Tapentadol - Adverse Effects

Adverse Effects

Nausea, dizziness, constipation, and CNS sedation are common side effects of opioid pain medications. In phase II trials, tapentadol has been shown to provide equianalgesic effect with a lower incidence of side effects compared to oxycodone and morphine. One trial, sponsored by Grünenthal, comparing tapentadol to morphine and ibuprofen for relief of postoperative pain found tapentadol to cause less nausea and dizziness than morphine, with no significant difference in the incidence of vomiting or drowsiness.

Tapentadol may impair physical and cognitive abilities and should not be used when operating heavy machinery, especially during initial treatment and following increases in dosage. Patients should not attempt to operate any vehicle until they know how tapentadol affects them.

The regular use of NUCYNTA® will generally result in dependence and can lead to addiction, producing unpleasant withdrawal symptoms when the dependent person attempts to abruptly discontinue use of the drug. Withdrawal may also be elicited in NUCYNTA® users if they are administered an opioid antagonist such as naloxone, or mixed opioid agonist/antagonists such as buprenorphine.

Clinical studies cite there is less incidence of select adverse gastrointestinal effects with the administration of tapentadol when compared to oxycodone.

A relative high incidence of hallucinations have been reported, especially among patients on anti-depressants, possibly due to its pro-adrenergic properties.

Combination with SSRIs/SNRIs, SRAs, serotonin receptor agonists and/or MAOIs may lead to potentially lethal serotonin syndrome.

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