The Practical Side Effects Experienced in Patients Treated With Medications Approved for Melanoma

May 2025 | Volume 24 | Issue 5 | 539 | Copyright © May 2025


Published online April 29, 2025

doi:10.36849/JDD.8368

Advaitaa Ravipati MSa, Tejus Pradeep MDb, Philippe Jean-Pierre BSa, Keyvan Nouri MD MBAa

aDr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL
bScheie Eye Institute, University of Pennsylvania, Philadelphia, PA

Abstract
Background: 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.

Citation: 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


INTRODUCTION

Melanoma is a deadly malignancy with rising incidence rates over the past 50 years, especially in fairly complected individuals.1 Since 1975, melanoma incidence in the United States has increased by over 320%.2 While exposure to ultraviolet radiation has been long associated with melanoma, advancements in scientific techniques have led to the identification of genetic alterations as well.2 Mutations involving signaling proteins such as v-raf murine sarcoma viral oncogene homolog B1 (BRAF) have paved the way for immunotherapeutics and other systemic medications.3

The arsenal of treatments for melanoma includes kinase inhibitors, oncolytic viruses, monoclonal antibodies, and other immune modulators which have improved prognosis and survival in patients with advanced disease.4 However, these treatments are not without downsides that need to be accounted for in the risk-benefit calculation. Side effects are an important consideration that should be discussed between patient and physician fostering trust and preparedness. Therefore, the goal of our study was to capture adverse events frequently reported with melanoma medications to increase our current knowledge of practical side effects experienced in patients.

MATERIALS AND METHODS

The FDA Adverse Events Reporting System (FAERS) was used to capture adverse events reported in patients using melanoma medications. We examined 13 out of the 14 medications approved for melanoma on the National Cancer Institute's site. These included aldesleukin, binimetinib, encorafenib, cobimetinib, dabrafenib, dacarbazine, talimogene laherparepvec, recombinant interferon alpha-2b, ipilimumab, pembrolizumab, trametinib dimethyl sulfoxide, nivolumab, and vemurafenib. Tebentafusp-tebn was excluded from analysis as its approval was listed for only uveal and ocular melanoma.

Descriptive statistics were performed to capture medications with the highest reaction counts and the most common side