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Drug Name: | Tapentadol/Aspadol/Nucynta |
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Key Safety Information About Tapentadol (Nucynta)
Use During Pregnancy and Breastfeeding
Using opioid medications like Nucynta during pregnancy can lead to neonatal opioid withdrawal syndrome—a serious and potentially life-threatening condition. Newborns exposed to opioids in utero may require prolonged medical treatment. Before using tapentadol while breastfeeding, consult your healthcare provider. Contact your doctor immediately if your baby shows signs of excessive drowsiness or slowed breathing. Never administer tapentadol to infants under any circumstances.
Who Should Not Use Tapentadol
Tapentadol is contraindicated in individuals with known hypersensitivity to the drug, those with severe respiratory issues, or those with gastrointestinal obstruction, including paralytic ileus. Inform your healthcare provider if you have a history of respiratory disorders, sleep apnea, head trauma, seizures, brain tumors, mental health conditions, substance use disorders, liver or kidney impairment, urinary retention, or diseases affecting the gallbladder, pancreas, thyroid, or adrenal glands.
Discontinuation and Storage
Abruptly stopping tapentadol can result in withdrawal symptoms. Always consult your physician before discontinuing the medication. Store at room temperature, protected from moisture and heat. Monitor your medication closely to prevent misuse. Do not keep unused opioids—improper or accidental use can be fatal. Participate in a drug take-back program for safe disposal. If one is unavailable, flush the remaining medication down the toilet according to FDA guidelines.
How to Take Tapentadol (Nucynta)
Tapentadol is available in 50 mg, 75 mg, and 100 mg strengths. Dosage should be tailored to each patient’s specific pain level, treatment history, and risk of misuse. Use the smallest effective dose for the shortest appropriate duration, as determined by your physician.
Take this medication exactly as prescribed. Do not alter the dose or frequency without medical advice. Follow the prescription label instructions and review all provided medication guides. Notify your doctor if you feel an increased need to take more of the medication.
Never share opioid medications with others. Misuse can cause addiction, overdose, or death. Keep this medication securely stored to prevent unauthorized access.
Discontinue any other medications containing tapentadol or tramadol when starting buy tapentadol extended-release tablets.
Take tapentadol by mouth with a full glass of water, preferably with food. Do not crush, break, or chew extended-release tablets. Swallow them whole to prevent the release of a potentially lethal dose.
Tapentadol may lead to constipation. Speak to your doctor before using laxatives or stool softeners.
Converting to Extended-Release (ER)
Patients transitioning from immediate-release Nucynta to Nucynta ER should receive the same total daily dose, divided into two equal doses taken approximately 12 hours apart. For instance, a patient taking 50 mg of immediate-release Nucynta four times a day (totaling 200 mg/day) may switch to 100 mg of Nucynta ER every 12 hours.
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Opioid Use Among Children in the United States
Opioid misuse is an increasingly serious issue affecting children and adolescents in the United States. Between 1999 and 2016, approximately 9,000 individuals under the age of 20 died from opioid overdoses, with a sharp rise in deaths among teenagers. Many of these cases involve unintentional ingestion or counterfeit pills containing fentanyl.
Beyond fatal overdoses, millions of children are impacted indirectly through parental opioid use. In 2017 alone, an estimated 2.2 million children lived in households affected by opioid misuse. Without significant intervention, this number could reach 4.3 million by 2030.
Among adolescents aged 10–19, overdose deaths more than doubled between late 2019 and late 2021. Over 90% of these deaths involved opioids—primarily illicit fentanyl.
Efforts to address this crisis include limiting access to opioids, increasing public awareness, expanding treatment services, and supporting families affected by substance use. Early intervention is essential to reducing long-term harm and saving lives.
Possible Side Effects of Nucynta (Tapentadol)
Seek Immediate Medical Attention
Call emergency services right away if you experience signs of a serious allergic reaction, such as:
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hives
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chest tightness or pain
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rapid heartbeat
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breathing difficulty
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swelling of the face, lips, tongue, or throat
Like other opioids, tapentadol online can cause severe respiratory depression. If you or someone near you exhibits slow or irregular breathing, bluish lips, or difficulty waking up, naloxone should be administered and emergency medical help sought immediately.
Contact Your Doctor Immediately If You Notice:
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irregular, shallow, or paused breathing
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sensation of fainting or near loss of consciousness
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unusual restlessness or overheating
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extreme drowsiness, dizziness, confusion, slurred speech, or unsteady balance
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seizures
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symptoms of serotonin syndrome: agitation, hallucinations, fever, rapid heart rate, muscle rigidity, tremors, poor coordination, nausea, diarrhea
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symptoms of adrenal insufficiency (low cortisol): nausea, vomiting, appetite loss, dizziness, persistent fatigue or weakness
Increased Risk Groups
Severe respiratory side effects may occur more frequently in older adults, people with chronic respiratory conditions, or individuals in a weakened state.
Common Side Effects
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constipation
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nausea or vomiting
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abdominal discomfort
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dizziness or drowsiness
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headache
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general fatigue
This is not a full list of possible adverse reactions. Always consult your healthcare provider for complete information. To report side effects, contact the FDA at 1-800-FDA-1088.
Important Warnings: Alcohol, Driving, and Drug Interactions
Avoid alcohol while taking Nucynta, as it can lead to serious complications or death. Until you know how the medication affects you, do not operate vehicles or heavy machinery. Drowsiness and dizziness may increase the risk of accidents, falls, and injuries.
Risk of Dependence, Abuse, and Misuse
Tapentadol is a controlled substance with a known potential for abuse, addiction, and misuse. These behaviors can result in overdose and death. Before prescribing, healthcare providers should assess each patient’s risk and monitor closely throughout treatment.