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Adverse Event Profile of Lidocaine

Adverse Event Profile of Lidocaine: A Pharmacovigilance Study Based on the FDA Adverse Event Reporting System (FAERS)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600131863
Enrollment
Unknown
Registered
2026-09-07
Start date
2026-09-15
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthetic Systemic Toxicity

Interventions

lidocaine group:None

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 100 Years

Inclusion criteria

Inclusion criteria: 1.Adverse events related to lidocaine as the "primary suspect drug" reported in the FDA Adverse Event Reporting System (FAERS) database (https://fis.fda. gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html) from the first quarter of 2004 to the second quarter of 2025.

Exclusion criteria

Exclusion criteria: 1.reports unrelated to medications, including “drug ineffective”, “off label use”, “no adverse event”, “wrong technique in product usage process”, “drug ineffective for unapproved indication”, “medication error” and product related PTs. The unclear symptoms were also deleted, including “toxicity to various agents”, “local anaesthetic systemic toxicity”, “systemic toxicity”, “systemic toxicity”.

Design outcomes

Primary

MeasureTime frame
Overall Profile of Lidocaine-Related Adverse Events;—

Countries

China

Contacts

Public ContactJiali Tang

Peking Union Medical College Hospital

tangjiali@pumch.cn+86 18500252430

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026