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BackgroundElagolix and Myfembree are gonadotropin-releasing hormone (GnRH)-pathway therapies used for endometriosis, but their post-marketing safety reporting patterns remain incompletely characterized. Because spontaneous reporting databases are susceptible to reporting bias and differential market exposure, comparative analyses require cautious interpretation.MethodsWe analyzed quarterly data from the FDA Adverse Event Reporting System (FAERS) from 2015Q3 to 2026Q1. Deduplicated female reports with endometriosis-related indications were identified and classified as elagolix, Myfembree, or other endometriosis-related reports. The primary analysis consisted of drug-specific case-noncase disproportionality analyses for elagolix and Myfembree separately within the female endometriosis reporting background. A direct elagolix-versus-Myfembree head-to-head analysis was performed as a secondary analysis. Reporting odds ratios (RORs), proportional reporting ratios (PRRs), and information components (ICs) were calculated at the preferred term (PT) level. Sensitivity analyses included serious-report-only, healthcare-professional-only, physician-only, complete-age, reporter-type-stratified, overlapping-market-period, and bootstrap analyses.ResultsA total of 4,428 deduplicated female endometriosis-related reports were included, comprising 1,744 elagolix reports, 280 Myfembree reports, and 2,404 other endometriosis-related reports. Serious reports accounted for 31.2% of elagolix reports and 26.8% of Myfembree reports. In drug-specific case-noncase analyses, elagolix showed robust disproportionality signals for hot flush, night sweats, and suicidal ideation. Myfembree showed distinct reporting signals for reproductive and bleeding-related PTs, including heavy menstrual bleeding and intermenstrual bleeding. In the secondary head-to-head analysis, selected PTs including hot flush, nausea, headache, depression, arthralgia, and suicidal ideation showed higher reporting signals for elagolix, whereas alopecia showed a lower reporting signal for elagolix. Sensitivity analyses using alternative algorithms, reporter-type restrictions, overlapping-market-period restriction, complete-age restriction, and bootstrap validation generally supported the direction of the main selected reporting patterns, although some estimates were limited by small cell counts.ConclusionsElagolix and Myfembree showed distinct post-marketing reporting signal profiles among female endometriosis-related FAERS reports. Elagolix was characterized mainly by vasomotor and selected neuropsychiatric reporting signals, whereas Myfembree was characterized mainly by reproductive and bleeding-related reporting signals. These findings represent hypothesis-generating reporting differences rather than clinical incidence rates or causal risk estimates. Further pharmacoepidemiologic studies with denominator data and adjustment for patient-level confounding are needed to clarify comparative safety profiles.

BackgroundSuzetrigine (Journavx; VX-548), the first selective NaV1.8 voltage-gated sodium channel inhibitor approved by the FDA on 30 January 2025, represents a novel non-opioid option for moderate-to-severe acute pain. Given its recent market entry and unique peripheral mechanism, comprehensive post-marketing safety surveillance is essential.ObjectiveThis study aimed to identify and characterize adverse event signals associated with suzetrigine in the FDA Adverse Event Reporting System (FAERS) using advanced disproportionality and comparator-referenced empirical Bayes (EB) methods, with external triangulation against published literature and WHO VigiBase data.MethodsWe analyzed FAERS reports through the first 8 months post-approval. Disproportionality metrics (ROR, PRR, IC) were supplemented by a comparator-referenced EB profiling approach that incorporated suzetrigine, acetaminophen, ibuprofen, and background “other drugs,” generating 3,000 posterior draws per preferred term (PT). Signals with EB q05 > 2 and no comparator overlap were classified as suzetrigine-unique. High-priority PTs were triangulated with Phase II/III trial data, systematic reviews, case reports, and VigiBase report counts (February 2026).ResultsOf 19 prioritized PTs, 14 were suzetrigine-unique. Dominant clusters included sensory disturbances (paresthesia, burning sensation, skin burning sensation, hypoaesthesia; EB q05 11.43–31.16), musculoskeletal events (muscle spasms EB q05 31.15), and cutaneous reactions (pruritus, rash). These signals were mechanistically consistent with peripheral NaV1.8 blockade of nociceptors and pruriceptors. Literature and VigiBase data corroborated neurological/sensory and musculoskeletal signals; psychiatric signals (euphoric mood, abnormal dreams) lacked external support and were deprioritized.ConclusionThis real-world pharmacovigilance analysis identifies a distinct safety signature for suzetrigine, with neurological and sensory disturbances (e.g., paresthesia, burning sensation, skin burning sensation, hypoaesthesia) emerging as prominent signals not fully characterized in pre-approval trials, whereas musculoskeletal and cutaneous events largely align with labeled reactions. These hypothesis-generating findings highlight the need for focused post-marketing surveillance on neurological/sensory preferred terms through prospective cohort studies and Phase IV trials to quantify incidence, identify risk factors, and optimize risk-minimization strategies for this promising non-opioid analgesic.

BackgroundAnthracyclines are key for acute myeloid leukemia (AML) but carry serious side effects. This study identifies their side effects across drugs and patient populations using the FDA Adverse Event Reporting System (FAERS).Materials and methodsWe analyzed 1,079 AML cases and 3,622 adverse events (AEs) from FAERS (2004–2024). Disproportionality analyses (PRR, ROR, BCPNN, MGPS) detected AE signals; Kruskal–Wallis tests evaluated time-to-onset by age/sex.ResultsDistinct risks emerged: epirubicin (strongest cardiotoxicity, ROR = 10.57), doxorubicin (highest pregnancy-related AEs, ROR = 9.97), daunorubicin (vascular disorders, ROR = 2.38), idarubicin (myelosuppression/infections). Most AEs occurred within 180 days. Idarubicin showed delayed onset in elderly (P < 0.05); males had delayed doxorubicin toxicity (P = 0.04) but accelerated idarubicin onset (P = 0.049) vs. females.ConclusionThis analysis identifies distinct safety profiles. Epirubicin and doxorubicin were associated with cardiac and pregnancy-related risks, while idarubicin showed signals suggesting potentially delayed onset in elderly patients. Observed sex differences indicate possible variations in AE patterns.

BackgroundDrug-induced acute respiratory distress syndrome (ARDS) represents an often overlooked yet potentially severe adverse reaction in clinical practice. Existing evidence predominantly stems from isolated case reports, and systematic investigations based on large-scale real-world data remain limited. This study aimed to comprehensively evaluate the risk signals of drug-related ARDS and identify potential high-risk drug classes using the US FDA Adverse Event Reporting System (FAERS).MethodsWe retrieved data from FAERS and extracted ARDS-related reports based on the MedDRA Preferred Terms (PT), followed by deduplication and data cleaning. Four disproportionality analysis methods were used to detect drug signals. LASSO regression and multivariable logistic regression were applied to identify potential independent risk factors. The time interval from drug exposure to ARDS onset was also assessed.ResultsA total of 15,986 drug-related ARDS reports were included, with the highest proportion occurring in middle-aged and older adults, and slightly more cases in males than in females. The five most frequently reported drugs were mycophenolic acid, methotrexate, rituximab, tacrolimus, and amiodarone. Signal detection indicated strong associations for prednisone, mycophenolic acid, amiodarone, and cytarabine. Multivariable analyses further identified 22 drugs significantly associated with ARDS risk. The median time to ARDS onset was 30 days, and approximately 75% of cases occurred within 150 days after treatment initiation.ConclusionUsing real-world data, this study identified multiple drug classes with significantly elevated ARDS risk, including immunosuppressants, antineoplastic agents, glucocorticoids, cardiovascular drugs, and nonsteroidal anti-inflammatory drugs (NSAIDs). These findings provide important evidence for clinical monitoring of high-risk medications.

Xiaohong Chen, Chunli Yang, Zhiying Lin Jiangxi Provincial People’s Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang, Jiangxi Province, 330006, People’s Republic of ChinaCorrespondence: Zhiying Lin, Jiangxi Provincial People’s Hospital, The First Affiliated Hospital of Nanchang Medical College, Nanchang, Jiangxi Province, People’s Republic of China, Tel +86 0791 86896209, Email lzy1191528410@126.comBackground: Hydromorphone and morphine, as classic opioid drugs, are commonly used for postoperative analgesia and as adjuncts in the treatment of moderate to severe cancer pain and chronic pain. The lack of specific criteria and the complexity of their respective adverse events (AEs) make it difficult for clinical workers to make a decision.Methods: This study utilized the FAERS database to compare the baseline risk of AEs between hydromorphone and morphine sulfate. AEs of opioid drugs “morphine” and “hydromorphone” were extracted from FAERS from 2004 to 2024. Non-proportional signal mining is performed by calculating the ratio of reports (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and empirical Bayesian geometric mean. Then they were filtered and mapped to a total of 25 types of AEs, including primary preference term (PT) signals and systemic organ categories.Results: According to the FAERS database, Among totals of 44303 case reports related to two types of drug, 14902 reports were related to hydromorphone, 29401 reports were related to morphine sulfate. The statistical analysis results include 21890177 AEs reports in the FAERS database, of which 18282801 AEs reports are the “main analysis objects” of Hydromorphone and morphine. This study found that “psychological disorders” and “immune system disorders” are closely related to both drugs. But psychological disorders have the strongest correlation with Hydromorphone (ROR 6.33), while immune system disorders have the strongest correlation with morphine sulfate (ROR 8.41). The signal “General disorders and administrative site conditions” is more significantly associated with Hydromorphone. In addition, drug dependence is a common PT signal in both drugs, and prognosis should be closely monitored after treatment.Conclusion: Prescription decision-making should be a comprehensive and balanced process. Our study identified potential new and unexpected AEs for Hydromorphone and morphine, providing valuable evidence for the safety research of Hydromorphone and morphine. Especially for prescribers of hydromorphone, clinical vigilance should extend beyond its known opioid-class effects to particularly raise awareness of two unexpected adverse events: for the immune related disorders and administration site reactions.Keywords: hydromorphone, morphine, FAERS, adverse reactions, drug safety

[This corrects the article DOI: 10.3389/fphar.2025.1561937.].

[This corrects the article DOI: 10.3389/fphar.2025.1488469.].

[This corrects the article DOI: 10.3389/fphar.2024.1440907.].

[This corrects the article DOI: 10.3389/fphar.2024.1255918.].

Introduction: Linezolid is an oxazolidinone antibiotic that is active against drug-resistant Gram-positive bacteria and multidrug-resistant Mycobacterium tuberculosis . Real-world studies on the safety of linezolid in large populations are lacking. This study aimed to determine the adverse events associated with linezolid in real-world settings by analyzing data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Methods: We retrospectively extracted reports on adverse drug events (ADEs) from the FAERS database from the first quarter of 2004 to that of 2023. By using disproportionality analysis including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), along with the multi-item gamma Poisson shrinker (MGPS), we evaluated whether there was a significant association between linezolid and ADE. The time to onset of ADE was further analyzed in the general population and within each age, weight, reporting population, and weight subgroups. Results: A total of 11,176 reports of linezolid as the “primary suspected” drug and 263 significant adverse events of linezolid were identified, including some common adverse events such as thrombocytopenia ( n = 1,139, ROR 21.98), anaemia ( n = 704, ROR 7.39), and unexpected signals that were not listed on the drug label such as rhabdomyolysis ( n = 90, ROR 4.33), and electrocardiogram QT prolonged ( n = 73, ROR 4.07). Linezolid-induced adverse reactions involved 27 System Organ Class (SOC). Gender differences existed in ADE signals related to linezolid. The median onset time of all ADEs was 6 days, and most ADEs ( n = 3,778) occurred within the first month of linezolid use but some may continue to occur even after a year of treatment ( n = 46). Conclusion: This study reports the time to onset of adverse effects in detail at the levels of SOC and specific preferred term (PT). The results of our study provide valuable insights for optimizing the use of linezolid and reducing potential side effects, expected to facilitate the safe use of linezolid in clinical settings.