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Adverse Drug Reactions to Opioids: A Study in a National Pharmacovigilance Database

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Abstract

Introduction

Opioids are commonly used as analgesics; however, like any medicine, they can produce adverse drug reactions (ADRs), including nausea, constipation, dependence, and respiratory depression, that result in harmful and fatal events. Therefore, it is essential to monitor the safety of these drugs in clinical practice.

Objective

This study aimed to characterize the safety profile of opioids by conducting a descriptive study based on a spontaneous reporting system (SRS) for ADRs in The Netherlands, focusing on abuse, misuse, medication errors, and differences between sexes.

Methods

Reports submitted to the Netherlands Pharmacovigilance Centre Lareb from January 2003 to December 2021 with an opioid drug as the suspected/interacting medicine were analyzed. Reporting odds ratios (RORs) for drug-ADR combinations were calculated, analyzed, and corrected for sex and drug utilization (expenditure) for the Dutch population.

Results

A total of 8769 reports were analyzed. Tramadol was the opioid with the most reports during the period (n = 2746), while oxycodone or tramadol had the highest number of reports per year in the study period. The most reported ADRs from opioid use were nausea, followed by dizziness and vomiting, independent of sex, and all of them were more often reported in women. Vomiting associated with tramadol (ROR females/males = 2.17) was significantly higher in women. Buprenorphine was responsible for most ADRs when corrected for expenditure, with high RORs observed with application site hypersensitivity, application site reaction, and application site rash. Fentanyl gave rise to most of the reports of ADRs concerning abuse, misuse, and medication errors.

Conclusion

Patients treated with opioids experienced ADRs, primarily nausea, dizziness, and vomiting. For those groups of drugs, no significant differences were found between the sexes, except for the vomiting associated with tramadol. In general, ADRs related to opioids presented higher RORs when uncorrected and corrected for sexes and expenditure than other drugs. There was more disproportionate reporting for ADRs concerning abuse, misuse, and medication errors for opioids than other drugs in the Dutch SRS.

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Authors and Affiliations

  1. Department of Pharmacology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

    Moa Gustafsson

  2. Polytechnic Institute of Coimbra, Coimbra Health School, Coimbra, Portugal

    Moa Gustafsson, Cristiano Matos & João Joaquim

  3. Netherlands Pharmacovigilance Centre Lareb, MH’s-Hertogenbosch, The Netherlands

    Joep Scholl & Florence van Hunsel

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Correspondence to Moa Gustafsson.

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Moa Gustaffson, Cristiano Matos, João Joaquim, Joep Scholl and Florence van Hunsel have no conflicts of interest to declare that are directly relevant to the contents of this study.

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Ethical approval was not needed for this study.

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The datasets for this manuscript are not publicly available due to the data protection policy of the Pharmacovigilance Centre Lareb. Requests to access the datasets should be directed to the first author and will be granted on reasonable request.

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The SQL statements for the data used in this article are not publicly available due to the data protection policy of Lareb. Requests to access the datasets should be directed to the first author and will be granted on reasonable request.

Authors’ contributions

The original study protocol was designed by MG and CM with input from FvH. JS established the query and dataset. Data analysis was performed by MG and CM, and the design of the manuscript was determined by all authors. All authors contributed to the final data analysis and manuscript drafting and revision. All authors approved the final version to be published and agreed to be accountable for all aspects of the work.

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Gustafsson, M., Matos, C., Joaquim, J. et al. Adverse Drug Reactions to Opioids: A Study in a National Pharmacovigilance Database. Drug Saf 46, 1133–1148 (2023). https://doi.org/10.1007/s40264-023-01351-y

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