Recommended Topic Related To:

Nucynta

"Nov. 26, 2014 -- Gift-buying season is here, and on top of the wish list for most people is the latest tech gadget or gizmo. But some experts are concerned that more tech may equal more pain for frequent users.

For starters, we take"...

Nucynta

Nucynta Side Effects Center

Pharmacy Editor: Melissa Conrad Stöppler, MD

Nucynta (tapentadol) immediate release oral tablets are indicated for the relief of moderate to severe acute pain in patients 18 years of age or older. The drug is an opioid analgesic and may be dosed at 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending upon pain intensity. Side effects can include nausea, vomiting, constipation, fatigue, dizziness, somnolence, and pruritus. Other side effects may occur.

Due to its mu-opioid agonist activity, Nucynta (tapentadol immediate-release oral tablets) may be expected to have additive effects when used in conjunction with alcohol, opioids, or illicit drugs that cause central nervous system depression, respiratory depression, hypotension, and profound sedation, coma or death. Patients should be advised not to breastfeed an infant during treatment with Nucynta. Tapentadol, like other drugs of this class, may be habit forming.

Our Nucynta Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Nucynta in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nucynta (Tapentadol Immediate-Release Oral Tablets) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Nucynta FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Based on data from nine Phase 2/3 studies that administered multiple doses (seven placebo- and/or active-controlled, one noncontrolled and one Phase 3 active-controlled safety study) the most common adverse reactions (reported by ≥ 10% in any NUCYNTA® dose group) were: nausea, dizziness, vomiting and somnolence.

The most common reasons for discontinuation due to adverse reactions in the studies described above (reported by ≥ 1% in any NUCYNTA® dose group) were dizziness (2.6% vs. 0.5%), nausea (2.3% vs. 0.6%), vomiting (1.4% vs. 0.2%), somnolence (1.3% vs. 0.2%) and headache (0.9% vs. 0.2%) for NUCYNTA®- and placebo-treated patients, respectively.

Seventy-six percent of NUCYNTA®-treated patients from the nine studies experienced adverse events.

NUCYNTA® was studied in multiple-dose, active- or placebo-controlled studies, or noncontrolled studies (n = 2178), in single-dose studies (n = 870), in open-label study extension (n = 483) and in Phase 1 studies (n = 597). Of these, 2034 patients were treated with doses of 50 mg to 100 mg of NUCYNTA® dosed every 4 to 6 hours.

The data described below reflect exposure to NUCYNTA® in 3161 patients, including 449 exposed for 45 days. NUCYNTA® was studied primarily in placebo- and active-controlled studies (n = 2266, and n = 2944, respectively). The population was 18 to 85 years old (mean age 46 years), 68% were female, 75% white and 67% were postoperative. Most patients received NUCYNTA® doses of 50 mg, 75 mg, or 100 mg every 4 to 6 hours.

Table 1 Adverse Reactions Reported by ≥ 1% of NUCYNTA®-Treated Patients In Seven Phase 2/3 Placebo- and/or Oxycodone-Controlled, One Non-controlled, and One Phase 3 Oxycodone-Controlled Safety, Multiple-Dose Clinical Studies

System/Organ Class MedDRA Preferred Term NUCYNTA® 21 mg - 120 mg
(n = 2178) %
Placebo
(n = 619) %
Gastrointestinal disorders
  Nausea 30 13
  Vomiting 18 4
  Constipation 8 3
  Dry mouth 4 < 1
  Dyspepsia 2 < 1
General disorders and administration site conditions
  Fatigue 3 < 1
  Feeling hot 1 < 1
Infections and infestations
  Nasopharyngitis 1 < 1
  Upper respiratory tract infection 1 < 1
  Urinary tract infection 1 < 1
Metabolism and nutrition disorders
  Decreased appetite 2 0
Nervous system disorders
  Dizziness 24 8
  Somnolence  15 3
  Tremor 1 < 1
  Lethargy 1 < 1
Psychiatric disorders
  Insomnia 2 < 1
  Confusional state 1 0
  Abnormal dreams 1 < 1
  Anxiety 1 < 1
Skin and subcutaneous tissue disorders
  Pruritus 5 1
  Hyperhidrosis 3 < 1
  Pruritus generalized 3 < 1
  Rash 1 < 1
Vascular disorders
  Hot flush 1 < 1

The following adverse drug reactions occurred in less than 1% of NUCYNTA®-treated patients in the pooled safety data from nine Phase 2/3 clinical studies:

Cardiac disorders: heart rate increased, heart rate decreased

Eye disorders: visual disturbance

Gastrointestinal disorders: abdominal discomfort, impaired gastric emptying

General disorders and administration site conditions: irritability, edema, drug withdrawal syndrome, feeling drunk

Immune system disorders: hypersensitivity

Investigations: gamma-glutamyltransferase increased, alanine aminotransferase increased, aspartate aminotransferase increased

Musculoskeletal and connective tissue disorders: involuntary muscle contractions, sensation of heaviness

Nervous system disorders: hypoesthesia, paresthesia, disturbance in attention, sedation, dysarthria, depressed level of consciousness, memory impairment, ataxia, presyncope, syncope, coordination abnormal, seizure

Psychiatric disorders: euphoric mood, disorientation, restlessness, agitation, nervousness, thinking abnormal

Renal and urinary disorders: urinary hesitation, pollakiuria

Respiratory, thoracic and mediastinal disorders: oxygen saturation decreased, cough, dyspnea, respiratory depression

Skin and subcutaneous tissue disorders: urticaria Vascular disorders: blood pressure decreased

In the pooled safety data, the overall incidence of adverse reactions increased with increased dose of NUCYNTA®, as did the percentage of patients with adverse reactions of nausea, dizziness, vomiting, somnolence, and pruritus.

Post-marketing Experience

The following additional adverse reactions have been identified during post-approval use of NUCYNTA®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably.

Gastrointestinal disorders: diarrhea

Nervous system disorders: headache

Psychiatric disorders: hallucination, suicidal ideation, panic attack

Cardiac disorders: palpitations

Anaphylaxis, angioedema, and anaphylactic shock have been reported very rarely with ingredients contained in NUCYNTA®. Advise patients how to recognize such reactions and when to seek medical attention.

Read the entire FDA prescribing information for Nucynta (Tapentadol Immediate-Release Oral Tablets) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Chronic Pain/Back Pain

Find tips and advances in treatment.