Vimovo Side Effects Center

Last updated on RxList: 3/22/2022
Vimovo Side Effects Center

What Is Vimovo?

Vimovo (naproxen and esomeprazole magnesium) is a combination of a nonsteroidal anti-inflammatory drug (NSAID) and a proton pump inhibitor (PPI) used to treat signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis when there is a high risk for stomach bleeding/ulcer.

What Are Side Effects of Vimovo?

Common side effects of Vimovo include:

  • upset stomach,
  • stomach pain,
  • heartburn,
  • nausea,
  • gas,
  • diarrhea,
  • constipation,
  • drowsiness, or
  • dizziness.

Tell your doctor if you have serious side effects of Vimovo including:

  • easy bruising or bleeding,
  • lightheadedness,
  • fainting,
  • signs of a lung infection (such as fever, cough, trouble breathing),
  • difficult or painful swallowing,
  • swelling of the hands or feet,
  • sudden or unexplained weight gain,
  • symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, or persistent muscle spasms, seizures).

Dosage for Vimovo

The dosage of Vimovo is one tablet twice daily, 375 mg naproxen/20 mg esomeprazole or 500 mg naproxen/20 mg esomeprazole.

What Drugs, Substances, or Supplements Interact with Vimovo?

Vimovo may interact with amphetamines, oral bisphosphonates, blood thinners, anti-platelet drugs, SSRI/SNRI antidepressants, clopidogrel, corticosteroids, HIV drugs, lithium, probenecid, digoxin, azole antifungals, iron supplements, other products containing naproxen, other proton pump inhibitors. Check medicine labels as many contain pain relievers/fever reducers similar to Vimovo and may increase the risk of side effects if taken together. Tell your doctor all medications and supplements you are taking.

Vimovo During Pregnancy and Breastfeeding

Vimovo should be used only when prescribed during the first 6 months of pregnancy. It is not recommended for use during the last 3 months of pregnancy due to the potential for harm to a fetus and interference with normal labor/delivery. Naproxen passes into breast milk. It is unknown if esomeprazole passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Vimovo (naproxen and esomeprazole magnesium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Slideshow: Exercises for Knee Osteoarthritis and Joint Pain See Slideshow
Vimovo Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, sneezing, runny or stuffy nose, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop taking this medicine and get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • heart problems-- swelling, rapid weight gain, feeling short of breath;
  • kidney problems-- fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;
  • liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes);
  • low magnesium--dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling;
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
  • new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking esomeprazole and naproxen long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use esomeprazole and naproxen for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

  • stomach discomfort; or
  • diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


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The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
  • GI Bleeding, Ulceration and Perforations [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
  • Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
  • Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
  • Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see WARNINGS AND PRECAUTIONS]
  • Fetal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
  • Active Bleeding [see WARNINGS AND PRECAUTIONS]
  • Acute Tubulointerstitial Nephritis [see WARNINGS AND PRECAUTIONS]
  • Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
  • Bone Fracture [see WARNINGS AND PRECAUTIONS]
  • Cutaneous and Systemic Lupus Erythematosus [see WARNINGS AND PRECAUTIONS]
  • Cyanocobalamin (Vitamin B-12) Deficiency [see WARNINGS AND PRECAUTIONS]
  • Hypomagnesemia and Mineral Metabolism [see WARNINGS AND PRECAUTIONS]
  • Fundic Gland Polyps [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Clinical Trials Experience With VIMOVO

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The adverse reactions reported below are specific to the clinical trials with VIMOVO.

The safety of VIMOVO was evaluated in clinical studies involving 2317 patients (aged 27 to 90 years) and ranging from 3 to 12 months. Patients received either 500 mg/20 mg of VIMOVO twice daily (n=1157), 500 mg of enteric-coated naproxen twice daily (n=426), or placebo (n=246). The average number of VIMOVO doses taken over 12 months was 696+44.

The table below lists all adverse reactions, regardless of causality, occurring in >2% of patients receiving VIMOVO and higher in the VIMOVO group than control from two clinical studies (Study 1 and Study 2). Both of these studies were randomized, multi-center, double-blind, parallel studies. The majority of patients were female (67%), white (86%). The majority of patients were 50-69 years of age (83%). Approximately one quarter were on low-dose aspirin.

Table 1: Adverse Reactions* in Study 1 and Study 2 (endoscopic studies)

Preferred term VIMOVO 500 mg/20 mg twice daily
(n=428) %
EC-Naproxen 500 mg twice daily
(n=426) %
Gastritis 17 14
Diarrhea 6 5
Upper respiratory tract infection 5 4
Flatulence 4 3
Headache 3 1
Urinary tract infection 2 1
Dysgeusia 2 1
*reported in >2% of patients and higher in the VIMOVO group than control

In Study 1 and Study 2, patients taking VIMOVO had fewer premature discontinuations due to adverse reactions compared to patients taking enteric-coated naproxen alone (7.9% vs. 12.5% respectively). The most common reasons for discontinuations due to adverse events in the VIMOVO treatment group were upper abdominal pain (1.2%, n=5), duodenal ulcer (0.7%, n=3) and erosive gastritis (0.7%, n=3). Among patients receiving enteric-coated naproxen, the most common reasons for discontinuations due to adverse events were duodenal ulcer 5.4% (n=23), dyspepsia 2.8% (n=12) and upper abdominal pain 1.2% (n=5). The proportion of patients discontinuing treatment due to any upper gastrointestinal adverse events (including duodenal ulcers) in patients treated with VIMOVO was 4% compared to 12% for patients taking entericcoated naproxen.

The table below lists all adverse reactions, regardless of causality, occurring in >2% of patients and higher in the VIMOVO group than placebo from 2 clinical studies conducted in patients with osteoarthritis of the knee (Study 3 and Study 4).

Table 2: Adverse Reactions* in Study 3 and Study 4

Preferred term VIMOVO 500 mg/20 mg twice daily
(n=490) %
(n=246) %
Diarrhea 6 4
Abdominal Pain Upper 4 3
Constipation 4 1
Dizziness 3 2
Peripheral edema 3 1
*reported in >2% of patients and higher in the VIMOVO group than placebo

The percentage of subjects who withdrew from the VIMOVO treatment group in these studies due to treatment-emergent adverse events was 7%. There were no preferred terms in which more than 1% of subjects withdrew from any treatment group.

The long-term safety of VIMOVO was evaluated in an open-label clinical trial of 239 patients, of which 135 patients received 500 mg/20 mg of VIMOVO for 12 months. There were no differences in frequency or types of adverse reactions seen in the long-term safety study compared to shorter-term treatment in the randomized controlled studies.

Clinical Trials Experience With Naproxen And Other NSAIDs

In patients taking naproxen in clinical trials, the most frequent reported adverse experiences in approximately 1% to 10% of patients are:

Gastrointestinal: heartburn, nausea, dyspepsia, stomatitis

Central Nervous System: drowsiness, lightheadedness, vertigo

Dermatologic: pruritus, skin eruptions, ecchymoses, sweating, purpura

Special Senses: tinnitus, visual disturbances, hearing disturbances

Cardiovascular: palpitations

General: dyspnea, thirst

In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients.

Gastrointestinal: gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting

General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes

The following are additional adverse experiences reported in <1% of patients taking naproxen during clinical trials.

Gastrointestinal: pancreatitis

Hepatobiliary: jaundice

Hemic and Lymphatic: melena, thrombocytopenia, agranulocytosis

Nervous System: inability to concentrate

Dermatologic: skin rashes

In patients taking NSAIDs, the following adverse experiences have also been reported in <1% of patients.

Body as a Whole: fever, infection, sepsis, anaphylactic reactions, appetite changes, death

Cardiovascular: hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction

Gastrointestinal: dry mouth, glossitis, eructation

Hepatobiliary: hepatitis, liver failure

Hemic and Lymphatic: rectal bleeding, lymphadenopathy, pancytopenia

Metabolic and Nutritional: weight changes

Nervous System: anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremor, coma, hallucinations

Respiratory: asthma, respiratory depression, pneumonia

Dermatologic: exfoliative dermatitis

Special Senses: blurred vision, conjunctivitis

Urogenital: cystitis, dysuria, oliguria/polyuria, proteinuria

Clinical Trials Experience With Esomeprazole Magnesium

Additional adverse reactions that were reported as possibly or probably related to esomeprazole magnesium with an incidence of <1% are listed below by body system:

Body as a Whole: abdomen enlarged, allergic reaction, asthenia, back pain, chest pain, substernal chest pain, facial edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema, malaise, pain, rigors

Cardiovascular: flushing, hypertension, tachycardia

Endocrine: goiter

Gastrointestinal: dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting

Hearing: earache, tinnitus

Hematologic: anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia

Hepatic: bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased

Metabolic/Nutritional: glycosuria, hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease

Musculoskeletal: arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatica

Nervous System/Psychiatric: anorexia, apathy, appetite increased, confusion, depression aggravated, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field defect

Reproductive: dysmenorrhea, menstrual disorder, vaginitis

Respiratory: asthma aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis

Skin and Appendages: acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculo-papular, skin inflammation, sweating increased, urticaria

Special Senses: otitis media, parosmia, taste loss

Urogenital: abnormal urine, albuminuria, cystitis, dysuria, fungal infection, hematuria, micturition frequency, moniliasis, genital moniliasis, polyuria

Visual: conjunctivitis, vision abnormal

The following potentially clinically significant laboratory changes in clinical trials, irrespective of relationship to esomeprazole magnesium, were reported in ≤ 1% of patients: increased creatinine, uric acid, total bilirubin, alkaline phosphatase, ALT, AST, hemoglobin, white blood cell count, platelets, serum gastrin, potassium, sodium, thyroxine and thyroid stimulating hormone.

Decreases were seen in hemoglobin, white blood cell count, platelets, potassium, sodium, and thyroxine.

Endoscopic findings that were reported as adverse reactions include: duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, hernia, benign polyps or nodules, Barrett's esophagus, and mucosal discoloration.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of VIMOVO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.


Body as a Whole: gait disturbance

Gastrointestinal: abdominal distension, abdominal pain, gastroesophageal reflux, hematochezia

Injury, Poisoning and Procedural Complications: contusion, fall

Musculoskeletal and Connective Tissue: joint swelling, muscle spasms

Urogenital: renal tubular necrosis


Body as a Whole: angioneurotic edema, menstrual disorders

Cardiovascular: congestive heart failure, vasculitis, pulmonary edema

Gastrointestinal: inflammation, bleeding (sometimes fatal, particularly in the elderly), ulceration, and obstruction of the upper or lower gastrointestinal tract, esophagitis, stomatitis, hematemesis, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease)

Hepatobiliary: hepatitis (some cases have been fatal) Hemic and Lymphatic: eosinophilia, hemolytic anemia, aplastic anemia

Metabolic and Nutritional: hyperglycemia, hypoglycemia

Nervous System: depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions

Respiratory: eosinophilic pneumonitis

Dermatologic: alopecia, urticaria, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematoses, bullous reactions, including Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

Special Senses: hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis,papilledema

Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine

Reproduction (female): infertility

Esomeprazole Magnesium

Blood and Lymphatic: agranulocytosis

Eye: blurred vision

Gastrointestinal: pancreatitis, microscopic colitis, fundic gland polyps

Hepatobiliary: hepatic failure, hepatitis with or without jaundice

Immune System: anaphylactic reaction/shock, systemic lupus erythematosus

Infections and Infestations: GI candidiasis, Clostridium difficile associated diarrhea

Metabolism and Nutritional Disorders: hypomagnesemia, hypocalcemia, hypokalemia [see WARNINGS AND PRECAUTIONS], hyponatremia

Musculoskeletal and Connective Tissue: muscular weakness, myalgia, bone fracture

Nervous System: hepatic encephalopathy

Psychiatric: aggression, agitation, hallucination

Renal and Urinary: interstitial nephritis

Reproductive System and Breast: gynecomastia

Respiratory, Thoracic, and Mediastinal: bronchospasm

Skin and Subcutaneous Tissue: alopecia, erythema multiforme, photosensitivity, SJS, TEN (some fatal), DRESS, AGEP, cutaneous lupus erythematosus


See Table 3 and Table 4 for clinically significant drug interactions and interactions with diagnostics with naproxen and esomeprazole magnesium.

Table 3: Clinically Significant Drug Interactions with Naproxen and Esomeprazole Magnesium - Affecting Drugs Co-Administered with VIMOVO and Interactions with Diagnostics

Clinical Impact: Naproxen
  • Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of naproxen and anticoagulants have increased the risk of serious bleeding compared to the use of either drug alone
  • Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Esomeprazole Magnesium
  • Increased INR and prothrombin time in patients treated with PPIs, including esomeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.
  • Concomitant use of esomeprazole 40 mg resulted in reduced plasma
Intervention: Monitor patients with concomitant use of VIMOVO with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see WARNINGS AND PRECAUTIONS].
Clopidogrel: Avoid concomitant use of clopidogrel with VIMOVO. Consider use of alternative anti-platelet therapy [see WARNINGS AND PRECAUTIONS].
Clinical Impact: A pharmacodynamics (PD) study has demonstrated an interaction in which lower dose naproxen (220mg/day or 220mg twice daily) interfered with the antiplatelet effect of low-dose immediate-release aspirin, with the interaction most marked during the washout period of naproxen [see CLINICAL PHARMACOLOGY]. There is reason to expect that the interaction would be present with prescription doses of naproxen or with enteric-coated low-dose aspirin; however, the peak interference with aspirin function may be later than observed in the PD study due to the longer washout period.
Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see WARNINGS AND PRECAUTIONS].
Intervention: Because there may be an increased risk of cardiovascular events following discontinuation of naproxen due to the interference with the antiplatelet effect of aspirin during the washout period, for patients taking low-dose aspirin for cardioprotection who require intermittent analgesics, consider use of an NSAID that does not interfere with the antiplatelet effect of aspirin, or non-NSAID analgesics where appropriate.
Concomitant use of VIMOVO and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS].
VIMOVO is not a substitute for low dose aspirin for cardiovascular protection.
ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers
Clinical Impact:
  • NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
  • In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
  • During concomitant use of VIMOVO and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
  • During concomitant use of VIMOVO and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted or have impaired renal function, monitor for signs of worsening renal function [see WARNINGS AND PRECAUTIONS].
Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.
Intervention: During concomitant use of VIMOVO with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS].
Clinical Impact: The effect of esomeprazole magnesium on antiretroviral drugs is variable. The clinical importance and mechanisms behind these interactions are not always known.
  • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with esomeprazole magnesium may reduce antiviral effect and promote the development of drug resistance [see CLINICAL PHARMACOLOGY].
  • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with esomeprazole magnesium may increase toxicity [see CLINICAL PHARMACOLOGY].
  • There are other antiretroviral drugs which do not result in clinically relevant interactions with esomeprazole magnesium.
Intervention: Rilpivirine-containins products: Concomitant use with VIMOVO is contraindicated [see CONTRAINDICATIONS].
Atazanavir: See prescribing information for atazanavir for dosing information.
Nelfinavir: Avoid concomitant use with VIMOVO.
Saquinavir: See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities.
Other antiretrovirals: See prescribing information of specific drugs.
Clinical Impact: Increased exposure of cilostazol and one of its active metabolites (3,4-dihydro-cilostazol) when coadministered with omeprazole magnesium, the racemate of esomeprazole [see CLINICAL PHARMACOLOGY].
Intervention: Consider reducing the dose of cilostazol to 50 mg twice daily.
Clinical Impact: Naproxen
  • The concomitant use of naproxen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.
Esomeprazole Magnesium
  • Potential for increased exposure of digoxin [see CLINICAL PHARMACOLOGY].
Intervention: Monitor digoxin concentrations during concomitant use of VIMOVO. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations.
Clinical Impact: NSAIDs have produced elevations of plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.
Intervention: During concomitant use of VIMOVO and lithium, monitor patients for signs of lithium toxicity.
Clinical Impact: Naproxen
  • Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
Esomeprazole Magnesium
  • Concomitant use of esomeprazole magnesium with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities [see WARNINGS AND PRECAUTIONS].
Intervention: During concomitant use of VIMOVO and methotrexate, monitor patients for methotrexate toxicity. A temporary withdrawal of VIMOVO may be considered in some patients receiving high-dose methotrexate.
Clinical Impact: Concomitant use of naproxen and cyclosporine may increase cyclosporine’s nephrotoxicity.
Intervention: During concomitant use of VIMOVO and cyclosporine, monitor patients for signs of worsening renal function.
Clinical Impact: Concomitant use of esomeprazole magnesium and tacrolimus may increase exposure of tacrolimus
Intervention: During concomitant use of VIMOVO and tacrolimus, monitor tacrolimus whole blood concentrations.
NSAIDs and Salicylates
Clinical Impact: Concomitant use of naproxen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see WARNINGS AND PRECAUTIONS].
Intervention: The concomitant use of VIMOVO with other NSAIDs or salicylates is not recommended.
Clinical Impact: Concomitant use of VIMOVO and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).
Intervention: During concomitant use of VIMOVO and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, mycophenoloate mofetil, ketoconazole)
Clinical Impact: Esomeprazole magnesium can reduce the absorption of other drugs due to its effect on reducing intragastric acidity
Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which esomeprazole magnesium is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving esomeprazole and MMF. Use VIMOVO with caution in transplant patients receiving MMF [see CLINICAL PHARMACOLOGY].
See the prescribing information for other drugs dependent on gastric pH for absorption.
Interactions with Investigations of Neuroendocrine Tumors
Clinical Impact: Serum chromogranin A (CgA) levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].
Intervention: Temporarily stop VIMOVO treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.
Clinical Impact: Increased exposure of diazepam [see CLINICAL PHARMACOLOGY].
Intervention: Monitor patients for increased sedation and adjust the dose of diazepam as needed.

Table 4: Clinically Significant Interactions with Esomeprazole Magnesium --Affecting Co-Administered Drugs

CYP2C19 or CYP3A4 Inducers
Clinical Impact: Decreased exposure of esomeprazole when used concomitantly with strong inducers [see CLINICAL PHARMACOLOGY].
Intervention: St. John’s Wort, rifampin: Avoid concomitant use with VIMOVO [see WARNINGS AND PRECAUTIONS].
CYP2C19 or CYP3A4 Inhibitors
Clinical Impact: Increased exposure of esomeprazole [see CLINICAL PHARMACOLOGY].
Intervention: Voriconazole: Avoid concomitant use with VIMOVO.

Read the entire FDA prescribing information for Vimovo (Naproxen and Esomeprazole Magnesium Delayed Release Tablets)

© Vimovo Patient Information is supplied by Cerner Multum, Inc. and Vimovo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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