PlainMeds provides educational information only. This is not medical advice. Always consult your doctor or pharmacist.

tapentadol

Verify with FDA → · CMS NADAC pricing →

Brand names: Nucynta

Opioid / Norepinephrine Reuptake Inhibitor Rx

Nucynta is a strong pain medicine. It is used to treat severe acute pain when other pain medicines are not strong enough.

Drug Pricing (NADAC)

Brand Price

$15.80/unit

Generic Available

Yes (1 manufacturer)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Nucynta is used to manage acute pain in adults and children (6 years and older weighing at least 88 pounds).

Common side effects

Feeling sick to your stomach (nausea), Feeling dizzy, Throwing up (vomiting)

Key warnings

Nucynta can cause addiction, abuse, and misuse, which can lead to overdose and death.

How It Works

Nucynta works in two ways to relieve pain. It acts on opioid receptors in the brain to reduce pain signals. It also prevents the reuptake of norepinephrine, which can also help reduce pain.

How to Take It

Take Nucynta exactly as your doctor tells you. You can take it with or without food. Your doctor will prescribe the lowest dose that works for you, for the shortest time needed. Do not change your dose without talking to your doctor.

Pregnancy & Breastfeeding

Using Nucynta for a long time during pregnancy can cause withdrawal symptoms in the newborn. Talk to your doctor about the risks if you are pregnant or plan to become pregnant. If you are breastfeeding, monitor your baby closely for any signs of drowsiness or breathing problems.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.

Storage

Store Nucynta at room temperature (68°F to 77°F) in a safe place, protected from moisture and out of reach of children.

Side Effects (from patient reports)

Based on 32,561 FDA adverse event reports.

Death
11,543
Harm from drugs or chemicals
9,292
Took too much medicine
5,817
Misusing medicine
1,414
Need for the drug
977
Baby has withdrawal symptoms from mother's medicine
932
Medicine not working
808
Took too much medicine by accident
656
Pain
602
Feeling sick to your stomach
520

FDA Adverse Event Report Analysis

Detailed analysis of 33,054 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2005–2025.

Total Reports

33,054

Death-Related Reports

20,529

Hospitalization Reports

4,458

Top Indication

Pain

Gender Distribution

Female 5,453 (63%)
Male 3,147 (36%)

Age Distribution

0–17 176
18–44 1,173
45–64 2,412
65–74 977
75+ 843

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 DEATH 11,641
2 TOXICITY TO VARIOUS AGENTS 9,719
3 OVERDOSE 5,886
4 DRUG ABUSE 1,549
5 DRUG DEPENDENCE 1,063
6 DRUG INEFFECTIVE 1,004
7 DRUG WITHDRAWAL SYNDROME NEONATAL 944
8 PAIN 743
9 NAUSEA 713
10 ACCIDENTAL OVERDOSE 705
11 FATIGUE 433
12 HEADACHE 408
13 DIZZINESS 403
14 INTENTIONAL PRODUCT MISUSE 398
15 SOMNOLENCE 386

Reactions in Death Reports

DEATH 11,633
TOXICITY TO VARIOUS AGENTS 8,078
OVERDOSE 5,602
DRUG ABUSE 1,213
ACCIDENTAL OVERDOSE 677
DRUG DEPENDENCE 648
INTENTIONAL PRODUCT MISUSE 327
COMPLETED SUICIDE 193
DRUG DIVERSION 109
DRUG INTERACTION 95

Reactions in Hospitalization Reports

TOXICITY TO VARIOUS AGENTS 1,497
DRUG ABUSE 414
DEATH 332
OVERDOSE 239
NAUSEA 183
PAIN 164
FALL 151
VOMITING 150
DRUG INEFFECTIVE 140
DRUG DEPENDENCE 131

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Nucynta can cause addiction, abuse, and misuse, which can lead to overdose and death. Your doctor will check your risk before prescribing and regularly during treatment. This medicine can also cause life-threatening breathing problems, especially when you start taking it or after a dose increase. Taking Nucynta with benzodiazepines (like Xanax or Valium), alcohol, or other CNS depressants can cause sleepiness, slowed breathing, coma, and death. Accidental ingestion, especially by children, can cause a fatal overdose. If you are pregnant and use Nucynta for a long time, your baby could have withdrawal symptoms after birth.

Known Drug Interactions

Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids,...

Mechanism: Taking these drugs together increases the risk of dangerous slowing of your breathing. They can also cause a serious buildup of a brain chemical called serotonin.

What to do: Use these medications together only if your doctor determines it is necessary. Monitor closely for extreme sleepiness or trouble breathing.

moderate metaxalone

Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids,...

Mechanism: Both of these medications can slow down your breathing and affect your brain's serotonin levels. Combining them makes these side effects more likely and more severe.

What to do: Your healthcare provider should monitor you closely for signs of respiratory distress. Avoid this combination unless specifically directed by your doctor.

Product Clinical Comment on Concomitant Use [See Contraindications (4.1)] ; Predominant Effect/Risk [Hypertensive Reaction (HR) [See Warnings and Precautions (5.3)] ; or Serotonin Syndrome (SS) [See Warnings and Precautions (5.7)] ] Altretamine Use with caution If not otherwise specified in this table, consider avoiding concomitant use (see also information on medication-free intervals , use agent at the lowest appropriate dose, monitor for effects of the interaction, advise the patient to report potential effects, and be prepared to discontinue the agent and treat effects of the interactio...

Mechanism: Combining these can lead to a toxic level of serotonin or a sudden rise in blood pressure. Both drugs increase chemicals in your system that can cause these serious side effects.

What to do: You should generally avoid taking these two drugs at the same time. If you must use both, your doctor will need to watch your health very carefully.

Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol.

Mechanism: Both drugs are sedatives that slow down your brain and nervous system. Taking them together can make you feel very sleepy or make it hard to breathe.

What to do: Use this combination with caution and watch for signs of extreme drowsiness or slow breathing.

Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Mechanism: Both medications increase a brain chemical called serotonin. If serotonin levels get too high, it can cause a serious medical problem called serotonin syndrome.

What to do: Watch for signs like confusion, sweating, or muscle shakes, and tell your doctor immediately if you notice these symptoms.

Check all your medications →

Common Questions

Can I stop taking Nucynta suddenly?
No, do not stop taking Nucynta suddenly. Stopping suddenly can cause withdrawal symptoms.
Can Nucynta cause constipation?
Yes, constipation is a possible side effect.
Is Nucynta a strong painkiller?
Yes, Nucynta is a strong opioid painkiller.
Can I drink alcohol while taking Nucynta?
No, do not drink alcohol while taking Nucynta. It can cause dangerous side effects.
What should I do if I think I have taken too much Nucynta?
Seek emergency medical help right away.
Can Nucynta make me feel sleepy?
Yes, sleepiness is a common side effect.
Will Nucynta interact with my other medications?
Yes, Nucynta can interact with other medications. Tell your doctor about all the medicines you take.
How often can I take Nucynta?
Take Nucynta as prescribed by your doctor, usually every 4 to 6 hours.
Can Nucynta be used for long-term pain?
Nucynta is usually used for acute pain. Your doctor will decide if it is right for you.
Is Nucynta addictive?
Yes, Nucynta is an opioid and can be addictive.
What are the common side effects of tapentadol?
The most commonly reported side effects of tapentadol include Feeling sick to your stomach (nausea), Feeling dizzy, Throwing up (vomiting), Feeling sleepy. Based on 32,561 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does tapentadol interact with other medications?
Yes, tapentadol has 16 known drug interactions. Notable interactions include cyclobenzaprine, metaxalone, tranylcypromine. Always inform your doctor about all medications you are taking.
What drug class is tapentadol?
tapentadol belongs to the Opioid / Norepinephrine Reuptake Inhibitor drug class. It requires a prescription (Rx). Nucynta is used to manage acute pain in adults and children (6 years and older weighing at least 88 pounds).
Is tapentadol safe during pregnancy?
Using Nucynta for a long time during pregnancy can cause withdrawal symptoms in the newborn. Talk to your doctor about the risks if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Related Medications in Opioid / Norepinephrine Reuptake Inhibitor

Other drugs grouped near tapentadol — same-class peers and common alternatives.

Compare tapentadol vs abatacept side-by-side →

Medication Guides

Related Health & Safety Data

Save on tapentadol

Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.

Disclosure: This link may earn us a commission at no extra cost to you. See our terms.

What the FDA Data Shows for tapentadol

The FDA label for tapentadol (sold under brand names such as Nucynta) classifies it as a prescription-only medication in the Opioid / Norepinephrine Reuptake Inhibitor class. Nucynta is used to manage acute pain in adults and children (6 years and older weighing at least 88 pounds). Official labeling lists 4 commonly reported side effects, including Feeling sick to your stomach (nausea), Feeling dizzy, Throwing up (vomiting).

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 32,561 voluntary reports. The database also lists 16 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: December 30, 2025

All federal data sources used on this page