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Dexketoprofen

AEMPS

Non-steroidal anti-inflammatory drugs, propionic acid derivatives

ATC code: M01AE17

Brand names: Enantyum

Updated · Methodology

Indications

A

Mild to moderate pain in adults

First line

Dexketoprofen 25 mg orally or 50 mg IM/IV is first-line therapy for acute mild-to-moderate pain: postoperative pain, dental pain, primary dysmenorrhea, musculoskeletal pain. Cochrane review Barden 2009 (10 RCTs, n=2155) showed NNT=3.2 for 20–25 mg in postoperative pain – comparable to other NSAIDs. Advantage of dexketoprofen is faster onset (30 minutes vs 60 minutes for ibuprofen and paracetamol). Maximum daily dose 75 mg (three 25 mg doses). Treatment course should not exceed 7 days.

Sources

  1. AEMPS: Ficha técnica de Dexketoprofeno (2024)
  2. Cochrane Database Syst Rev: Single dose oral ketoprofen or dexketoprofen for acute postoperative pain in adults. (2017)

ICD-10: R52 · ICD-11: MG31

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Memory and concentration enhancement

Not recommended

Dexketoprofen is a nonsteroidal anti-inflammatory drug (NSAID). It is prescribed for short-term symptomatic treatment of acute pain (AEMPS Ficha Técnica). For unconfirmed migraine, any headache, or vigor in fatigue, dexketoprofen is not used: for migraine, triptans and other proven options work; for fatigue, NSAIDs do not help (they are not an anti-fatigue drug). Regular dexketoprofen use creates risks of severe gastrointestinal bleeding, perforation, cardiovascular events, and acute kidney injury. If dexketoprofen was prescribed for migraine or vigor, consider seeking a second opinion.

Sources

  1. AEMPS: Ficha técnica de Dexketoprofeno (2024)
  2. Cochrane: Ginkgo biloba for cognitive impairment and dementia (2009)
How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Dexketoprofen is the dextrorotatory enantiomer of ketoprofen (S-(+)-ketoprofen), the active form. It non-selectively inhibits cyclooxygenases COX-1 and COX-2, blocking prostaglandin and thromboxane synthesis. Analgesic and anti-inflammatory effect develops within 30 minutes after oral administration, peak at 30–60 minutes. Half-life 1.65 hours – substantially shorter than racemic ketoprofen. Efficacy is comparable to diclofenac 50 mg and ibuprofen 400 mg at lower dose and with faster onset.

Safety

Contraindications

  • Hypersensitivity to NSAIDs
  • Active peptic ulcer disease
  • GI bleeding
  • Severe hepatic or renal impairment
  • Severe heart failure (NYHA IV)
  • Third trimester pregnancy
  • Breastfeeding
  • Age under 18 (tablets – use cautiously in adolescents)
  • Aspirin-induced asthma

Serious adverse effects

  • GI bleeding and perforation
  • Acute kidney injury
  • Severe skin reactions (Stevens-Johnson syndrome)
  • Bronchospasm in aspirin-sensitive asthma
  • Acute cardiovascular events (increased risk with long-term high doses)

Common adverse effects

  • Nausea, heartburn, abdominal discomfort
  • Diarrhoea
  • Headache, dizziness
  • Rash
  • Transaminase elevation

Pregnancy: can you take Dexketoprofen?

AEMPS summary of product characteristics (section 4.6): dexketoprofen is contraindicated in the third trimester; in the first and second trimesters it is given only if absolutely necessary, at the lowest dose and for the shortest time. Epidemiological data suggest that prostaglandin synthesis inhibitors used early in pregnancy raise the risk of miscarriage, cardiac malformation and gastroschisis; the absolute risk of cardiovascular malformations rose from less than 1% to about 1.5%, and the risk is thought to grow with dose and duration. From week 20, dexketoprofen can cause oligohydramnios from fetal renal dysfunction, usually reversible after stopping, and ductus arteriosus constriction has been reported after second-trimester treatment. After several days of exposure from week 20, antenatal monitoring for oligohydramnios and ductal constriction should be considered, and treatment is stopped if either is found. In the third trimester, prostaglandin synthesis inhibitors can cause premature constriction or closure of the ductus arteriosus, pulmonary hypertension and renal dysfunction in the fetus, and near term they can prolong bleeding time in the mother and newborn, even at very low doses, and delay or prolong labour.

Breastfeeding: can you take Dexketoprofen?

Contraindicated during breastfeeding: drug is excreted in breast milk.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Russian practice note

In Russia, dexketoprofen (Dexalgin, generics) is available as 25 mg tablets and 50 mg/2 mL injectable solutions. Cost of 10 tablets is 250–450 ₽. Take with food or after meals to reduce GI side effects. In patients at risk of NSAID gastropathy (age 65+, peptic ulcer history, anticoagulant use), combine with a proton pump inhibitor (omeprazole 20 mg/day).

Drug interactions

Standard NSAID profile. Enhances anticoagulant effect of warfarin, direct oral anticoagulants, and UFH – bleeding risk. Reduces antihypertensive effect of ACE inhibitors, ARBs, diuretics. With methotrexate, lithium, digoxin – their concentrations rise (renal clearance interaction). Combining with other NSAIDs is irrational – additive bleeding and gastropathy risk without analgesic enhancement.

Drug–drug interactions

2 pairs found. Sorted from critical to minor.

MajorIbuprofenNon-steroidal anti-inflammatory drugs (NSAIDs)

Mechanism

The dexketoprofen label lists other NSAIDs among the combinations that are not recommended and explains why: giving several NSAIDs together potentiates the risk of gastrointestinal ulcers and bleeding through a synergistic effect. Dexketoprofen acts fast and ibuprofen covers the hours that follow, leaving the mucosa without protective prostaglandins for most of the day.

Symptoms

Epigastric pain, nausea, black stools, vomiting blood. Reduced urine output, oedema and high blood pressure if the kidney was already compromised or the patient takes diuretics or ACE inhibitors. Pain may not improve despite the double dose, because the target is already saturated.

Management

Pick one of the two. Dexketoprofen is reserved for short courses of severe acute pain, and ibuprofen is withdrawn during that time, including self-medication for headache or period pain. To reinforce analgesia, add paracetamol, which does not share the mechanism.

Sources

Pair details →Ibuprofen →

MinorParacetamolAnilides. Analgesics and antipyretics

Mechanism

Dexketoprofen is an NSAID and paracetamol is not, so the label restriction on combining several NSAIDs does not apply here. The mechanisms differ: peripheral cyclooxygenase inhibition versus central action, which is why the pair is used in moderate acute pain. Neither drug alters the metabolism of the other.

Symptoms

No symptoms specific to the pair. Dexketoprofen brings the gastrointestinal and renal risk of any NSAID: epigastric pain, nausea, black stools, oedema or reduced urine output. Paracetamol brings hepatic risk once the 4 g daily limit is passed.

Management

They can be combined or alternated in acute pain. Dexketoprofen is used in short courses at the lowest effective dose and is not stacked with another NSAID. Paracetamol is counted separately, up to 4 g a day.

Sources

Pair details →Paracetamol →

Label mentions20 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Majoranticoagulantesclass named in the label
    «Anticoagulantes: los AINEs pueden aumentar los efectos de los anticoagulantes tipo dicumarínico (ver sección 4.4) debido a la elevada unión del dexketoprofeno a proteínas plasmáticas, a la inhibición…»

    AEMPS, section 4.5 · Open on CIMA

  • Majorcorticosteroidesclass named in the label
    «Corticosteroides: existe un riesgo aumentado de ulceración gastrointestinal o hemorragia (ver sección 4.4).»

    AEMPS, section 4.5 · Open on CIMA

  • MajorLithium
    «Litio (descrito con varios AINEs): los AINEs aumentan los niveles del litio en sangre, que pueden alcanzar valores tóxicos (disminución de la excreción renal del litio). Por tanto este parámetro…»

    AEMPS, section 4.5 · Open on CIMA

  • MajorMethotrexate
    «Metotrexato, administrado a elevadas dosis de 15 mg/semana o más: los antiinflamatorios en general aumentan la toxicidad hematológica del metotrexato, debido a una disminución de su aclaramiento…»

    AEMPS, section 4.5 · Open on CIMA

  • MajorWarfarin
    «Seguridad cardiovascular y cerebrovascular: Todos los AINEs no selectivos pueden inhibir la agregación plaquetaria y prolongar el tiempo de sangrado por inhibición de la síntesis de prostaglandinas…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateAcetylsalicylic acid
    «Seguridad gastrointestinal: Se aconsejará precaución a los pacientes que reciben medicaciones concomitantes que puedan incrementar el riesgo de úlcera o hemorragia, tales como corticosteroides…»

    AEMPS, section 4.4 · Open on CIMA

  • Moderateaminoglucósidosclass named in the label
    «Diuréticos, inhibidores de la enzima de conversión de la angiotensina (IECA), antibióticos aminoglucósidos y antagonistas de los receptores de la angiotensina II (ARA II): el dexketoprofeno puede…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateantiagregantesclass named in the label
    «Antiagregantes plaquetarios: aumentan el riesgo de úlcera o sangrado gastrointestinal (ver sección 4.4).»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateARA IIclass named in the label
    «Diuréticos, inhibidores de la enzima de conversión de la angiotensina (IECA), antibióticos aminoglucósidos y antagonistas de los receptores de la angiotensina II (ARA II): el dexketoprofeno puede…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatebetabloqueantesclass named in the label
    «Beta-bloqueantes: el tratamiento con AINEs puede disminuir su efecto antihipertensivo debido a la inhibición de la síntesis de prostaglandinas.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateCiclosporin
    «Ciclosporina y tacrolimus: la nefrotoxicidad puede verse aumentada por los AINEs debido a los efectos mediados por las prostaglandinas renales. Debe controlarse la función renal durante la terapia…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateDeferasirox
    «Deferasirox: el uso concomitante con AINEs puede aumentar el riesgo de toxicidad gastrointestinal. Se requiere un estricto control clínico cuando se combina deferasirox con estas sustancias.»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatedigitálicosclass named in the label
    «Glucósidos cardiacos: los AINEs pueden aumentar los niveles plasmáticos de los glucósidos cardíacos.»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatediuréticosclass named in the label
    «Diuréticos, inhibidores de la enzima de conversión de la angiotensina (IECA), antibióticos aminoglucósidos y antagonistas de los receptores de la angiotensina II (ARA II): el dexketoprofeno puede…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateinhibidores de la ECAclass named in the label
    «Diuréticos, inhibidores de la enzima de conversión de la angiotensina (IECA), antibióticos aminoglucósidos y antagonistas de los receptores de la angiotensina II (ARA II): el dexketoprofeno puede…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateISRSclass named in the label
    «Inhibidores selectivos de la recaptación de serotonina (ISRS): riesgo aumentado de hemorragia gastrointestinal (ver sección 4.4).»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatesulfonilureasclass named in the label
    «Sulfonilureas: los AINEs pueden aumentar el efecto hipoglicemiante de las sulfonilureas por desplazamiento de los puntos de fijación a proteínas plasmáticas.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateTacrolimus
    «Ciclosporina y tacrolimus: la nefrotoxicidad puede verse aumentada por los AINEs debido a los efectos mediados por las prostaglandinas renales. Debe controlarse la función renal durante la terapia…»

    AEMPS, section 4.5 · Open on CIMA

  • MinorMifepristone
    «Mifepristona: existe un riesgo teórico de que los inhibidores de la síntesis de prostaglandinas alteren la eficacia de la mifepristona. Evidencias científicas limitadas sugieren que la…»

    AEMPS, section 4.5 · Open on CIMA

  • Minorquinolonasclass named in the label
    «Quinolonas antibacterianas: Datos en animales indican que altas dosis de quinolonas en combinación con AINEs pueden aumentar el riesgo de convulsiones.»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Dexketoprofen used for?

Dexketoprofen is evaluated for the following indications with varying evidence strength: Mild to moderate pain in adults (evidence tier A), Memory and concentration enhancement (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Dexketoprofen?

Common side effects of Dexketoprofen (≥ 1 in 100): Nausea, heartburn, abdominal discomfort, Diarrhoea, Headache, dizziness, Rash, Transaminase elevation. See the Safety section for uncommon and serious reactions.

Is Dexketoprofen safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): dexketoprofen is contraindicated in the third trimester; in the first and second trimesters it is given only if absolutely necessary, at the lowest dose and for the shortest time. Epidemiological data suggest that prostaglandin synthesis inhibitors used early in pregnancy raise the risk of miscarriage, cardiac malformation and gastroschisis; the absolute risk of cardiovascular malformations rose from less than 1% to about 1.5%, and the risk is thought to grow with dose and duration. From week 20, dexketoprofen can cause oligohydramnios from fetal renal dysfunction, usually reversible after stopping, and ductus arteriosus constriction has been reported after second-trimester treatment. After several days of exposure from week 20, antenatal monitoring for oligohydramnios and ductal constriction should be considered, and treatment is stopped if either is found. In the third trimester, prostaglandin synthesis inhibitors can cause premature constriction or closure of the ductus arteriosus, pulmonary hypertension and renal dysfunction in the fetus, and near term they can prolong bleeding time in the mother and newborn, even at very low doses, and delay or prolong labour.

Is Dexketoprofen compatible with breastfeeding?

Contraindicated during breastfeeding: drug is excreted in breast milk.

Who should not take Dexketoprofen?

Dexketoprofen is contraindicated in: Hypersensitivity to NSAIDs; Active peptic ulcer disease; GI bleeding; Severe hepatic or renal impairment; Severe heart failure (NYHA IV). Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Diclofenac, Etoricoxib, Glucosamine, Glucosamine + Chondroitin, Ketoprofen, Naproxen, Proteolytic enzyme complex (bromelain, papain, pancreatin, trypsin, chymotrypsin, rutoside), Ibuprofen