Adverse reactions: Information sources

Last updated: Sunday, July 05, 2015

Most SPCs include details of adverse events reported during clinical trials and their frequency, and information about side effects detected after product launch. Don't just look at section 4.8 ('Undesirable effects'), you may 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'. We have a guide to using online SPCs here.

The MHRA's yellow card data are available online as 'Drug Analysis Prints' (DAPS); make sure you’ve read the detailed interpretation guide first. DAPs for vaccines are only available upon request from pharmacovigilanceservice@mhra.gsi.gov.uk. The MHRA’s current awareness publication, Drug Safety Update, is also available electronically with a helpful search engine.

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Subscription resources such as Martindale and the AHFS Drug Information, and Lexicomp or Micromedex, can be very useful places to look for information on ADRs. These sources are valuable because 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 and Embase but choose your search terms carefully.

Expert clinicians or specialist clinical pharmacists can often give valuable advice on complex cases (e.g. a dermatologist’s opinion on a skin reaction).

Manufacturers’ medical information departments can sometimes help, but be aware that there is a requirement for enquiries about suspected ADRs to be followed up by sending out adverse event reporting forms.

Be careful about conducting a general internet search on this subject. If you do, you may like to look at our brief guide to evaluating websites about medicines.

Presenting your answer 

Once you’ve asked sufficient questions, gathered the information required and assessed it, you’ll need to provide an answer. We can offer you some general guidance on answering clinical problems.