Naproxen
Aleve, Miranax, Nalgesin Akut, Naprobene · ATC code M01AE02
Also known as: Naproksen · Brand names: Aleve, Miranax, Nalgesin Akut, Naprobene, Naproliquid, Naproxen Genericon, Naproxen Hcs, Naproxen Infectopharm, Proxen, Suspension, Aspidolo, Dolormin Für Frauen Bei Menstruationsbeschwerden Mit, Dolormin Gs, Naprostad, A-Nox Fort …
- Key facts
- Active substance
- Naproxen
- ATC code
- M01AE02
- 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 treatment and may increase with duration of use [see Warnings and Precautions (5.1)].
- Naproxen sodium tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4), 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
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). Per the US label, naproxen sodium is used for inflammatory joint diseases, acute gout, pain and primary dysmenorrhea.
What it is used for
- Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis
- Tendonitis, bursitis, acute gout
- Pain and primary dysmenorrhea
Dosing
- Lowest effective dose for the shortest duration
- Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: 275 mg or 550 mg twice daily
- Acute gout: starting dose 825 mg, then 275 mg every 8 hours
- Do not combine with other naproxen-containing products; formulations are not interchangeable
- Moderate to severe renal impairment (creatinine clearance <30 mL/min): not recommended; hepatic impairment: caution
Contraindications
- Known hypersensitivity to naproxen or any component
- History of asthma, urticaria or allergic-type reactions after aspirin or other NSAIDs
- In the setting of coronary artery bypass graft (CABG) surgery
Important warnings
- Boxed warning: increased risk of serious cardiovascular thrombotic events (myocardial infarction, stroke), which may occur early in treatment
- Boxed warning: GI bleeding, ulceration and perforation, which can occur without warning; greater risk in the elderly and with prior ulcer disease
- Hypertension, heart failure and oedema; monitor blood pressure
- Renal toxicity, hyperkalaemia, hepatotoxicity, serious skin reactions and anaphylaxis
Side effects
- Serious: cardiovascular events, GI bleeding, hepatic and renal injury, hypertension, heart failure
- Anaphylactic reactions, serious skin reactions, haematologic toxicity
- Other adverse reactions by frequency in the full text
Interactions
- Anticoagulants such as warfarin and serotonin reuptake inhibitors: increased bleeding risk
- ACE inhibitors, thiazide and loop diuretics: response may be impaired
- Lithium: increased lithium levels, monitor for toxicity; methotrexate: see the full text
Pregnancy and breastfeeding
- From about 20 weeks risk of fetal renal dysfunction/oligohydramnios; avoid at about 30 weeks and later (premature closure of the ductus arteriosus)
- Found in breast milk at low levels; weigh breastfeeding benefits against the mother's need
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.
Common questions – ask Medelix
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
- AleveBayer Austria Gmbh · 1 register entry
- MiranaxGrünenthal Österreich Gmbh · 1 register entry
- Nalgesin AkutKrka, D.D., Novo Mesto · 1 register entry
- NaprobeneTeva B.V · 1 register entry
- NaproliquidInfectopharm Arzneimittel Und Consilium Gmbh, De, Heppenheim · 1 register entry
- Naproxen GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry
- Naproxen HcsHcs Bvba · 1 register entry
- Naproxen InfectopharmInfectopharm Arzneimittel Und Consilium Gmbh, De, Heppenheim · 1 register entry
- ProxenGrünenthal Österreich Gmbh · 1 register entry
- SuspensionInfectopharm Arzneimittel Und Consilium Gmbh, De, Heppenheim · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- AspidoloBayer Vital Gmbh · 1 register entry
- Dolormin Für Frauen Bei Menstruationsbeschwerden MitKenvue Germany Gmbh · 1 register entry
- Dolormin GsKenvue Germany Gmbh · 1 register entry
- NaprostadStada Arzneimittel Ag · 1 register entry
- Naproxen123 Acurae Pharma Gmbh, 1 A Pharma Gmbh, Infectopharm Arzneimittel Und Consilium Gmbh, De, Heppenheim, Aristo Pharma Gmbh (Art 57), Axicorp Pharma Gmbh, Hexal Ag, Stadapharm Gmbh, Aliud Pharma Gmbh, Abz-Pharma Gmbh · 10 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- A-Nox FortAROMA İLAÇ SAN. LTD. ŞTİ. · 2 register entries
- AleveBAYER TÜRK KİMYA SAN. LTD. ŞTİ. · 1 register entry
- Apraljin ForteDEVA HOLDİNG A.Ş. · 2 register entries
- ApranaxABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
- Aprodent FortAVİXA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- AproflexALİ RAİF İLAÇ SAN. A.Ş. · 1 register entry
- AprolBİLİM İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
- ApromedKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 4 register entries
- AprowellALİ RAİF İLAÇ SAN. A.Ş. · 4 register entries
- ArmanaksACON İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
- AtrenİLAÇSAN İLAÇ SAN. TİC. LTD. ŞTİ. · 4 register entries
- BonminAKSU FARMA TIBBİ ÜRÜNLER İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
Show all 32 brand names
- ExvileTRIPHARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- FemininABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- FlamaksATABAY İLAÇ FABRİKASI A.Ş. · 2 register entries
- InaprolHÜSNÜ ARSAN İLAÇLARI A.Ş., BİLİM İLAÇ SAN. VE TİC. A.Ş. · 9 register entries
- KaroksenMÜNİR ŞAHİN İLAÇ SAN. VE TİC A.Ş., TERRA İLAÇ VE KİMYA SAN. TİC. A.Ş. · 4 register entries
- MednapKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 2 register entries
- MotrinaxJNTL TURKEY TÜKETİCİ SAĞLIĞI LTD. ŞTİ. · 4 register entries
- NaponalMÜNİR ŞAHİN İLAÇ SAN. VE TİC A.Ş. · 2 register entries
- Napradol ForteYAVUZ İLAÇ ECZA DEPOSU MEDİKAL ÜRÜNLER SAN.VE TİC. A.Ş. · 2 register entries
- Napren SİLSAN İLAÇ VE HAMMADDELERİ SAN. TİC. A.Ş. · 2 register entries
- NaproffWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
- NaprolNOBEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- NaprosynABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
- NexproPHARMAPLACE İLAÇ TİC. A.Ş. · 4 register entries
- OpraksTOPRAK İLAÇ VE KİMYEVİ MADDELER SAN.VE TİC. A.Ş. · 4 register entries
- RandolHÜSNÜ ARSAN İLAÇLARI A.Ş. · 3 register entries
- RelokapRECORDATİ İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- RumazolidinOSEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- SodinaxOSEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
- SynaxBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
USA
- Rugby All Day Relief1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28
Brand names in 27 more European countries
- Belgium
- Aleve, Apranax, Naprosyne, Naproxen Ab, Naproxen Eg, Naproxen Hcs, Naproxen Krka, Naproxene Eg, Naproxene Forte Eg
- Bulgaria
- Налгезин
- Croatia
- Nalgesin
- Cyprus
- Naprorex, Priaxen
- Czechia
- Emoxen, Nalgesin
- Denmark
- Bonyl, Naproxen-E Viatris, Naproxen Evolan
- Estonia
- Emox, Nalgesin Forte, Nalgesin S
- Finland
- Miranax, Naprometin, Napromex, Naproxen Accord, Naproxen Krka, Naproxen Orion, Pronaxen
- France
- Aleve, Alevetabs, Antalnox, Apranax, Naprosyne, Naproxene Sodique Arrow, Naproxene Sodique Eg, Naproxene Sodique Newline Pharma, Naproxene Sodique Teva
- Greece
- Anaprox, Naprosyn
- Hungary
- Aleve, Analgesin, Apranax
- Iceland
- Naproxen-E Viatris, Naproxen Viatris
- Ireland
- Naprosyn Ec, Naproxen Azure Pharmaceuticals
- Italy
- Dololibre, Femmedol, Laser, Lasonil Antinfiammatorio E Antireumatico, Momendol, Naprius, Naprossene Aurobindo, Naprosyn, Naproxene Sodico Doc Generici, Naproxene Sodico Hcs, Synflex
- Latvia
- Emox, Nalgedol, Nalgesin
- Lithuania
- Emox, Nalgesin Forte, Nalgesin S
- Luxembourg
- Aleve, Apranax, Naprosyne Enteric Coated, Naproxen Eg
- Malta
- Naprorex, Naprosyn, Naproxen
- Netherlands
- Aleve Classic Bij Pijn En Koorts, Aleve Feminax Bij Menstruatiepijn, Aleve Intense, Aleve Select, Naproxen Accord, Naproxen Aurobindo, Naproxen Basic Pharma Manufacturing, Naproxen Cf, Naproxen Ec Aurobindo, Naproxen Ec Mylan, Naproxen Hcs, Naproxen Msr Teva, Naproxen Mylan, Naproxen Pharmamatch, Naproxen Sodium Aurobindo, Naproxen Sodium Leidapharm, Naproxen Sodium Marel, Naproxen Sodium Sameko, Naproxen Teva, Naproxen Zetpil Cf, Naproxennatrium Banner, Naproxennatrium Da, Naproxennatrium Etos, Naproxennatrium Htp, Naproxennatrium Liquid Caps Kruidvat, Proxa, Trekpleister
- Norway
- Napren-E, Naproxen-E Mylan, Naproxen Evolan, Naproxen Norfri, Naproxen Orion, Naproxen Viatris, Proxan
- Poland
- 4flex, Aleve, Anapran, Apo-Napro, Aponapro Active, Dololibre, Nalgesin, Napritum, Naproxen Aflofarm, Naproxen Emo Bausch Health Ireland, Naproxen Hasco, Naxii, Opokan Actigel
- Portugal
- Actronadol, Ilgesin, Momendol, Naprosumo, Naprosyn, Naproxeno (Naproxeno Sódico) Krka, Naproxeno Generis, Naproxeno Gp, Naproxeno Labesfal, Naproxeno Tolife, Reuxen
- Romania
- Mobilat Pro, Naldorex, Reuxen
- Slovakia
- Emoxen Gél, Nalgesin Forte, Nalgesin S
- Slovenia
- Nalgesin, Naprosyn
- Spain
- Actromadol, Antalgin, Lidet, Lundiran, Maxen, Naprelle, Naprosyn, Naproxeno, Olseron
- Sweden
- Ipaflex, Naprocur, Naprosyn Entero, Naproxen Abece, Naproxen Apofri, Naproxen Bluefish, Naproxen Evolan, Naproxen Orifarm, Naproxen Viatris, Pronaxen
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. Naproxen Sodium (Aurobindo Pharma Limited) – Prescribing Information, 2025-09-05. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37b264f9-b46d-4635-8fab-246b1e08b653
- 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/
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.