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.

Some side effects of Nucynta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to tapentadol: oral tablet, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking tapentadol (the active ingredient contained in Nucynta) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• weak or shallow breathing, weak pulse, slow heartbeat;

• seizure (convulsions);

• severe drowsiness or dizziness;

• confusion, problems with speech or balance; or

• agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects of tapentadol may include:

• mild nausea or vomiting;

• constipation;

• mild dizziness, drowsiness;

• dry mouth;

• itching; or

• increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to tapentadol: oral tablet, oral tablet extended release

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, constipation, dry mouth, dyspepsia, abdominal discomfort, impaired gastric emptying, and decreased appetite.

Nervous system

Nervous system side effects have included dizziness, somnolence, tremor, lethargy hypoesthesia, paresthesia, disturbance in attention, sedation, dysarthria, depressed level of consciousness, memory impairment, ataxia, presyncope, syncope, abnormal coordination, and seizures. Postmarketing reports have included headache.

Psychiatric

Psychiatric side effects have included insomnia, confusional state, abnormal dreams, anxiety, irritability, drug withdrawal syndrome, feeling drunk, euphoric mood, disorientation, restlessness, agitation, nervousness, and abnormal thinking. Postmarketing reports have included hallucinations.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, involuntary muscle contractions, and sensation of heaviness.

Dermatologic

Dermatologic side effects have included pruritus, hyperhidrosis, generalized pruritus, and urticaria.

Cardiovascular

Cardiovascular side effects have included hot flushes, heart rate increased, heart rate decreased, edema, and decreased blood pressure.

Respiratory

Respiratory side effects have included decreased oxygen saturation, cough, dyspnea, upper respiratory tract infection, nasopharyngitis, and respiratory depression.

Genitourinary

Genitourinary side effects have included urinary tract infection, urinary hesitation, and pollakiuria.

General

General side effects have included fatigue and feeling hot.

Immunologic

Immunologic side effects have included hypersensitivity.

Ocular

Ocular side effects have included visual disturbance.

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