If you take more VIMOVO than your healthcare provider recommends, call your Poison Control Center at 1-800-222-1222.

Your healthcare provider may do certain tests from time to time to check you for side effect of VIMOVO.

What should I avoid while taking VIMOVO?

VIMOVO can cause drowsiness, dizziness, or depression. You should not drive or do other activities that require you to be alert until you know how VIMOVO affects you.

What are the possible side effects of VIMOVO?

VIMOVO may cause serious side effects.

See “What is the most important information I should know about VIMOVO?”

High blood pressure.

Heart problems such as congestive heart failure. Tell your healthcare provider about any swelling of your body, hands or feet, sudden weight gain or trouble breathing.

Active bleeding. Tell your healthcare provider if you have signs of active bleeding including:

passing black sticky bowel movements (stools)

having bloody diarrhea

vomiting or coughing up blood or dark particles that look like coffee grounds

Serious allergic reactions. Tell your healthcare provider or get medical help right away if you develop sudden wheezing, swelling of your lips, tongue, throat or body, rash, fainting or problems breathing or swallowing (severe allergic reaction).

Serious skin reactions. Tell your healthcare provider or get medical help right away if you develop:

reddening of your skin with blisters or peeling

blisters and bleeding of your lips, eye lids, mouth, nose, and genitals.

Liver problems. Tell your healthcare provider if you develop:

yellowing of the skin or the whites of your eyes

dark urine

feel tired

nausea

right upper stomach area (abdomen) pain

flu-like symptoms

Bone Fracture. Talk to your healthcare provider about your risk for fractures if you take VIMOVO for a long period of time.

Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away if you have any of these symptoms:

seizures

dizziness

abnormal or fast heart beat

jitteriness

jerking movements or shaking (tremors)

muscle weakness

spasms of the hands and feet

cramps or muscle aches

spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking VIMOVO, during treatment, or if you will be taking VIMOVO for a long period of time.

The most common side effects of VIMOVO include

inflammation of the lining of the stomach, with or without loss of the protective layer of the stomach (erosive gastritis)

indigestion

diarrhea

stomach ulcers

upper stomach-area (abdominal) pain

nausea

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of VIMOVO. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store VIMOVO?

Store VIMOVO at 59°F to 86°F (15°C to 30°C)

Keep VIMOVO in the original container and keep the b