Open Pharmacovigilance

Drug safety data is complex and largely inaccessible to researchers

To address this, we have built OpenPV - which is a free, accessible research tool to conduct signal detection for adverse drug reactions. 

Currently, we offer signal detection using data from the UK national database, the Yellow Card Scheme.  

OpenPV: Signal detection in the UK national database - Yellow Card Scheme  

OpenPV enables signal detection for adverse drug reactions in the UK national spontaneous database, called the Yellow Card Scheme. It is a research and educational tool and should not be used for clinical decisions. Prior to use, please read the disclaimer. 

OpenPV contains all Yellow Card adverse drug reaction reports published by the UK Medicines and Healthcare products regulatory agency (MHRA).  The tool is updated quarterly (last update: March 2025 when MHRA had published all events reported up until May 2024). More detailed description of the data is available here.  

User instructions: 

• Type drug name in the drug search box.  Note that this does not search by drug class or brand name, but by recorded drug name within the Yellow Card database.  Please note that vaccine data is not included in the database. 
  
  

• Click search and select appropriate drug.
  
  

• Type MedDRA preferred term (PT) symptom in the search symptom box. Note that all possible terms that are reported for the entire Yellow Card database are included in the search function, even if there are no reports for the drug in question. If you cannot find the term - please refer to MedDRA terms in the MHRA interactive drug analysis profiles.
  
  

• Click search and select appropriate MedDRA preferred term.
  
  

• Click calculate signal.
  
  

• Use the additional metrics toggle to switch between different pharmacovigilance signal methods (reporting odds ratio, proportional reporting ratio, information component, empirical Bayes geometric mean). Users are invited to familiarise themselves with these methods.   
  
  

• You can download the raw results as a csv file.

Interpretation of results: 

• The tool outputs the number of reports for a suspected side-effect of a given drug, as well as the number of reports for the side-effect, across all other drugs within the Yellow Card database. It also displays the number of reports for all other suspected side-effects for the given drug, as well as all other suspected side-effects for all other drugs in the database. These figures can then be used to estimate various pharmacovigilance metrics. Please see the methods section for more details.
  
  

• The tool is based on disproportionality statistics - showing how much more or less an adverse event is reported for a drug compared to the background reporting for that same symptom across all other drugs within the Yellow Card  Scheme database.
  
  

• It is important not to compare the magnitude of disproportionality between different drugs, as there could be other factors that could influence the reporting of a side-effect with a given drug (e.g. drug is new on the market and under greater surveillance, greater utilisation versus other drugs).
  
  

• Please consider any signal within the context of existing evidence and literature. Please consider whether this signal can be replicated in other settings, such as observational studies or if it is reported within the drug's summary of product characteristics or the British National Formulary.
  
  

• The information on this website relates to suspected side effects , i.e. medical events that have been observed following the use of a medicine, but which are not necessarily related to or caused by the medicine.
   

• Information on suspected side effects should not be interpreted as meaning that the medicine or the active substance causes the observed effect or is unsafe to use.

Research using OpenPV: 

• Please acknowledge the tool if it is used in any publications or presentations.
  
  

• Please note that all searches are anonymously stored so that the OpenPV platform can analyse search frequencies. It is our intention to publish data relating to search frequencies over time.
  
  

• Please contact us if any issues arise with the tool or if you have any suggestions for improvements. 

This tool was developed by Dr David Ryan, NIHR Doctoral Fellow, University College London and ST4 Doctor in Clinical Pharmacology.

Github: https://github.com/dkdryan

Please get in touch via the contact us page if there are any questions about this tool or more bespoke analysis is required.