Introduction:

Adverse drug reactions are an emerging disease, with a great social, economic and welfare impact.

Objective:

To characterize low frequency of onset´s adverse drug reactions.

Method:

Observational, descriptive, cross-sectional study of a series of cases in Pharmacovigilance, based on the spontaneous reporting of suspected adverse reactions that were received in the National Coordinating Unit of Pharmacovigilance from 2004 to 2013. The information was obtained from the national database of pharmacovigilance data. Low frequency adverse reactions are described in terms of sex, age, type of adverse effect, severity and imputability.

Results:

51 523 adverse drug reactions were evaluated. Those classified as occasional, with 30 323 notifications (58.8 %), prevailed. The group of 60 years old or more was the one with the highest reporting rate for a value of 29.6 per thousand inhabitants. Out of the total number of cases presented, female sex representing 65.2 % prevailed. The skin and appendages were more affected, and dipyrone (29.2 %) and penicillin (28.9%) were the most implicated drugs. Adverse drug reactions of moderate low frequency (58.3 %), probable (66.5 %) and type B (50,1 %) were predominant, and the last one depending on the production mechanism.

Conclusions:

The notification of low frequency adverse reactions, especially if they are of recent marketing allows a better knowledge of their toxicity profile and contributes to reduce the risks in the population.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )