Side Effects of tapentadol: A Synthesis of Findings from 31 Studies

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Original Abstract of the Article

Main Research Findings

Tapentadol is a novel atypical opioid. Anecdotal evidence suggests that tapentadol has a lower toxicity than conventional opioids. 6 . Tapentadol has been shown to be more effective than conventional opioids for the treatment of chronic pain with fewer side effects, including gastrointestinal symptoms, drowsiness, and dizziness. 24 . Tapentadol has been shown to have lower potential for addiction and abuse with a lower risk of dependence. 14 .

Reasons for Side Effects

Tapentadol's side effects are due to both its μ-opioid receptor agonist and norepinephrine reuptake inhibitor actions. 21 . Tapentadol may have fewer side effects such as gastrointestinal symptoms and drowsiness compared to conventional opioids, which may be due to its norepinephrine reuptake inhibitor action. 7 .

Common Side Effects

Gastrointestinal

Tapentadol can cause constipation, a well-known side effect of opioids. 8 . However, it has been shown that the incidence of gastrointestinal symptoms is lower compared to conventional opioids. 26 . 2 . Tapentadol may also cause nausea and vomiting. 1 .

Central Nervous System

Tapentadol may cause side effects such as drowsiness, dizziness, and headache. 1 . Tapentadol can also impair concentration and cognitive function. 7 . Additionally, tapentadol can intensify side effects such as respiratory depression when used in combination with other central nervous system depressants. 3 .

Other

Tapentadol can cause skin symptoms such as rash and itching. 1 . Tapentadol can change blood pressure and heart rate. 7 . Tapentadol can also alter hormone levels. 7 . Tapentadol may have an impact on bone metabolism. 31 .

Countermeasures for Side Effects

Constipation

Constipation caused by tapentadol can be improved with diet and exercise. 5 . Laxatives may also be used if necessary. 5 .

Drowsiness

Drowsiness caused by tapentadol can be improved by adjusting the dosage. 1 . If drowsiness is severe, it is important to avoid driving or operating machinery. 1 .

Respiratory Depression

Tapentadol poses a risk of respiratory depression. 3 . Consult a doctor immediately if respiratory depression is suspected. 3 .

Comparison between Studies

Commonalities among Studies

Many studies have shown that tapentadol is more effective than conventional opioids and has fewer side effects, including gastrointestinal symptoms and drowsiness. 26 . 24 . 7 .

Differences among Studies

There is some variability in the side effects of tapentadol among studies. 1 . This is likely due to differences in research methods and subject characteristics. 1 . Additionally, the incidence of tapentadol side effects may vary depending on the dosage and duration of use. 1 .

Points to Note Regarding Real-Life Application

While tapentadol is an effective drug for treating chronic pain, it is important to remember that it carries a risk of side effects. 3 . When taking tapentadol, it is crucial to follow the doctor's instructions and take the appropriate dosage. 3 . If you experience side effects such as drowsiness while taking tapentadol, you should take safety precautions, such as avoiding driving or operating machinery. 1 . Tapentadol can intensify side effects such as respiratory depression when combined with other central nervous system depressants. 3 . Therefore, it is important to consult your doctor if you are taking other medications. 3 .

Limitations of Current Research

Research on the safety and effectiveness of tapentadol is still insufficient. 26 . In particular, research on long-term safety and effectiveness is lacking. 26 .

Future Research Directions

Further research is needed to evaluate the long-term safety and effectiveness of tapentadol. 26 . Additionally, research on the addiction and abuse potential of tapentadol is necessary. 14 .

Conclusion

Tapentadol is considered to be a drug that is more effective than conventional opioids and has fewer side effects, including gastrointestinal symptoms and drowsiness. 26 . However, tapentadol also carries risks such as addiction and abuse. 14 . It is crucial to follow the doctor's instructions and take the appropriate dosage when taking tapentadol. 3 .

Keywords
Benefit Keywords
Less GI side effects
Pain relief
1
Improved pain management
Reduced GI side effects
2
Gastrointestinal tolerability
Hepatic and renal safety
Improved tolerability
Pain relief
3
Chronic pain management
Pain relief
4
Pain management
5
Lower toxicity than conventional opioids
6
Chronic pain treatment
Neuropathic pain treatment
7
Minimal digestive side effects
Pain relief
8
Improved chronic pain treatment
9
Postoperative pain management
10
Noninferior to TAP
Superior efficacy
11
Long-term analgesia
12
Reduced gastrointestinal adverse effects
13
analgesia
low abuse
14
Opioid tolerability
Pain relief
15
Improved neck function
Pain reduction
Reduced neuropathic symptoms
16
Cancer pain relief
17
Diabetic neuropathy
Pain management
18
Analgesic effect
19
Improved gastrointestinal tolerability
Improved overall health
Reduced knee pain
20
Analgesic effects
21
Reduced oxidative stress
23
Reduced side effects
24
Reduced side effects
Synergistic analgesia
25
Chronic pain relief (tapentadol)
26
Pain relief
27
Musculoskeletal pain treatment
28
Lower side effects
Pain relief
29
Pain management
30
Early detection of hormonal impairment
31
Risk Keywords
CNS depressant interactions
Contraindicated with MAOIs
Dizziness
Nausea
Somnolence
Vomiting
3
Opioid-related side effects
5
Mortality
Serious adverse effects
6
Cognitive impairment
Gastrointestinal side effects
Hormonal changes
Serotonin syndrome
7
Constipation
Nausea
Somnolence
8
Drug interactions
Opioid side effects
9
Preoperative opioid use
10
None reported
11
Narcotic side effects
12
gastrointestinal side effects
14
Erythema
Vomiting
15
GI side effects
18
Constipation
Gastrointestinal adverse events
Nausea
Vomiting
20
Opioidergic side-effects
21
Opioid mortality
Opioid overdose
22
Opioid side effects
23
Opioid risks
Tapentadol AE uncertainty
26
Toxicity
27
Constipation
Nausea
29
Abuse risk
Addiction risk
Misuse risk
30
Increased risk of fracture
Opioid-associated androgen deficiency
Opioid-induced hypogonadism
Osteoporosis
31
Literature analysis of 31 papers
Positive Content
28
Neutral Content
0
Negative Content
3
Article Type
3
4
4
9
31
1.

[Undesired side effects of tapentadol in comparison to oxycodone. A meta-analysis of randomized controlled comparative studies].

Author: MerkerM, DingesG, KochT, KrankeP, MorinA M

Less GI side effects
Pain relief

This study reviewed randomized controlled trials comparing tapentadol and oxycodone for pain management. The objective was to evaluate the relative amount of adverse effects associated with each drug.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : German

2.

Tapentadol results in less deterioration of gastrointestinal function and symptoms than standard opioid therapy in healthy male volunteers.

Author: MarkEsben Bolvig, NedergaardRasmus Bach, HansenTine Maria, NissenThomas Dahl, FrøkjaerJens Brøndum, ScottS Mark, KroghKlaus, DrewesAsbjørn Mohr

Improved pain management
Reduced GI side effects

This study aims to investigate the effects of tapentadol and oxycodone on gastrointestinal motility and side effects, focusing on a more precise assessment of mechanistic effects and comparisons with other opioids or placebo.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Safe Use of Opioids in Chronic Kidney Disease and Hemodialysis Patients: Tips and Tricks for Non-Pain Specialists.

Author: ColuzziFlaminia, CaputiFrancesca Felicia, BilleciDomenico, PastoreAntonio Luigi, CandelettiSanzio, RoccoMonica, RomualdiPatrizia

Pain management
Opioid-related side effects

This review focuses on the correct and safe use of opioids in patients with chronic kidney disease (CKD) and hemodialysis (HD).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

6.

Toxicity of tapentadol: a systematic review.

Author: ChannellJessie S, SchugStephan

Lower toxicity than conventional opioids
Mortality
Serious adverse effects

Tapentadol use, whether prescribed or abused, has been associated with mortality and serious adverse events including respiratory depression, confusion, coma, hallucination, seizures, tachycardia, hypertension, agitation, tremor, miosis, hypotension, dyspnea, electrolyte abnormality, atrial fibrillation, and severe upper abdominal pain.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

8.

[Clinical Utility of Tapentadol].

Author: KanazawaKunihito, YoshizawaAkitaka, IshigureHiroyuki, ShimodaAtsuko, HiratsukaRie, IkedaHiroyoshi, YoshizawaTakayuki

Minimal digestive side effects
Pain relief
Constipation
Nausea
Somnolence

Tapentadol, a new strong opioid analgesic, has shown promise in treating neuropathic pain with a sedative response rate of 70%. The most common side effects were somnolence, nausea, and constipation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : Japanese

9.

Current considerations for the treatment of severe chronic pain: the potential for tapentadol.

Author: PergolizziJoseph, AlegreCayetano, BlakeDavid, AlénJaime Calvo, CaporaliRoberto, CasserHans-Raimund, Correa-IllanesGerardo, FernandesPedro, GalileaEugenio, JanyRichard, JonesAnthony, MejjadOthmane, Morovic-VerglesJadranka, Oteo-ÁlvaroÁngel, ÁlvaroÁngel Oteo, Radrigán ArayaFrancisco J, SimõesMaria Eugénia C, UomoGeneroso

Improved chronic pain treatment
Drug interactions
Opioid side effects

Tapentadol, a novel analgesic combining μ-opioid receptor agonism and noradrenaline reuptake inhibition, shows promise for treating chronic pain. Preclinical and clinical trials suggest that tapentadol offers similar efficacy to oxycodone with fewer gastrointestinal side effects and lower discontinuation rates, providing a potential alternative to current analgesics.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

10.

Considerations for perioperative opioid analgesic stewardship in Australia: a focus on tapentadol.

Author: Ternel LebretStephanie C

Postoperative pain management
Preoperative opioid use

Tapendatol is an opioid analgesic that is often used as an alternative to oxycodone for postoperative pain management in Australia. This review found that tapendatol was associated with lower rates of gastrointestinal adverse effects, less sedation, and a lower risk of persistent postoperative opioid use compared to oxycodone.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

13.

Pharmacokinetic and pharmacodynamic modeling of opioid-induced gastrointestinal side effects in patients receiving tapentadol IR and oxycodone IR.

Author: XuXu Steven, EtropolskiMila, UpmalisDavid, OkamotoAkiko, LinRachel, NandyPartha

Reduced gastrointestinal adverse effects

Tapentadol showed a lower risk of opioid-related gastrointestinal adverse effects compared to oxycodone and its active metabolite, oxymorphone, supporting its clinical findings of reduced nausea, vomiting, and constipation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Evaluation of Abuse and Route of Administration of Extended-Release Tapentadol Among Treatment-Seeking Individuals, as Captured by the Addiction Severity Index-Multimedia Version (ASI-MV).

Author: VosburgSuzanne K, BeaumontJared, Dailey-GovoniS Taryn, ButlerStephen F, GreenJody L

analgesia
low abuse
gastrointestinal side effects

Tapentadol, an analgesic with dual mechanisms of action, shows low levels of abuse and diversion according to postmarketing surveillance data. This suggests potential for lower abuse liability compared to full mu opioid agonists.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

Oxycodone/naloxone versus tapentadol in real-world chronic non-cancer pain management: an observational and pharmacogenetic study.

Author: BarrachinaJordi, MargaritCesar, MurielJavier, López-GilSantiago, López-GilVicente, Vara-GonzálezAmaya, PlanellesBeatriz, IndaMaría-Del-Mar, MoralesDomingo, PeiróAna M

Opioid tolerability
Pain relief
Erythema
Vomiting

This study compared the effectiveness and safety of tapentadol (TAP) and oxycodone/naloxone (OXN) in patients with chronic non-cancer pain (CNCP). Both drugs showed significant pain relief compared to controls. OXN achieved greater pain relief but was associated with more adverse events. TAP showed better tolerability and had a lower number of adverse events. The study highlights the potential influence of pharmacogenetic markers on the response to OXN.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

17.

Spinal neuronal correlates of tapentadol analgesia in cancer pain: a back-translational approach.

Author: FalkS, PatelR, HeegaardA, MercadanteS, DickensonA H

Cancer pain relief

Tapentadol, a novel dual-action drug, is being investigated for its efficacy in treating cancer-induced bone pain.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

20.

Tapentadol prolonged-release for moderate-to-severe chronic osteoarthritis knee pain: a double-blind, randomized, placebo- and oxycodone controlled release-controlled study.

Author: SerrieAlain, LangeBernd, SteupAchim

Improved gastrointestinal tolerability
Improved overall health
Reduced knee pain
Constipation
Gastrointestinal adverse events
Nausea
Vomiting

Tapentadol prolonged release (PR) was better tolerated than oxycodone controlled release (CR) in patients with moderate-to-severe chronic osteoarthritis knee pain, with fewer gastrointestinal side effects.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

21.

Effect of tapentadol on neurons in the locus coeruleus.

Author: Torres-SanchezSonia, Alba-DelgadoCristina, Llorca-TorralbaMeritxell, MicoJuan A, BerrocosoEsther

Analgesic effects
Opioidergic side-effects

This study investigated the acute effects of tapentadol, a novel centrally acting analgesic, on the locus coeruleus (LC) in rats. Tapentadol inhibited the spontaneous activity of LC neurons in a dose-dependent manner, an effect that was primarily mediated by the activation of alpha2-adrenoceptors. These findings suggest that both the noradrenergic and opioid systems contribute to the analgesic effects of tapentadol.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

22.

Comparative Rates of Mortality and Serious Adverse Effects Among Commonly Prescribed Opioid Analgesics.

Author: MurphyDavid L, LebinJacob A, SevertsonStevan G, OlsenHeather A, DasguptaNabarun, DartRichard C

Opioid mortality
Opioid overdose

This study examined the relationship between potency of prescription opioid analgesics and serious adverse events (SAEs). There were 19,480 cases of SAE during the 7-year study period. Higher potency opioid analgesics were associated with a higher rate of SAEs per 100 kg of drug dispensed. This relationship was linear, with a 2.04 increase in SAEs per 100 kg of drug dispensed for each 1-unit rise in MME (p = 0.004).

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

24.

Tapentadol Safety and Patient Characteristics Associated with Treatment Discontinuation in Cancer Therapy: A Retrospective Multicentre Study in Japan.

Author: IwakiMichihiro, KessokuTakaomi, KanamoriTaro, AbeKentaro, TakenoNobuhiro, KawaharaRyoko, FujimotoTaisuke, IgarashiTakashi, KumakuraYasutomo, SuzukiNaoki, KamiyaKouhei, SuzukiNaoto, TagamiKeita, SaekiTomoya, MawatariHironori, SakuraiHiroki, HigashibataTakahiro, HirohashiTakeshi, NakajimaAtsushi, IchikawaYasushi, IshikiHiroto,

Reduced side effects

This multicenter study aimed to evaluate the safety of tapentadol, an opioid analgesic, in the Japanese population. It also sought to identify characteristics of patients who are more likely to discontinue tapentadol treatment due to adverse events.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

25.

Tapentadol versus oxycodone analgesia and side effects after laparoscopic hysterectomy: A randomised controlled trial.

Author: ComelonMarlin, RaederJohan, DrægniTomas, LiengMarit, LenzHarald

Reduced side effects
Synergistic analgesia

Tapentadol, an opioid with a dual mechanism of action, was investigated for its effectiveness in postoperative pain management.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

26.

Safety of tapentadol compared with other opioids in chronic pain treatment: network meta-analysis of randomized controlled and withdrawal trials.

Author: FreynhagenR, EllingC, RadicT, SohnsM, LiedgensH, JamesD, McCoolR, EdwardsM

Chronic pain relief (tapentadol)
Opioid risks
Tapentadol AE uncertainty

Tapentadol is associated with lower odds of adverse events compared to other opioid analgesics for moderate or severe chronic pain in adults. However, it should be prescribed only after other analgesics have been considered.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

27.

Comparative pharmacology and toxicology of tramadol and tapentadol.

Author: FariaJ, BarbosaJ, MoreiraR, QueirósO, CarvalhoF, Dinis-OliveiraR J

Pain relief
Toxicity

Tapentadol, an opioid analgesic, has potential advantages over tramadol, including lower serotonergic, dependence, and abuse potential. Both drugs cause similar toxicological damage.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

28.

Clinical and economic evaluation of tapentadol extended release and oxycodone/naloxone extended release in comparison with controlled release oxycodone in musculoskeletal pain.

Author: ColuzziFlaminia, RuggeriMatteo

Musculoskeletal pain treatment

This meta-analysis compared the clinical and economic effectiveness of tapentadol ER and oxycodone/naloxone ER for treating musculoskeletal pain with controlled-release (CR) oxycodone. The analysis suggests that tapentadol ER and oxycodone/naloxone ER may be effective alternatives to CR oxycodone for treating musculoskeletal pain.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

29.

Efficacy and Safety of Tapentadol Immediate Release Assessment in Treatment of Moderate to Severe Pain: A Systematic Review and Meta-Analysis.

Author: XiaoJing-Ping, LiAi-Ling, FengBi-Min, YeYun, WangGuo-Jun

Lower side effects
Pain relief
Constipation
Nausea

This meta-analysis of nine RCTs found that tapentadol IR (50, 75, and 100 mg doses) provided significant improvements in moderate to severe pain relief compared to placebo. Tapentadol IR 75 mg was found to be an optimal dose, providing comparable efficacy to oxycodone HCL IR 10 mg with fewer side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

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