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Pharmacoepidemiol Drug Saf. 2019 Sep;28(9):1175-1179. doi: 10.1002/pds.4839. Epub 2019 Jun 17.

Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care.

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Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Groningen Research Institute of Pharmacy, Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, The Netherlands.
Dutch Medicines Evaluation Board, Utrecht, The Netherlands.



Little is known about adverse drug events (ADEs) experienced over time during chronic drug use. The purpose of this study was to assess ADE patterns experienced by patients with diabetes.


Patients who received an oral glucose-lowering drug completed a daily diary for 13 weeks. The diary asked for experienced symptoms and whether patients related these symptoms to any drug they used. Summaries of Product Characteristics were used to check whether the ADEs were known adverse drug reactions (ADRs) of the drugs used. Patterns of weekly occurring ADEs were assessed with descriptive statistics.


We included 78 patients. Almost half of them reported at least one ADE (N = 36; 46%). In total, 80 ADEs were reported. Of these ADEs, 71 (90%) were known ADRs. ADEs lasted less than 1 week in 27 cases (34%) and between 2 and 12 weeks in 15 cases (19%). The remaining ADEs fluctuated (16 cases; 20%) or persisted (22 cases; 28%) during the entire study period.


ADEs experienced by patients with diabetes can fluctuate or persist over long periods of drug use.


diabetes mellitus; drug-related side effects and adverse reactions; patients; pharmacoepidemiology; primary health care; type 2

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