Association of serum acetaminophen levels with hepatorenal toxicity: A prospective observational study in Tripura, India

Abstract: OBJECTIVES: To evaluate the association between serum acetaminophen levels and hepatorenal function in patients receiving therapeutic doses of acetaminophen over a short period. MATERIALS AND METHODS: A prospective observational study was conducted in the department of physical medicine and rehabilitation at a tertiary care hospital in Tripura, India, from August 2021 to July 2022. A total of 109 patients receiving therapeutic doses of acetaminophen were enrolled. Blood samples were collected on day 1 (within 4 h of the first dose) and day 7 of continuous administration. Plasma acetaminophen concentrations were estimated using liquid chromatography–mass spectrometry. Hepatic markers (serum glutamic-oxaloacetic transaminase [SGOT], serum glutamic-pyruvic transaminase [SGPT], total bilirubin, total protein, alkaline phosphatase, albumin, and globulin), and renal markers (serum urea, creatinine, and uric acid) were measured using a fully automated biochemical analyzer. RESULTS: Mean plasma acetaminophen levels increased significantly from 15.09 ± 6.25 μg/ml on day 1 to 17.08 ± 7.34 μg/ml on day 7 ( P = 0.001). Mild but statistically significant elevations in SGOT and SGPT ( P < 0.05) were observed. Serum urea ( P = 0.013) and creatinine ( P = 0.031) also showed minor increases, although all values remained within normal reference ranges and were clinically insignificant. CONCLUSION: Therapeutic use of acetaminophen over a short period may lead to subtle hepatorenal changes. While these alterations are not clinically significant, periodic monitoring is advisable in patients requiring prolonged or repeated use. Further studies are warranted to evaluate long-term safety.