Note: This document contains side effect information about tapentadol. Some dosage forms listed on this page may not apply to the brand name Nucynta ER.
Applies to tapentadol: oral conventional tablets, oral extended-release tablets, oral oral solution.
Warning
Special Alerts:
- FDA drug safety communication (4/13/2023):500 As part of its ongoing efforts to address the nation’s opioid crisis, FDA is requiring several updates to the prescribing information of opioid pain medicines. The changes are being made to provide additional guidance for safe use of these drugs while also recognizing the important benefits when used appropriately. The changes apply to both immediate-release (IR) and extended-release/long-acting preparations (ER/LA).
- Updates to the IR opioids state that these drugs should not be used for an extended period unless the pain remains severe enough to require an opioid pain medicine and alternative treatment options are insufficient, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
- Updates to the ER/LA opioids recommend that these drugs be reserved for severe and persistent pain requiring an extended period of treatment with a daily opioid pain medicine and for which alternative treatment options are inadequate.
- A new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal.
- Information in the boxed warning for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS).
- Other changes will also be required in various other sections of the prescribing information to educate clinicians, patients, and caregivers about the risks of these drugs.
REMS:
FDA approved a REMS for tapentadol to ensure that the benefits outweigh the risk. The REMS may apply to one or more preparations of tapentadol and consists of the following: medication guide and elements to assure safe use. See the FDA REMS page ([Web]).
Side effects include:
Nausea, dizziness, vomiting, somnolence, constipation, pruritus, dry mouth, hyperhidrosis, fatigue, headache, vomiting, diarrhea, decreased appetite, anxiety, insomnia, dyspepsia, hot flush. In several clinical studies, adverse GI effects (nausea, vomiting, constipation) reported more commonly with oxycodone than with tapentadol (the active ingredient contained in Nucynta ER)
For Healthcare Professionals
Applies to tapentadol: oral tablet, oral tablet extended release.
General
The most common adverse reactions were nausea, dizziness, vomiting, constipation, headache, and somnolence.[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 30%), vomiting (up to 18%), constipation (up to 17%)
Common (1% to 10%): Dry mouth, dyspepsia, diarrhea, abdominal discomfort
Rare (less than 0.1%): Impaired gastric emptying[Ref]
Nervous system
Very common (10% or more): Dizziness (up to 24%), headache (up to 15%), somnolence (up to 15%)
Common (1% to 10%): Tremor, lethargy, vertigo, disturbance in attention, sedation, hypoesthesia
Uncommon (0.1% to 1%): Memory impairment, mental impairment, syncope, balance disorder, dysarthria, paresthesia, depressed level of consciousness, presyncope, ataxia
Rare (less than 0.1%): Convulsion, coordination abnormal
Frequency not reported: Seizure, serotonin syndrome[Ref]
Psychiatric
Common (1% to 10%): Insomnia, confusion, abnormal dreams, anxiety, depression, irritability, nervousness, drug withdrawal syndrome, restlessness, sleep disorder, hallucination, depressed mood
Uncommon (0.1% to 1%): Disorientation, agitation, perception disturbances, euphoric mood, nightmare
Rare (less than 0.1%): Thinking abnormal, drug dependence
Postmarketing reports: Suicidal ideation, panic attack[Ref]
Other
Common (1% to 10%): Fatigue, asthenia, chills, edema, feeling hot, feeling cold, feeling of body temperature change, mucosal dryness
Uncommon (0.1% to 1%): Feeling abnormal, feeling drunk, feeling of relaxation[Ref]
Dermatologic
Common (1% to 10%): Pruritus, hyperhidrosis, pruritus generalized, rash, flushing
Uncommon (0.1% to 1%): Urticaria
Postmarketing reports: Angioedema[Ref]
Respiratory
Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, dyspnea
Uncommon (0.1% to 1%): Respiratory depression, oxygen saturation decreased, cough[Ref]
Cardiovascular
Common (1% to 10%): Hot flush, hypotension
Uncommon (0.1% to 1%): Heart rate increased, heart rate decreased, blood pressure decreased, palpitations, left bundle branch block[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection, erectile dysfunction
Uncommon (0.1% to 1%): Urinary hesitation, pollakiuria, sexual dysfunction[Ref]
Musculoskeletal
Common (1% to 10%): Myalgia, involuntary muscle contractions, muscle spasms
Uncommon (0.1% to 1%): Bone pain, sensation of heaviness[Ref]
Metabolic
Common (1% to 10%): Decreased appetite
Uncommon (0.1% to 1%): Weight decreased[Ref]
Ocular
Common (1% to 10%): Vision blurred
Uncommon (0.1% to 1%): Visual disturbance[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Anaphylaxis, anaphylactic shock[Ref]
Hepatic
Uncommon (0.1% to 1%): GGT increased, ALT increased, AST increased[Ref]
