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This document outlines critical safety information and warnings for the medication Vimovo, which contains naproxen and esomeprazole. It is important to understand the potential risks, necessary precautions, and specific instructions for certain populations when using this medication. Please consult with your healthcare provider if you have any concerns or questions.

• Cardiovascular Risks: There is a potential for increased risk of heart attack or stroke associated with naproxen, particularly with prolonged use, high doses, or existing heart conditions. Individuals with a history of heart disease, high blood pressure, or recent heart surgery should exercise caution.

• Gastrointestinal Risks: Vimovo can cause serious stomach bleeding, ulcers, or tears in the digestive tract. While esomeprazole is included to reduce these risks, bleeding can occur at any time without prior symptoms. Older adults, those with a history of ulcers, or individuals taking other medications that increase bleeding risk should be particularly vigilant.

• Liver Concerns: Elevated liver enzyme levels may occur, indicating potential liver damage. Although rare, the damage could be severe.

• Blood Pressure and Fluid Retention: Vimovo may cause new or worsening high blood pressure and lead to fluid retention, which can exacerbate heart failure. Those with a history of high blood pressure or heart failure should monitor their condition closely.

• Kidney Health: There is a risk of kidney damage. Patients with pre-existing kidney conditions should discuss the safety of this medication with their healthcare provider, and monitoring kidney function may be necessary.

• Allergic Reactions: Serious allergic reactions, including anaphylaxis or severe skin reactions, can occur. Those with known allergies to naproxen or esomeprazole should avoid this medication.

• Nutrient and Electrolyte Imbalances: Prolonged use may lead to elevated potassium levels and reduced magnesium or vitamin B12 levels, particularly in individuals with kidney damage or those taking certain medications.

• Bone Fractures: Long-term use of esomeprazole may increase the risk of bone fractures, especially in individuals with osteoporosis.

• Lupus: New or worsening lupus symptoms may develop. Discontinue use and consult your healthcare provider if symptoms arise.

• Pregnancy Risks: Vimovo is not recommended during pregnancy, particularly from the 20th week onward, due to potential harm to the unborn baby.

Contraindications:

• Do not use if allergic to naproxen, esomeprazole, aspirin, or other NSAIDs.
• Avoid if you have a history of asthma related to NSAID use.
• Do not use in conjunction with rilpivirine-containing medications or if you have undergone recent heart bypass surgery.

In case of overdose, seek emergency medical attention immediately. Always discuss the benefits and risks of this medication with your healthcare provider.

When taking this medication, some common side effects may include upset stomach, heartburn, diarrhea, drowsiness, and dizziness. These effects are generally mild, but if they persist or worsen, it’s advisable to consult your healthcare provider. Gastritis, which involves inflammation of the stomach lining and can cause stomach pain, nausea, and loss of appetite, is also reported by some users.

In addition to these, you may experience passing gas, headaches, changes in taste, or infections such as upper respiratory tract infections or urinary tract infections. These are typically not severe but should still be monitored.

There are more serious side effects that, although rare, require immediate medical attention. These include symptoms of a heart attack, such as chest or arm pain and shortness of breath, or signs of a stroke, like sudden weakness on one side of the body and severe headache. Serious bleeding, especially in the stomach, and signs of liver damage, such as jaundice and upper right stomach pain, should also be treated urgently.

Kidney damage may manifest as changes in urination or blood in the urine, while severe allergic reactions can present as rash, hives, or breathing difficulties. In very rare cases, this medication may cause severe intestinal conditions or vitamin B-12 deficiency if taken long-term. Always seek medical help if you notice these or any other unusual symptoms.

Some medications can interact with this drug, affecting how it works or increasing side effects. These include aliskiren, ACE inhibitors like captopril and lisinopril, angiotensin II receptor blockers such as valsartan and losartan, corticosteroids like prednisone, lithium, mavacamten, high-dose methotrexate, rifampin, St John's wort, and diuretics such as furosemide.

This medication may heighten bleeding risk if taken with other drugs that also cause bleeding, like anti-platelet agents such as clopidogrel and blood thinners including dabigatran, enoxaparin, and warfarin.

Some drugs require stomach acid for proper absorption, which can be affected by this medication as it reduces stomach acid levels. Medications that might be impacted include atazanavir, erlotinib, levoketoconazole, nelfinavir, pazopanib, rilpivirine, sparsentan, and certain azole antifungals like itraconazole, ketoconazole, and posaconazole.

It's important to review all prescription and over-the-counter medications, as many contain pain relievers or fever reducers, such as aspirin and NSAIDs like celecoxib, ibuprofen, or ketorolac. These can be similar to naproxen and increase the risk of side effects. However, if your doctor has advised taking low-dose aspirin (81-162 milligrams daily) to prevent heart attack or stroke, continue as directed unless advised otherwise. Naproxen can reduce aspirin's efficacy in heart attack or stroke prevention. Discuss with your doctor about alternative pain or fever treatments.

This drug may also interfere with certain laboratory tests, potentially leading to incorrect results. Ensure that all healthcare providers and lab staff are aware of your medication use.