NSAID + PPI Pregnancy: Contraindicated during the third trimester of pregnancy. In women attempting to conceive or during the first and second trimester, VIMOVO should not be given unless the potential benefit outweighs the potential risk to the foetus, and if used the dose should be kept as low and the duration as short as possible. From the 20th week of pregnancy onward it may cause oligohydramnios resulting from foetal renal dysfunction, and ductus arteriosus constriction has been reported after second-trimester treatment — antenatal monitoring for both should be considered after exposure for several days from gestational week 20 onward, and VIMOVO discontinued if either is found. In the third trimester all prostaglandin synthesis inhibitors may expose the foetus to cardiopulmonary toxicity (premature constriction or closure of the ductus arteriosus and pulmonary hypertension) and renal dysfunction, and the mother and neonate to possible prolongation of bleeding time and inhibition of uterine contractions resulting in delayed or prolonged labour. Epidemiological data suggest an increased risk of miscarriage, cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy (absolute risk of cardiovascular malformation increased from under 1% to approximately 1.5%). For the esomeprazole component there is a limited amount of data in pregnant women; data on a larger number of exposed pregnancies with the racemic mixture omeprazole indicate no malformative or foetotoxic effects.

Naproxen with esomeprazole

Brand names: Vimovo

This is a fixed-dose combination of the NSAID naproxen with the proton pump inhibitor esomeprazole, formulated to provide anti-inflammatory pain relief while reducing the risk of NSAID-associated gastric and duodenal ulceration in patients needing ongoing treatment.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 1 tablet (naproxen 500 mg / esomeprazole 20 mg) twice daily

Route: Oral. The tablet must be swallowed whole with water and must NOT be split, chewed or crushed. It is recommended that it is taken at least 30 minutes prior to food intake.

Frequency: Twice daily

Max: The UK SPC gives no dose above 1 tablet twice daily — that regimen delivers naproxen 1,000 mg plus esomeprazole 40 mg per day. Where a total daily naproxen dose of 1,000 mg (500 mg twice daily) is not considered appropriate, the SPC directs that alternative treatment with a lower strength of naproxen or another NSAID as a NON-FIXED combination should be used instead, and the need for continuing gastroprotection re-evaluated.

SOURCE: UK SPC (VIMOVO 500 mg/20 mg modified-release tablets, https://www.medicines.org.uk/emc/product/5743/smpc), section 4.2. Verbatim: 'The recommended dose is 1 tablet (500 mg/20 mg) twice daily.' This SPC covers the FIXED COMBINATION product, so the dose is complete for both components. (The openFDA fallback in the same bundle is for naproxen alone, not the fixed combination, and was NOT used for the dose.) GENERAL PRINCIPLES: undesirable effects of naproxen may be minimised by using the lowest effective dose for the shortest duration possible. In patients not previously treated with an NSAID, a lower daily dose of naproxen or of another NSAID should be considered, for which non-fixed combination products are available. Treatment should be continued to achieve individual treatment goals, reviewed at regular intervals, and discontinued if no benefit or if worsening is seen. The prescriber should assess at clinically meaningful intervals whether sufficient pain control is possible with lower doses of NSAIDs as non-fixed combinations, to prevent overtreatment. ONSET LIMITATION: because of the delayed release of naproxen from the enteric-coated formulation (3 to 5 hours), VIMOVO is NOT intended for rapid relief of acute pain conditions such as dental pain; however, flares of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis may be treated with it. HEPATIC IMPAIRMENT: in mild to moderate hepatic impairment use cautiously and monitor hepatic function closely, and consider a reduction in the total daily naproxen dose (which requires switching to non-fixed components); contraindicated in severe hepatic impairment. ELDERLY (over 65 years): older people are at increased risk of the serious consequences of adverse reactions; where 1,000 mg naproxen daily is not appropriate (e.g. in older people with impaired renal function or low body weight), a lower-strength non-fixed alternative should be used and the need for continued gastroprotection re-evaluated. CONCOMITANT NSAIDs: the combination of VIMOVO with other NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided; VIMOVO can be used with low-dose acetylsalicylic acid. EXCIPIENTS: contains very low levels of methyl- and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). CAUTION (section 4.4): naproxen should only be used after a rigorous benefit-risk assessment in inducible porphyrias and in systemic lupus erythematosus or mixed connective tissue disease (rare cases of aseptic meningitis). Patients on long-term treatment, particularly beyond a year, should be kept under regular surveillance. PAEDIATRIC: 'The safety and efficacy of VIMOVO in children aged 0 to 18 years has not been established. No data are available.' No paediatric dose is stated for the fixed combination, so paedDose is null; verify any under-18 use against a children's formulary. SPC sections 4.4, 4.6 and 4.8 were truncated at the source-fetch limit.

Dose adjustments

Renal

Contraindicated in severe renal impairment (creatinine clearance below 30 mL/minute) because accumulation of naproxen metabolites has been seen in patients with severe renal failure and in those on dialysis. In mild to moderate renal impairment VIMOVO should be used cautiously with close monitoring of renal function, and a reduction in the total daily naproxen dose should be considered — where a total daily naproxen dose of 1,000 mg is not considered appropriate, alternative treatment with a lower strength of naproxen or another NSAID as a non-fixed combination should be used, and the need for continued gastroprotective treatment re-evaluated.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances, to any of the excipients, or to substituted benzimidazoles
History of asthma, urticaria or allergic-type reactions induced by administration of acetylsalicylic acid or other NSAIDs
Third trimester of pregnancy
Severe hepatic impairment (e.g. Child-Pugh C)
Severe heart failure
Severe renal impairment
Active peptic ulceration
Gastrointestinal bleeding, cerebrovascular bleeding or other bleeding disorders
Must not be used concomitantly with atazanavir and nelfinavir

Side effects

FREQUENCY CAVEAT: the section 4.8 table in the fetched text has lost its column alignment, so the very common / common / uncommon / rare categories cannot be reliably assigned to individual terms. The reactions below are listed as reported for VIMOVO in clinical trials, without asserting a frequency band.
Gastrointestinal: dyspepsia, abdominal pain, constipation, diarrhoea, oesophagitis, flatulence, gastric and duodenal ulcers (detected by scheduled routine endoscopy), gastritis, nausea, vomiting; also dry mouth, eructation, gastrointestinal bleeding, stomatitis, glossitis, haematemesis and rectal bleeding
Nervous system: dizziness, headache, taste disturbance, paraesthesia, syncope, somnolence, tremor; tinnitus and vertigo
Skin: skin rashes, dermatitis, hyperhidrosis, pruritus, urticaria, alopecia, ecchymoses; hypersensitivity reactions
Cardiovascular and respiratory: hypertension, arrhythmia, palpitations, myocardial infarction, tachycardia; asthma, bronchospasm, dyspnoea
Renal and general: proteinuria, renal failure, oedema, asthenia, fatigue, pyrexia; investigations — abnormal liver function tests and raised serum creatinine; blood — eosinophilia and leucopenia; metabolic — fluid retention, hyperkalaemia, hyperuricaemia

Interactions

Atazanavir and nelfinavir — UK SPC section 4.3 states VIMOVO must NOT be used concomitantly with these (esomeprazole component)
Other NSAIDs including cyclooxygenase-2 selective inhibitors — UK SPC section 4.4 states the combination should be avoided because of cumulative risks of serious NSAID-related adverse events; VIMOVO can be used with low-dose acetylsalicylic acid
Anticoagulants, corticosteroids, other NSAIDs including low-dose acetylsalicylic acid — UK SPC section 4.4 lists concomitant use as risk factors for NSAID-related gastrointestinal complications
NOTE ON SOURCE: UK SPC section 4.5 was NOT fetched in this bundle. The entries below are from the US naproxen label (section 7) and describe the naproxen component only; they must be checked against UK SPC section 4.5, which also covers the esomeprazole component.
Drugs that interfere with haemostasis (US label) — warfarin and other anticoagulants have a synergistic effect on bleeding with naproxen; SSRIs and SNRIs may potentiate the bleeding risk more than an NSAID alone. Monitor for signs of bleeding.
Aspirin (US label) — a pharmacodynamic study demonstrated that lower-dose naproxen (220 mg/day or 220 mg twice daily) interfered with the antiplatelet effect of low-dose immediate-release aspirin, most marked during the naproxen washout period.

Clinical monograph

How it works

Naproxen non-selectively inhibits cyclo-oxygenase to reduce prostaglandin-mediated inflammation and pain, while esomeprazole irreversibly blocks the gastric proton pump to lower acid secretion and protect the upper gastrointestinal mucosa.

Prescribing in practice

Although the esomeprazole component reduces upper gastrointestinal risk, it does not abolish the NSAID hazards of serious bleeding, cardiovascular and renal harm, so the lowest effective dose for the shortest time still applies.
The fixed combination is intended for patients at risk of NSAID-induced ulcers and is not suitable where the individual component doses are inappropriate, including significant renal impairment.
Be aware of esomeprazole interactions and effects, such as reduced absorption of certain drugs and the small risks linked to long-term acid suppression.

Monitoring

Monitor blood pressure, renal function and for any gastrointestinal symptoms despite the protective component, particularly with prolonged use.

Counselling the patient

Swallow the combination tablet whole and do not add separate anti-inflammatory painkillers.
Report black stools, vomiting blood or severe stomach pain straight away.
Mention this medicine before starting new drugs, as the acid-reducing part can affect their absorption.

Evidence & guidelines

Fixed-dose naproxen with esomeprazole is licensed in the UK for symptomatic arthritis where gastroprotection is needed, reflecting evidence that PPIs reduce NSAID-related ulcer risk.

Reference: NICE CG177; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

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