Tapentadol Side Effects

It is possible that some side effects of tapentadol may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

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

As well as its needed effects, tapentadol may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking tapentadol, check with your doctor immediately:

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 tapentadol side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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.

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

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

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

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

Dermatologic

Common (1% to 10%): Pruritus, hyperhidrosis, pruritus generalized, rash, flushing
Uncommon (0.1% to 1%): Urticaria
Postmarketing reports: Angioedema

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, dyspnea
Uncommon (0.1% to 1%): Respiratory depression, oxygen saturation decreased, cough

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

Genitourinary

Common (1% to 10%): Urinary tract infection, erectile dysfunction
Uncommon (0.1% to 1%): Urinary hesitation, pollakiuria, sexual dysfunction

Musculoskeletal

Common (1% to 10%): Myalgia, involuntary muscle contractions, muscle spasms
Uncommon (0.1% to 1%): Bone pain, sensation of heaviness

Metabolic

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

Ocular

Common (1% to 10%): Vision blurred
Uncommon (0.1% to 1%): Visual disturbance

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Anaphylaxis, anaphylactic shock

Hepatic

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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