Exploring the Risk of Hyperhidrosis with Tramadol in Real-World Settings: A Pharmacovigilance Study

Tramadol, an analgesic for moderate-to-severe pain, is widely prescribed owing to its potent efficacy and favorable safety profile.However, the number of serious and non-serious adverse events, including hyperhidrosis, reported have increased with the use of tramadol.This study aimed to determine the risk of tramadol-induced hyperhidrosis using real-world global safety data.Individual case safety reports retrieved from the World Health Organization pharmacovigilance database (VigiBase) were used.A disproportionality analysis was conducted over all drugs and opioids using proportional reporting ratios, reporting odds ratios, and information component.An analysis was performed to exclude the influence of concomitant serotonergic drugs, excluding cases involving the use of serotonergic drugs.Among 23,811,236 safety reports, the number of reports involving the use of tramadol and opioids was 220,216 (0.92%) and 818,032 (3.4%), respectively.Hyperhidrosis was detected as a signal over all drugs and opioids.Although 7.5% of hyperhidrosis cases were concomitant with the use of serotonergic drugs, tramadol-related hyperhidrosis was still detected as a signal regardless of the concomitant use of serotonergic drugs.Based on a real-world database, this study demonstrated that tramadol has a higher risk of hyperhidrosis than opioids and that tramadol itself carries a risk of hyperhidrosis.