Drug Safety Information for NUCYNTA (Tapentadol hydrochloride)

REMS for Nucynta (TAPENTADOL HYDROCHLORIDE) Rx Drug: FDA Link

Shared FDA Risk Evaluation and Mitigation Strategy

Safety-related Labeling Changes for NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for NUCYNTA (TAPENTADOL HYDROCHLORIDE) Rx Drug: FDA 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:

Pharmacokinetic, efficacy, and safety study or studies of Nucynta for the management of moderate to severe acute pain in pediatric patients ages birth to less than 17 years. Due Date: 2021-12-31

Original FDA Drug Approval Date for NUCYNTA: 2008-11-20

Adverse Drug Reactions for NUCYNTA* (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
(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 " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking NUCYNTA
(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

Total Reports Filed with FDA: 9893

Number of FDA Adverse Event Reports by Patient Age for NUCYNTA

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.

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.