Naproxen

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Naproxen on Prescriptsy

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Naproxen is a non-steroidal anti-inflammatory drug (NSAID) widely used to relieve pain, reduce inflammation and lower fever.

It belongs to the propionic acid class of NSAIDs and is one of the most commonly prescribed analgesic and anti-inflammatory medicines in the United Kingdom.

Naproxen is used to treat a broad range of conditions, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute gout, musculoskeletal injuries, period pain (dysmenorrhoea), dental pain and acute migraine.

It is available as 250 mg and 500 mg tablets on prescription (POM), and lower-strength preparations are available as pharmacy (P) medicines for short-term use.

Pain and inflammation are among the most common reasons for consulting a GP or pharmacist in the UK.

Effective management requires balancing analgesic efficacy against safety, particularly gastrointestinal, cardiovascular and renal risks.

Among the non-selective NSAIDs, naproxen holds a notable position because it is associated with the lowest cardiovascular risk, making it the preferred choice when long-term NSAID therapy is needed.

This page provides a comprehensive clinical overview of naproxen, including its mechanism of action, dosage guidance, side effects, important safety warnings, and how to obtain it in the United Kingdom.

Important safety information about naproxen

• Naproxen can cause serious gastrointestinal side effects including stomach ulcers and bleeding. Take it with or after food.
• All NSAIDs carry a small increased risk of heart attack and stroke. Naproxen has the lowest cardiovascular risk among commonly used NSAIDs.
• Do not take naproxen if you have had an allergic reaction (asthma, rash or swelling) to aspirin or another NSAID.
• Naproxen may worsen asthma in susceptible patients.
• Do not take naproxen in the third trimester of pregnancy.
• Co-prescription of a proton pump inhibitor (PPI) is recommended for patients at increased gastrointestinal risk.

Understanding NSAIDs and inflammation

Inflammation is the body's natural response to injury, infection or tissue damage.

It involves the release of chemical mediators, including prostaglandins, which cause blood vessels to dilate, tissues to swell, and nerves to become more sensitive to pain.

While acute inflammation is a protective process, chronic inflammation drives many conditions, including rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

NSAIDs are a class of medicines that reduce inflammation, relieve pain and lower fever by inhibiting cyclo-oxygenase (COX) enzymes. There are two main COX isoforms: COX-1 and COX-2.

COX-1 is constitutively expressed in most tissues and plays a protective role in the stomach (maintaining the gastric mucosal barrier), the kidneys (regulating blood flow) and the platelets (promoting aggregation).

COX-2 is induced at sites of inflammation and is the primary target for the anti-inflammatory effects of NSAIDs.

Traditional (non-selective) NSAIDs such as naproxen inhibit both COX-1 and COX-2, which explains both their therapeutic effects and their gastrointestinal side effects.

Selective COX-2 inhibitors (coxibs) such as celecoxib and etoricoxib were developed to spare COX-1 and reduce gastrointestinal toxicity, but they carry higher cardiovascular risk.

How naproxen works: mechanism of action

Naproxen is a non-selective COX inhibitor that blocks both COX-1 and COX-2 enzymes.

By inhibiting COX-2 at sites of inflammation, naproxen reduces the production of prostaglandins E2 and I2, which are key mediators of pain, swelling, redness and fever.

The analgesic effect results from reduced sensitisation of peripheral pain receptors (nociceptors) and potentially from central effects within the spinal cord.

The anti-inflammatory effect is due to reduced vascular permeability, leukocyte migration and tissue swelling at the site of injury or disease.

The antipyretic effect is mediated by inhibition of prostaglandin synthesis in the hypothalamus, which resets the thermoregulatory set point.

Naproxen also inhibits COX-1 in the stomach and platelets. Gastric COX-1 produces prostaglandins that protect the stomach lining by stimulating mucus secretion, bicarbonate production and mucosal blood flow.

Inhibition of these protective prostaglandins increases the risk of gastric irritation, erosion, ulceration and bleeding. In the platelets, COX-1 produces thromboxane A2, which promotes platelet aggregation.

By inhibiting thromboxane production, naproxen has an antiplatelet effect, which may contribute to its favourable cardiovascular profile compared with other NSAIDs.

Pharmacokinetics of naproxen

Naproxen is rapidly and completely absorbed after oral administration, with a bioavailability of approximately 95 percent. Peak plasma concentrations are reached within 2 to 4 hours.

The elimination half-life is 12 to 15 hours, which is considerably longer than ibuprofen (2 to 4 hours) and diclofenac (1 to 2 hours).

This long half-life allows twice-daily dosing for most indications, improving convenience and adherence. Naproxen is more than 99 percent bound to plasma albumin.

It is metabolised in the liver primarily by CYP2C9 to 6-O-desmethyl naproxen, which has negligible anti-inflammatory activity.

Approximately 95 percent of the dose is excreted in the urine, mainly as the glucuronide conjugate of naproxen and its metabolite.

Clinical evidence and UK prescribing context

Naproxen has been used clinically for over 50 years and is supported by a substantial body of evidence.

Its efficacy in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis has been established in numerous randomised controlled trials and is reflected in its inclusion in the British National Formulary and NICE guidelines.

The cardiovascular safety of naproxen relative to other NSAIDs is a key clinical consideration.

The Coxib and traditional NSAID Trialists' (CNT) Collaboration published a landmark meta-analysis in The Lancet (2013) comparing the vascular risks of different NSAIDs.

This analysis found that naproxen was not associated with a significant increase in major vascular events (myocardial infarction, stroke, vascular death), whereas diclofenac was associated with a risk comparable to COX-2 inhibitors, and ibuprofen at high doses increased coronary events.

On this basis, NICE and the BNF recommend that when an NSAID is needed, naproxen should be preferred, especially for patients with cardiovascular risk factors.

NICE guideline CG177 on osteoarthritis recommends oral NSAIDs as an option alongside or instead of paracetamol, at the lowest effective dose for the shortest time.

Naproxen is explicitly mentioned as the NSAID with the lowest cardiovascular risk.

NICE guideline NG100 on rheumatoid arthritis supports the short-term use of NSAIDs as an adjunct to disease-modifying antirheumatic drugs (DMARDs).

The BNF advises prescribers to assess cardiovascular, gastrointestinal and renal risk before prescribing any NSAID and to co-prescribe a PPI for gastroprotection in at-risk patients.

Naproxen compared with other NSAIDs

The UK formulary includes several commonly used NSAIDs, and understanding their differences helps inform clinical decisions. Ibuprofen is the most widely used OTC NSAID.

It has a short half-life (2 to 4 hours) requiring three to four times daily dosing.

At anti-inflammatory doses (1,200 to 2,400 mg daily), ibuprofen has a cardiovascular risk intermediate between naproxen and diclofenac.

Diclofenac is a potent NSAID with good efficacy but carries the highest cardiovascular risk among commonly used non-selective NSAIDs; the MHRA has restricted it from OTC availability and it is contraindicated in patients with established cardiovascular disease.

Celecoxib and etoricoxib are selective COX-2 inhibitors with lower gastrointestinal risk but higher cardiovascular risk. Mefenamic acid is primarily used for dysmenorrhoea and menorrhagia.

For patients needing long-term NSAID therapy (for example, in chronic arthritis), naproxen is generally the preferred choice due to its favourable cardiovascular profile.

For short-term use in acute pain, ibuprofen remains appropriate for most patients.

When gastrointestinal risk is the primary concern and cardiovascular risk is low, a COX-2 inhibitor plus a PPI may be considered.

Dosage and administration

For musculoskeletal conditions and rheumatic disease, the usual adult dose is 250 mg to 500 mg twice daily, taken with or after food.

The maximum daily dose is 1,000 mg. Treatment should begin at the lowest effective dose.

For acute gout, 750 mg is taken initially, followed by 250 mg every 8 hours until the attack resolves.

For period pain, 500 mg initially, then 250 mg every 6 to 8 hours as needed (maximum 1,250 mg on day 1, then 1,000 mg daily).

For acute migraine, 500 mg at onset, with a further 250 mg after 6 to 8 hours if needed.

Swallow the tablets whole with a full glass of water. Do not crush or chew. Taking naproxen with food reduces the risk of stomach irritation.

In elderly patients, use the lowest effective dose for the shortest duration.

A proton pump inhibitor should be co-prescribed for patients over 65 and for those with risk factors for gastrointestinal complications.

Dose reduction is required in renal and hepatic impairment.

Side effects of naproxen

Common side effects

Gastrointestinal symptoms are the most frequent side effects and include nausea, dyspepsia, abdominal pain, heartburn, diarrhoea, constipation and flatulence. These affect approximately 10 to 20 percent of users.

Taking naproxen with food and using the lowest effective dose can help. Headache, dizziness and drowsiness may also occur.

Serious gastrointestinal complications

Gastric and duodenal ulcers, gastrointestinal bleeding and perforation are the most clinically important risks.

These can occur at any time during treatment, often without warning symptoms, and can be life-threatening, particularly in elderly patients.

The risk increases with dose, duration, concurrent corticosteroid or anticoagulant use, history of peptic ulcer disease, and concomitant use of other NSAIDs or low-dose aspirin.

If you notice dark or tarry stools, blood in your vomit, or severe stomach pain, seek urgent medical attention.

Cardiovascular effects

All NSAIDs are associated with a small increased risk of myocardial infarction and stroke. Naproxen carries the lowest cardiovascular risk among commonly used NSAIDs.

This risk is proportional to dose and duration of use.

Patients with pre-existing cardiovascular disease, hypertension, diabetes or hyperlipidaemia should use the lowest effective dose for the shortest duration.

Renal effects

NSAIDs can impair renal function by reducing prostaglandin-mediated renal blood flow.

This is particularly relevant in elderly patients, those with pre-existing renal disease, heart failure or dehydration, and those taking ACE inhibitors, ARBs or diuretics.

Fluid retention and oedema may occur. Monitor renal function in at-risk patients.

Other important side effects

Elevated liver enzymes, skin rashes, photosensitivity and tinnitus may occur. Rare but serious reactions include Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema and severe bronchospasm. Naproxen should be avoided in aspirin-sensitive asthma.

When to seek urgent advice

Stop naproxen and seek immediate medical help or call 999 if you experience signs of gastrointestinal bleeding (black stools, vomiting blood), chest pain or breathlessness (possible heart attack), sudden weakness or speech difficulty (possible stroke), severe allergic reaction (facial swelling, throat tightness, difficulty breathing) or severe skin reaction (widespread blistering).

Contact your GP or NHS 111 for persistent stomach pain, ankle swelling, or any unexplained symptoms. Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Contraindications

Naproxen must not be used in patients with known hypersensitivity to naproxen or any NSAID, a history of asthma, urticaria or allergic reaction triggered by aspirin or another NSAID, active peptic ulceration or gastrointestinal bleeding, severe heart failure, severe renal impairment, severe hepatic impairment, or during the third trimester of pregnancy.

Cardiovascular precautions

Assess cardiovascular risk before prescribing. Avoid in uncontrolled hypertension. Use the lowest dose for the shortest duration. NSAIDs may attenuate the effect of antihypertensive medicines. Monitor blood pressure during treatment.

Gastrointestinal precautions

Co-prescribe a PPI for patients at increased risk: those over 65, those with a history of peptic ulcer or gastrointestinal bleeding, those taking corticosteroids, anticoagulants, antiplatelet agents or SSRIs concurrently, and those requiring long-term NSAID treatment.

Renal and hepatic precautions

Monitor renal function in patients with impairment and in those taking ACE inhibitors, ARBs or diuretics. Avoid the "triple whammy" combination (NSAID plus ACE inhibitor/ARB plus diuretic) wherever possible. Avoid naproxen in severe renal or hepatic impairment.

Asthma

Naproxen can provoke bronchospasm in patients with aspirin-exacerbated respiratory disease (AERD). It should be avoided in this population. Use with caution in asthma patients who do not have known NSAID sensitivity.

Drug interactions

Naproxen interacts with lithium (increased plasma levels), methotrexate (reduced excretion, risk of toxicity), warfarin and DOACs (increased bleeding risk), antihypertensives (reduced efficacy), diuretics (reduced efficacy and risk of renal impairment), corticosteroids (increased gastrointestinal risk), SSRIs (increased bleeding risk), ciclosporin (increased nephrotoxicity) and other NSAIDs (avoid combination).

Naproxen may reduce the cardioprotective effect of low-dose aspirin if taken concomitantly; take aspirin at least 30 minutes before or 8 hours after naproxen to minimise this interaction.

Pregnancy and breastfeeding

Naproxen is contraindicated in the third trimester of pregnancy due to the risk of premature closure of the ductus arteriosus, prolonged labour and oligohydramnios.

In the first and second trimesters, it should be avoided unless clearly necessary.

The BNF states that the amount of naproxen excreted in breast milk is too small to be harmful, and it can be used with caution during breastfeeding.

How to get naproxen in the UK

Prescription-strength naproxen (250 mg and 500 mg tablets) is available from your GP, hospital specialist, or an authorised online prescriber registered with the GPhC.

It is available on the NHS. The standard prescription charge of 9.90 pounds per item applies in England; prescriptions are free in Scotland, Wales and Northern Ireland.

Lower-strength naproxen (250 mg) is available as a pharmacy medicine from pharmacies for short-term use without a prescription, under the supervision of a pharmacist.

Lifestyle advice while taking naproxen

Always take naproxen with or after food. Stay well hydrated, as dehydration increases the risk of renal side effects. Avoid combining naproxen with other NSAIDs (including ibuprofen).

If you need additional pain relief, paracetamol can be taken alongside naproxen. Limit alcohol intake, as alcohol increases the risk of gastric irritation and bleeding.

If you are taking naproxen for a chronic condition such as arthritis, attend regular reviews with your prescriber to assess continued need, dosage, and any emerging side effects.

Regular exercise, weight management, and physiotherapy can help reduce reliance on analgesics for musculoskeletal conditions.

Sources

• Naproxen 250 mg/500 mg Tablets, Summary of Product Characteristics (EMC)
• Naproxen, British National Formulary (BNF)
• NICE CG177: Osteoarthritis
• Naproxen, NHS
• MHRA Yellow Card Scheme