Nucynta Side Effects

Generic Name: tapentadol

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 solution, oral tablet, oral tablet extended release

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
• convulsions
• 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
• 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 breathing or swallowing

Incidence not known

• Changes in behavior
• dizziness
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seeing, hearing, or feeling things that are not there
• thoughts of killing oneself

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
• nausea
• vomiting

Less common

• Abnormal dreams
• decreased appetite
• difficulty with moving
• heartburn or indigestion
• increased sweating
• 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]

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