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Nucynta Side Effects

Generic name: tapentadol

Medically reviewed by Drugs.com. Last updated on Apr 19, 2023.

Note: This document contains side effect information about tapentadol. Some dosage forms listed on this page may not apply to the brand name Nucynta.

Applies to tapentadol: oral tablet, oral tablet extended release.

Warning

Oral route (Tablet, Extended Release)

Addiction, Abuse, and MisuseTapentadol extended-release tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing tapentadol extended-release tablets, and monitor all patients regularly for the development of 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 REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to, complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.Life-threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of tapentadol extended-release tablets. Monitor for respiratory depression, especially during initiation of tapentadol extended-release tablets or following a dose increase. Instruct patients to swallow tapentadol extended-release tablets whole; crushing, chewing, or dissolving tapentadol extended-release tablets can cause rapid release and absorption of a potentially fatal dose of tapentadol.Accidental IngestionAccidental ingestion of even 1 dose of tapentadol extended-release tablets, especially by children, can result in a fatal overdose of tapentadol.Neonatal Opioid Withdrawal SyndromeProlonged use of tapentadol extended release during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Interaction With AlcoholInstruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking tapentadol extended release. The co-ingestion of alcohol with tapentadol extended-release tablets may result in increased plasma tapentadol levels and a potentially fatal overdose of tapentadol.Risks From Concomitant Use With Benzodiazepines Or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of tapentadol extended release and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Oral route (Tablet)

Addiction, Abuse, and Misuse

Because the use of tapentadol oral tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing tapentadol and reassess all patients regularly for the development of these behaviors and conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of tapentadol oral tablets, especially during initiation or following a dose increase. To reduce the risk of respiratory depression, proper dosing and titration of tapentadol tablets are essential.

Accidental Ingestion

Accidental ingestion of even 1 dose of tapentadol oral tablets, especially by children, can result in a fatal overdose of tapentadol.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing tapentadol tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.Neonatal Opioid Withdrawal SyndromeIf opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure the management by neonatology expert will be available at delivery.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription.

Serious side effects of Nucynta

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
  • chest tightness
  • 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
  • trouble swallowing
  • trouble with speaking or hoarseness

Incidence not known

  • Agitation
  • changes in behavior
  • confusion
  • darkening of the skin
  • diarrhea
  • dizziness
  • fainting
  • increased sensitivity to pain
  • 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
  • worsening of pain

Get emergency help immediately if any of the following symptoms of overdose occur while taking tapentadol:

Symptoms of overdose

  • Change in consciousness
  • chest pain or discomfort
  • cold, clammy skin
  • coughing that sometimes produce a pink frothy sputum
  • decreased awareness or responsiveness
  • difficult or trouble breathing
  • increased sweating
  • irregular, fast or slow, or shallow breathing
  • lightheadedness, dizziness or fainting
  • loss of consciousness
  • pale or blue lips, fingernails, or skin
  • sleepiness or unusual drowsiness
  • swelling in the legs and ankles

Other side effects of Nucynta

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

Adult patients: The most common adverse reactions included nausea, dizziness, vomiting, constipation, headache, and somnolence.

Pediatric patients (6 years and older): The most common adverse reactions included vomiting constipation, nausea, pruritus, and pyrexia.[Ref]

Cardiovascular

Common (1% to 10%): Hot flush/flushing

Uncommon or Rare (less than 1%): Heart rate increased, heart rate decreased, blood pressure decreased, palpitations

Frequency not reported: Hypotension or peripheral vasodilation (including orthostatic hypotension, syncope)[Ref]

Dermatologic

Common (1% to 10%): Pruritus, hyperhidrosis, pruritus generalized, rash

Uncommon (less than 1%): Urticaria

Postmarketing reports: Angioedema[Ref]

Endocrine

Frequency not reported: Inhibition of hormone secretions (adrenocorticotropic hormone, cortisol, and luteinizing hormone), stimulation of secretions (prolactin secretion, growth hormone secretion, and pancreatic secretions of insulin and glucagon), hypogonadism

Postmarketing reports: Androgen deficiency (including symptoms of low libido, impotence, erectile dysfunction, amenorrhea or infertility), adrenal insufficiency (often with greater than 1 month of use)

Gastrointestinal

Very common (10% or more): Nausea (up to 30%), vomiting (up to 24.7%), constipation (up to 16.5%; higher rate in older adults)

Common (1% to 10%): Dry mouth, dyspepsia, diarrhea

Uncommon or Rare (less than 0.1%): Impaired gastric emptying, abdominal discomfort

Frequency not reported: Spasm of sphincter of Oddi, increased serum amylase, reduction in pancreatic secretions[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary hesitation, pollakiuria, sexual dysfunction[Ref]

Hepatic

Uncommon (less than 1%): GGT increased, ALT increased, AST increased

Frequency not reported: Reduction in biliary secretions[Ref]

Hypersensitivity

Uncommon (less than 1%): Hypersensitivity

Postmarketing reports: Anaphylaxis, anaphylactic shock[Ref]

Metabolic

Common (1% to 10%): Decreased appetite

Uncommon (0.1% to 1%): Weight decreased[Ref]

Musculoskeletal

Common (1% to 10%): Muscle spasms, involuntary muscle contractions

Uncommon (less than 1%): Sensation of heaviness[Ref]

Nervous system

Very common (10% or more): Dizziness (24%), somnolence (15%), headache (up to 10.2%)

Common (1% to 10%): Tremor, lethargy, disturbance in attention

Uncommon or Rare (less than 1%): Hypoesthesia, paresthesia, sedation, dysarthria, depressed level of consciousness, memory impairment, ataxia, presyncope and syncope, seizure/convulsion, abnormal coordination

Postmarketing reports: Delirium[Ref]

Ocular

Uncommon (less than 1%): Visual disturbance

Frequency not reported: Red eyes (due to peripheral vasodilation/histamine release), miosis (even in total darkness), mydriasis (seen in hypoxia in overdose)[Ref]

Other

Common (1% to 10%): Fatigue, feeling hot, pyrexia, asthenia, feeling of body temperature change

Uncommon (less than 1%): Edema, feeling drunk, feeling abnormal, feeling of relaxation

Frequency not reported: Drug tolerance (reduced response of drug), physical dependence on drug[Ref]

Psychiatric

Common (1% to 10%): Insomnia/sleep disorder, hallucination, confusional state, abnormal dreams, anxiety, nervousness, restlessness

Uncommon (less than 1%): Irritability, drug withdrawal syndrome, euphoric mood, disorientation, restlessness, agitation, thinking abnormal, depressed mood

Frequency not reported: Addiction, neonatal opioid withdrawal syndrome

Postmarketing reports: Suicidal ideation, panic attack, hyperalgesia, allodynia, serotonin syndrome[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, dyspnea

Uncommon (less than 1%): Oxygen saturation decreased, cough, dyspnea, respiratory depression[Ref]

Renal

Common (1% to 10%): Urinary tract infection

Uncommon (less than 1%): Urinary hesitation, pollakiuria

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Nucynta (tapentadol). PriCara Pharmaceuticals. 2009.

4. Product Information. Nucynta (tapentadol). Collegium Pharmaceutical, Inc. 2023.

5. Product Information. Nucynta ER (tapentadol). Collegium Pharmaceutical, Inc. 2021.

6. Product Information. Palexia IR (tAPENTadol). CSL Limited. 2022.

7. Product Information. Palexia SR (tAPENTadol). Seqirus Pty Ltd. 2022.

8. Product Information. Ationdo SR (tapentadol). Grunenthal Ltd. 2023.

9. Product Information. Palexia (tapentadol). Grunenthal Ltd. 2023.

10. Product Information. Palexia SR (tapentadol). Grunenthal Ltd. 2023.

11. Product Information. Tapimio (tapentadol). Neuraxpharm UK Ltd. 2022.

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.

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