Drug Safety Information for NUCYNTA ER (Tapentadol hydrochloride)
REMS for Nucynta (TAPENTADOL HYDROCHLORIDE) Rx Drug: Safety Information Link
Shared FDA Risk Evaluation and Mitigation Strategy
FDA Safety-related Labeling Changes for NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for NUCYNTA (TAPENTADOL HYDROCHLORIDE) Rx Drug: Safety Information Link
various updates including risk of life threatening respiratory depression Consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration (2.2), Warnings and Precautions
Required post-approval safety study:
Deferred pediatric study under PREA: A pharmacokinetic, efficacy, and safety study of Nucynta ER for the management of chronic pain in pediatric patients ages 7 to <17 years. Due Date: 2023-12-31
Required post-approval safety study:
A prospective, observational study designed to quantify the serious risks of misuse, abuse, and addiction associated with long-term use of opioid analgesics for management of chronic pain among patients prescribed ER/LA opioid analgesics. This study must address at a minimum the following specific objectives: a. Estimate the incidence of misuse, abuse, and addiction associated with long-term use of opioid analgesics for chronic pain. Examine the effect of product/formulation, dose and duration of opioid use, prescriber specialty, indication, and other clinical factors (e.g., concomitant psychotropic medications, personal or family history of substance abuse, history of psychiatric illness) on the risk of misuse, abuse, and addiction. b. Evaluate and quantify other risk factors for misuse, abuse, and addiction associated with long-term use of opioid analgesics for chronic pain, including but not limited to the following: demographic factors, psychosocial/behavioral factors, medical factors, and genetic factors. Identify confounders and effect modifiers of individual risk factor/outcome relationships. Due Date: 2020-03-31
Original FDA Drug Approval Date for NUCYNTA ER: 2011-08-25
Adverse Drug Reactions for NUCYNTA ER* (Tapentadol hydrochloride)
These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).
Top 20 Adverse Effects Associated with NUCYNTA ER
(reported in FDA Medwatch/FAERS Reports)
| Side Effect | # of FDA Reports | |
|---|---|---|
| 1 | Drug ineffective* | 273 |
| 2 | Nausea* | 201 |
| 3 | Pain | 179 |
| 4 | Drug dose omission | 160 |
| 5 | Dizziness* | 128 |
| 6 | Headache* | 122 |
| 7 | Somnolence* | 119 |
| 8 | Hallucination | 118 |
| 9 | Confusional state | 107 |
| 10 | Feeling abnormal | 105 |
| 11 | Dyspnoea | 104 |
| 12 | Vomiting | 103 |
| 13 | Depression | 93 |
| 14 | Fatigue | 92 |
| 15 | Serotonin syndrome | 92 |
| 16 | Toxicity to various agents | 86 |
| 17 | Diarrhoea | 82 |
| 18 | Insomnia* | 81 |
| 19 | Malaise | 79 |
| 20 | Drug interaction | 77 |
* This side effect also appears in "Top 10 Side Effects of NUCYNTA ER " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking NUCYNTA ER
(associated with FDA Medwatch/FAERS Reports)
| Reason | # of FDA Reports | |
|---|---|---|
| 1 | Pain* | 2464 |
| 2 | Product used for unknown indication | 2287 |
| 3 | Back pain* | 759 |
| 4 | Procedural pain | 316 |
| 5 | Breakthrough pain | 204 |
| 6 | Analgesic therapy | 187 |
| 7 | Arthralgia | 173 |
| 8 | Neuralgia* | 172 |
| 9 | Fibromyalgia | 143 |
| 10 | Neuropathy peripheral | 73 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for NUCYNTA ER
Total Reports Filed with FDA: 9893
Number of FDA Adverse Event Reports by Patient Age for NUCYNTA ER
Total Reports Filed with FDA: 9893*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Tapentadol hydrochloride (Nucynta er, Nucynta)
Charts are based on 9893 reports filed with the FDA between 2004 and June 2015.
Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.
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Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.