Prescription medication · Vasodilator
hydralazine
Also sold as Apresoline. Hydralazine is used to treat high blood pressure (hypertension).
Data updated 2026-05-15
- 28,498
- FDA reportsModerately reported
- 3
- InteractionsFew interactions
- 1
- Recall record
What the data shows
hydralazine (Apresoline) is a prescription Vasodilator, reported at a middle-of-the-pack volume (28,498 FDA reports), with 3 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 (Apresoline) is a prescription Vasodilator. Hydralazine is used to treat high blood pressure (hypertension).
Hydralazine is a drug that lowers blood pressure by relaxing blood vessels. It can be used alone or with other medications.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.03/unit
Generic Available
Yes (21 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: HYDRALAZINE 10 MG TABLET
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -13.9% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| June 19, 2024 | $0.0309/EA | - | 1 |
| December 18, 2024 | $0.0266/EA | -13.9% | 18 |
What it does
Hydralazine is used to treat high blood pressure (hypertension).
Common side effects
Headache, Loss of appetite, Nausea
Key warnings
Taking high doses of hydralazine can cause a drug-induced lupus erythematosus (L.
The sections below are summarized in plain English from hydralazine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Hydralazine works by relaxing the muscles in your blood vessels. This allows blood to flow more easily. As a result, your blood pressure goes down.
Side Effects (from patient reports)
Based on 28,498 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for hydralazine, by number of reports
- Chronic Kidney Disease
Chronic Kidney Disease
2,819 reports
- Acute Kidney Injury
Acute Kidney Injury
2,616 reports
- Renal Failure
Renal Failure
2,097 reports
- End Stage Renal Disease
End Stage Renal Disease
1,585 reports
- Fatigue
Fatigue
1,542 reports
- Dyspnoea
Dyspnoea
1,535 reports
- Diarrhoea
Diarrhoea
1,407 reports
- Nausea
Nausea
1,337 reports
- Death
Death
1,316 reports
- Hypertension
Hypertension
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.
Reports over time
Adverse-event reports filed for hydralazine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where hydralazine sits
hydralazine has more FDA adverse-event reports than 62% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is hydralazine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 28,498 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1995–2025.
Total Reports
28,498
Reports Mentioning Death
3,510
12.3% of reports — not proof of cause
Hospitalization Reports
12,190
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | CHRONIC KIDNEY DISEASE | 2,819 |
| 2 | ACUTE KIDNEY INJURY | 2,616 |
| 3 | RENAL FAILURE | 2,097 |
| 4 | END STAGE RENAL DISEASE | 1,585 |
| 5 | FATIGUE | 1,542 |
| 6 | DYSPNOEA | 1,535 |
| 7 | DIARRHOEA | 1,407 |
| 8 | NAUSEA | 1,337 |
| 10 | DEATH | 1,316 |
| 11 | HYPERTENSION | 1,312 |
| 13 | ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS | 1,005 |
| 14 | ASTHENIA | 973 |
| 15 | DIZZINESS | 958 |
| 16 | HEADACHE | 943 |
| 17 | CARDIAC FAILURE CONGESTIVE | 884 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Taking high doses of hydralazine can cause a drug-induced lupus erythematosus (L.E.) cell syndrome. Your doctor will monitor your dose to avoid this.
Known Drug Interactions
Although not studied with alosetron, inhibition of N-acetyltransferase may have clinically relevant consequences for drugs such as isoniazid, procainamide, and hydralazine.
Mechanism: Alosetron may interfere with the way your body processes hydralazine, potentially leading to higher drug levels.
Other Cardiovascular Agents Enalapril maleate has been used concomitantly with beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine, prazosin and digoxin without evidence of clinically significant adverse interactions.
Mechanism: These two blood pressure medicines work in different ways to relax your blood vessels and have not been shown to cause harmful interactions when used together.
Pindolol has been used with a variety of antihypertensive agents, including hydrochlorothiazide, hydralazine, and guanethidine without unexpected adverse interactions.
Mechanism: These two blood pressure medicines can be used together safely. They do not have any harmful interactions when taken at the same time.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I stop taking hydralazine if I feel better?
Will hydralazine cure my high blood pressure?
Can I drink alcohol while taking hydralazine?
What should I do if I feel dizzy after taking hydralazine?
Does hydralazine interact with other medications?
Can hydralazine cause weight gain?
How long does it take for hydralazine to start working?
Can I take hydralazine if I have kidney problems?
Is it safe to drive while taking hydralazine?
What are the symptoms of L.E. cell syndrome?
What are the common side effects of hydralazine?
Does hydralazine interact with other medications?
What drug class is hydralazine?
What pregnancy or breastfeeding source fields are listed for hydralazine?
Has hydralazine been recalled?
Active Recalls
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
Related Medications in Vasodilator
Other drugs grouped near hydralazine - same-class peers and common alternatives.
acebutolol
Sectral
Acebutolol is a medicine that helps lower blood pressure and control irregular heartbeats.
Compare with hydralazine →
aliskiren
Tekturna
Tekturna is a medicine used to treat high blood pressure.
Compare with hydralazine →
amiloride
Midamor
Amiloride is a water pill that helps your body hold onto potassium.
Compare with hydralazine →
amlodipine
Norvasc
Amlodipine (Norvasc) is a drug that lowers blood pressure and treats chest pain.
Compare with hydralazine →
amlodipine/benazepril
Lotrel
Lotrel is a combination medicine that contains amlodipine and benazepril.
Compare with hydralazine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for hydralazine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 28,498.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 12.32%.
- olanzapine Δ 0.05 pts · 103,356 reports · Atypical Antipsychotic 12.37%death share
- phenobarbital Δ 0.06 pts · 13,998 reports · Anticonvulsant (Barbiturate) 12.38%death share
- nortriptyline Δ 0.07 pts · 5,503 reports · Tricyclic Antidepressant (TCA) 12.25%death share
- diclofenac Δ 0.08 pts · 82,165 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 12.23%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for hydralazine
The FDA label for hydralazine (sold under brand names such as Apresoline) classifies it as a prescription-only medication in the Vasodilator class. Hydralazine is used to treat high blood pressure (hypertension). Official labeling lists 7 commonly reported side effects, including Headache, Loss of appetite, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 28,498 voluntary reports. The database also lists 3 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.03.
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 (currently 1 recall record on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: July 1, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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