Nucynta

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.

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.

Applies to tapentadol: 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
• 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

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

Applies to tapentadol: oral tablet, oral tablet extended release

The most common adverse reactions were nausea, dizziness, vomiting, constipation, headache, and somnolence.

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

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

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

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

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

Uncommon (0.1% to 1%): Urticaria

Postmarketing reports: Angioedema

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

Uncommon (0.1% to 1%): Respiratory depression, oxygen saturation decreased, cough

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

Common (1% to 10%): Urinary tract infection, erectile dysfunction

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

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

Uncommon (0.1% to 1%): Bone pain, sensation of heaviness

Common (1% to 10%): Decreased appetite

Uncommon (0.1% to 1%): Weight decreased

Common (1% to 10%): Vision blurred

Uncommon (0.1% to 1%): Visual disturbance

Uncommon (0.1% to 1%): Hypersensitivity

Postmarketing reports: Anaphylaxis, anaphylactic shock

Uncommon (0.1% to 1%): GGT increased, ALT increased, AST increased