Adverse reactions: Information sources
Most SmPCs include details of adverse events and their frequency. Don't just look at section 4.8 ('Undesirable effects'). Depending upon the circumstances, you may also need to look in sections: 4.3 'Contra-indications', 4.4 'Special warnings and precautions', 4.7 'Effects on ability to drive and use machines', and 4.9 'Overdose'.Subscription resources such as Martindale and AHFS Drug Information, and Lexicomp or Micromedex, can be valuable. They may give data on the outcome of a side effect (e.g. reversibility, duration) and its management (e.g. treatment options). References are usually provided so you can follow these up if necessary.
Consider using Medline, Embase and Google Scholar if you can't find what you need in other sources, but choose your search terms carefully.
The MHRA's Yellow Card data are available online as 'interactive Drug Analysis Profiles' (iDAPs); make sure you’ve read the interpretation guide at the bottom of the each iDAP first. Note that the likelihood of experiencing an adverse drug reaction when taking a medicine cannot be estimated from the data in the Interactive Drug Analysis Profile. This is because the MHRA have limited information about how many people have taken the medicine without experiencing a reaction. In addition, no details about the individual patients involved in the reports are provided including concomitant medicines or co-morbidities. iDAPs for COVID-19 vaccines are available online upon request, but iDAPs for all other vaccines are only available on request.
The MHRA's Yellow Card data are available online as 'interactive Drug Analysis Profiles' (iDAPs); make sure you’ve read the interpretation guide at the bottom of the each iDAP first. Note that the likelihood of experiencing an adverse drug reaction when taking a medicine cannot be estimated from the data in the Interactive Drug Analysis Profile. This is because the MHRA have limited information about how many people have taken the medicine without experiencing a reaction. In addition, no details about the individual patients involved in the reports are provided including concomitant medicines or co-morbidities. iDAPs for COVID-19 vaccines are available online upon request, but iDAPs for all other vaccines are only available on request.
The MHRA’s useful
publication Drug Safety Update is available online with a helpful search facility, and you can also subscribe to it via e-mail to keep yourself up-to-date with major safety issues.
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Expert clinicians or specialist clinical pharmacists can often give practical advice on complex cases (e.g. a dermatologist’s opinion on a skin reaction).
Be careful about conducting a general internet search for information on an adverse reaction. If you do, you may like to look at our brief guide to evaluating websites about medicines.