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Ann Pharmacother. 2015 Dec;49(12):1311-6. doi: 10.1177/1060028015604631. Epub 2015 Sep 14.

Comparative Toxicity of Tapentadol and Tramadol Utilizing Data Reported to the National Poison Data System.

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California Poison Control System, University of California San Francisco, San Francisco, CA, USA
California Poison Control System, University of California San Francisco, San Francisco, CA, USA.
Medical Communications Genentech, A Member of the Roche Group, South San Francisco, CA, USA.



Tapentadol (TAP) and tramadol (TRA) provide pain relief through similar monoaminergic and opioid agonist properties.


To compare clinical effects and medical outcomes between TAP and TRA exposures reported to the National Poison Data System of the American Association of Poison Control Centers.


A retrospective cohort study was conducted analyzing national data for single medication TAP or TRA cases reported from June 2009 through December 2011. Case outcomes, dichotomized as severe versus mild; clinical effects; and use of naloxone were compared.


There were 217 TAP and 8566 TRA cases. Significantly more severe outcomes were associated with TAP exposures for an all-age comparison (relative risk [RR] = 1.24; 95% CI = 1.04-1.48), and for the <6-year-old age group (RR = 5.76; 95% CI = 2.20-15.11). Patients with TAP exposures had significantly greater risk of respiratory depression (RR = 5.56; 95% CI = 3.50-8.81), coma (RR = 4.16; 95% CI = 2.33-7.42), drowsiness/lethargy (RR = 1.38; 95% CI = 1.15-1.66), slurred speech (RR = 3.51; 95% CI = 1.98-6.23), hallucination/delusion (RR = 7.25; 95% CI = 3.61-14.57), confusion (RR = 2.54; 95% CI = 1.56-4.13) and use of naloxone (RR = 3.80; 95% CI = 2.96-4.88). TRA exposures had significantly greater risk of seizures (RR = 7.94; 95% CI = 2.99-20.91) and vomiting (RR = 1.96; 95% CI = 1.07-3.60).


TAP was associated with significantly more toxic clinical effects and severe outcomes consistent with an opioid agonist. TRA was associated with significantly higher rates of seizures and vomiting.


adverse effects; tapentadol; toxicity; tramadol

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