BACKGROUND: Tapentadol is a novel atypical opioid. Anecdotal evidence suggests that tapentadol has a lower toxicity than conventional opioids.
OBJECTIVES: To evaluate all single-drug mortality due to tapentadol and assess serious adverse events caused by tapentadol.
METHODS: The Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) reporting guidelines, an evidence-based minimum set of items for reporting in systematic reviews, were followed in this systematic review.
RESULTS: 24 peer-reviewed papers were identified. They indicate that tapentadol toxicity can cause mortality and serious adverse effects.
CONCLUSION(S): At least four confirmed fatalities, and serious adverse effects have been documented for individuals abusing or using tapentadol as prescribed. Serious adverse effects of tapentadol use may include respiratory depression, confusion, coma, hallucination/delusion, seizures, tachycardia, hypertension, agitation, tremor, miosis, hypotension, dyspnea, electrolyte abnormality, atrial fibrillation or severe upper abdominal pain. Tapentadol is unlikely to cause serotonin syndrome. The toxicity of tapentadol is significantly less than pure mu opioids, such as oxycodone.