Introduction:

diclofenac sodium is a non-steroidal anti-inflammatory drug that has beneficial therapeutic properties to the relieve of pain and inflammation in diseases of the osteomyoarticular system; however, in recent years it has been the target of criticism due to cardiovascular safety alerts that place it in the risk-benefit balance.

Objective:

to characterize adverse reactions to diclofenac sodium reported in the Orthopedics Service at Joaquin Albarran Hospital, in the period from 2018 to 2020.

Methods:

observational, descriptive, cross-sectional, pharmacovigilance (PhV) study developed at Joaquin Albarran Hospital, during the period from 2018 to 2020 using the proactive method of detection of adverse reactions. The target group comprised 21 patients treated with diclofenac sodium who presented adverse reactions to this drug, working with them all. Descriptive statistics was applied.

Results:

the predominant age group was 26 to 59 years old (57,1 %) and female sex (57,1 %), with headache (42,8 %) and hypertension (38,1 %) as the main adverse reactions reported. In terms of severity, moderate adverse reactions predominated (52,4%); all the notifications were classified as probable and according to frequency as occasional.

Conclusions:

it is concluded that during the period of time in which the study was carried out, moderate adverse reactions were identified between 26 and 59 years old, mostly cardiovascular and with the same prevalence in female sex. Headache was the most common symptom according to the results obtained.

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