NUCYNTA SIDE EFFECTS
- Generic Name: tapentadol extended-release film-coated tablets
- Brand Name: Nucynta ER
- Drug Class: Opioid Analgesics, Synthetic, Opioids
SIDE EFFECTS
The following adverse reactions are discussed, or described in greater detail in other sections:
- Addiction, Abuse, and Misuse
- Life-Threatening Respiratory Depression
- Neonatal Opioid Withdrawal Syndrome
- Interactions with CNS Benzodiazepine or Other Depressants
- Serotonin Syndrome
- Adrenal Insufficiency
- Severe Hypotension
- Gastrointestinal Adverse Reactions
- Seizures
- Withdrawal
Clinical Trials 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 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 | ||
| 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: urticarial
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 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.
Gastrointestinal disorders: diarrhea
Nervous system disorders: headache
Psychiatric disorders: hallucination, suicidal ideation, panic attack
Cardiac disorders: palpitations
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
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 oral solution.
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids.