Hydralazine Hydrochloride

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Hydralazine Hydrochloride
Generic name
HYDRALAZINE HYDROCHLORIDE
Manufacturer
Zydus Pharmaceuticals USA Inc.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
f0db9c3c-d841-46f9-8409-9ffca83d7a97
SPL ID
080a71a3-1d50-42bf-b329-bf64a84893d6
Version
2
Effective date
2026-05-06
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:36:10
Harmonized routes table
Harmonized routes
INTRAMUSCULAR, INTRAVENOUS

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS In a few patients hydralazine may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydralazine should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary (see PRECAUTIONS, Laboratory Tests ).

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

ADVERSE REACTIONS Adverse reactions with hydralazine hydrochloride are usually reversible when dosage is reduced. However, in some cases it may be necessary to discontinue the drug. The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency. Common: Headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris. Less Frequent: Digestive: constipation, paralytic ileus. Cardiovascular: hypotension, paradoxical pressor response, edema. Respiratory: dyspnea. Neurologic: peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety. Genitourinary: difficulty in urination. Hematologic: blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly. Hypersensitive Reactions: rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and, rarely, hepatitis. Other: nasal congestion, flushing, lacrimation, conjunctivitis.

adverse reactions table

<table ID="ID17" width="601" styleCode="Noautorules"><col width="120"/><col width="481"/><tbody><tr><td valign="top" align="left"><content styleCode="bold"> Common:</content> </td><td valign="top" align="left"> Headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris. </td></tr><tr><td valign="top" align="left"><content styleCode="bold"> Less Frequent:</content> </td><td valign="top" align="left"><content styleCode="italics">Digestive: </content> constipation, paralytic ileus. <content styleCode="italics">Cardiovascular: </content> hypotension, paradoxical pressor response, edema. <content styleCode="italics">Respiratory: </content> dyspnea. <content styleCode="italics">Neurologic: </content> peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety. <content styleCode="italics">Genitourinary: </content> difficulty in urination. <content styleCode="italics">Hematologic: </content> blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly. <content styleCode="italics">Hypersensitive Reactions: </content> rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and, rarely, hepatitis. <content styleCode="italics">Other:</content> nasal congestion, flushing, lacrimation, conjunctivitis. </td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.