Investigating tralokinumab-related adverse events in treating atopic dermatitis: insights from the FAERS database

Deucravacitinib, a selective inhibitor of TYK2 kinase, has been recently approved for the treatment of moderate to severe plaque psoriasis. Although the safety of deucravacitinib has been observed in clinical trials, its safety in the real world remains to be fully understood. The purpose of this study was to analyze post-marketing adverse events (AEs) associated with deucravacitinib using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) to better understand its safety in real-world conditions. This study performed a retrospective analysis of AEs associated with deucravacitinib from the FAERS database, spanning from the third quarter of 2022 to the second quarter of 2024. AEs were classified according to the Medical Dictionary for Regulatory Activities (MedDRA, Version 27.0). Disproportionality analysis was conducted using several statistical methods, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-Item Gamma Poisson Shrinker, and Bayesian Confidence Propagation Neural Network. Additionally, time-to-onset analyses and sensitivity analyses were performed to provide a comprehensive assessment. AE reports from 1573 individuals were analyzed, revealing a total of 2895 AEs. Most of these events occurred within the first month of treatment. The primary AEs were associated with skin and subcutaneous tissue disorders, as well as infections and infestations. The study confirmed several known common AEs, including acne (n = 172, ROR 75, PRR 70.61, EBGM 69.14, IC 6.11), folliculitis (n = 51, ROR 62.45, PRR 61.37, EBGM 60.25, IC 5.91), and herpes zoster (n = 18, ROR 6.46, PRR 6.43, EBGM 6.42, IC 2.68), and identified some unexpected AEs such as urticaria (n = 36, ROR, PRR 5.27, EBGM 5.27, IC 2.4), skin burning sensation (n = 42, ROR 21.84, PRR 21.54, EBGM 21.41, IC 4.42), and myalgia (n = 26, ROR 3.93, PRR 3.9, EBGM 3.9, IC 1.96). Our study confirms the known AEs associated with deucravacitinib and identifies several potential AEs. These findings provide preliminary safety data for the practical use of deucravacitinib.

This study aims to analyze the safety profile of sparsentan in real-world clinical settings using data from the FDA Adverse Event Reporting System (FAERS) database, providing insights for its clinical application. Data from the FAERS database were collected between the first quarter of 2023 and the fourth quarter of 2024. Adverse events (AEs) associated with sparsentan were identified using the proportional reporting ratio (PRR), reporting odds ratio (ROR), Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS). The temporal distribution of AEs was further analyzed using the Weibull distribution to comprehensively assess the safety profile of the drug in clinical practice. A total of 1776 reports of AEs were retrieved from the FAERS database, with sparsentan identified as the primary suspect (PS) drug. These AEs were reported across 25 system organ classes (SOCs). Forty-four preferred terms (PTs) were retained by the four algorithms, including well-documented adverse reactions listed on the drug label, such as hypotension, hyperkalemia, peripheral edema, and dizziness. In addition, previously unmentioned potential AEs were identified, including nasopharyngitis, ear discomfort, renal pain, and musculoskeletal chest pain. The median time to onset of sparsentan-associated AEs was 18days (IQR 4-60.5days), with most events occurring within the first month of treatment. This study provides real-world data on the clinical application of sparsentan and analyzes the AEs associated with its use. It not only confirms several known adverse effects, but also identifies potential new AEs. These findings offer valuable guidance for clinicians prescribing sparsentan, aiding in the reduction of drug-related risks.

Dwarfism, a condition characterized by short stature, has been the focus of therapeutic advancements with the emergence of novel peptide drugs. Vosoritide, indicated for certain types of dwarfism, has shown therapeutic potential in clinical trials. However, a comprehensive safety profile is essential for its clinical application. The current literature lacks a detailed assessment of vosoritide's safety, indicating a significant gap that this study aims to address. We conducted a retrospective pharmacovigilance study by analyzing the FDA Adverse Event Reporting System (FAERS) database to evaluate adverse events (AEs) associated with vosoritide monotherapy. The study employed a case/non-case methodology and applied signal detection algorithms, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS), to identify AE signals related to vosoritide use. The study included 9319269 reports from the FAERS database, covering the period from 2022 to 2023, with 274 reports specifically citing vosoritide. A significant number of AEs were identified, with a notable incidence in the pediatric population. The most frequently reported AEs were related to endocrine disorders, including altered growth hormone levels and glucose homeostasis issues. Other affected system organ classes (SOCs) were infections and infestations, as well as skin and subcutaneous tissue disorders. Specific preferred terms (PTs) associated with vosoritide included "growth deceleration," "glycemic dysregulation," and "local injection site reactions." The findings from this study underscore the importance of close monitoring of vosoritide treatment, particularly in pediatric patients. The identification of both expected and unexpected AEs highlights the necessity for ongoing pharmacovigilance and further research to fully understand the safety profile of vosoritide in clinical practice. This study contributes to the broader field by emphasizing the critical need for patient safety considerations in the development of new therapeutic agents.

Background Tazemetostat is an oral inhibitor of enhancer of zeste homolog 2 (EZH2) and is used for the treatment of epithelioid sarcoma (ES) and follicular lymphoma (FL). In this study, we investigated the adverse events (AEs) of tazemetostat based on real data from the U.S Food and Drug Administration(FDA) Adverse Event Reporting System (FAERS). Methods To quantify the signals of AEs associated with tazemetostat, we employed disproportionality analyze, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) algorithms. Results A total of 7,133,678 reports of AEs were collected from the FAERS database, of which 1,110 reports were identified with tazemetostat as the “primary suspect (PS)”. A total of 32 significant disproportionality preferred terms(PTs) conforming to the four algorithms were simultaneously retained. There were multiple unexpected AEs caused by tazemetostat that were not mentioned in the label yet, including pleural effusion (ROR = 3.84, PRR = 3.83, IC = 3.83, IBGM = 1.94), lymphadenopathy (ROR = 3.88, PRR = 3.88, IC = 3.87, IBGM = 1.95) and taste disorder(ROR = 20.48, PRR = 20.23, IC = 20.16, IBGM = 4.33). Additionally, the majority of tazemetostat-associated AEs occurred within the first month of treatment initiation (n = 126, 49.8%). Conclusion Clinicians need to monitor safety for tazemetostat during the first 30 days and pay more attention to new AE signals.

Voclosporin, a novel calcineurin inhibitor (CNI), was FDA-approved in 2021 for treating lupus nephritis (LN). However, post-marketing studies and reports on adverse events (AEs) associated with voclosporin remain limited. This study analyzes voclosporin-associated AEs using FDA Adverse Event Reporting System (FAERS) data. AEs with voclosporin as the primary suspected (PS) drug were extracted from the FAERS database, covering the period from the first quarter of 2021 to the second quarter of 2024. Disproportionality analysis, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS), was used to analyze AE signals. We identified 3,785 reports of AEs associated with voclosporin as PS, encompassing a total of 10,795 AEs. After applying 4 disproportionality algorithms, 6 system organ classes (SOCs) and 88 preferred terms (PTs) were detected, respectively. AEs with the strongest signal intensities included: glomerular filtration rate decreased, urine protein/creatinine ratio increased, hypertension, diarrhea, headache, and blood potassium increased. The median onset time for AEs was 56 days (interquartile range 4-208 days), with ~43% of AEs occurring within the first month of commencing voclosporin therapy. Our findings are consistent with AEs reported in previous clinical trials and outlined in the drug's labeling. The study results further confirm the reliability of the adverse reactions listed in the prescribing information.

Donepezil in combination with memantine is a widely used clinical therapy for moderate to severe dementia. However, real-world population data on the long-term safety of donepezil in combination with memantine are incomplete and variable. Therefore, the aim of this study was to analyze the adverse events (AEs) of donepezil in combination with memantine according to US Food and Drug Administration Adverse Event Reporting System (FAERS) data to provide evidence for the safety monitoring of this therapy. We retrospectively analyzed reports of AEs associated with the combination of donepezil and memantine from 2004 to 2023 extracted from the FAERS database. Whether there was a significant association between donepezil and memantine combination therapy and AEs was assessed using four disproportionality analysis methods, namely, the reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker methods. To further investigate potential safety issues, we also analyzed differences and similarities in the time of onset and incidence of AEs stratified by sex and differences and similarities in the incidence of AEs stratified by age. Of the 2,400 adverse drug reaction (ADR) reports in which the combination of donepezil and memantine was the primary suspected drug, most of the affected patients were female (54.96%) and older than 65years of age (79.08%). We identified 22 different system organ classes covering 100 AEs, including some common AEs such as dizziness and electrocardiogram PR prolongation; fall, pleurothotonus and myoclonus were AEs that were not listed on the drug label. Moreover, we obtained 88 reports of AEs in men and 100 reports of AEs in women; somnolence was a common AE in both men and women and was more common in women, whereas pleurothotonus was a more common AE in men. In addition, we analyzed 12 AEs in patients younger than 18years, 16 in patients between 18 and 65years, and 113 in patients older than 65years. The three age groups had distinctive AEs, but lethargy was the common AE among all age groups. Finally, the median time to AE onset was 19days in all cases. In both men and women, most AEs occurred within a month of starting donepezil plus memantine, but some continued after a year of treatment. Our study identified potential and new AEs of donepezil in combination with memantine; some of these AEs were the same as in the specification, and some of the AE signals were not shown in the specification. In addition, there were sex and age differences in some of the AEs. Therefore, our findings may provide valuable insights for further studies on the safety of donepezil and memantine combination therapy, which are expected to contribute to the safe use of this therapy in clinical practice.

Enfortumab vedotin (EV) is an antibody-drug conjugate (ADC) that has been approved by the FDA for patients with locally advanced or metastatic urothelial carcinoma (UC). This study presents a comprehensive pharmacovigilance analysis of the post-marketing safety profile of EV in the real-world based on the US Food and Drug Administration Adverse Event Reporting System (FAERS). Adverse event (AE) reports regarding EV between January 2020 and December 2023 were obtained from the FAERS database. The standardized MedDRA query (SMQ) narrow search AEs on the preferred term (PT) level were used. Disproportionality analysis was performed to identify the AE signals for EV with the reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), and Bayesian confidence propagation neural network (BCPNN). A total of 2,216 reports regarding EV were included in the present study. SMQ analysis results indicated that a stronger strength signal was found in severe cutaneous adverse reactions, retroperitoneal fibrosis, and peripheral neuropathy. A total of 116 significant disproportionality PTs referring to 14 system organ classes (SOCs) were retained by disproportionality analysis, with 49 PTs not listed on the EV drug label. Frequently reported EV-related AEs included rash, peripheral neuropathy, decreased appetite, alopecia, and pruritus. The time to onset of the majority of EV-related AEs was within 30 days (66.05%), with only 0.73% events occurring after 1 year. The disproportionality analysis highlights that dermatologic toxicity and peripheral neuropathy were the major AEs induced by EV. The potential AEs not listed on the drug label were mainly related to gastrointestinal, hepatic, and pulmonary events. Further research is needed to confirm and explore the EV-related AEs in clinical practice.

ObjectiveEdaravone is a neuroprotective agent, but the characteristics of its adverse events (AEs) remain insufficiently explored. This study aims to examine AEs associated with edaravone use by analyzing real-world data from the FDA Adverse Event Reporting System (FAERS).MethodsThis retrospective study extracted adverse event reports related to edaravone from the FAERS database, spanning from the second quarter of 2017 to the second quarter of 2024. Disproportionality analysis methods, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN), were employed to detect AE signals associated with edaravone use.ResultsAmong 2,931 adverse event reports (AERs) in which edaravone was identified as the primary suspected drug, 86 preferred terms (PTs) and 20 system organ classes (SOCs) were included. At the PTs level, the significant drug-related adverse events were death (n = 589, ROR = 8.64), disease progression (n = 266, ROR = 28.26) and drug ineffectiveness (n = 252, ROR = 2.16). Additionally, rare but notably strong adverse event signals were observed, including thrombosis at the catheter site thrombosi, gastric fistula, and vein collapse.ConclusionOur research found that edaravone has some overlooked adverse reactions. Further epidemiological studies are needed to more comprehensively explore and assess the risk-benefit profile of edaravone.

Mitomycin, a cytotoxic antitumor antibiotic, has been approved for the treatment of low-grade upper tract urothelial carcinoma (UTUC) and non-muscle invasive bladder cancer (NMIBC). It is also used off-label in ophthalmic procedures and gastrointestinal malignancies. Although the efficacy of mitomycin is well recognized, its safety profile, particularly regarding rare or serious adverse events (AEs), remains insufficiently characterized in large real-world populations. This study aimed to evaluate mitomycin-associated AEs through comprehensive analysis of two major global pharmacovigilance databases, with the goal of identifying high-risk organ systems and specific AE signals requiring increased clinical awareness. AE data were retrieved from the FDA Adverse Event Reporting System (FAERS) covering Q1 2004 to Q3 2024. Data were deduplicated and standardized according to MedDRA terminology. Complementary data were collected from the World Health Organization VigiAccess database. Disproportionality analysis was performed using four signal detection algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). The time-to-onset of adverse events was analyzed using non-parametric statistical methods. A total of 1461 mitomycin-related reports, comprising 3652 AEs, were identified in the FAERS database. Notably, strong safety signals have emerged at the system organ class (SOC) level for eye, renal and urinary, blood and lymphatic system, and skin and subcutaneous tissue disorders. At the preferred term (PT) level, high disproportionality values were observed for serious events, such as scleral thinning (OR = 7129.60, 95% CI 4576.64-11,106.7) and bladder perforation (OR = 1585.69, 95% CI 1111.91-2261.33). Over two-thirds of AEs occurred within 30days of drug administration, although 68.93% of the reports lacked valid onset-time data. The VigiAccess findings corroborated the SOC trends observed in FAERS. Mitomycin is associated with a broad range of organ-specific toxicities, many of which occur early in the treatment course and may have serious clinical consequences. This study highlights the need for early risk identification, individualized monitoring strategies, and greater pharmacovigilance in populations treated with mitomycin. These findings provide an important foundation for optimizing the safe and effective use of mitomycin in oncology and in other therapeutic settings.

Background Invasive fungal infections (IFIs) have become an increasingly serious public health problem. Amphotericin B (AmB) remains the important component in the treatment of IFIs. But its clinical application is limited due to its adverse reactions. Research design and methods In this study we mined the adverse drug event signals of AmB based on the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2023, using the Reported Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network and Multi-item Gamma Poisson Shrinker methods to provide a reference for the safe clinical use. Results A total of 3597 adverse event (AE) reports for the primary suspect drug AmB were obtained, involving 22 system organ classes (SOCs), 1355 AEs. Patients aged 18–60 (47.93%) and female patients (53.82%) were at a higher risk of AEs with AmB. High risk signals in the report include hypokalemia, pyrexia, chill, renal failure. Additional high risk signals not mentioned in the instructions conclude respiratory failure, tachycardia, deafness. Conclusions Mining the adverse reaction signal study of AmB based on the FAERS database provides support for the clinical monitoring and risk identification of this drug.

BackgroundFinasteride is commonly utilized in clinical practice for treating androgenetic alopecia, but real-world data regarding the long-term safety of its adverse events remains incomplete, necessitating ongoing supplementation. This study aims to evaluate the adverse events (AEs) associated with finasteride use, based on data from the US Food and Drug Administration Adverse Event Reporting System (FAERS), to contribute to its safety assessment.MethodsWe reviewed adverse event reports associated with finasteride from the FAERS database, covering the period from the first quarter of 2004 to the first quarter of 2024. We assessed the safety of finasteride medication and AEs using four proportional disproportionality analyses: reported odds ratio, proportionate reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPN), and Multi-Item Gamma Poisson Shrinkage (MGPS). These methods were used to evaluate the of finasteride medication and AEs. whether there is a significant association between finasteride drug use and AEs. To investigate potential safety issues related to drug use, we further analyzed the similarities and differences in the onset time and AEs by gender, as well as the similarities and differences in AEs by age.ResultsAmong the 11,557 adverse event reports where finasteride was the primary suspected drug, most patients affected were male (86.04%), with a significant proportion being the young adult aged 18-45 years (27.22%). We categorized 73 adverse events (AEs) into 7 different system organ categories (SOCs), which included common AEs like erectile dysfunction and sexual dysfunction. Notably, Peyronie’s disease and post 5α reductase inhibitor syndrome were AEs not listed in the drug insert. We identified 102 AEs for men and 7 for women. Depression and anxiety were notable AEs for both male and female. Additionally, we examined 17 adverse events (AEs) in patients under 18 years old, 157 in patients aged 18 to 65 years, and 133 in patients aged 65 years and older. Each age group exhibited unique AEs, although erectile dysfunction, decreased libido, depression, suicidal ideation, psychotic disorder, and attention disturbance were common AEs observed across different age brackets. Ultimately, the median onset time for all instances was 61 days. The onset was mainly within one month after initiation of finasteride and it is noteworthy that the second highest number of cases involved adverse drug reactions persisted beyond one year of treatment.ConclusionThe results of our study uncovered both known and novel AEs associated with finasteride medication. Some of these AEs were identical to the specification, and some of them signaled AEs that were not demonstrated in the specification. In addition, some AEs showed variations based on gender and age in our study. Consequently, our findings offer valuable insights for future research on the safety of finasteride medication and are anticipated to enhance its safe use in clinical practice.

Purpose: On 12 April 2019, erdafitinib gained the first FDA approval as the second-line treatment for adult patients with locally advanced or metastatic urothelial cancer following progression during or after at least one previous line of platinum-based chemotherapy. However, the long-term safety profile of erdafitinib in a large patient population remains unexplored. The current study aimed to assess the adverse events (AEs) associated with erdafitinib through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS).Method: The reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms based on disproportionality were employed to quantify the signals of erdafitinib-associated AEs.Results: A total of 6,322,279 reports of AEs were retrieved from the FAERS database spanning 2019 to 2022, out of which, 700 reports of erdafitinib as the “primary suspected” were identified. These erdafitinib-induced AEs were observed across 24 targeted system organ classes (SOCs). After conforming to the four algorithms at the same time, a total of 441 signals of erdafitinib-induced AEs were detected across 23 SOCs. Notably, signals associated with metabolism and nutrition disorders, eye disorders, and skin and subcutaneous tissue disorders were among the most prevalent. The median onset time for AEs was found to be 54 days [interquartile range (IQR) 17–112 days], with a majority of AEs occurring within the initial 6 months after initiating erdafitinib (37.23% within the first month, 15.53% within the second month, and 16.79% within the third month).Conclusion: The findings of this study align with existing clinical observations, offering a comprehensive long-term post-marketing safety evaluation of erdafitinib. The results provide valuable evidence to enhance the understanding of erdafitinib’s safety profile, aiding further research and guiding clinical practice.

BackgroundAlthough filgotinib, a selective Janus kinase 1 inhibitor, has been increasingly applied in the treatment of inflammatory diseases, its comprehensive safety profile remains insufficiently characterized. Using data from the FAERS database covering Q1 2014 to Q2 2024, this study attempts to analyze adverse event signals linked to filgotinib and provide guidance for the safe and sensible clinical usage of filgotinib.MethodsFrom Q1 2014 to Q2 2024, information on adverse drug events (ADEs) associated with filgotinib was gathered. The reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) were among the signal detection methods that were employed for analysis following data normalization.ResultsFilgotinib was shown to be the main suspected medication in ADE reports, exposing 103 preferred terms (PTs) in 17 system organ classes (SOCs). Infections, gastrointestinal disorders, and musculoskeletal and connective tissue disorders were the most commonly reported adverse effects. Additionally, atrial fibrillation, alopecia, elevated serum creatinine, blood creatinine increased, pulmonary embolism, epididymitis, respiratory failure, and osteopenia were identified as potential disproportionate reporting signals for filgotinib, although these were not listed in the official drug label. Notable significant signals included large intestine erosion (ROR 2186.05, 95%CI(ROR): 1015.94–4703.86, PRR 2176.18, 95%CI(PRR): 1014.64–4667.42), mesenteric arterial occlusion (ROR 1832.17, 95%CI(ROR): 897.68–3739.48, PRR 1822.71, 95%CI(PRR): 896.17–3707.20), repetitive strain injury (ROR 1149.27, 95%CI(ROR): 363.16–3637.01, PRR 1147.05, 95%CI(PRR): 363.24–3622.15), oligoarthritis (ROR 755.02, 95%CI(ROR): 310.74–1834.54, PRR 752.59, 95%CI(PRR): 310.60–1823.51), and periostitis (ROR 676.03, 95%CI(ROR): 319.36–1431.06, PRR 672.98, 95%CI(PRR): 318.97–1419.87). The subgroup analysis identified obvious sex and age-specific trends in filgotinib-related adverse reactions, emphasizing a higher risk of renal disorders in females, a preponderance of gastrointestinal events in males, and age-dependent trends involving mesenteric occlusion, increased serum creatinine, and immunoglobulin reduction.ConclusionWhile filgotinib demonstrates therapeutic efficacy, it is associated with a range of potential adverse events, underscoring the need for vigilant clinical monitoring. Particular attention should be given to gastrointestinal, cardiovascular, respiratory, and metabolic complications.

Voriconazole is a broad-spectrum antifungal agent. It is used widely for the prevention and treatment of invasive fungal infections in patients with a hematological malignancy, but studies on its safety in this population are scarce. We assessed the adverse drug events (ADEs) of voriconazole in this population based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database to improve understanding of the safety of voriconazole. ADE reports for patients with a hematological malignant tumor using voriconazole between the first quarter of 2004 to the first quarter of 2024 were retrieved. Then, they were classified using the preferred terminology (PT) and system organ category (SOC) in the Medical Dictionary for Regulatory Activities. Data mining was done using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). A total of 605 ADEs were included: 116 (19.17%) in children and 489 (80.83%) in adults. The types of SOC involved in children and adults were 22 and 24, respectively. The only positive SOC signal that satisfied all four algorithms simultaneously in children was "psychiatric disorders", whereas in adults they were "endocrine disorders" and "hepatobiliary disorders". At the PT level, the types involved in children and adults were 28 and 74, respectively. The highest ROR signal intensities were found for "hallucinations, mixed" in children and "toxic optic neuropathy" in adults. The median time of onset of the ADE in children and adults was 11 and 8.5days, respectively. We used four algorithms (ROR, PRR, BCPNN, MGPS) to mine the signals of voriconazole in patients with a hematological malignant tumor, and compared the differences between children and adults. This study is important for targeting the monitoring, and could help to improve the safety of voriconazole.

The objective of this research is to scrutinize adverse events (AEs) linked to Trifluridine/Tipiracil (TFTD/TPI), using data from the FDA Adverse Event Reporting System (FAERS) database. The AEs data related to TFTD/TPI were collected from the fourth quarter of 2015 through the fourth quarter of 2023. After normalizing the data, multiple signal quantification techniques including Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian approaches such as Bayesian Confidence Propagation Neural Network (BCPNN) and the Multi-item Gamma Poisson Shrinker (MGPS) were used for overall and subgroup analysis and visualization analyses were performed. From the FAERS database, we analyzed 13,520,073 reports, identifying 8,331 as primary suspect (PS) AEs for TFTD/TPI, occurring across 27 organ systems. The study retained 99 significant disproportionality Preferred Terms (PTs) across four algorithms and unveiled unexpected serious AEs such as iron deficiency and intestinal perforation, hepatic failure, cholangitis and so on. The median onset of TFTD/TPI-associated AEs was 44days (IQR 20-97 days), with most occurring within the first 30 days of treatment. This research uncovers critical new safety signals for TFTD/TPI, supporting its clinical monitoring and risk identification.