Articles with "vigibase" as a keyword



Vomiting and constipation associated with tramadol and codeine: a comparative study in VigiBase®

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Published in 2018 at "European Journal of Clinical Pharmacology"

DOI: 10.1007/s00228-018-2536-z

Abstract: The most frequent adverse drug reactions (ADRs) of codeine and tramadol, the two main step 2 opioid analgesics, include nausea, dizziness, sedation, vomiting, and constipation [1]. The relative importance of vomiting and constipation remains discussed… read more here.

Keywords: codeine; tramadol; vigibase; study ... See more keywords

Uncovering Pregnancy Exposures in Pharmacovigilance Case Report Databases: A Comprehensive Evaluation of the VigiBase Pregnancy Algorithm

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Published in 2025 at "Drug Safety"

DOI: 10.1007/s40264-025-01559-0

Abstract: Information on the safety of medicine use during pregnancy is limited at the time of marketing, making post-marketing surveillance essential. However, the lack of a specific indicator for pregnancy-related case reports within the international standard… read more here.

Keywords: information; dataset; pregnancy; case ... See more keywords

Clozapine may consistently protect from suicidal behaviors while other antipsychotics may lack a specific protective effect: a comprehensive VigiBase study interpreted in the context of the prior literature

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Published in 2024 at "Expert Opinion on Drug Safety"

DOI: 10.1080/14740338.2024.2399094

Abstract: ABSTRACT Background In the United States, clozapine was first approved for treatment-resistant schizophrenia and then for suicidality in schizophrenia psychoses. Systematic reviews support clozapine’s anti-suicidal effect, but the forensic literature stresses its lethality during overdoses.… read more here.

Keywords: clozapine may; prior literature; vigibase; clozapine ... See more keywords

Clozapine-treated patients and myocardial infarction in adults: a pharmacovigilance study in VigiBase interpreted in the context of the literature.

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Published in 2025 at "Expert opinion on drug safety"

DOI: 10.1080/14740338.2025.2518234

Abstract: BACKGROUND Clozapine is the best treatment for treatment-resistant schizophrenia (TRS) but is associated with metabolic adverse drug reactions (ADRs). RESEARCH DOSING/METHODS The international pharmacovigilance database (VigiBase) uses the information component (IC) as a disproportionality analysis.… read more here.

Keywords: treated patients; myocardial infarction; clozapine treated; pharmacovigilance ... See more keywords

Association between myocarditis and antipsychotics other than clozapine: a systematic literature review and a pharmacovigilance study using VigiBase

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Published in 2022 at "Expert Review of Clinical Pharmacology"

DOI: 10.1080/17512433.2022.2032659

Abstract: ABSTRACT Introduction Pharmacovigilance studies have definitely established that clozapine can cause myocarditis. Two published reviews suggested that on rare occasions other antipsychotics may induce myocarditis. Areas covered This review explored myocarditis associated with antipsychotics other… read more here.

Keywords: review; pharmacovigilance; literature; antipsychotics clozapine ... See more keywords

OP0237 THROMBOEMBOLIC SAFETY PROFILE OF TOFACITINIB AND BARICITINIB: AN ANALYSIS OF WHO VIGIBASE

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Published in 2020 at "Annals of the Rheumatic Diseases"

DOI: 10.1136/annrheumdis-2020-eular.2823

Abstract: The Janus Kinase (JAK) inhibitors tofacitinib and baricitinib are new targeted treatments for rheumatoid arthritis. Recent concerns regarding the risk of thrombosis have led to warnings by the European Medicines Agency (EMA) and the Food… read more here.

Keywords: ror; vigibase; risk; baricitinib ... See more keywords

Association between exposure to proton pump inhibitors and hypertension: a descriptive and disproportionality analysis of VigiBase

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Published in 2025 at "BMJ Open"

DOI: 10.1136/bmjopen-2025-105962

Abstract: Objectives The potential link between proton pump inhibitors (PPIs) and hypertension remains unclear. It is uncertain whether such an association exists, whether it represents a class-of-PPI effect and whether a dose–response relationship is involved. This… read more here.

Keywords: proton pump; association; hypertension; dose response ... See more keywords

Hepatic disorders associated with the use of Ivermectin for SARS-CoV-2 infection in adults: a pharmacovigilance study in VigiBase

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Published in 2022 at "Gastroenterology and Hepatology From Bed to Bench"

DOI: 10.22037/ghfbb.v15i4.2383

Abstract: Aim: The aim of the present study was to review in VigiBase the reports of serious hepatic disorders associated with the use of ivermectin for COVID-19 in adults. Background: In the face of the global… read more here.

Keywords: disorders associated; use ivermectin; vigibase; ivermectin ... See more keywords
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Adverse events reported from the COVID-19 vaccines: A descriptive study based on the WHO database (VigiBase®)

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Published in 2021 at "Journal of Applied Pharmaceutical Science"

DOI: 10.7324/japs.2021.110801

Abstract: The emergency approval of a few COVID-19 vaccines provided a ray of hope to fight the deadly pandemic. However, their approval was solely based on limited data from the clinical trials in a short period,… read more here.

Keywords: database; vigibase; study; adverse events ... See more keywords