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Nucynta ER

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Nucynta ER

Nucynta ER Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Nucynta ER (tapentadol) is a mu-opioid receptor agonist indicated for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Currently, there is no generic Nucynta ER available. Common side effects seen with the use of Nucynta ER are gastrointestinal disorders, dizziness, headache, sleepiness, insomnia, anxiety, and fatigue.

Nucynta is available in extended-release oral tablets in strengths corresponding to 50, 100, 150, 200, and 250 mg of tapentadol. The maximum total daily dose of Nucynta ER is 500 mg. Do not exceed a total daily dose of Nucynta ER of 500 mg. Nucynta ER tablets must be taken one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth.

IMPORTANT: Nucynta ER tablets must be swallowed whole and must not be split, broken, chewed, dissolved, or crushed. Taking split, broken, chewed, dissolved, or crushed Nucynta ER tablets could lead to rapid release and absorption of a potentially fatal dose of tapentadol. Nucynta ER is not intended for use as an as-needed analgesic. Nucynta ER is not indicated for the management of acute or postoperative pain. Do not drink alcohol, or use prescription or non-prescription medicines that contain alcohol while being treated with Nucynta ER. Alcohol can cause very high levels of tapentadol in the blood and can cause death due to an overdose of tapentadol. Serious side effects include respiratory depression and a potential for drug addiction. There is a risk of serotonin syndrome in patients who take other tarpentadol-based medications or tramadol. Patients must be slowly weaned off the drug to avoid opioid withdrawal syndrome

.

Patients should inform their doctors if they are pregnant or planning to become pregnant. Pregnant women who have taken Nucynta ER regularly before birth risk having babies with breathing problems and withdrawal symptoms. Patients should not breastfeed while taking Nucynta ER. Safety and effectiveness of Nucynta ER in pediatric patients has not been established.

Our Nucynta ER 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 ER 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 ER (Tapentadol Extended-Release Film-Coated Tablets) »

What is Prescribing information?

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

Nucynta ER 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.

Commonly-Observed Adverse Reactions in Clinical Studies with NUCYNTA® ER in Patients with Chronic Pain due to Low Back Pain or Osteoarthritis

The safety data described in Table 1 below are based on three pooled, randomized, double-blind, placebo-controlled, parallel group, 15-week studies of NUCYNTA® ER (dosed 100 to 250 mg BID after a 50 mg BID starting dose) in patients with chronic pain due to low back pain (LBP) and osteoarthritis (OA). These trials included 980 NUCYNTA® ER-treated patients and 993 placebotreated patients. The mean age was 57 years old; 63% were female and 37% were male; 83% were White, 10% were Black, and 5% were Hispanic.

The most common adverse reactions (reported by ≥ 10% in any NUCYNTA® ER dose group) were: nausea, constipation, dizziness, headache, and somnolence.

The most common reasons for discontinuation due to adverse reactions in eight Phase 2/3 pooled studies reported by ≥ 1% in any NUCYNTA® ER dose group for NUCYNTA® ER- and placebo-treated patients were nausea (4% vs. 1%), dizziness (3% vs. < 1%), vomiting (3% vs. < 1%), somnolence (2% vs. < 1%), constipation (1% vs. < 1%), headache (1% vs. < 1%), and fatigue (1% vs. < 1%), respectively.

Table 1: Adverse Drug Reactions Reported by ≥ 1% of NUCYNTA® ER-Treated Patients and Greater than Placebo-treated Patients in Pooled Parallel-Group Trials1

  NUCYNTA® ER 50 to 250 mg BID2
(n=980)
Placebo
(n=993)
Nausea 21% 7%
Constipation 17% 7%
Dizziness 17% 6%
Headache 15% 13%
Somnolence 12% 4%
Fatigue 9% 4%
Vomiting 8% 3%
Dry mouth 7% 2%
Hyperhidrosis 5% < 1%
Pruritus 5% 2%
Insomnia 4% 2%
Dyspepsia 3% 2%
Lethargy 2% < 1%
Asthenia 2% < 1%
Anxiety 2% 1%
Decreased appetite 2% < 1%
Vertigo 2% < 1%
Hot flush 2% < 1%
Disturbance in attention 1% < 1%
Tremor 1% < 1%
Chills 1% 0%
Abnormal dreams 1% < 1%
Depression 1% < 1%
Vision blurred 1% < 1%
Erectile dysfunction 1% < 1%
1 MedDRA preferred terms. The trials included forced titration during the first week of dosing.
2 NUCYNTA® ER dosed between 100 and 250 mg BID after a starting dose of
50 mg BID

Commonly-Observed Adverse Reactions in Clinical Studies with NUCYNTA® ER in Patients with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy The types of adverse reactions seen in the studies of patients with painful diabetic peripheral neuropathy (DPN) were similar to what was seen in the low back pain and osteoarthritis trials. The safety data described in Table 2 below are based on two pooled, randomized withdrawal, double-blind, placebocontrolled, 12-week studies of NUCYNTA® ER (dosed 100 to 250 mg BID) in patients with neuropathic pain associated with diabetic peripheral neuropathy. These trials included 1040 NUCYNTA® ER-treated patients and 343 placebotreated patients. The mean age was 60 years old; 40% were female and 60% were male; 76% were White, 12% were Black, and 12% were “Other”. The most commonly reported ADRs (incidence ≥ 10% in NUCYNTA® ER-treated subjects) were: nausea, constipation, vomiting, dizziness, somnolence, and headache.

Table 2 lists the common adverse reactions reported in 1% or more of NUCYNTA® ER-treated patients and greater than placebo-treated patients with neuropathic pain associated with diabetic peripheral neuropathy in the two pooled studies.

Table 2: Adverse Drug Reactions Reported by ≥ 1% of NUCYNTA® ER-Treated Patients and Greater than Placebo-Treated Patients in Pooled Trials (Studies DPN-1 and DPN-2) 1

  NUCYNTA® ER 50 to 250 mg BID2
(n=1040)
Placebo3
(n=343)
Nausea 27% 8%
Dizziness 18% 2%
Somnolence 14% < 1%
Constipation 13% < 1%
Vomiting 12% 3%
Headache 10% 5%
Fatigue 9% < 1%
Pruritus 8% 0%
Dry mouth 7% < 1%
Diarrhea 7% 5%
Decreased appetite 6% < 1%
Anxiety 5% 4%
Insomnia 4% 3%
Hyperhidrosis 3% 2%
Hot flush 3% 2%
Tremor4 3% 3%
Abnormal dreams 2% 0%
Lethargy 2% 0%
Asthenia 2% < 1%
Irritability 2% 1%
Dyspnea 1% 0%
Nervousness 1% 0%
Sedation 1% 0%
Vision blurred 1% 0%
Pruritus generalized 1% 0%
Vertigo 1% < 1%
Abdominal discomfort 1% < 1%
Hypotension 1% < 1%
Dyspepsia 1% < 1%
Hypoesthesia 1% < 1%
Depression 1% < 1%
Rash 1% < 1%
Chills4 1% 1%
Feeling cold4 1% 1%
Drug withdrawal syndrome 1% < 1%
1 MedDRA preferred terms.
2 NUCYNTA® ER dosed between 100 and 250 mg BID after a starting dose of 50 mg BID. It includes ADR reported in the open-label titration period for all subjects and in the double-blind maintenance period for the subjects who were randomized to NUCYNTA® ER.
3 It includes ADR reported in the double-blind maintenance period for the subjects who were randomized to placebo after receiving NUCYNTA® ER during the open-label titration period.
4 Tremor was observed in 3.4% of NUCYNTA® ER-treated subjects vs. 3.2% in placebo group, chills- in 1.3% vs. 1.2% in placebo, and feeling cold- in 1.3% vs. 1.2% in placebo.

Other Adverse Reactions Observed During the Premarketing Evaluation of NUCYNTA® ER

The following additional adverse drug reactions occurred in less than 1% of NUCYNTA® ER-treated patients in ten Phase 2/3 clinical studies:

Nervous System Disorders: paresthesia, balance disorder, syncope, memory impairment, mental impairment, depressed level of consciousness, dysarthria, presyncope, coordination abnormal

Gastrointestinal disorders: impaired gastric emptying

General disorders and administration site conditions: feeling abnormal, feeling drunk

Psychiatric disorders: perception disturbances, disorientation, confusional state, agitation, euphoric mood, drug dependence, thinking abnormal, nightmare

Skin and subcutaneous tissue disorders: urticaria

Metabolism and nutrition disorders: weight decreased

Cardiac disorders: heart rate increased, palpitations, heart rate decreased, left bundle branch block

Vascular Disorder: blood pressure decreased

Respiratory, thoracic and mediastinal disorders: respiratory depression

Renal and urinary disorders: urinary hesitation, pollakiuria

Reproductive system and breast disorders: sexual dysfunction

Eye disorders: visual disturbance

Immune system disorders: drug hypersensitivity

Postmarketing Experience

The following adverse reactions, not noted in Section 6.1 above, have been identified during post approval use of tapentadol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Psychiatric disorders: hallucination, suicidal ideation

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

Read the entire FDA prescribing information for Nucynta ER (Tapentadol Extended-Release Film-Coated Tablets) »

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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.


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