Abstract
Melanoma continues to remain one of the most feared malignancies among patients and dermatologists. Significant strides have been made in expanding the treatment arsenal with systemic medications and immunotherapeutics. With many more drugs available, side effects remain an important component of constructing treatment plans. Using the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS), cases of real-world side effects reported with melanoma medications were assessed to capture practical patient experiences. Treatments with the highest counts of adverse events were ipilimumab, nivolumab, dabrafenib, and vemurafenib. Individuals reported pyrexia (12.9%), rash (9.8%), diarrhea (9.5%), fatigue (7.0%), and colitis (6.7%) most frequently. Males were more likely to experience pyrexia (aOR 1.1, P=0.006), nausea (aOR 1.4, P<0.001), rash (aOR 1.3, P<0.001), vomiting (aOR 1.2, P=0.005), and headache (aOR 1.3, P<0.001). Females had higher odds of fatigue (aOR 1.2, P=0.002), decreased appetite (aOR 1.2, P=0.004), and dyspnea (aOR 1.3, P<0.001). Patients 62 years old or younger had higher odds of pyrexia (aOR 1.4, P<0.001), nausea (aOR 1.2, P=0.001), vomiting (aOR 1.3, P<0.001), and headache (aOR 2.9, P<0.001). Individuals older than 62 were more likely to report diarrhea (aOR 1.2, P<0.001), fatigue (aOR 1.4, P<0.001), and decreased appetite (aOR 1.5, P<0.001). With patients who have to already digest a difficult diagnosis, the ability to counsel individuals based on the practical side effects of treatments can pave the way for better dialogue and more trust.BACKGROUNDMelanoma continues to remain one of the most feared malignancies among patients and dermatologists. Significant strides have been made in expanding the treatment arsenal with systemic medications and immunotherapeutics. With many more drugs available, side effects remain an important component of constructing treatment plans. Using the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS), cases of real-world side effects reported with melanoma medications were assessed to capture practical patient experiences. Treatments with the highest counts of adverse events were ipilimumab, nivolumab, dabrafenib, and vemurafenib. Individuals reported pyrexia (12.9%), rash (9.8%), diarrhea (9.5%), fatigue (7.0%), and colitis (6.7%) most frequently. Males were more likely to experience pyrexia (aOR 1.1, P=0.006), nausea (aOR 1.4, P<0.001), rash (aOR 1.3, P<0.001), vomiting (aOR 1.2, P=0.005), and headache (aOR 1.3, P<0.001). Females had higher odds of fatigue (aOR 1.2, P=0.002), decreased appetite (aOR 1.2, P=0.004), and dyspnea (aOR 1.3, P<0.001). Patients 62 years old or younger had higher odds of pyrexia (aOR 1.4, P<0.001), nausea (aOR 1.2, P=0.001), vomiting (aOR 1.3, P<0.001), and headache (aOR 2.9, P<0.001). Individuals older than 62 were more likely to report diarrhea (aOR 1.2, P<0.001), fatigue (aOR 1.4, P<0.001), and decreased appetite (aOR 1.5, P<0.001). With patients who have to already digest a difficult diagnosis, the ability to counsel individuals based on the practical side effects of treatments can pave the way for better dialogue and more trust.Ravipati A, Pradeep T, Jean-Pierre P, et al. The practical side effects experienced in patients treated with medications approved for melanoma. J Drugs Dermatol. 2025;24(5):539-542. doi:10.36849/JDD.8368.CITATIONRavipati A, Pradeep T, Jean-Pierre P, et al. The practical side effects experienced in patients treated with medications approved for melanoma. J Drugs Dermatol. 2025;24(5):539-542. doi:10.36849/JDD.8368.