What is TAPENTADOL HYDROCHLORIDE used for?

TAPENTADOL HYDROCHLORIDE (brand name TAPENTADOL) is a Opioid Analgesic indicated for abuse, and misuse with opioids, which can occur at any dosage or duration.

What are the most common side effects of TAPENTADOL HYDROCHLORIDE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for TAPENTADOL HYDROCHLORIDE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is TAPENTADOL HYDROCHLORIDE the same as TAPENTADOL?

TAPENTADOL is a brand name for TAPENTADOL HYDROCHLORIDE. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

TAPENTADOL HYDROCHLORIDE

Q: How does TAPENTADOL HYDROCHLORIDE work?

TAPENTADOL HYDROCHLORIDE works through the following mechanism: 12.1 Mechanism of Action Tapentadol is a centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that tapentadol is a mu-opioid receptor (MOR) agonist and a norepinephrine reuptake inhibitor (NRI). Analgesia in animal models is derived from both of these properties..

Opioid Analgesic

Brand names: TAPENTADOL

Oral

Mechanism of Action

12.1 Mechanism of Action Tapentadol is a centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that tapentadol is a mu-opioid receptor (MOR) agonist and a norepinephrine reuptake inhibitor (NRI). Analgesia in animal models is derived from both of these properties.

Indications

abuse

and misuse with opioids

which can occur at any dosage or duration

and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1) ]

reserve tapentadol extended-release tablets for use in patients for whom alternative treatment options (e.g.

non-opioid analgesics or immediate-release opioids) are ineffective

Contraindications

• including paralytic ileus Hypersensitivity (e.g.
• anaphylaxis

FDA Warnings

5 WARNINGS AND PRECAUTIONS Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain
10 ) Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness : Monitor for sedation and respiratory depression
As an opioid, tapentadol extended-release tablets expose users to the risks of addiction, abuse, and misuse
Because extended-release products such as tapentadol extended-release tablets deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of tapentadol present [see Drug Abuse and Dependence (9) ]

Known Side Effects

6 documented side effects by frequency

Drug Not Working

0.1-1%

Nausea

0.1-1%

Fatigue

0.1-1%

Headache

0.1-1%

Dizziness

0.1-1%

Drowsiness

0.1-1%

Community Discussions

No community discussions found for TAPENTADOL HYDROCHLORIDE yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → TAPENTADOL HYDROCHLORIDE openFDA label JSON → TAPENTADOL HYDROCHLORIDE FAERS adverse-event reports → TAPENTADOL HYDROCHLORIDE ClinicalTrials.gov → completed Phase 2+ trials of TAPENTADOL HYDROCHLORIDE

Compare With

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Formulations

Dosage Forms

Tablet

Route

Oral