NUCYNTA ER SIDE EFFECTS
- Generic Name: tapentadol extended-release film-coated tablets
- Brand Name: Nucynta ER
- Drug Class: Opioid Analgesics, Synthetic, Opioids
SIDE EFFECTS
The following serious adverse reactions are described, or described in greater detail, in other sections:
- Addiction, Abuse, and Misuse
- Life-Threatening Respiratory Depression
- Neonatal Opioid Withdrawal Syndrome
- Interaction with Benzodiazepine or Other CNS Depressants
- Serotonin Syndrome
- Adrenal Insufficiency
- Severe Hypotension
- Gastrointestinal Adverse Reactions
- Seizures
- Withdrawal
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.
SRC: NLM .