IMPORTANT SAFETY INFORMATION

INDICATION

BiDil^® (isosorbide dinitrate and hydralazine hydrochloride)

BiDil is a prescription medicine that is approved for use with other heart medicines to treat heart failure in black patients to improve survival, improve heart failure symptoms, and help patients stay out of the hospital longer. There is little experience in patients with heart failure who experience significant symptoms while at rest. Most patients in the clinical study of BiDil also received other heart failure medicines.

ADDITIONAL IMPORTANT SAFETY INFORMATION

Do not receive BiDil if you are:

• Allergic to BiDil, or any of the ingredients in BiDil, especially if you’re sensitive to nitrates, such as nitroglycerin tablets or isosorbide dinitrate (Isordil^®). BiDil has a nitrate component, so you need to let your doctor know about any allergies you have.
• Taking any erectile dysfunction or pulmonary hypertension drugs like Viagra^® or Revatio^™ (sildenafil), Levitra^® (vardenafil) or Cialis^®(tadalafil).

What are the possible side effects of BiDil?

BiDil can cause serious side effects including:

• Low blood pressure (hypotension). Tell your doctor if you are taking any medication to decrease blood pressure because when taken with BiDil, blood pressure may become too low.
• Headaches. It is possible you’ll get headaches, especially at first, but they often lessen over time. Keep your doctor posted on your headache progress; they may want to adjust your dosage.
• Dizziness. If you experience dizziness, call your doctor. Please make sure to tell your doctor about any of the signs or symptoms mentioned below or about any unusual events that worry you.
  • Drinking less fluids than your doctor recommends or losing fluid due to diarrhea, sweating, or vomiting may cause low blood pressure, lightheadedness, or fainting. If fainting occurs, stop taking BiDil and contact your doctor immediately.
  • Lightheadedness may occur when standing, especially after sitting or lying down.
• Rash, fever, chest pain or fatigue. If you experience any achy and/or swollen joints, unexplained fever for more than a few days, skin rashes, chest pain, prolonged weakness or fatigue (even after a good night’s sleep), or any other unexplained signs or symptoms, make sure to tell your doctor as they may be signs of a serious medical condition.
• Rapid heartbeat or chest pain. You may also experience rapid heartbeat that could lead to chest pain or aggravate chest pain, or numbness or tingling in the hands or feet. Call your doctor if you are experiencing these side effects.

Before taking Bidil, tell your doctor about all your medical conditions, including:

• Inability to get or maintain an erection long enough to have sexual intercourse (erectile dysfunction).
• Heart damage caused by poor blood flow to your heart (ischemic heart disease, especially hypertrophic cardiomyopathy).
• Your heart works harder than normal to pump blood into the lungs (pulmonary hypertension).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BiDil with certain other medicines can affect each other. Especially, tell your healthcare provider if you take:

• Erectile dysfunction medication. Viagra^® or Revatio^™ (sildenafil), Levitra^® (vardenafil) or Cialis^®(tadalafil).
• Soluble guanylate cyclase (sGC) stimulators, like riociguat.

Keep a list of your medicines and show them to your healthcare provider and pharmacist when you get a new medicine.

The most common side effects of BiDil include:

• headache.
• dizziness.

These are not all the possible side effects of BiDil. Please see Full Prescribing Information for a full list.

To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or http://www.fda.gov/MedWatch.

BiDil^® is a trademark of Arbor Pharmaceuticals LLC, a subsidiary of Azurity Pharmaceuticals, Inc.

©2025 Azurity Pharmaceuticals, Inc.

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