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The following safety information outlines critical warnings and precautions associated with the use of Azor (amlodipine / olmesartan). Please read carefully and discuss any concerns with your healthcare provider.

• Harm to Unborn Baby: Use of this medication during pregnancy can lead to serious, potentially fatal harm to an unborn baby, including life-threatening kidney development issues. It is crucial to avoid pregnancy while on this medication. Discuss reliable birth control options with your doctor and inform them immediately if you are planning to become pregnant, are pregnant, or suspect pregnancy.

• Low Blood Pressure: Azor may cause your blood pressure to drop significantly, resulting in dizziness, fatigue, or lightheadedness. This risk is heightened when starting the medication, increasing the dose, or if you are dehydrated. Maintain good hydration and monitor for symptoms of low blood pressure. If you experience severe dizziness, sit down slowly and contact your healthcare provider. Seek immediate medical attention if you fall and hit your head. Risk factors include dehydration, prolonged diarrhea or vomiting, low salt levels, high diuretic doses, and narrow heart valves.

• Heart Attack or Chest Pain Risk: There is a chance of worsening chest pain or heart attack, particularly when initiating or increasing the dose of Azor, especially if you have coronary artery disease. Seek emergency medical assistance if you encounter chest pain, pressure, heartburn, dizziness, or breathing difficulties.

• Kidney Damage Potential: While Azor can protect the kidneys, it may also impair kidney function, especially in those with severe heart failure, existing kidney issues, or those on medications that affect kidney health. Report urination problems to your doctor, as this may signal decreased kidney function.

• Severe Diarrhea: Rarely, Azor can cause a serious condition known as sprue-like enteropathy, leading to persistent diarrhea, weight loss, stomach pain, tiredness, nausea, and vomiting. If you experience severe diarrhea, seek medical help promptly and ensure adequate hydration with fluids and electrolytes.

• High Potassium Levels: The olmesartan in Azor can increase potassium levels, particularly when combined with certain other medications like spironolactone or eplerenone. Watch for signs of high potassium, such as nausea, muscle weakness, or irregular heartbeat, and inform your healthcare provider. Untreated high potassium can be dangerous, so regular monitoring of potassium levels may be necessary.

• Contraindications: Azor should not be used concurrently with aliskiren (Tekturna) in individuals with diabetes due to serious health risks.

Adhering to these guidelines can help manage risks and promote safe use of this medication. Always consult your healthcare provider for personalized advice.

When taking this medication, some common side effects may include dizziness, lightheadedness, headache, flushing, and swelling, which may occur as your body adjusts. While these effects are typically mild, it is advisable to consult your healthcare provider if they persist or worsen. To minimize dizziness and lightheadedness, it is helpful to rise slowly from sitting or lying positions.

In addition to these, some patients may experience sleepiness, a feeling of heart pounding, diarrhea, rash or itching, and problems with urination. Although these side effects are generally not severe, contacting your healthcare provider is recommended if they become bothersome.

Rare but serious side effects that require immediate medical attention include dangerously low blood pressure, which may present as dizziness, fainting, or pale skin. Symptoms of a heart attack, such as chest pain, cold sweats, or shortness of breath, also necessitate urgent care. Kidney issues could manifest as reduced urination or swelling in the limbs, while high blood potassium levels might cause nausea, muscle weakness, or irregular heartbeats. Severe diarrhea, characterized by frequent watery bowel movements and weight loss, should be promptly addressed.

A severe allergic reaction, though rare, is another critical concern. Symptoms include rash, itching, swelling of the face, tongue, or throat, severe dizziness, and trouble breathing. Seek medical help immediately if these occur. Always inform your healthcare provider of any unusual side effects not listed here.

Azor, which contains Amlodipine and Olmesartan, can interact with various medications and supplements. It is important to inform your doctor and pharmacist about all medications, including prescription, over-the-counter, vitamins, and herbal supplements, that you are currently taking. Below is a summary of potential interactions:

1. Medications to Avoid: Aliskiren should not be used with Azor. Your doctor may choose an alternative treatment if you're taking this medication.

2. Medications Usually Not Recommended: Combining Azor with drugs such as Abametapir, Atazanavir, Benazepril, Captopril, and others listed, is typically not advised. However, if necessary, your doctor might adjust doses or the frequency of use.

3. Medications That May Increase Side Effects: Taking Azor with NSAIDs like Ibuprofen, Naproxen, and others could heighten the risk of side effects. If these combinations are necessary, your doctor may modify how you use these medications.

Additionally, some products, particularly those for cough and cold, diet aids, or pain relief (NSAIDs), may elevate blood pressure. It is wise to consult your pharmacist about the safe use of such products while taking Azor.