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Note: This document contains side effect information about tapentadol. Some of the dosage forms listed on this page may not apply to the brand name Nucynta.
In SummaryCommon side effects of Nucynta include: drowsiness, nausea, and vomiting. Other side effects include: constipation, pruritus, and xerostomia. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to tapentadol: oral tablet, oral tablet extended release
Oral route (Tablet; Tablet, Extended Release)
Addiction, Abuse, and MisuseTapentadol oral tablets or extended-release tablets expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS):To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.
Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.
Accidental IngestionAccidental ingestion of tapentadol oral tablets or extended-release tablets, especially by children, can result in a fatal overdose of tapentadol.Neonatal Opioid Withdrawal SyndromeProlonged use of tapentadol oral tablets or extended-release tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.
Along with its needed effects, tapentadol (the active ingredient contained in Nucynta) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking tapentadol:
Less common
Rare
Incidence not known
Some side effects of tapentadol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Rare
For Healthcare Professionals
Applies to tapentadol: oral tablet, oral tablet extended release
GeneralThe most common adverse reactions were nausea, dizziness, vomiting, constipation, headache, and somnolence.
GastrointestinalVery common (10% or more): Nausea (up to 30%), vomiting (up to 18%), constipation (up to 17%)
Common (1% to 10%): Dry mouth, dyspepsia, diarrhea, abdominal discomfort
Rare (less than 0.1%): Impaired gastric emptying
Nervous systemVery common (10% or more): Dizziness (up to 24%), headache (up to 15%), somnolence (up to 15%)
Common (1% to 10%): Tremor, lethargy, vertigo, disturbance in attention, sedation, hypoesthesia
Uncommon (0.1% to 1%): Memory impairment, mental impairment, syncope, balance disorder, dysarthria, paresthesia, depressed level of consciousness, presyncope, ataxia
Rare (less than 0.1%): Convulsion, coordination abnormal
Frequency not reported: Seizure, serotonin syndrome
PsychiatricCommon (1% to 10%): Insomnia, confusion, abnormal dreams, anxiety, depression, irritability, nervousness, drug withdrawal syndrome, restlessness, sleep disorder, hallucination, depressed mood
Uncommon (0.1% to 1%): Disorientation, agitation, perception disturbances, euphoric mood, nightmare
Rare (less than 0.1%): Thinking abnormal, drug dependence
Postmarketing reports: Suicidal ideation, panic attack
OtherCommon (1% to 10%): Fatigue, asthenia, chills, edema, feeling hot, feeling cold, feeling of body temperature change, mucosal dryness
Uncommon (0.1% to 1%): Feeling abnormal, feeling drunk, feeling of relaxation
DermatologicCommon (1% to 10%): Pruritus, hyperhidrosis, pruritus generalized, rash, flushing
Uncommon (0.1% to 1%): Urticaria
Postmarketing reports: Angioedema
RespiratoryCommon (1% to 10%): Nasopharyngitis, upper respiratory tract infection, dyspnea
Uncommon (0.1% to 1%): Respiratory depression, oxygen saturation decreased, cough
CardiovascularCommon (1% to 10%): Hot flush, hypotension
Uncommon (0.1% to 1%): Heart rate increased, heart rate decreased, blood pressure decreased, palpitations, left bundle branch block
GenitourinaryCommon (1% to 10%): Urinary tract infection, erectile dysfunction
Uncommon (0.1% to 1%): Urinary hesitation, pollakiuria, sexual dysfunction
MusculoskeletalCommon (1% to 10%): Myalgia, involuntary muscle contractions, muscle spasms
Uncommon (0.1% to 1%): Bone pain, sensation of heaviness
MetabolicCommon (1% to 10%): Decreased appetite
Uncommon (0.1% to 1%): Weight decreased
OcularCommon (1% to 10%): Vision blurred
Uncommon (0.1% to 1%): Visual disturbance
HypersensitivityUncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Anaphylaxis, anaphylactic shock
HepaticUncommon (0.1% to 1%): GGT increased, ALT increased, AST increased
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/3/2022.
Source: Drugs.com Nucynta (www.drugs.com/nucynta.html).
August 4, 2022
August 4, 2022
August 4, 2022
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