Background/Objectives: The combination drug sulfamethoxazole/trimethoprim (ST) is a broad-spectrum antibiotic used against various infections; however, it is associated with several serious adverse events. The ST package inserts contain warnings about these adverse events. However, warnings vary internationally, and specific measures to address ST-related adverse events are unclear. Therefore, we aimed to comprehensively evaluate ST-related adverse events using the Japanese Adverse Drug Event Report (JADER) database and analyze the onset time for each event. Methods: Adverse events due to ST were analyzed using the JADER database between April 2004 and June 2023. The reported odds ratio and 95% confidence interval (95% confidence interval [CI]) were calculated, with a signal detected if the 95% CI lower limit exceeded 1. The Weibull distribution was used to characterize the onset time of adverse events with detected signals. Results: The total number of cases in the JADER database during the study period was 862,952, and the number of adverse events involving ST as a suspected drug was 4203. Adverse events associated with ST include hyperkalemia, syndrome of inappropriate antidiuretic hormone secretion, hematopoietic cytopenia, acute renal failure, hypoglycemia, disseminated intravascular coagulation syndrome, hepatic disorder, and the Stevens–Johnson syndrome/toxic epidermal necrolysis. Conclusions: Weibull analysis indicated an early failure-type onset time for all adverse events, suggesting the need for intensive adverse event monitoring of ST, especially in the first month of use. These findings may support revising drug package inserts in Japan to better reflect the identified risks.

Background/Objectives: In the acute and subacute phases of spontaneous intracerebral hemorrhage (ICH), appropriate systolic blood pressure (SBP) control is important to limit hematoma expansion. However, optimal blood pressure management should be individualized according to hemorrhage severity and the patient’s clinical condition. In clinical practice, dose control of antihypertensive agents and timing of transition from intravenous to oral agents have been left at the discretion of attending physicians, resulting in fluctuations in blood pressure and delayed withdrawal from intravenous agents. In this study, pharmacists and physicians collaborated to develop a standardized blood pressure management protocol for acute ICH to achieve the target SBP and facilitate early withdrawal from intravenous antihypertensive agents. Methods: In March 2022, we developed a protocol comprising strict blood pressure control during the first 24 h, standardized titration of intravenous antihypertensive agents, and predefined oral antihypertensive therapy. We evaluated the effects of the protocol on achievement of SBP < 140 mmHg over 7 days, timing of withdrawal from intravenous antihypertensive agents, and unfavorable consequences associated with prolonged intravenous infusion, including delirium. Results: Achievement of SBP < 140 mmHg significantly increased from 20% (9/46) to 54% (27/50) after protocol implementation (p = 0.001), with a significant adjusted association (adjusted odds ratio, 5.51; 95% CI, 2.09–14.51). Median time to nicardipine discontinuation decreased from 72.5 to 37.5 h (log-rank p = 0.018). Delirium incidence was unchanged, whereas its median duration among affected patients decreased from 2 to 1 day. Conclusions: Protocol implementation was associated with improved target SBP achievement and earlier intravenous nicardipine discontinuation. Clinical benefits and safety require further investigation.