Nucynta Side Effects
Generic Name: tapentadol
Medically reviewed by Drugs.com. Last updated on Oct 23, 2020.
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 Summary
Common 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 Consumer
Applies to tapentadol: oral tablet, oral tablet extended release
Warning
Oral route (Tablet; Tablet, Extended Release)
Addiction, Abuse, and Misuse
Tapentadol 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 Depression
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.
Accidental Ingestion
Accidental 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 Depressants
Concomitant 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.
Side effects requiring immediate medical attention
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
- Bladder pain
- bloody or cloudy urine
- body aches or pain
- chills
- cough
- difficult, burning, or painful urination
- difficulty with breathing
- fever
- headache
- loss of voice
- lower back or side pain
- muscle aches
- unusual tiredness or weakness
Rare
- Anxiety
- being forgetful or confused
- clumsiness or unsteadiness
- drowsiness
- fast or irregular heartbeat
- feeling drunk
- irritability or restlessness
- joint pain, stiffness, or swelling
- pale or blue lips, fingernails, or skin
- rash, hives, or itching
- seizures
- sensation of heaviness
- shakiness or trembling
- slurred speech
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- trouble with speaking or hoarseness
- troubled swallowing
Incidence not known
- Agitation
- changes in behavior
- confusion
- darkening of the skin
- diarrhea
- dizziness
- fainting
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of appetite
- mental depression
- nausea
- overactive reflexes
- poor coordination
- seeing, hearing, or feeling things that are not there
- shivering
- sweating
- talking or acting with excitement you cannot control
- thoughts of killing oneself
- trembling or shaking
- twitching
- vomiting
Side effects not requiring immediate medical attention
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
- Abnormal dreams
- heartburn or indigestion
- muscle pain or stiffness
- redness of the face, neck, arms, and occasionally, upper chest
- stomach discomfort, upset, or pain
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Rare
- Change in vision
For Healthcare Professionals
Applies to tapentadol: oral tablet, oral tablet extended release
General
The most common adverse reactions were nausea, dizziness, vomiting, constipation, headache, and somnolence.[Ref]
Gastrointestinal
Very 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[Ref]
Nervous system
Very 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[Ref]
Psychiatric
Common (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[Ref]
Other
Common (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[Ref]
Dermatologic
Common (1% to 10%): Pruritus, hyperhidrosis, pruritus generalized, rash, flushing
Uncommon (0.1% to 1%): Urticaria
Postmarketing reports: Angioedema[Ref]
Respiratory
Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, dyspnea
Uncommon (0.1% to 1%): Respiratory depression, oxygen saturation decreased, cough[Ref]
Cardiovascular
Common (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[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection, erectile dysfunction
Uncommon (0.1% to 1%): Urinary hesitation, pollakiuria, sexual dysfunction[Ref]
Musculoskeletal
Common (1% to 10%): Myalgia, involuntary muscle contractions, muscle spasms
Uncommon (0.1% to 1%): Bone pain, sensation of heaviness[Ref]
Metabolic
Common (1% to 10%): Decreased appetite
Uncommon (0.1% to 1%): Weight decreased[Ref]
Ocular
Common (1% to 10%): Vision blurred
Uncommon (0.1% to 1%): Visual disturbance[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Anaphylaxis, anaphylactic shock[Ref]
Hepatic
Uncommon (0.1% to 1%): GGT increased, ALT increased, AST increased[Ref]
References
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. "Product Information. Nucynta (tapentadol)." PriCara Pharmaceuticals, Raritan, NJ.
More about Nucynta (tapentadol)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Images
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Español
- 262 Reviews
- Drug class: narcotic analgesics
- FDA Alerts (1)
- FDA Approval History
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.