Tapentadol Side Effects

Some side effects of tapentadol 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 solution, oral tablet, oral tablet extended release

Along with its needed effects, tapentadol 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, fever
  • cough
  • difficult, burning, or painful urination
  • difficulty with breathing
  • headache
  • loss of voice
  • lower back or side pain
  • muscle aches
  • unusual tiredness or weakness
Rare
  • Anxiety or nervousness
  • being forgetful or confused
  • clumsiness or unsteadiness
  • convulsions
  • drowsiness
  • fast or irregular heartbeat
  • feeling drunk
  • irritability or restlessness
  • itching
  • joint pain, stiffness, or swelling
  • pale or blue lips, fingernails, or skin
  • rash or hives
  • 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

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 and panic attacks.

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.

Hypersensitivity

Postmarketing reports: Anaphylactic shock

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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