A Pharmacovigilance Study of Brain Oedema

University of Peshawar9,524 enrolled

Overview

Literature reports the development of brain oedema following the use of certain drugs. Therefore, this study aims to present a comprehensive disproportionality analysis of brain oedema cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS).

Brain oedema is a serious neurological condition, as it possesses a significant impact on the functional abilities of an individual by causing irreversible brain damage and potentiates the risk of mortality. Apart from a number of medical conditions causing brain oedema, evidence suggests the association of various drugs with brain oedema. Therefore, this study aims to provide a comprehensive disproportionality analysis of the drug-induced brain oedema reports in the FAERS database.

Study Type

OBSERVATIONAL

Enrollment

9,524

Conditions

Brain Edema Brain Edema Caused by Drugs

Interventions

Drugs, GenericDRUG

All drugs having 19 or more Brain Oedema cases reported to the FAERS database

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Brain Oedema cases reported in the FAERS database till 31/03/2019 * Adverse event reported was included using the MedDRA term: Brain Oedema Exclusion Criteria: * Drugs with less than 19 brain oedema reports

Locations (1)

University of Peshawar

Peshawar, KPK, Pakistan

Outcomes

Primary Outcomes

Identification of drugs associated with Brain Oedema

The search includes MedDRA (v-22) Preferred Term, "Brain Oedema (MedDRA code: 10048962) for the identification of all Brain Oedema case reports and drugs.