Prescription medication · Vasodilator / Nitrate Combination
hydralazine/isosorbide dinitrate
Also sold as BiDil. BiDil is used to treat heart failure in self-identified Black patients.
Data updated 2026-05-15
- 17,561
- FDA reports
- 2
- InteractionsFew interactions
- $4.38
- Brand price (NADAC)
What the data shows
hydralazine/isosorbide dinitrate (BiDil) is a prescription Vasodilator / Nitrate Combination, with 17,561 FDA adverse-event reports on file, with 2 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
hydralazine/isosorbide dinitrate (BiDil) is a prescription Vasodilator / Nitrate Combination. BiDil is used to treat heart failure in self-identified Black patients.
BiDil is a medicine that combines two drugs to help treat heart failure. It contains isosorbide dinitrate and hydralazine hydrochloride, which work together to widen blood vessels.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$4.38/unit
Generic Available
No
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
BiDil is used to treat heart failure in self-identified Black patients.
Common side effects
Headache, Dizziness
Key warnings
BiDil can cause low blood pressure, especially when you stand up.
The sections below are summarized in plain English from hydralazine/isosorbide dinitrate's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
BiDil contains two medicines that work in different ways to widen your blood vessels. Isosorbide dinitrate widens both arteries and veins. Hydralazine hydrochloride mainly widens arteries.
How to Take It
Start by taking one BiDil tablet three times a day. Your doctor may increase the dose up to two tablets three times a day, if you can handle it. If you have side effects, your doctor may lower the dose to one-half tablet three times a day. Try to increase the dose again as soon as the side effects get better.
This is a plain-language summary of hydralazine/isosorbide dinitrate's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if BiDil is safe to use during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant. It is also not known if BiDil passes into breast milk. Talk to your doctor about the best way to feed your baby if you are taking BiDil.
This is a plain-language summary of hydralazine/isosorbide dinitrate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of hydralazine/isosorbide dinitrate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store BiDil tablets at room temperature (between 59°F and 86°F) in a tightly closed container, protected from light.
Side Effects (from patient reports)
Based on 17,561 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for hydralazine/isosorbide dinitrate, by number of reports
- Long-term kidney disease
Long-term kidney disease
2,819 reports
- Sudden kidney damage
Sudden kidney damage
2,616 reports
- Kidney failure
Kidney failure
2,097 reports
- Final stage of kidney failure
Final stage of kidney failure
1,585 reports
- Tiredness
Tiredness
1,541 reports
- Shortness of breath
Shortness of breath
1,535 reports
- Diarrhea
Diarrhea
1,406 reports
- Feeling sick to your stomach
Feeling sick to your stomach
1,334 reports
- Death
Death
1,316 reports
- High blood pressure
High blood pressure
1,312 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Serious Warnings
BiDil can cause low blood pressure, especially when you stand up. This is more likely if you are dehydrated or have low salt levels. Hydralazine hydrochloride, one of the medicines in BiDil, can cause a lupus-like syndrome. If you have symptoms, your doctor may tell you to stop taking BiDil. BiDil can also worsen chest pain, especially if you have certain heart conditions.
Known Drug Interactions
7 DRUG INTERACTIONS 7.1 Phosphodiesterase Inhibitors BiDil is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), PDE5 inhibitors such as avanafil, sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates.
Mechanism: Both drugs work to relax blood vessels, and taking them together can cause your blood pressure to drop to a dangerously low level.
What to do: Do not take these two medications together.
7 DRUG INTERACTIONS 7.1 Phosphodiesterase Inhibitors BiDil is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), PDE5 inhibitors such as avanafil, sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates.
Mechanism: These medicines both lower blood pressure in a similar way, and using them at the same time can cause a severe and unsafe drop in blood pressure.
What to do: You should not use these drugs together as it is strictly advised against.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What should I avoid while taking BiDil?
Can I drive while taking BiDil?
How long does it take for BiDil to work?
What if I have liver problems?
Can I take BiDil with other medications?
What are the ingredients in BiDil?
What do the tablets look like?
How do I dispose of unused BiDil?
What if I have side effects?
What are the common side effects of hydralazine/isosorbide dinitrate?
Does hydralazine/isosorbide dinitrate interact with other medications?
What drug class is hydralazine/isosorbide dinitrate?
Is hydralazine/isosorbide dinitrate safe during pregnancy?
Related Medications in Vasodilator / Nitrate Combination
Other drugs grouped near hydralazine/isosorbide dinitrate - same-class peers and common alternatives.
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amiodarone
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atropine
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bumetanide
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Bumetanide is a water pill (diuretic).
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carvedilol
Coreg
Carvedilol is a medicine that lowers blood pressure and helps your heart work better.
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Medication Guides
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What the FDA Data Shows for hydralazine/isosorbide dinitrate
The FDA label for hydralazine/isosorbide dinitrate (sold under brand names such as BiDil) classifies it as a prescription-only medication in the Vasodilator / Nitrate Combination class. BiDil is used to treat heart failure in self-identified Black patients. Official labeling lists 2 commonly reported side effects, including Headache, Dizziness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 17,561 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: November 30, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages