Side Effects of VIMOVO

VIMOVO is a treatment option for patients with osteoarthritis that combines naproxen, a prescription-strength NSAID (nonsteroidal anti-inflammatory drug), with esomeprazole magnesium, a proton pump inhibitor (PPI). VIMOVO is indicated to relieve your osteoarthritis symptoms and decrease the chance you will develop stomach ulcers if you are at risk.

Talk to your doctor about the benefits and risks of VIMOVO.

Understanding the risks of VIMOVO treatment
Who should not take VIMOVO
What to discuss with your doctor before taking VIMOVO
Common side effects with VIMOVO

Understanding the risks of VIMOVO treatment

All prescription NSAIDs, including VIMOVO, may increase the chance of heart attack or stroke, which can lead to death. This chance increases

If you have heart disease
If you take NSAIDs for a long time

NSAID-containing medications, such as VIMOVO, should never be used before or after a type of heart surgery called coronary artery bypass graft (CABG).

Stomach and intestine problems and serious skin reactions can occur without warning. With any of these medications, people also taking aspirin and the elderly are at increased risk for stomach and intestinal bleeding and ulcers.

Who should not take VIMOVO

If you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID
For pain right before or after heart bypass surgery
If you are allergic to any of the ingredients in VIMOVO or any other proton pump inhibitor (PPI) medicine
If you are in the late stages of pregnancy (third trimester)

What to discuss with your doctor before taking VIMOVO

All of your medical conditions, including kidney or liver problems
All of the medicines you take, even over-the-counter medications. NSAIDs and some other medicines can interact with each other and cause serious side effects
If you are pregnant or breastfeeding. NSAIDs should not be used by pregnant women late in their pregnancy
If you have ulcerative colitis or Crohn’s disease (inflammatory bowel disease or IBD)

Common side effects with VIMOVO

The most common side effects with VIMOVO include

Inflammation of the lining of the stomach
Indigestion
Diarrhea
Stomach ulcers
Abdominal pain
Nausea

For complete information about side effects, please see the full Prescribing Information and the Medication Guide .

You will need Adobe^® Acrobat^® to view the full Prescribing Information. You can download it from the Adobe site.

Next: VIMOVO Savings Card

Important Safety Information

Like all medications that contain nonsteroidal anti-inflammatory drugs (NSAIDs), VIMOVO may increase the chance of a heart attack or stroke that can lead to death. This chance increases
- With longer use of NSAID medicines
- In people who have heart disease
NSAID-containing medications, such as VIMOVO, should never be used before or after a type of heart surgery called coronary artery bypass graft (CABG)
As with all medications that contain NSAIDs, VIMOVO may increase the chance of stomach and intestinal problems, such as bleeding or an ulcer, which can occur without warning and may cause death
- Elderly patients are at greater risk for serious gastrointestinal events

VIMOVO is not right for everyone, including patients who have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine, patients who are allergic to any of the ingredients in VIMOVO, or women in late stages of pregnancy.

Serious allergic reactions, including skin reactions, can occur without warning and can be life-threatening; discontinue use of VIMOVO at the first appearance of a skin rash, or if you develop sudden wheezing; swelling of the lips, tongue or throat; fainting; or problems swallowing.

VIMOVO should be used at the lowest dose and for the shortest amount of time as directed by your health care provider.

Tell your health care provider right away if you develop signs of active bleeding from any source.

VIMOVO can lead to onset of new hypertension or worsening of existing high blood pressure, either of which may contribute to an increased risk of a heart attack or stroke.

Speak with your health care provider before starting VIMOVO if you

Have a history of ulcers or bleeding in the stomach or intestines
Have heart problems, high blood pressure, or are taking high blood pressure medications
Have kidney or liver problems

Tell your health care provider about all of the medicines you take including prescription and non-prescription drugs, vitamins, and herbal supplements before starting VIMOVO.

Talk to your health care provider about your risk for bone fractures if you take VIMOVO for a long period of time.

Talk to your health care provider about your risk for developing low levels of magnesium if you take VIMOVO for a long period of time.

The most common side effects of VIMOVO include: inflammation of the lining of the stomach, indigestion, diarrhea, stomach ulcers, abdominal pain, and nausea.

Approved Uses for VIMOVO

VIMOVO is approved to relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment with NSAIDs.

VIMOVO is not recommended as a starting treatment for relief of acute pain. Controlled studies do not extend beyond
6 months.

For further information on VIMOVO, please see the full Prescribing Information, including Boxed Warnings.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

This product information is intended for US consumers only.

VIMOVO is a registered trademark of the AstraZeneca group of companies.

Patient Information

Side Effects of VIMOVO

Understanding the risks of VIMOVO treatment

Who should not take VIMOVO

What to discuss with your doctor before taking VIMOVO

Common side effects with VIMOVO

Prescription savings

Information on taking VIMOVO

Important Safety Information

Approved Uses for VIMOVO

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