1 Research Unit of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark, Odense, Denmark

2 Department of Pharmacy, Section for Social and Clinical Pharmacy, University of Copenhagen, Denmark


Objective: To characterize adverse drug reactions (ADRs) reported by European (EU) 
consumer for antineoplastic and immunomodulating medications.
Methods: ADRs reported by consumers of antineoplastic and immunomodulating 
medications (anatomical therapeutic chemical [ATC]) group L from 2007 to 2011 and 
located in the EU ADR database, EudraVigilance, were analyzed. Data were categorized 
with respect to age and sex, category, and seriousness of reported ADRs and medications. 
The unit of analysis was one ADR.
Findings: We located 9649 ADRs reported for antineoplastic and immunomodulating 
medications, which approximately 15% of were serious, including 26 deaths. Less than 5% 
of ADRs were reported in children. Totally 73% of ADRs were reported for women and 
27% for men. The majority of ADRs were of the type “general disorders and administration 
site conditions” (54% of total ADRs), followed by “skin and subcutaneous disorders” 
(7% of total ADRs), and “infections and infestations” (6% of total ADRs). Reports 
encompassed medicines from the therapeutic groups: Imunosupressants (ATC group L04) 
(90% of all ADRs), immunostimulants (ATC group L03) (6% of all ADRS), and antineoplastic 
agents (ATC group L01) (4% of all ADRs). Many ADRs were reported for etanercept (Enbrel®), 
Interferon beta (Betaferon®/Extavia®), and imatinib (Glivec®) with only few being serious.
Conclusion: In general, consumers reported a high number of ADRs from the use of 
antineoplastic and immunostimulant medications and many of these were classified as 
non‑serious. This indicates that consumers are interesting in reporting ADRs, but since 
the investigated substances potentially have the risk of causing many ADRs, we expected a 
higher number of serious ADRs.


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