Celecoxib
Regulatory sources consulted
- openfda-label-2bbd635f-76fa-4feb-9d3d-f84505d0e381
- aemps-ft-63891
- ansm-rcp-68952704
- PubMed PMID:39293828 ↗
- PubMed PMID:35453005 ↗
- PubMed PMID:34160823 ↗
- PubMed PMID:38412399 ↗
- PubMed PMID:34572131 ↗
- OpenFDA · M01AH01
- RxNorm rxcui 140587 ↗
Approved indications
- For the management of the signs and symptoms of Osteoarthritis (OA).
- For the management of the signs and symptoms of Rheumatoid Arthritis (RA).
- For the management of the signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older.
- For the management of the signs and symptoms of Ankylosing Spondylitis (AS).
- For the management of acute pain in adults.
- For the management of primary dysmenorrhea.
Contraindications
Absolute
- Hypersensitivity to celecoxib, sulfonamides, or any components of the drug product.
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- In the setting of coronary artery bypass graft (CABG) surgery.
- Active peptic ulcer or gastrointestinal (GI) bleeding.
- Congestive heart failure (NYHA II-IV), established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
- Pregnancy and women of childbearing potential not using effective contraception.
Clinical warnings
- Boxed warning · Risk of Serious Cardiovascular Thrombotic Events: NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use. — FDA
- Boxed warning · Risk of Gastrointestinal Bleeding, Ulceration, and Perforation: NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. — FDA
Drug interactions
- HighWarfarinB01AA03
Mechanism: Synergistic effect on bleeding. Increased risk of serious bleeding.
Recommendation: Closely monitor INR and for signs of bleeding, particularly during the first few days of therapy or when changing the dose.
ANSM RCPOpenFDA label
- ModerateACE Inhibitors / Angiotensin Receptor BlockersC09A
Mechanism: NSAIDs may diminish the antihypertensive effect and increase the risk of deterioration of renal function.
Recommendation: Monitor blood pressure and renal function during concomitant use, especially in elderly, volume-depleted, or renally impaired patients.
OpenFDA label
- ModerateCYP2D6 Substrates (e.g., metoprolol, dextromethorphan)C07AB02
Mechanism: Celecoxib is a CYP2D6 inhibitor, which can increase plasma concentrations of drugs metabolized by this enzyme.
Recommendation: Dose reduction of CYP2D6 substrates may be necessary when initiating treatment with celecoxib, or an increase upon its discontinuation.
ANSM RCP
- ModerateCyclosporineL04AD01
Mechanism: Concomitant administration may increase the nephrotoxicity of cyclosporine.
Recommendation: Renal function should be monitored when celecoxib is combined with cyclosporine.
ANSM RCP
Adverse events
Common (≥1%)
abdominal pain · diarrhea · dyspepsia · flatulence · peripheral edema · dizziness · pharyngitis · rhinitis · sinusitis · upper respiratory tract infection · rash
Rare but serious
cardiovascular thrombotic events · gastrointestinal bleeding · hepatotoxicity · hypertension · heart failure · renal toxicity · anaphylactic reactions · serious skin reactions (SJS/TEN)
Pregnancy and lactation
FDA category: Contraindicated (EU) / D (3rd trimester, US)
Contraindicated during pregnancy (European SPC). In the US, use of NSAIDs, including celecoxib, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction. Limit dose and duration between 20-30 weeks of gestation and avoid use from 30 weeks onward.
Recent literature (PubMed)
Revisión sistemática y metaanálisis en red que compara 17 intervenciones farmacológicas para el tratamiento agudo de la migraña. Eletriptán fue el más eficaz para la ausencia de dolor a las 2 horas. Celecoxib fue superior al placebo, pero menos eficaz que otros agentes como los triptanes para este resultado.
Revisión narrativa sobre el uso de AINEs en ancianos. Sugiere que los inhibidores selectivos de la COX-2 como celecoxib pueden ser una mejor opción para pacientes jóvenes, con dolor agudo o con gastritis sintomática, debido a un menor riesgo gastrointestinal en comparación con los AINEs no selectivos.
Actualización del consenso de la American Headache Society que integra nuevos tratamientos para la migraña. Menciona la solución oral de celecoxib como un nuevo tratamiento agudo, junto con los gepantes y lasmiditán, proporcionando recomendaciones prácticas para su uso clínico.
Este ensayo sobre diclofenaco tópico para prevenir el síndrome mano-pie inducido por capecitabina menciona que celecoxib oral previene este efecto adverso al inhibir la COX-2, pero sus efectos secundarios sistémicos limitan su uso rutinario para esta indicación.
Revisión que discute candidatos terapéuticos potenciales para la degeneración macular asociada a la edad (DMAE). Celecoxib se menciona como uno de los candidatos en investigación por sus mecanismos de citoprotección, aunque no es un uso clínico establecido.