NSAID, acetic acid derivative, COX-1/COX-2 inhibitor
Updated · Methodology
Second line
Symptomatic treatment of knee and hip osteoarthritis with marked pain. 2019 and 2023 set topical NSAIDs and paracetamol as first-line pharmacotherapy; oral NSAIDs including aceclofenac are second-line with shortest possible duration.
Sources
ICD-10: M17 · ICD-11: FA01
Second line
Used in acute pain (dental, postoperative, musculoskeletal) in courses up to 7 days. Dose 100 mg twice daily. Effective in dysmenorrhea.
ICD-10: R52 · ICD-11: MG31
Second line
Used for symptomatic relief in rheumatoid arthritis as an NSAID alternative. Dose 100 mg twice daily. Does not modify disease – 2022 builds treatment on DMARDs (methotrexate, sulfasalazine, leflunomide). Patel 2011 meta-analysis showed efficacy comparable to diclofenac with fewer GI side effects.
Sources
ICD-10: M06.9 · ICD-11: FA20
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Aceclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It is prescribed in short courses for osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis (AEMPS Ficha Técnica). In anti-aging regimens, aceclofenac is positioned as a safer diclofenac for long-term use in age-related joint pain. Long-term NSAID use in people without a confirmed inflammatory disease is not justified: 2020 and 2023 recommend non-pharmacological approaches (weight loss, exercise, physiotherapy) as the basis of osteoarthritis care, with NSAIDs reserved for short flare courses. The drug carries serious risks on chronic use: gastrointestinal bleeding, blood-pressure elevation, acute kidney injury, and cardiovascular events. If aceclofenac was prescribed for age-related pain as long-term therapy, consider seeking a second opinion.
An acetic acid derivative related to diclofenac. Inhibits COX-1 and COX-2 with preferential COX-2 activity in vitro – less GI toxicity than diclofenac. Reduces prostaglandin synthesis at inflammation sites. Metabolized to 4-hydroxyaceclofenac and further to diclofenac – part of the effect is mediated by this metabolite. Half-life 4 hours. In Spain widely prescribed under the Airtal brand by Almirall.
Contraindicated in T3 – risk of premature ductus arteriosus closure, oligohydramnios. T1 and T2 not recommended without clear indication. For musculoskeletal inflammation in pregnancy, paracetamol is first-line.
Ibuprofen with more data is preferred during lactation.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Verbatim lines from the interaction sections, in the language of the label
«Litio y digoxina: como muchos fármacos antiinflamatorios no esteroideos inhiben el aclaramiento renal del litio y la digoxina, aumentando las concentraciones séricas de ambos. Debe evitarse el…»AEMPS, section 4.5 · Open on CIMA
«Litio y digoxina: como muchos fármacos antiinflamatorios no esteroideos inhiben el aclaramiento renal del litio y la digoxina, aumentando las concentraciones séricas de ambos. Debe evitarse el…»AEMPS, section 4.5 · Open on CIMA
«Riesgos gastrointestinales: Se debe recomendar una precaución especial a aquellos pacientes que reciben tratamientos concomitantes que podrían elevar el riesgo de úlcera o sangrado gastrointestinal…»AEMPS, section 4.4 · Open on CIMA
«Riesgos gastrointestinales: Se debe recomendar una precaución especial a aquellos pacientes que reciben tratamientos concomitantes que podrían elevar el riesgo de úlcera o sangrado gastrointestinal…»AEMPS, section 4.4 · Open on CIMA
«Anticoagulantes: como los demás agentes antiinflamatorios no esteroideos, aceclofenaco puede aumentar los efectos de los anticoagulantes tipo dicumarínico debido a una posible acción de inhibición de…»AEMPS, section 4.5 · Open on CIMA
«Antidiabéticos orales: estudios clínicos han puesto de manifiesto que aceclofenaco puede administrarse conjuntamente con antidiabéticos orales sin alterar su efecto clínico. Sin embargo, se han…»AEMPS, section 4.5 · Open on CIMA
«Antidiabéticos orales: estudios clínicos han puesto de manifiesto que aceclofenaco puede administrarse conjuntamente con antidiabéticos orales sin alterar su efecto clínico. Sin embargo, se han…»AEMPS, section 4.5 · Open on CIMA
«Riesgos gastrointestinales: Se debe recomendar una precaución especial a aquellos pacientes que reciben tratamientos concomitantes que podrían elevar el riesgo de úlcera o sangrado gastrointestinal…»AEMPS, section 4.4 · Open on CIMA
«Cuando se administre concomitantemente con diuréticos ahorradores de potasio, deben monitorizarse los niveles de potasio sérico.»AEMPS, section 4.5 · Open on CIMA
«Antihipertensivos : los AINEs pueden reducir el efecto de los antihipertensivos. El riesgo de insuficiencia renal aguda, que normalmente es reversible, puede aumentar en algunos pacientes con función…»AEMPS, section 4.5 · Open on CIMA
«Riesgos gastrointestinales: Se debe recomendar una precaución especial a aquellos pacientes que reciben tratamientos concomitantes que podrían elevar el riesgo de úlcera o sangrado gastrointestinal…»AEMPS, section 4.4 · Open on CIMA
«Metotrexato: la posible interacción entre los antiinflamatorios no esteroideos y metotrexato debe tenerse en cuenta cuando se utilizan dosis bajas de metotrexato, especialmente en pacientes con…»AEMPS, section 4.5 · Open on CIMA
«Riesgos gastrointestinales: Se debe recomendar una precaución especial a aquellos pacientes que reciben tratamientos concomitantes que podrían elevar el riesgo de úlcera o sangrado gastrointestinal…»AEMPS, section 4.4 · Open on CIMA
«Ciclosporina, tacrolimus : se cree que la administración concomitante de antiinflamatorios no esteroideos y ciclosporina o tacrolimus, aumenta el riesgo de nefrotoxicidad debido a la menor síntesis…»AEMPS, section 4.5 · Open on CIMA
«Zidovudina: la administración conjunta de zidovudina y AINEs puede aumentar el riesgo de toxicidad hematológica. Existen indicios de aumento del riego de hemoartrosis y hematomas en hemofílicos VIH…»AEMPS, section 4.5 · Open on CIMA
«Ciclosporina, tacrolimus : se cree que la administración concomitante de antiinflamatorios no esteroideos y ciclosporina o tacrolimus, aumenta el riesgo de nefrotoxicidad debido a la menor síntesis…»AEMPS, section 4.5 · Open on CIMA
Opens the checker prefilled with this drug. Pick the second one from your regimen.
Summary of a multi-drug list →
Medicine list: everything you take in one place →
Aceclofenac is evaluated for the following indications with varying evidence strength: Knee osteoarthritis (evidence tier A), Rheumatoid arthritis (evidence tier B), Mild to moderate pain in adults (evidence tier B). See the full indication matrix with dosing and citations above on this page.
Common side effects of Aceclofenac (≥ 1 in 100): Dyspepsia, nausea, Abdominal pain, Diarrhea or constipation, Headache, Dizziness, Elevated liver enzymes. See the Safety section for uncommon and serious reactions.
Contraindicated in T3 – risk of premature ductus arteriosus closure, oligohydramnios. T1 and T2 not recommended without clear indication. For musculoskeletal inflammation in pregnancy, paracetamol is first-line.
Ibuprofen with more data is preferred during lactation.
Aceclofenac is contraindicated in: Hypersensitivity to aceclofenac, diclofenac, or other NSAIDs; Active peptic ulcer, GI bleeding; Inflammatory bowel disease; Severe hepatic impairment; Severe renal impairment (eGFR under 30). Full list in the Safety section.
Direct links to regulator labels. Open in a new tab.
Boswellia, Celecoxib, Dexketoprofen, Diclofenac, Glucosamine, Ketorolac, Naproxen, Etoricoxib