Nucynta ER Side Effects

Generic name: tapentadol

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

Note: This document provides detailed information about Nucynta ER Side Effects associated with tapentadol. Some dosage forms listed on this page may not apply specifically to the brand name Nucynta ER.

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

Important warnings This medicine can cause some serious health issues

Oral route (tablet, extended release)

Addiction, Abuse, and Misuse. Tapentadol 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 Depression. Serious, 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 Ingestion. Accidental ingestion of even 1 dose of tapentadol extended-release tablets, especially by children, can result in a fatal overdose of tapentadol.Neonatal Opioid Withdrawal Syndrome. Prolonged 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 Alcohol. Instruct 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 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 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 Syndrome. If 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.

Common side effects of Nucynta ER

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

• constipation

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

Serious side effects of Nucynta ER

Along with its needed effects, tapentadol (the active ingredient contained in Nucynta ER) 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

For healthcare professionals

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

General

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

Pediatric: The most common adverse reactions included vomiting constipation, nausea, pruritus, and pyrexia.^[Ref]

Cardiovascular

• Common (1% to 10%): Hot flush/flushing
• Uncommon (less than 1%): Heart rate increased, heart rate decreased, blood pressure decreased, palpitations
• Frequency not reported: Hypotension or peripheral vasodilation

Hypotension or peripheral vasodilation included orthostatic hypotension and syncope.

Dermatologic

• Common (1% to 10%): Pruritus, hyperhidrosis, generalized pruritus, rash
• Uncommon (less than 1%): Urticaria
• Postmarketing reports: Angioedema

Endocrine

• Frequency not reported: Inhibition of hormone secretions, stimulation of secretions, hypogonadism
• Postmarketing reports: Androgen deficiency, adrenal insufficiency

Inhibition of hormone secretions included inhibition of adrenocorticotropic hormone, cortisol, and luteinizing hormone.

Stimulation of secretions included secretion of prolactin, growth hormone, insulin, and glucagon.

Androgen deficiency included symptoms of low libido, impotence, erectile dysfunction, amenorrhea, and infertility.

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 (less than 0.1%): Impaired gastric emptying, abdominal discomfort
• Frequency not reported: Spasm of sphincter of Oddi, increased serum amylase, reduced pancreatic secretions

Genitourinary

• Common (1% to 10%): Urinary tract infection
• Uncommon (less than 1%): Urinary hesitation, pollakiuria, sexual dysfunction

Hepatic

• Uncommon (less than 1%): GGT increased, ALT increased, AST increased
• Frequency not reported: Reduced biliary secretions

Hypersensitivity

• Uncommon (less than 1%): Hypersensitivity
• Postmarketing reports: Anaphylaxis, anaphylactic shock

Metabolic

• Common (1% to 10%): Decreased appetite
• Uncommon (0.1% to 1%): Weight decreased

Musculoskeletal

• Common (1% to 10%): Muscle spasms, involuntary muscle contractions
• Uncommon (less than 1%): Sensation of heaviness

Nervous system

• Very common (10% or more): Dizziness (up to 24%), somnolence (up to 15%), headache (up to 10.2%)
• Common (1% to 10%): Tremor, lethargy, disturbance in attention
• Uncommon (less than 1%): Hypoesthesia, paresthesia, sedation, dysarthria, depressed level of consciousness, memory impairment, ataxia, presyncope and syncope, seizure/convulsion, abnormal coordination
• Postmarketing reports: Delirium

Ocular

• Uncommon (less than 1%): Visual disturbance
• Frequency not reported: Red eyes, miosis, mydriasis

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 drug response, physical dependence

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

Respiratory

• Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, dyspnea
• Uncommon (less than 1%): Oxygen saturation decreased, cough, dyspnea, respiratory depression

Frequently asked questions

• What does XR or ER mean after a drug name?

Further information

Nucynta ER side effects can vary depending on the individual. 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