Nucynta ER
- Generic Name: tapentadol extended-release film-coated tablets
- Brand Name: Nucynta ER
- Drug Class: Opioid Analgesics, Synthetic, Opioids
Nucynta ER(Tapentadol Extended-Release Film-Coated Tablets) side effects drug center
Nucynta ER Side Effects Center
What Is Nucynta ER?
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.
What Are Side Effects of Nucynta ER?
Common side effects of Nucynta ER include:
- nausea,
- vomiting,
- constipation,
- dizziness,
- drowsiness,
- dry mouth,
- itching,
- increased sweating,
- headache,
- sleepiness,
- trouble sleeping (insomnia),
- anxiety,
- fatigue,
- indigestion,
- weakness,
- anxiety,
- decreased appetite,
- spinning sensation,
- hot flashes,
- tremor,
- chills,
- abnormal dreams,
- depression,
- blurred vision, and
- impotence.
Dosage for Nucynta ER
The starting dose of Nucynta ER is 50 mg orally twice daily (approximately every 12 hours). Nucynta ER tablets must be taken whole. Crushing, chewing, or dissolving Nucynta ER tablets will result in uncontrolled delivery of tapentadol and can lead to overdose or death.
What Drugs, Substances, or Supplements Interact with Nucynta ER?
Nucynta ER may interact with cold or allergy medicines, sedatives, narcotic pain medicines, sleeping pills, muscle relaxers, and medicines for seizures, depression, or anxiety. Tell your doctor all medications and supplements you use.
Nucynta ER During Pregnancy and Breastfeeding
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.
Additional Information
Our Nucynta ER Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Nucynta ER Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
- noisy breathing, sighing, shallow breathing, breathing that stops;
- a light-headed feeling, like you might pass out;
- agitation, feeling hot;
- severe drowsiness or dizziness, confusion, problems with speech or balance;
- a seizure;
- serotonin syndrome--agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea; or
- low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.
Common side effects may include:
- constipation, nausea, vomiting, stomach pain;
- headache, feeling tired; or
- drowsiness, dizziness.
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)
Nucynta ER Professional Information
SIDE EFFECTS
The following serious adverse reactions are described, or described in greater detail, in other sections:
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Interaction with Benzodiazepine or Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
- Severe Hypotension [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Withdrawal [see WARNINGS AND PRECAUTIONS]
Clinical Trial 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 placebo-treated 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-GroupTrials1
| 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% |
| 1MedDRA 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 |
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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, placebo-controlled, 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 placebo-treated 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. |
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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 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 frequencyor establish a causal relationship to drug exposure.
Psychiatric disorders: hallucination, suicidal ideation, panic attack
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergicdrugs.
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis: Anaphylaxis has been reported with ingredients contained in NUCYNTA ER. Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].
DRUG INTERACTIONS
Table 3 includes clinically significant drug interactions with NUCYNTA ER.
Table 3: Clinically Significant Drug Interactions with NUCYNTA ER
| Alcohol | |
| Clinical Impact: | Concomitant use of alcohol with NUCYNTA ER can result in an increase of tapentadol plasma levels and potentially fatal overdose of tapentadol. |
| Intervention: | Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products containing alcohol while on NUCYNTA ER therapy. |
| Benzodiazepines and Other Central Nervous System (CNS) Depressants | |
| Clinical Impact: | Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. |
| Intervention: | Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation. If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS]. |
| Examples: | Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol. |
| Serotonergic Drugs | |
| Clinical Impact: | The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome [see WARNINGS AND PRECAUTIONS]. |
| Intervention: | If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue NUCYNTA ER if serotonin syndrome is suspected. |
| Examples: | Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Monoamine Oxidase Inhibitors (MAOIs) | |
| Clinical Impact: | MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see WARNINGS AND PRECAUTIONS]. |
| Intervention: | Do not use NUCYNTA ER in patients taking MAOIs or within 14 days of stopping such treatment |
| Examples: | phenelzine, tranylcypromine, linezolid |
| Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics | |
| Clinical Impact: | May reduce the analgesic effect of NUCYNTA ER and/or precipitate withdrawal symptoms. |
| Intervention: | Avoid concomitant use. |
| Examples: | butorphanol, nalbuphine, pentazocine, buprenorphine |
| Muscle Relaxants | |
| Clinical Impact: | Tapentadol may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. |
| Intervention: | Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of NUCYNTA ER and/or the muscle relaxant as necessary. Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, consider prescribing naloxone for the emergency treatment of opioid overdose [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS] |
| Examples: | cyclobenzaprine, metaxalone |
| Diuretics | |
| Clinical Impact: | Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. |
| Intervention: | Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed. |
| Anticholinergic Drugs | |
| Clinical Impact: | The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. |
| Intervention: | Monitor patients for signs of urinary retention or reduced gastric motility when NUCYNTA ER is used concomitantly with anticholinergic drugs. |
Read the entire FDA prescribing information for Nucynta ER (Tapentadol Extended-Release Film-Coated Tablets)
&Copy; Nucynta ER Patient Information is supplied by Cerner Multum, Inc. and Nucynta ER Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.