shape its safety profile. Global postmarketing reporting patterns bring those concerns into focus around central nervous system, psychiatric, and misuse-related events, prompting investigators to examine how pregabalin-associated reactions were being recorded worldwide.

Investigators conducted a retrospective, descriptive pregabalin-associated adverse drug reactions analysis using the World Health Organization-VigiAccess database. All pregabalin-related adverse drug reactions (ADRs) reported up to October 2025 were extracted and categorized according to the Medical Dictionary for Regulatory Activities (MedDRA) across System Organ Classes and Preferred Terms. Frequencies and percentages were summarized descriptively, with no comparator arm and no basis for causal inference.

Psychiatric disorders accounted for 9% of reports, and injury, poisoning, and procedural complications accounted for 8%. Working-age adults accounted for most reports, with a slight female predominance, and the highest reporting came from the Americas and Europe, emphasizing that this was a worldwide reporting pattern rather than a US-specific estimate. Common neuropsychiatric preferred terms included dizziness, somnolence, ataxia, euphoria, and aggression.

The WHO-VigiAccess pregabalin safety analysis reports 3,835 social-circumstances reports, described by the authors as ≈1%, that included explicit misuse- and dependence-related terms such as drug abuser, drug diversion, substance abuser, and prescription form tampering. The same reporting stream also captured impaired driving ability (n = 710) and impaired work ability (n = 585), extending the signal from misuse-related terminology to day-to-day functioning.

According to the authors, this large global reporting snapshot extends pregabalin safety concerns beyond common neuropsychiatric complaints to misuse-related entries and reports of impaired daily functioning. These findings remain descriptive signals from reported adverse reactions.

Clinician Questions

What did the social-circumstances reports capture in pregabalin adverse-reaction reporting?

Social-circumstances entries captured both explicit misuse- and dependence-related terminology and functional consequences. The named terms included drug abuser, drug diversion, substance abuser, and prescription form tampering, and the same reporting stream also included impaired driving ability and impaired work ability.

Were pregabalin adverse-reaction reports concentrated in certain age groups or regions?

The report described adults aged 18 to 64 years as the group accounting for most reports, noted a slight female predominance, and placed the highest reporting in the Americas and Europe. It did not provide adjusted risk comparisons across age, sex, or geography.

Can the WHO-VigiAccess pregabalin data estimate incidence or confirm that pregabalin caused the reported events?

No. The WHO-VigiAccess pregabalin analysis summarized spontaneously reported pregabalin adverse drug reactions descriptively, with frequencies and percentages but no comparator arm, no incidence denominator, and no causal confirmation.