Ketoprofen

Non-steroidal anti-inflammatory drug, propionic acid derivative

ATC code: M01AE03

Updated 23 Sep 2026 · Methodology

Indications

Dysmenorrhea

First line

Primary dysmenorrhoea is named directly in the AEMPS Fastum label, and the mechanism fits best here: endometrial prostaglandins produce the pain, and ketoprofen blocks their synthesis. The practical point is timing: the drug starts within the first hours of pain or at the onset of menstruation, not after cramping has unfolded. The course is short, covering the first day or two of the cycle, and that is usually enough. Limits are those of any NSAID: active ulcer, severe cardiac, hepatic or renal impairment, aspirin-induced asthma. If the pain needs ever larger doses each month or fails to answer NSAIDs, the question is no longer analgesia but the cause, endometriosis included.

Sources

AEMPS: Ficha técnica Fastum 50 mg cápsulas duras (2023)

ICD-10: N94.4 · ICD-11: GA34.3

Mild to moderate pain in adults

First line

Ketoprofen covers acute mild to moderate pain in adults: musculoskeletal, dental, and primary dysmenorrhoea. That is how the AEMPS Fastum label frames its indications. The rule common to every NSAID applies: the smallest dose for the shortest time, because the risk of ulcer, perforation and bleeding rises with both dose and duration. The label lists the combinations that raise that risk: a second NSAID or high-dose salicylates, anticoagulants, antiplatelet drugs, SSRIs and systemic corticosteroids. The second weak point is the kidney: in older patients, in dehydration and alongside a diuretic, an ACE inhibitor or a sartan, ketoprofen can drop filtration as far as acute injury. With lithium and methotrexate the label calls for level monitoring and blood counts.

Sources

AEMPS: Ficha técnica Fastum 50 mg cápsulas duras (2023)

ICD-10: R52 · ICD-11: MG31

Osteoarthritis

Second line

In osteoarthritis ketoprofen takes off pain and morning stiffness but does not change the disease: it neither rebuilds cartilage nor slows progression. The AEMPS Fastum label names osteoarthritis among its indications. The 2019 and Arthritis Foundation guideline for hand, hip and knee osteoarthritis builds treatment around loading, movement and weight, keeping NSAIDs for flares. The practical frame for an older patient with knee osteoarthritis: a short course rather than continuous use, with gastroprotection agreed in advance if aspirin, an anticoagulant or a systemic corticosteroid sits in the same regimen. With stable hypertension and reduced renal function, the effect of the NSAID on blood pressure and creatinine is checked rather than waited for.

Sources

ICD-10: M19 · ICD-11: FA0Z

Pain control in rheumatoid arthritis

Adjunct

In rheumatoid arthritis ketoprofen stays an add-on to disease-modifying therapy: it relieves pain and stiffness but does not halt joint inflammation or prevent bone damage. Methotrexate and biologics do that work, and an NSAID does not replace them. The AEMPS Fastum label names rheumatoid arthritis among its indications and describes the dangerous neighbour in the same breath: at methotrexate doses of 15 mg weekly and above, NSAIDs raise its haematological toxicity by reducing renal clearance, and at low doses blood counts are monitored during the first weeks of combined use. The second frequent neighbour is a systemic corticosteroid, ever-present in these regimens: the label states plainly that ulcer and bleeding risk goes up.

Sources

AEMPS: Ficha técnica Fastum 50 mg cápsulas duras (2023)

ICD-10: M06.9 · ICD-11: FA20.Z

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.

Sports recovery

Not recommended

Sports forums suggest taking ketoprofen before training or a race to get ahead of pain and recover faster. No such indication exists in the AEMPS Fastum label or in the Russian registration, and the research shows the other side. In a randomised trial of 89 ultramarathon runners, ibuprofen 400 mg every 4 hours produced acute kidney injury in 52% of runners against 34% on placebo, with a number needed to harm of 5.5. In a crossover study of nine trained men, ibuprofen before cycling raised the small-bowel injury marker I-FABP to 875 pg/mL against 474 pg/mL without the drug and increased intestinal permeability. Ketoprofen shares the mechanism, and dehydration plus muscular work add their own load on the kidney. If an NSAID has been suggested as part of a recovery plan, consider seeking a second opinion.

Sources

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

Ketoprofen blocks both cyclooxygenase isoforms, so prostaglandin synthesis drops in two places at once. In inflamed tissue that means analgesia and less swelling. In the gastric mucosa, the kidney and the platelet, prostaglandins run protection and normal blood flow, so the same blockade turns into erosions, sodium retention and a fall in glomerular filtration. That explains every key interaction: a second NSAID, a systemic corticosteroid, an anticoagulant or an SSRI hit the same mucosa and the same platelet, while a diuretic or an ACE inhibitor leaves the kidney without its prostaglandin reserve. Ketoprofen binds plasma proteins heavily and displaces other drugs from those sites, sulfonylureas among them.

Safety

Contraindications

Hypersensitivity to ketoprofen, acetylsalicylic acid or other NSAIDs
Asthma attacks triggered by acetylsalicylic acid or other NSAIDs
Active gastric or duodenal ulcer; previous gastrointestinal bleeding, ulceration or perforation
Severe heart failure
Severe hepatic impairment
Moderate to severe renal impairment
Third trimester of pregnancy and breastfeeding

Serious adverse effects

Ulcer, perforation and gastrointestinal bleeding, at times fatal
Acute kidney injury, tubulointerstitial nephritis
Bronchospasm, particularly with acetylsalicylic acid intolerance
Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis
Liver injury and hepatitis
Aseptic meningitis, seizures
Arterial thrombotic events with high doses and long treatment

Common adverse effects

Dyspepsia, nausea, vomiting, abdominal pain, diarrhoea, constipation, flatulence
Maculopapular rash, urticaria
Somnolence or insomnia, headache, dizziness
Gastritis, rectal bleeding, intestinal ulceration

Pregnancy: can you take Ketoprofen?

Ketoprofen is contraindicated in the third trimester. In the first and second it is given only when unavoidable, at the lowest dose for the shortest time: epidemiological data link prostaglandin synthesis inhibitors in early pregnancy with a higher risk of miscarriage and cardiac malformation, the absolute risk of cardiovascular malformation rising from below 1% to about 1.5%. From week 20 oligohydramnios can follow fetal renal dysfunction, and ductus arteriosus constriction has been reported after second-trimester treatment; with several days of use the label requires prenatal monitoring for both.

Breastfeeding: can you take Ketoprofen?

The AEMPS Fastum label lists breastfeeding among the contraindications. When a breastfeeding woman needs analgesia, the choice falls on a drug with known milk transfer rather than ketoprofen.

Calculate RID

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

Label mentions26 mentions

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

From this drug’s label

Majorantiagregantesclass named in the label
«Antiagregantes plaquetarios (p. ej., ticlopidina, clopidogrel).»
AEMPS, section 4.5 · Open on CIMA
Majoranticoagulantesclass named in the label
«Anticoagulantes : los AINE pueden aumentar los efectos de los anticoagulantes tipo dicumarínico debido a la elevada unión del ketoprofeno a proteínas plasmáticas y a la inhibición de la función…»
AEMPS, section 4.5 · Open on CIMA
MajorApixaban
«Inhibidores directos del factor Xa (p. ej., apixaban, rivaroxaban, edoxaban).»
AEMPS, section 4.5 · Open on CIMA
MajorClopidogrel
«Antiagregantes plaquetarios (p. ej., ticlopidina, clopidogrel).»
AEMPS, section 4.5 · Open on CIMA
MajorDabigatran
«Inhibidores de la trombina (p. ej., dabigatran).»
AEMPS, section 4.5 · Open on CIMA
MajorLithium
«Litio (descrito con varios AINE): 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 dosis elevadas 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
MajorRivaroxaban
«Inhibidores directos del factor Xa (p. ej., apixaban, rivaroxaban, edoxaban).»
AEMPS, section 4.5 · Open on CIMA
MajorWarfarin
«Antagonistas de Vitamina K (p. ej., warfarina) (ver sección 4.4).»
AEMPS, section 4.5 · Open on CIMA
ModerateAcetylsalicylic acid
«Seguridad gastrointestinal: Se debe recomendar una precaución especial a aquellos pacientes que reciben tratamientos concomitantes que pueden aumentar el riesgo de úlcera o sangrado gastrointestinal…»
AEMPS, section 4.4 · Open on CIMA
Moderatebetabloqueantesclass named in the label
«Beta-bloqueantes inhibidores de la ECA, diuréticos : el tratamiento con un AINE puede disminuir su efecto antihipertensivo debido a la inhibición de la síntesis de prostaglandinas.»
AEMPS, section 4.5 · Open on CIMA
ModerateCiclosporin
«Los fármacos que pueden promover hipercalemia como diuréticos ahorradores de potasio, inhibidores de la ECA, antagonistas de angiotensina II, sales de potasio, AINEs, heparinas (de bajo peso…»
AEMPS, section 4.5 · Open on CIMA
Moderatecorticosteroidesclass named in the label
«Corticosteroides : aumentan el riesgo de úlcera o sangrado gastrointestinales (ver sección 4.4).»
AEMPS, section 4.5 · Open on CIMA
Moderatedigitálicosclass named in the label
«Glucósidos cardiacos : los AINE pueden aumentar los niveles plasmáticos de los glucósidos cardíacos.»
AEMPS, section 4.5 · Open on CIMA
Moderatediuréticosclass named in the label
«Diuréticos : los pacientes y en particular los pacientes deshidratados en tratamiento con diuréticos, tienen un mayor riesgo de desarrollar fallo renal secundario a la reducción del flujo sanguíneo…»
AEMPS, section 4.5 · Open on CIMA
Moderatediuréticos ahorradores de potasioclass named in the label
«Los fármacos que pueden promover hipercalemia como diuréticos ahorradores de potasio, inhibidores de la ECA, antagonistas de angiotensina II, sales de potasio, AINEs, heparinas (de bajo peso…»
AEMPS, section 4.5 · Open on CIMA
Moderateinhibidores de la ECAclass named in the label
«Inhibidores de la ECA y antagonistas de angiotensina II: en pacientes con la función renal comprometida (p. ej., pacientes deshidratados o pacientes de edad avanzada), la administración conjunta de…»
AEMPS, section 4.5 · Open on CIMA
ModerateISRSclass named in the label
«Inhibidores selectivos de la recaptación de serotonina (ISRS): aumentan el riesgo de sangrado gastrointestinal (ver sección 4.4).»
AEMPS, section 4.5 · Open on CIMA
Moderatesulfonilureasclass named in the label
«Sulfonilureas : los AINE 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
Moderatesuplementos de potasioclass named in the label
«Los fármacos que pueden promover hipercalemia como diuréticos ahorradores de potasio, inhibidores de la ECA, antagonistas de angiotensina II, sales de potasio, AINEs, heparinas (de bajo peso…»
AEMPS, section 4.5 · Open on CIMA
ModerateTacrolimus
«Los fármacos que pueden promover hipercalemia como diuréticos ahorradores de potasio, inhibidores de la ECA, antagonistas de angiotensina II, sales de potasio, AINEs, heparinas (de bajo peso…»
AEMPS, section 4.5 · Open on CIMA
ModerateTrimethoprim
«Los fármacos que pueden promover hipercalemia como diuréticos ahorradores de potasio, inhibidores de la ECA, antagonistas de angiotensina II, sales de potasio, AINEs, heparinas (de bajo peso…»
AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

ModerateLeflunomide
«Dosis repetidas de A771726 aumentaron la C max media y AUC (1,43- y 1,54-veces, respectivamente) de cefaclor, sugiriendo que el A771726 es un inhibidor del OAT3 in vivo. Por tanto, se recomienda…»
AEMPS, section 4.5 · Open on CIMA
ModerateLeflunomide
«DRUG INTERACTIONS: Teriflunomide inhibits the activity of OAT3 in vivo . In patients taking leflunomide, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin…»
FDA, section 7 · Open on DailyMed
Warfarin
«Fármacos que desplazan a los anticoagulantes de su unión a proteínas plasmáticas, con potenciación de la actividad anticoagulante: ácido etacrínico, ácido nalidíxico, antiinflamatorios no…»
AEMPS, section 4.5 · Open on CIMA
Warfarin
«Drugs that Increase Bleeding Risk: Nonsteroidal Anti-Inflammatory Agents celecoxib, diclofenac, diflunisal, fenoprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, naproxen…»
FDA, section 7 · Open on DailyMed

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Frequently asked

What is Ketoprofen used for?

Ketoprofen is evaluated for the following indications with varying evidence strength: Mild to moderate pain in adults (evidence tier A), Dysmenorrhea (evidence tier A), Osteoarthritis (evidence tier B). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Ketoprofen?

Common side effects of Ketoprofen (≥ 1 in 100): Dyspepsia, nausea, vomiting, abdominal pain, diarrhoea, constipation, flatulence, Maculopapular rash, urticaria, Somnolence or insomnia, headache, dizziness, Gastritis, rectal bleeding, intestinal ulceration. See the Safety section for uncommon and serious reactions.

Is Ketoprofen safe during pregnancy?

Is Ketoprofen compatible with breastfeeding?

The AEMPS Fastum label lists breastfeeding among the contraindications. When a breastfeeding woman needs analgesia, the choice falls on a drug with known milk transfer rather than ketoprofen.

Who should not take Ketoprofen?

Ketoprofen is contraindicated in: Hypersensitivity to ketoprofen, acetylsalicylic acid or other NSAIDs; Asthma attacks triggered by acetylsalicylic acid or other NSAIDs; Active gastric or duodenal ulcer; previous gastrointestinal bleeding, ulceration or perforation; Severe heart failure; Severe hepatic impairment. Full list in the Safety section.

Official sources

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

AEMPS / CIMALabel dated 12/20/2023
GRLS

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