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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

Managing side effects (general information)

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.

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.

Medical Disclaimer