How does Vimovo work?

Vimovo contains two ingredients: naproxen and esomeprazole. Naproxen is an NSAID that works by decreasing substances in the body that cause pain and inflammation. Esomeprazole, a PPI, works by decreasing acid production in the stomach, thereby reducing the risk of developing an ulcer from the NSAID.

What drugs should not be taken with Vimovo?

Vimovo has many drug interactions. Before taking Vimovo, review your medication list with your healthcare provider, including prescription and OTC drugs, vitamins, and herbal supplements. Some examples of drugs that interact with Vimovo include blood thinners , certain antidepressants , and certain heart and blood pressure medications.

When do I stop taking Vimovo?

Your healthcare provider will advise you on how long to take Vimovo.

What is the boxed warning associated with taking Vimovo?

Vimovo contains a boxed warning, which is the FDA's highest safety-related warning assigned to be placed on a medication label and any package inserts. Vimovo has a boxed warning because it contains an NSAID (naproxen). The warning states: NSAIDs can increase the risk of clots, including heart attack and stroke, which can cause death. The risk is there as soon as treatment begins and increases with longer treatment. NSAIDs should not be used before, during, or after a coronary artery bypass graft (CABG) surgery. NSAIDs can cause serious GI problems, such as bleeding, ulcers, and perforation of the stomach and intestines. These complications can occur at any time during treatment and without warning. You are at higher risk if you are 65 and older or have a history of stomach ulcers or other GI-related problems.

Vimovo (Naproxen and Esomeprazole) Oral: Uses, Effects

Warning:

Vimovo (naproxen and esomeprazole), like all nonsteroidal anti-inflammatory drugs (NSAIDs), has a boxed warning, which is the most serious warning required by the Food and Drug Administration (FDA). The warning states the following safety risks with Vimovo.

NSAIDs, such as naproxen in Vimovo, can increase the risk of clots, including heart attack and stroke, which can cause death. The risk can occur as soon as treatment begins and increases with longer treatment. Get emergency medical help immediately if you are experiencing chest pain that spreads to the jaw or shoulder, sudden weakness or numbness on one side of the body, slurred speech, or shortness of breath.

NSAIDs should not be used before, during, or after coronary artery bypass graft (CABG) surgery.

NSAIDs increase the risk of serious gastrointestinal (GI) problems. These may include bleeding, ulcers, and perforation of the stomach or intestines and can cause death. These complications can happen at any time during treatment and without any warning. Older adults and people with a history of stomach ulcers or other stomach problems are at higher risk for these complications.

…

What Is Vimovo?

Vimovo (naproxen and esomeprazole) is an oral combination medication used to treat arthritis symptoms in people at risk of developing ulcers from nonsteroidal anti-inflammatory drug (NSAID) use.

Vimovo contains two drugs in one tablet: an NSAID called naproxen and a proton pump inhibitor (PPI) called esomeprazole. Esomeprazole helps to reduce the risk of ulcers, which can occur from NSAIDs like naproxen, in people taking Vimovo.

Naproxen works by decreasing substances in the body that cause pain and inflammation, and esomeprazole works by decreasing acid production in the stomach.

Vimovo is available by prescription as an oral delayed-release tablet.

Drug Facts

Generic Name: Naproxen and esomeprazole

Brand Name(s): Vimovo

Drug Availability: Prescription

Administration Route: Oral

Therapeutic Classification: NSAID and PPI combination

Available Generically: Yes

Controlled Substance: N/A

Active Ingredient: Naproxen and esomeprazole magnesium

Dosage Form(s): Delayed-release tablet

What Is Vimovo Used For?

The Food and Drug Administration (FDA) approved Vimovo to:

Relieve symptoms of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis in adults who are at risk of developing ulcers from NSAID use.
Relieve symptoms of juvenile idiopathic arthritis in adolescents 12 years and older who are at risk of developing ulcers from NSAID use.

Naproxen is an NSAID that helps with pain and inflammation. However, NSAIDs can also increase the risk of stomach problems, such as ulcers. The other component of Vimovo, esomeprazole, helps lower the risk of developing ulcers from naproxen.

How to Take Vimovo

If you are prescribed Vimovo, remember to read the medication label and information leaflet that comes with your prescription. Consult your healthcare provider if you have any questions.

Use Vimovo exactly as directed; do not skip any doses. Swallow the delayed-release tablet whole, with liquid. Do not chew, crush, break, or dissolve the tablet. You should take Vimovo at least 30 minutes before eating. Taking it with food will reduce how much of the drug is absorbed in the body.

Storage

Store at room temperature (between 68 F and 77 F), away from heat, direct light, and moisture. Do not store it in the bathroom. Keep this medication in its original labeled container and out of reach of children and pets. Keep the bottle tightly closed when not in use.

How Long Does Vimovo Take to Work?

After taking a dose of Vimovo, the naproxen reaches its highest level in the body within about three hours. However, it will take about three to four days for the drug to reach its steady state in the body. Esomeprazole, on the other hand, is rapidly absorbed and reaches peak concentration around 40 minutes to one hour after taking it.

What Are the Side Effects of Vimovo?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

The most common side effects of Vimovo are:

Stomach problems such as gastritis (irritation of the stomach lining), stomach pain, nausea, diarrhea, constipation, gas, indigestion, stomach ulcer
Dizziness
Drowsiness
Headache
Swelling of the extremities
Altered taste
Rash
Ringing in the ears
Increased liver enzymes based on liver function tests
Bruising
Shortness of breath
Sun sensitivity
Delayed ovulation (people who are trying to get pregnant should consult their healthcare provider)

Severe Side Effects

Vimovo, like all NSAIDs, has a boxed warning, which is the most serious warning required by the FDA. The warning states:

NSAIDs, such as naproxen in Vimovo, can increase the risk of clots, including heart attack and stroke, which can cause death. The risk can occur as soon as treatment begins and increases with longer treatment. People experiencing chest pain that spreads to the jaw or shoulder, sudden weakness or numbness on one side of the body, slurred speech, or shortness of breath should get emergency medical help right away.
NSAIDs should not be used before, during, or after CABG surgery.
NSAIDs increase the risk of serious GI problems. These may include bleeding, ulcers, and perforation of the stomach or intestines and can cause death. These complications can happen anytime during treatment and without any warning. Older adults and people who have a history of stomach ulcers or other stomach problems are at higher risk for these complications.

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

In addition to the possible side effects listed in the boxed warning above, other serious side effects and their symptoms can include the following:

Hypersensitivity reaction or anaphylaxis: Rash; hives; swelling around the lips, tongue, and face; and difficulty breathing
Severe skin reactions: Fever, red and purple rash, blistering and peeling skin, burning eyes, and sore throat
High blood pressure
Heart failure: Swelling, shortness of breath, fast weight gain
Lupus: Joint pain and/or a skin rash that gets worse in sunlight
Anemia (low red blood cells): Tiredness, pale skin, lightheadedness, shortness of breath, cold hands and feet
Prolonged bleeding time (blood takes longer to clot)
Kidney problems: Fever, rash, nausea, appetite loss, joint pain, decreased urination, blood in the urine
Liver problems: Dark urine, clay-colored stools, tiredness, stomach pain, yellowing of the skin or the whites of the eyes
Narrowing of the airways, which can cause shortness of breath and wheezing
Bullseye-shaped lesions
Drug reaction with eosinophilia and systemic symptoms (DRESS): A reaction that can cause skin problems and problems with internal organs.

Fractures: Bone fractures are more likely in people who take a PPI, such as the esomeprazole in Vimovo, for more than one year or who take multiple doses per day
Low levels of magnesium: Dizziness, fast or irregular heart rate, jitters, muscle cramps or spasms, feeling like you are choking
High levels of potassium
Diarrhea that is severe/watery/bloody and can be life-threatening
Inflamed pancreas: Severe belly pain, nausea, vomiting
Hernia: A bump, lump, or bulge under the skin that may cause pain or swelling
Esophagus problems

Long-Term Side Effects

While many people tolerate Vimovo well, long-term or delayed side effects are possible. Some long-term side effects can be mild, such as:

Purpura (purple spots on the skin due to small blood vessels bursting)
Ringing in the ears
Infection
Cough
Leukocytosis (high white blood cell count)
Nosebleeds
Numbness and tingling
Appetite and weight changes
Altered sense of smell
Hair loss
Muscle and joint pain
Sore throat
Menstrual cramps
Reflux/heartburn
Small bumps on the trunk and extremities
Sun sensitivity
Enlarged breasts in men

Moderate long-term side effects can include:

Gastritis
Stomach growths called fundic gland polyps
Swelling and sores in the mouth
Swelling of the extremities
Constipation
Difficulty swallowing
Dark stools
Swollen lymph nodes
A high number of eosinophils (a type of white blood cell)
Low red blood cells, white blood cells, and platelets
Depression
Stiff muscles
Erectile dysfunction
Impaired cognition
Pinkeye
Jaundice (yellowing of the skin or whites of the eyes due to liver problems)
Increased liver enzymes/liver problems
Blood in the urine
Urinary tract infection
High levels of uric acid in the blood
Vaginal inflammation/itching
Goiter (enlarged thyroid)
Esophagitis (inflamed esophagus)
Fluid retention
Vitamin B12 deficiency
Pernicious anemia (decreased red blood cells due to vitamin B12 deficiency)
Myasthenia (muscle weakness and fatigue)
Low potassium, magnesium, and calcium levels
High blood sugar
Pneumonitis (lung inflammation)
Yeast infection
Colitis (inflamed colon)
Infertility

Severe long-term side effects may include:

Inflamed pancreas
Gastrointestinal (GI) bleeding
Agranulocytosis (low white blood cells)
Hearing loss
Kidney problems or kidney failure
Ulcers
Vomiting blood
Esophageal stricture (narrowing of the esophagus)
GI perforation (a hole in the stomach, bowel, or intestine)
GI obstruction (food or stool cannot move through the intestines)
Hemolytic anemia (decreased red blood cells)
Pancytopenia (low numbers of white and red blood cells and platelets)
Aplastic anemia (the body stops making new blood cells due to bone marrow damage)
Eye and vision problems
Swelling of the optic nerve, which can cause headache, nausea, and vomiting
Liver problems/liver failure
Inflammation of the brain and spinal cord
High levels of potassium in the blood
Heart failure
Blood clots
Blood vessel inflammation
Heart attack
Stroke
Severe and life-threatening skin reactions
Bone fractures
Lupus-like symptoms (tiredness, joint pain, fever, rash)

Report Side Effects

Vimovo may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA)'s MedWatch Adverse Event Reporting Program online or by phone (800-332-1088).

(800) 332-1088

Dosage: How Much Vimovo Should I Take?

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (delayed-release tablets):
- For juvenile idiopathic arthritis:
  - Children 12 years of age and older and weighs more than 50 kilograms (kg)—1 tablet (375 milligrams (mg) naproxen and 20 mg esomeprazole or 500 mg naproxen and 20 mg esomeprazole) 2 times a day.
  - Children 12 years of age and older and weighs 38 kg to less than 50 kg—1 tablet (375 milligrams (mg) naproxen and 20 mg esomeprazole) 2 times a day.
  - Children younger than 12 years of age and weighs less than 38 kg—Use and dose must be determined by your doctor.
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—1 tablet (375 milligrams (mg) naproxen and 20 mg esomeprazole or 500 mg naproxen and 20 mg esomeprazole) 2 times a day.
  - Children—Use and dose must be determined by your doctor.

Modifications

Be aware of the following treatment or dosage modifications when taking Vimovo:

People who are 65 years or older are at higher risk for heart, stomach, and kidney problems from NSAIDs like Vimovo. Your healthcare provider will weigh benefits versus risks.
People with severe liver problems or advanced kidney disease should not take Vimovo.
Vimovo can be used in adolescents who are at least 12 years old and weigh at least 83.6 pounds (38 kilograms) to relieve symptoms of juvenile idiopathic arthritis and lower the risk of developing ulcers from naproxen. Vimovo is not approved for children who are younger than 12 years old or weigh less than 83.6 pounds.
People who are pregnant or planning to become pregnant should consult their healthcare provider before taking Vimovo. NSAIDs, such as Vimovo, can cause serious harm to the unborn fetus, especially starting at 20 weeks of pregnancy (and through the rest of the pregnancy).
People who are breastfeeding should consult their healthcare provider for medical advice.

Missed Dose

If you miss a dose of Vimovo, take it as soon as you can. If it is almost time for the next dose, skip the missed dose. Do not take two doses together.

Overdose: What Happens If I Take Too Much Vimovo?

Taking too much Vimovo can cause drowsiness, severe weakness, stomach pain, or vomiting. GI bleeding may also occur in severe cases.

What Happens If I Overdose on Vimovo?

If you think you or someone else may have overdosed on Vimovo, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Vimovo, call 911 immediately.

911

Precautions

It is very important that your doctor check your or your child's progress at regular visits to see if the medicine is working properly and to decide if you should continue to take it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects.

Do not use this medicine together with medicines containing rilpivirine (Complera®, Edurant®, Odefsey®). Using these medicines together may cause unwanted side effects.

Naproxen may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Get emergency help right away if you have any symptoms of a heart attack or stroke. Some possible symptoms are chest pain or discomfort, uneven heartbeat, pain that spreads to your arm or jaw, unusual sweating, feeling faint, trouble breathing, slurred speech, or weakness on one side of your body.

Naproxen may cause bleeding in your stomach or bowels. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (eg, steroids or a blood thinner).

This medicine may cause a serious type of allergic reaction, called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you or your child have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Using this medicine during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

Check with your doctor right away if you or your child have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or eyes.

If you or your child are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

This medicine may cause kidney problems. Tell your doctor right away if you or your child has blood in the urine, decreased urine output, confusion, dizziness, headache, muscle twitching, rapid weight gain, swelling of your face, ankles, or hands, or unusual tiredness or weakness.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Call your doctor right away if you have confusion, nausea or vomiting, weakness or heaviness of the legs, uneven heartbeat, trouble breathing, numbness or tingling in your hands, feet, or lips.

Check with your doctor right away if you or your child has a change in frequency of urination or amount of urine, blood in the urine, fever, joint pain, loss of appetite, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after using this medicine. These could be symptoms of acute tubulointerstitial nephritis.

Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.

This medicine may cause hypomagnesemia (low magnesium in the blood). Your doctor may want to check your blood levels if you are taking this medicine for more than 1 year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Check with your doctor right away if you have seizures, fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

Serious stomach conditions may occur while taking this medicine alone. Check with your doctor immediately if you or your child has stomach cramps, bloated feeling, watery and severe diarrhea which may be bloody sometimes, fever, nausea, vomiting, or unusual tiredness or weakness.

This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.

Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you or your child has joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.

This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you are receiving this medicine for more than 1 year. Talk to your doctor if you have concerns.

Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop the medicine for a while, or to change to a different medicine before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, atazanavir, nelfinavir, Reyataz®, Viracept®) or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

What Are Reasons I Shouldn’t Take Vimovo?

Vimovo is not appropriate for everyone. You should not take this medication if you are allergic to naproxen, esomeprazole, omeprazole, or any of the inactive ingredients in Vimovo.

You should not take Vimovo if you:

Are at least 20 weeks pregnant (people in earlier pregnancy should consult their healthcare provider for advice)
Have severe kidney or liver problems
Are getting CABG surgery
Have aspirin triad (an allergy to NSAIDs, asthma, and sinus disease with nasal polyps)

Additionally, medications containing the drug rilpivirine should not be used with Vimovo. Therefore, your healthcare provider may not prescribe Vimovo if you take the following:

Edurant (rilpivirine)
Juluca (dolutegravir/rilpivirine)
Complera (emtricitabine/rilpivirine/tenofovir disoproxil)
Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide)
Cabenuva (cabotegravir and rilpivirine)

Certain health conditions or life stages may require the cautious use of Vimovo. Your healthcare provider may still prescribe it to you if they determine it is safe. This includes use in:

Older adults (65 years and above)
Debilitated (weak) individuals
Early pregnancy (less than 10 weeks) or people trying to become pregnant
Mild or moderate kidney or liver problems
Heart disease or risk of heart disease
High blood pressure
Stomach bleeding or a history of ulcers
People who drink alcohol or smoke
Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
Blood clotting problems
People on a sodium-restricted diet
Asthma
People with low levels of magnesium

What Other Medications May Interact With Vimovo?

Tell your healthcare provider about all of the medicines you take, including prescription, over-the-counter (OTC) medicines, and vitamins or supplements.

Certain antidepressants can make you bleed more easily if taken with Vimovo. These include:

Examples of other medications that can interact with Vimovo include:

Angiotensin-converting enzyme (ACE) inhibitors such as Altace (ramipril), Vasotec (enalapril), or Zestril (lisinopril)
Angiotensin receptor blockers (ARBs) such as Cozaar (losartan) or Diovan (valsartan)
Beta-blockers such as Lopressor or Toprol XL (metoprolol) or Tenormin (atenolol)
Blood thinners such as Jantoven (warfarin)
Diuretics such as Microzide (hydrochlorothiazide) or Lasix (furosemide)
Edurant (rilpivirine) or other drugs that contain rilpivirine
Lanoxin (digoxin)
Lithium
Trexall or Rheumatrex (methotrexate)
Other NSAIDs
Plavix (clopidogrel)
Rifadin or Rimactane (rifampin)
St. John’s wort
Steroids such as Rayos (prednisone) or Medrol (methylprednisolone)
Valium (diazepam)

Other drug interactions may occur with Vimovo. Consult your healthcare provider for a complete list of drug interactions.

What Medications Are Similar?

Vimovo contains naproxen, an NSAID, and esomeprazole, a PPI.

Medications similar to Vimovo include:

Duexis (ibuprofen and famotidine): Duexis contains an NSAID and a histamine-2 blocker, a type of drug that decreases stomach acid production. It is used to improve symptoms of rheumatoid arthritis and osteoarthritis. Additionally, it lowers the risk of developing ulcers from NSAIDs.
Arthrotec (diclofenac sodium and misoprostol): Arthrotec contains diclofenac sodium, which is an NSAID, and misoprostol, which can help prevent stomach ulcers from NSAIDs. It has the same uses as Duexis.

Some healthcare providers will prescribe two separate NSAID and PPI drugs to achieve the same combined result of arthritis symptom relief and protecting the stomach.

For example, for symptom relief, they may prescribe an NSAID such as:

Celebrex (celecoxib)
Mobic (meloxicam)
Advil, Motrin (ibuprofen)
Naprosyn (naproxen)
Relafen (nabumetone)
Voltaren (diclofenac sodium)

In addition to an NSAID, a PPI may be prescribed to lower the risk of stomach ulcers, such as:

Some NSAIDs and acid-reducing medications listed above are also available OTC, For example, naproxen is available OTC as Aleve. It is also available by prescription in a higher dose.

This is a list of drugs also prescribed for arthritis in people at high risk for stomach ulcers. It is NOT a list of drugs recommended to take with Vimovo. Talk to your pharmacist or a healthcare provider if you have questions.

Frequently Asked Questions

What is Vimovo used for?

Vimovo is used to improve symptoms in adults with osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis who are at risk of developing ulcers due to NSAID use. It can also be used to improve symptoms of juvenile idiopathic arthritis in adolescents 12 years and older who are at risk of developing ulcers due to NSAID use.
How does Vimovo work?

Vimovo contains two ingredients: naproxen and esomeprazole. Naproxen is an NSAID that works by decreasing substances in the body that cause pain and inflammation. Esomeprazole, a PPI, works by decreasing acid production in the stomach, thereby reducing the risk of developing an ulcer from the NSAID.
What drugs should not be taken with Vimovo?

Vimovo has many drug interactions. Before taking Vimovo, review your medication list with your healthcare provider, including prescription and OTC drugs, vitamins, and herbal supplements.
Some examples of drugs that interact with Vimovo include blood thinners, certain antidepressants, and certain heart and blood pressure medications.
What are the side effects of Vimovo?

The most common side effects of Vimovo are stomach problems, which may include irritation, pain, nausea, diarrhea, constipation, gas, indigestion, and stomach ulcers. Stomach problems can become very serious or life-threatening in some cases.
Other common side effects may include dizziness, drowsiness, headache, swelling, altered taste, rash, ringing in the ears, bruising, shortness of breath, and sun sensitivity.
Before taking Vimovo, talk to your healthcare provider about side effects and how to address them. Read the patient information carefully, and make sure you understand all of the risks associated with Vimovo.
When do I stop taking Vimovo?

Your healthcare provider will advise you on how long to take Vimovo.
What is the boxed warning associated with taking Vimovo?
Vimovo contains a boxed warning, which is the FDA's highest safety-related warning assigned to be placed on a medication label and any package inserts.
Vimovo has a boxed warning because it contains an NSAID (naproxen). The warning states:
- NSAIDs can increase the risk of clots, including heart attack and stroke, which can cause death. The risk is there as soon as treatment begins and increases with longer treatment.
- NSAIDs should not be used before, during, or after a coronary artery bypass graft (CABG) surgery.
- NSAIDs can cause serious GI problems, such as bleeding, ulcers, and perforation of the stomach and intestines. These complications can occur at any time during treatment and without warning. You are at higher risk if you are 65 and older or have a history of stomach ulcers or other GI-related problems.

How Can I Stay Healthy While Taking Vimovo?

Before taking Vimovo, discuss your medical history and all medications you take with your healthcare provider.

When taking Vimovo, follow your healthcare provider’s instructions for use. Read the patient information leaflet that comes with your prescription and talk to your healthcare provider if you have any questions.

Many people who take Vimovo do not experience any serious side effects. However, there are some serious side effects associated with all NSAIDs. Before you take Vimovo, discuss these risks with your healthcare provider. Some things to look out for include:

Heart and clotting problems, which can include chest pain, shortness of breath, weakness, or slurring of speech
Heart failure and swelling (edema), which may include shortness of breath, rapid weight gain, and swelling
GI bleeding/ulcer/perforation, which can cause stomach pain, indigestion, dark stools, or vomiting blood
Liver problems, with nausea, tiredness, itching, diarrhea, stomach pain, flu-like symptoms, and yellowing of the skin and whites of the eyes
Severe allergic reactions, which can include hives, difficulty breathing, and swelling of the face, lips, tongue, or throat
Serious skin reactions, like a rash

Get medical help immediately if any of these symptoms occur. Additionally, avoid alcohol while taking Vimovo. Ask your healthcare provider about what other treatment measures you can take for arthritis pain, such as physical therapy or hot or cold therapy.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

7 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

DailyMed. Label: Vimovo- naproxen and esomeprazole magnesium tablet, delayed release.
Wiesner A, Zwolińska-Wcisło M, Paśko P. Effect of food and dosing regimen on safety and efficacy of proton pump inhibitors therapy—a literature review. Int J Environ Res Public Health. 2021;18(7):3527. doi: 10.3390/ijerph18073527
Prescribers’ Digital Reference. Esomeprazole magnesium/naproxen - drug summary.
Epocrates. Vimovo.
Gwee KA, Goh V, Lima G, Setia S. Coprescribing proton-pump inhibitors with nonsteroidal anti-inflammatory drugs: risks versus benefits. J Pain Res. 2018;11:361-374. doi:10.2147/JPR.S156938
Food and Drug Administration. Duexis label.
DailyMed. Label: Arthrotec- diclofenac sodium and misoprostol tablet, film coated.

By Karen Berger, PharmD
Karen Berger, PharmD, is a community pharmacist and medical writer/reviewer.

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Vimovo (Naproxen and Esomeprazole) - Oral