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A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Pharmacology".

Deadline for manuscript submissions: 25 May 2026 | Viewed by 26495

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Special Issue Editors

Dr. Andrej Belančić

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Guest Editor

1. Department of Clinical Pharmacology, Clinical Hospital Centre Rijeka, Rijeka, Croatia
2. Department of Basic and Clinical Pharmacology with Toxicology, Faculty of Medicine, University of Rijeka, Rijeka, Croatia
Interests: clinical pharmacology; diabetes; evidence-based medicine; metabolic syndrome; obesity
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Dr. Ivana Mudnić

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Guest Editor

Department of Pharmacology, University of Split School of Medicine, Šoltanska 2a, 21000 Split, Croatia
Interests: rational pharmacotherapy; cardiovascular pharmacology; lifestyle medicine

Special Issue Information

Dear Colleagues,

The Journal of Clinical Medicine (JCM) is pleased to announce the launch of this Special Issue, entitled “Clinical Pharmacology: Adverse Drug Reactions”. This Special Issue aims to explore the latest advancements in understanding, detecting, and preventing adverse drug reactions (ADRs), a critical challenge in pharmacology and patient safety.

The scope of this Special Issue includes, but is not limited to, pharmacovigilance, drug interactions, genetic predispositions, real-world evidence, and innovative strategies for ADR mitigation. We welcome studies utilizing clinical trials, observational studies, and advanced analytical methods to improve drug safety and therapeutic outcomes. Submissions focusing on the role of biomarkers in ADR prediction, personalized medicine approaches, and regulatory frameworks for drug safety monitoring are highly encouraged. Additionally, research on ADRs in special populations, such as pediatric, geriatric, and polypharmacy patients, is of particular interest.

Dr. Andrej Belančić
Dr. Ivana Mudnić
Guest Editors

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Keywords

pharmacology
adverse drug reactions
drug interactions
pharmacovigilance
drug safety

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Published Papers (6 papers)

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Research

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15 pages, 582 KB

Open AccessFeature PaperArticle

The Role of the Lymphocyte Transformation Test in Immune-Related Adverse Events from Immune Checkpoint Inhibitors: A Case Series

by Fiorela C. Dueñas Lopez, Zoraida del Solar Moreno, Daniela Aguilar-Concepción, Carmen Ruiz-Fernández, Ibtissam Akatbach-Bousaid, Olga Rogozina, Susana Martín-López, Ana Martínez Feito, Miguel González-Muñoz and Elena Ramírez

J. Clin. Med. 2025, 14(23), 8596; https://doi.org/10.3390/jcm14238596 - 4 Dec 2025

Viewed by 164

Abstract

Background: Immune-related adverse events (irAEs) represent a considerable complication associated with the use of immune checkpoint inhibitors (ICIs) in oncology patients. Assessing causality is particularly challenging in patients administered multiple therapeutic agents. The Lymphocyte Transformation Test (LTT) may aid in causality analysis, although its clinical utility remains investigational. Objectives: To evaluate the potential utility of the Lymphocyte Transformation Test (LTT) in the causality analysis of irAEs in cancer patients and to assist clinicians in the decision-making process regarding ICI rechallenge. Methodology: We present a case series of seventeen cancer patients who developed irAEs during ICI therapy. Causality was assessed using the Spanish Pharmacovigilance System, and LTT was performed for both ICIs and co-medications. Results: Events primarily affect hepatic, respiratory, and renal functions. Five patients showed a positive LTT to ICIs (range 3.9–13.6), all with high-grade irAEs, and none underwent rechallenge. Six patients were positive for concomitant drugs: three tested positive for both. The initial high-grade irAEs rate was 53.9%. After rechallenging, 81.8% had all-grade and 45.5% had high-grade irAEs, predominantly pneumonitis. Conclusions: LTT may provide supportive evidence in complex irAE cases and assist clinicians in decision-making regarding ICI rechallenge. More prospective studies are needed. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

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11 pages, 1174 KB

Open AccessArticle

Comparative Renal Safety of Tirzepatide and Semaglutide: An FDA Adverse Event Reporting System (FAERS)—Disproportionality Study

by Ayush Gandhi, Nilay Bhatt and Alireza Parhizgar

J. Clin. Med. 2025, 14(21), 7678; https://doi.org/10.3390/jcm14217678 - 29 Oct 2025

Viewed by 2728

Abstract

Background: Acute kidney injury (AKI) remains a serious complication among individuals with type 2 diabetes. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are widely prescribed and often regarded as kidney-protective, yet post-marketing reports have linked them to AKI. Tirzepatide, a newer dual GIP/GLP-1 agonist, shows well-documented metabolic benefits, but its renal safety in real-world use is not well characterized. Methods: We conducted a disproportionality analysis of the U.S. FDA Adverse Event Reporting System (FAERS) from January 2022 to September 2025. Reporting odds ratios (RORs) and proportional reporting ratios (PRRs) were used to compare AKI reporting between tirzepatide and semaglutide. Results: Among 133,872 reports (92,807 tirzepatide; 41,065 semaglutide), AKI was listed in 432 (0.47%) and 440 (1.07%) cases, respectively. The ROR for tirzepatide versus semaglutide was 0.44 (95% CI, 0.38–0.50), suggesting a lower reporting frequency for AKI with tirzepatide. Conclusions: In this real-world pharmacovigilance analysis, semaglutide but not tirzepatide showed a disproportionality signal for AKI. While causality cannot be confirmed, clinicians should ensure hydration and renal monitoring when initiating GLP-1 RAs, particularly semaglutide. Semaglutide showed a higher AKI reporting rate than tirzepatide, though these findings should be interpreted cautiously given reporting bias and potential confounders. Both agents appear safe, with low AKI frequency in practice. Further studies should determine if differences reflect biological or reporting effects. These findings support the need for larger epidemiologic studies to define risk modifiers and optimize clinical safety strategies. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

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23 pages, 1561 KB

Open AccessArticle

Isotretinoin Treatment for Acne Vulgaris: A Five-Year Retrospective Analysis of Clinical and Biochemical Adverse Effects

by Igor Jarosław Feszak, Piotr Brzeziński, Sylwia Feszak, Aleksandra Kitowska, Monika Waśkow, Piotr Kawczak and Tomasz Bączek

J. Clin. Med. 2025, 14(18), 6473; https://doi.org/10.3390/jcm14186473 - 14 Sep 2025

Cited by 1 | Viewed by 7170

Abstract

Objectives: Oral isotretinoin remains the most effective therapy for severe acne, but its exceptional efficacy is often accompanied by relatively frequent adverse effects. In this study, we quantified the frequency- and dose-related predictors of clinical and biochemical adverse effects during isotretinoin treatment in routine Polish practice. Methods: The records of 370 patients (mean age: 28 ± 12 years) who began isotretinoin treatment between June 2020 and June 2025 were reviewed. The mean daily isotretinoin and cumulative isotretinoin doses were 23.4 ± 9.1 mg and 88.3 ± 31.5 mg/kg, respectively. The adverse events documented at two-monthly visits were correlated with age and dosing. Lipid, hepatic, thyroid and prolactin panels were compared with age- and sex-matched controls using χ² statistics and odds ratios (ORs). Results: Xerosis (70%), retinoid dermatitis (20%) and cheilitis (15.5%) predominated. Hand eczema rose with higher daily isotretinoin doses (ρ = 0.082; p = 0.037), whereas pruritus declined with greater cumulative isotretinoin exposure (ρ = −0.088; p = 0.037). Retinoid dermatitis was linked to a younger age (ρ = −0.080; p = 0.0286), whereas desquamation increased slightly with age (ρ = +0.083 p = 0.0228). Overall, dyslipidemia was twice as common as in the controls (OR: 2.06; 95% CI: 1.49–2.86; p-value: <0.0001), which was driven by an elevated total cholesterol (OR: 1.93; 95% CI: 1.34–2.77; p-value: 0.0004), LDL (OR: 3.40; 95% CI: 2.26–5.10; p-value: <0.0001) and triglycerides (OR: 1.95; 95% CI: 1.20–3.17; p-value: 0.0062) and decreased HDL (OR: 2.68; 95% CI: 1.75–4.10; p-value: <0.0001). Interestingly, hyperprolactinemia occurred eight-fold more often (OR: 8.42; 95%; 95% CI: 2.97–23.84; p-value: <0.00001). Aminotransferase and TSH elevations were infrequent and statistically non-significant. Conclusions: At moderate cumulative doses, isotretinoin was generally well tolerated; however, clinically relevant lipid and prolactin disturbances were frequent. Routine lipid and endocrine monitoring, early emollient prophylaxis and dose individualization are recommended to ensure safe isotretinoin usage in everyday practice. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

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11 pages, 204 KB

Open AccessArticle

Post-Marketing Safety of Spinal Muscular Atrophy Therapies: Analysis of Spontaneous Adverse Drug Reactions from EudraVigilance

by Andrej Belančić, Petar Mas, Lara Miletić, Barbara Kovačić Bytyqi and Dinko Vitezić

J. Clin. Med. 2025, 14(9), 3173; https://doi.org/10.3390/jcm14093173 - 3 May 2025

Cited by 1 | Viewed by 1331

Abstract

Background/Objectives: Spinal muscular atrophy (SMA) treatment has evolved with the approval of nusinersen, onasemnogene abeparvovec, and risdiplam. This study aims to assess the post-marketing safety profile of these therapies through the spontaneous adverse drug reaction (ADR) reports available in EudraVigilance (EV). Methods: Data from EV were retrieved via adrreports.eu for the suspected ADRs associated with nusinersen, onasemnogene abeparvovec, and risdiplam from their approval in the European Economic Area (EEA) to 31 December 2024. The ADR reports were exported and analysed using descriptive statistics in Microsoft Excel. Reporting odds ratios (RORs) with 95% confidence intervals (CIs) were calculated for suspected ADRs, focusing on reactions with a lower limit of the 95% CI exceeding 1. Results: A total of 3196, 806, and 956 individual case safety reports (ICSRs) were identified for nusinersen, onasemnogene abeparvovec, and risdiplam, respectively. The most frequently reported ADRs with significantly increased RORs included post-lumbar puncture syndrome (nusinersen: 11%), pyrexia (onasemnogene abeparvovec: 23%), and pneumonia (risdiplam: 9%). While some ADRs were therapy-specific, others were consistent with SMA disease progression and complications. Onasemnogene abeparvovec showed a notable prevalence of hepatotoxicity, while risdiplam was associated with gastrointestinal and respiratory events. Conclusions: To conclude, the analysis reinforces the known safety profiles of these SMA treatments while highlighting potential areas for further investigation. ADRs related to SMA complications require careful differentiation from true drug-related effects. Future pharmacovigilance efforts should focus on long-term safety assessments and real-world evidence to optimize treatment strategies. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

Review

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40 pages, 553 KB

Open AccessReview

Drug-Induced Hyponatremia: Insights into Pharmacological Mechanisms and Clinical Practice Management

by Miguel Capinha, Marta Lavrador, Joana Liberato, Adriana Pinheiro, Ana Aveiro, Isabel Vitória Figueiredo and Margarida Castel-Branco

J. Clin. Med. 2025, 14(18), 6584; https://doi.org/10.3390/jcm14186584 - 18 Sep 2025

Viewed by 6906

Abstract

Background: Hyponatremia (serum sodium concentration < 135 mmol/L) represents the most common electrolyte disturbance in clinical practice, particularly among high-risk populations such as older adults. Its severity ranges from moderately severe to life-threatening symptoms, contributing to increased mortality. Its etiology is widely heterogeneous and leads to different classifications according to volume status such as hypovolemic, euvolemic and hypervolemic hyponatremia. Drug-induced hyponatremia presents itself as one of the most prevalent but frequently overlooked causes, since many confounding factors like associated comorbidities and polypharmacy complicate the identification of specific medicines as the main offenders. Objectives: This narrative review was performed to provide a comprehensive analysis on drug-induced hyponatremia, focusing not only on the underlying pharmacological mechanisms, but also on management strategies in clinical practice. Methods: A narrative literature review was conducted using PubMed, Science Direct and Google Scholar. Results: This narrative review focused not only on the most common drug classes to induce hyponatremia through different mechanisms, including diuretics, antidepressants, anticonvulsants, and antipsychotics, but also on other pharmacological classes, that, although to a lesser extent, might also be associated with decreasing serum sodium levels (antineoplastic and immunomodulating agents, drugs acting on digestive and locomotor systems, anti-infective drugs, endocrine diseases drugs, among others). It also explores recommendations on the management of drug-induced hyponatremia and it emphasizes the role of healthcare providers in addressing this electrolyte disorder. Conclusions: As drug-induced hyponatremia poses significant challenges in clinical practice, understanding its mechanisms, coupled with effective management strategies, can enhance patient safety. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

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25 pages, 1139 KB

Open AccessReview

Lamotrigine Therapy: Relation Between Treatment of Bipolar Affective Disorder and Incidence of Stevens–Johnson Syndrome—A Narrative Review of the Existing Literature

by Kacper Żełabowski, Kacper Wojtysiak, Zuzanna Ratka, Kamil Biedka and Agnieszka Chłopaś-Konowałek

J. Clin. Med. 2025, 14(12), 4103; https://doi.org/10.3390/jcm14124103 - 10 Jun 2025

Cited by 2 | Viewed by 7667

Abstract

Lamotrigine is the drug of choice for the treatment of depressive episodes in bipolar disorder (BD). Despite its generally favorable tolerability profile, lamotrigine use is associated with a risk of Cutaneous Adverse Drug Reactions (cADRs), including Stevens–Johnson Syndrome (SJS) and Lyell’s syndrome, also known as toxic epidermal necrolysis (TEN). Genetic markers HLA and, in particular, HLA-B 15:02 and HLA-A 31:01 are crucial in predicting individuals’ susceptibility to developing the symptoms. The symptoms are triggered by type IV hypersensitivity developing because of CTL and NK cell activation, leading to keratinocyte apoptosis, epidermal necrosis and skin detachment. The exact pharmacotherapy that should be widely utilized in treating affected patients has not yet been established. New therapies including JAK inhibitors or cyclosporine show potential in improving outcomes by reducing mortality and enhancing the period of recovery. Key factors in preventing cADRs may include adequate patient observation, gradual titration of the patient’s dose, and reduction of risk factors through screening for HLA polymorphisms. When the initial symptoms of cADR are identified, it is imperative to make an immediate decision to discontinue treatment, as this can significantly reduce the risk of progression to SJS/TEN and systemic complications. The purpose of this review is to identify a significant correlation between lamotrigine use in BD and the occurrence of SJS by showing the risk factors, neuropharmacological mechanisms, immune response and correctness of pharmacotherapy. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

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