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This document outlines critical safety information and warnings associated with the use of BiDil (isosorbide dinitrate / hydralazine). Please read carefully and discuss any concerns with your healthcare provider.

• Low Blood Pressure: BiDil may significantly lower your blood pressure, leading to dizziness, fatigue, or lightheadedness. This is more likely when starting the medication or increasing the dose, particularly if you are dehydrated or have conditions causing dehydration, such as diarrhea or vomiting. If you experience a significant drop in blood pressure, sit down slowly with support and inform your healthcare provider. Seek immediate medical attention if you suffer a head injury from a fall. Report any symptoms of dizziness, lightheadedness, fainting, fatigue, or confusion to your healthcare provider promptly. Higher risk factors include being over 65, dehydration, or concurrent use of PDE-5 inhibitors like Viagra (sildenafil) or other blood pressure-lowering medications.

• Lupus-like Symptoms: Hydralazine in BiDil may rarely induce lupus. Symptoms include muscle or joint pain, swelling, fatigue, or fever, and typically resolve upon discontinuation of the drug. Contact your healthcare provider immediately if you experience these symptoms.

• Worsening Heart Problems: In patients with hypertrophic cardiomyopathy (HCM), hydralazine may increase heart rate and decrease blood pressure, potentially worsening blood flow and chest pain. If you have HCM, consult with your healthcare team regarding the risks and benefits of using BiDil.

• Numbness or Tingling: BiDil may lead to neuropathy, presenting as numbness, tingling, or a "pins-and-needles" sensation. Notify your prescriber if these occur; they may suggest a vitamin B6 (pyridoxine) supplement.

Contraindications: Do not use BiDil if you have an allergy to nitrates or are taking PDE-5 inhibitors or Adempas (riociguat) concurrently, as this could pose serious health risks. Always consult your healthcare provider if any of these conditions apply to you.

When taking this medication, some individuals may experience common side effects such as headache, dizziness, weakness, nausea, and low blood pressure. These effects are generally mild and often improve as your body adjusts to the medication. If these symptoms persist or become bothersome, consult your healthcare provider. Headaches are notably common and can sometimes indicate that the medication is working. Over-the-counter pain relievers like acetaminophen might be recommended for relief.

Other side effects, which are less common, include sinus inflammation, a sensation of pins and needles in the hands or feet, vomiting, and a lazy eye. These should be reported to your healthcare provider, especially if they become severe.

More serious side effects, although rare, can occur. These include severely low blood pressure, which may manifest as lightheadedness, dizziness, faintness, tiredness, and confusion. If you experience any of these symptoms, seek medical attention immediately. Additionally, severe side effects such as chest, jaw, or left arm pain require urgent medical care.

In rare cases, the medication may cause severe allergic reactions, nerve problems, or other critical issues like a rash on the nose and cheeks, swollen glands, or signs of kidney problems. Symptoms of a severe allergic reaction include rash, itching, swelling, severe dizziness, and trouble breathing. If you notice any of these serious symptoms, seek emergency medical help. Always report any unlisted side effects to your healthcare provider for further advice.