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The following safety information outlines crucial warnings associated with the use of Yosprala (aspirin/omeprazole). It is important to review these details and consult your healthcare provider if you have any concerns.

• Risk of Bleeding and Stomach Irritation: Yosprala can irritate the stomach or intestines, potentially causing pain, heartburn, swelling, bleeding, or ulcers. The risk of bleeding is heightened by alcohol consumption, especially for those consuming three or more alcoholic drinks daily or regularly. The risk is also increased if taken with blood thinners like warfarin or other NSAIDs. If you experience persistent stomach pain, vomit blood, or have bloody or black stools, contact your healthcare provider immediately. Factors that increase this risk include a history of stomach issues, genetic bleeding disorders, liver disease, vitamin K deficiency, concurrent use of other medications that increase bleeding risk, alcohol use, age over 55, prolonged use of high doses of aspirin, or taking higher doses of Yosprala than recommended.

• Kidney or Liver Damage: Use of Yosprala may result in kidney damage, with increased risk for individuals with a history of kidney problems or prolonged use of the medication. Discontinue use and inform your provider if you notice reduced urination, fever, muscle weakness, nausea, or loss of appetite, as these could indicate kidney damage.

• Bone Fractures: There is an increased risk of bone fractures in the hip, wrist, or spine, particularly with long-term use or higher-than-recommended doses of Yosprala. Those at risk of osteoporosis should discuss bone health strategies with their provider, including the potential need for vitamin D and calcium supplements.

• Lupus: Omeprazole in Yosprala can exacerbate or cause new onset of lupus, an autoimmune condition. Symptoms include frequent fevers, fatigue, rash, or joint pain. If these symptoms occur, stop the medication and consult your provider. Symptoms typically improve within 4 to 12 weeks after discontinuation.

• Low Vitamin B12 and Magnesium Levels: Long-term use of Yosprala may lead to decreased levels of vitamin B12 and magnesium, especially if used concurrently with other medications that affect magnesium levels. Symptoms like irregular heart rate, muscle cramps, and tremors for magnesium, or weakness and dizziness for vitamin B12, should prompt a medical evaluation for supplementation needs.

• Harm to Unborn Baby: Pregnant individuals, especially those 20 weeks or later, should avoid Yosprala due to potential developmental risks to the baby's kidneys, lungs, and heart. Discuss potential risks and benefits with your provider.

• Severe Allergic or Skin Reactions: Yosprala can cause life-threatening allergic or skin reactions. Immediate medical attention is required if symptoms such as fever, rash, peeling or blistering skin, swollen lymph nodes, or facial swelling occur.

Contraindications: Do not use Yosprala if you have an allergy to NSAIDs, a history of asthma, rhinitis, and nasal polyps (aspirin triad), or are a child or teenager with suspected viral infections due to Reye's syndrome risk. It is also contraindicated with medications containing rilpivirine and should not be used as the first dose for heart attack symptoms. Always consult with your healthcare provider before starting Yosprala if any of these conditions apply to you.

When taking this medication, some individuals may experience common side effects, which are usually mild and manageable. These include an upset stomach, nausea, and diarrhea. If these persist or worsen, it's advisable to consult a healthcare provider for further guidance.

There are also other side effects that can occur, though less frequently, such as chest pain and the development of stomach polyps. While stomach polyps typically do not cause symptoms, seeking medical advice if you experience chest pain is important.

On rare occasions, more serious side effects may arise, necessitating immediate medical attention. These include signs of bleeding, such as unexplained or persistent bruising, blood in the urine or stool, or vomit that resembles coffee grounds. Stomach bleeding is especially concerning if stools appear bloody or black.

Additionally, kidney damage is a serious risk, indicated by symptoms like reduced urination, fever, muscle weakness, nausea, and a loss of appetite. A severe allergic reaction, though rare, would manifest as a rash, hives, difficulty breathing, or swelling of the face, lips, tongue, or throat. If any of these serious symptoms occur, urgent medical care is essential.

Proton pump inhibitors like this medication have also been associated with vitamin B-12 deficiency, especially if used daily over a long period. Watch for symptoms such as unusual weakness, a sore tongue, or numbness in the hands or feet. Lastly, a rare but severe intestinal condition caused by C. difficile bacteria could develop during or after treatment, marked by persistent diarrhea and abdominal pain. Avoid using anti-diarrhea or opioid products, as they may worsen the condition. If any side effects not listed here are noticed, contacting a healthcare provider is recommended.

Certain drugs may interact with this medication. These include corticosteroids like prednisone, mavacamten, and high doses of methotrexate. Additionally, mifepristone, ginkgo biloba, and medications that increase bleeding risk, such as antiplatelet drugs (e.g., clopidogrel, ticagrelor), NSAIDs (e.g., ibuprofen, naproxen), and blood thinners (e.g., warfarin, dabigatran), may also interact. Carefully read all labels of prescription and over-the-counter medicines, as many contain pain relievers or fever reducers similar to this medication, which could heighten side effect risks. Consult your doctor or pharmacist for guidance.

Some medications require stomach acid for proper absorption, and this drug reduces stomach acid, potentially altering their effectiveness. Affected drugs include atazanavir, erlotinib, levoketoconazole, nelfinavir, pazopanib, rilpivirine, sparsentan, and certain azole antifungals like itraconazole, ketoconazole, and posaconazole.

Other drugs, such as rifampin and St John's wort, may influence how your body eliminates this medication, affecting its efficacy. Avoid using esomeprazole-containing products while taking this medication, as they are very similar.

This medication could interfere with some lab or medical tests, leading to incorrect results. Inform all healthcare professionals and lab personnel that you are using this medication.