Celecoxib
Celebrex, Celecoxib Ratiopharm · ATC code M01AH01
Also known as: Selekoksib · Brand names: Celebrex, Celecoxib Ratiopharm, Celecaxiro, Elyxyb, Celgyn, Eloxib, Selkap, ELYXYB - celecoxib, Vyscoxa
- Key facts
- Active substance
- Celecoxib
- Drug class
- COX-2 inhibitor
- ATC code
- M01AH01
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
Boxed warning
Cardiovascular Thrombotic Events
- Nonsteroidal anti-inflammatory drugs (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 [see Warnings and Precautions (5.1)] .
- Celecoxib is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1)] .
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. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2)] .
Key facts
Celecoxib is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID). Per the US prescribing information, it is used for osteoarthritis, rheumatoid arthritis, juvenile RA, ankylosing spondylitis, acute pain and primary dysmenorrhea.
What it is used for
- Signs and symptoms of osteoarthritis and rheumatoid arthritis
- Juvenile rheumatoid arthritis in patients 2 years and older
- Ankylosing spondylitis
- Acute pain in adults
- Primary dysmenorrhea
Dosing
- General: lowest effective dosage for the shortest duration; without regard to meals
- Osteoarthritis: 200 mg per day as a single dose or 100 mg twice daily
- Rheumatoid arthritis: 100 mg to 200 mg twice daily
- JRA by weight: >10 kg to <25 kg 50 mg twice daily; >25 kg 100 mg twice daily
- Ankylosing spondylitis: 200 mg daily; if no effect after 6 weeks, a trial of 400 mg daily
- Acute pain/dysmenorrhea: 400 mg initially, an additional 200 mg if needed on day one, then 200 mg twice daily as needed
- Moderate hepatic impairment (Child-Pugh B): reduce dose by 50%; severe: not recommended
- Poor CYP2C9 metabolizers: start with half of the lowest recommended dose
Contraindications
- Known hypersensitivity to celecoxib or any component
- History of asthma, urticaria or allergic-type reactions after aspirin or other NSAIDs
- In the setting of CABG surgery
- Allergic-type reactions to sulfonamides
Important warnings
- Boxed warning: increased risk of serious cardiovascular thrombotic events (MI, stroke), possibly early in treatment
- Boxed warning: GI bleeding, ulceration and perforation, which can be fatal and occur without warning
- Hepatotoxicity, hypertension, heart failure and edema
- Renal toxicity and hyperkalemia
- Anaphylactic reactions and serious skin reactions
Side effects
- Cardiovascular thrombotic events, GI bleeding and ulceration
- Hepatotoxicity, hypertension, heart failure, edema
- Renal toxicity, hyperkalemia, hematologic toxicity
- Anaphylactic reactions and serious skin reactions
Interactions
- Anticoagulants (e.g., warfarin), antiplatelet drugs (e.g., aspirin), SSRIs and SNRIs: increased bleeding risk; monitor
- Further clinically significant interactions are in Table 3 of the label
Pregnancy and breastfeeding
- NSAIDs can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios
- Limit dose and duration between about 20 and 30 weeks of gestation; avoid at about 30 weeks and later
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
Austria
- CelebrexViatris Healthcare Limited · 1 register entry
- Celecoxib RatiopharmTeva B.V · 2 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- CelebrexViatris Pharma Gmbh · 1 register entry
- CelecaxiroMedical Valley Invest Ab · 1 register entry
- Celecoxib1 A Pharma Gmbh, Micro Labs Gmbh, Ratiopharm Gmbh, Puren Pharma Gmbh & Co. Kg, Heumann Pharma Gmbh & Co. Generica Kg, Zentiva Pharma Gmbh, Viatris Germany Gmbh, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Abz-Pharma Gmbh, Tad Pharma Gmbh, Aliud Pharma Gmbh · 13 register entries
- ElyxybBetapharm Arzneimittel Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- CelebrexVİATRİS İLAÇLARI LİMİTED ŞİRKETİ · 2 register entries
- CelgynWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- EloxibDR. SERTUS İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
- SelkapWORLD MEDICINE İLAÇLARI LTD. ŞTİ. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
USA
- CelebrexViatris Specialty LLC · 1 register entry
- ELYXYB - celecoxibSCILEX PHARMACEUTICALS INC. · 1 register entry
- VyscoxaCarwin Pharmaceutical Associates, LLC · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28
Brand names in 27 more European countries
- Belgium
- Celebrex, Celecoxib Ab, Celecoxib Eg, Celecoxib Krka, Celecoxib Sandoz, Celecoxib Teva
- Bulgaria
- Аклекса, Дефинакс, Селебрекс, Целекоксиб Екофарм
- Croatia
- Aclexa, Celixib
- Cyprus
- Celebrex, Celecoxib Accord
- Czechia
- Aclexa, Celebrex, Celecoxib Zentiva
- Denmark
- Celebra, Celecoxib Accord, Celecoxib Krka, Celecoxib Medical Valley, Celecoxib Stada
- Estonia
- Aclexa, Celebrex, Celecoxib Accord, Celecoxib Inteli
- Finland
- Celebra, Celecoxib Krka, Celecoxib Stada, Celecoxib Viatris
- France
- Celebrex, Celecoxib Arrow Lab, Celecoxib Biogaran, Celecoxib Cristers, Celecoxib Eg, Celecoxib Hcs, Celecoxib Sandoz, Celecoxib Teva, Celecoxib Viatris, Celecoxib Zentiva, Celecoxib Zydus, Celecoxibe Eg
- Greece
- Celebrex
- Hungary
- Aclexa, Celebrex, Celekoxib aurobindo, Sussyn
- Iceland
- Celebra, Celecoxib Actavis, Celecoxib Medical, Celecoxib Stada, Celecoxib Teva, Cloxabix
- Ireland
- Celebrex, Celecoxib Accord Healthcare Ireland, Celecoxib Krka
- Italy
- Celartrox, Celebrex, Celecoxib Alter, Celecoxib Aurobindo, Celecoxib Doc Generici, Celecoxib Eg, Celecoxib Maxmind, Celecoxib Mylan, Celecoxib Pensa Pharma, Celecoxib Sandoz, Celecoxib Tecnigen, Celecoxib Teva, Celecoxib Viatris, Celecoxib Zentiva, Coxart, Coxiben
- Latvia
- Celebrex, Celecoxib Inteli, Celecoxib Zentiva
- Lithuania
- Aclexa, Celecoxib Accord, Celecoxib Inteli, Celecoxib Zentiva
- Luxembourg
- Celebrex, Celecoxib Eg
- Malta
- Aclexa, Celebrex
- Netherlands
- Bixocel, Celebrex, Celecoxib Accord, Celecoxib Aurobindo, Celecoxib Krka, Celecoxib Sandoz, Celecoxib Teva, Celecoxib Viatris, Clibex, Licebril
- Norway
- Celebra, Celecoxib Accord, Celecoxib Medical Valley
- Poland
- Aclexa, Celebrex, Elecoxel
- Portugal
- Celebrex, Celecoxib Alter, Celecoxib Atrolif Pentafarma - Sociedade Tecnico-Medicinal, Celecoxib Bluepharma, Celecoxib Ciclum, Celecoxib Farmoz, Celecoxib Generis, Celecoxib Helm, Celecoxib Krka, Celecoxib Pentafarma, Celecoxib Ratiopharm
- Romania
- Aclexa, Capsule Teva, Celebrex, Celecoxib Terapia, Celecoxib Teva
- Slovakia
- Aclexa, Celebrex
- Slovenia
- Aclexa, Celebrex, Celekoksib Lek
- Spain
- Artilog, Axatal, Celebrex, Celecoxib Almus, Celecoxib Alter, Celecoxib Aurovitas, Celecoxib Cinfa, Celecoxib Combix, Celecoxib Kern Pharma, Celecoxib Krka, Celecoxib Mabo, Celecoxib Normon, Celecoxib Opko, Celecoxib Pensa, Celecoxib Sandoz, Celecoxib Stada, Celecoxib Sun, Celecoxib Tarbis Farma, Celecoxib Tecnigen, Celecoxib Teva, Celecoxib Tevagen, Celecoxib Viatris, Celecoxib Vir-Pharma, Celenib, Meticel
- Sweden
- Celebra, Celecoxib Accord, Celecoxib Krka, Celecoxib Medical Valley, Celecoxib Sandoz, Celecoxib Stada, Celecoxib Upjohn, Solexa
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- U.S. Food and Drug Administration. CELECOXIB (Micro Labs Limited) – Prescribing Information, 2025-05-13. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=408b30d6-f5c2-4239-b993-d8f77a8e160b
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
- Wikidata (CC0): ATC M01AH.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.