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Hydralazine Use and Risk of Vasculitis.

Deena Fremont1, Shan Dhaliwal1,2, Mark Canney1,3

  • 1Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

JAMA Network Open
|March 16, 2026
PubMed
Summary
This summary is machine-generated.

Hydralazine use in older adults was linked to a slightly increased risk of vasculitis, but this association was not clinically significant and disappeared when considering other health risks. The overall risk of vasculitis from hydralazine remains rare.

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Area of Science:

  • Cardiovascular Medicine
  • Rheumatology
  • Pharmacovigilance

Background:

  • Hydralazine is a cardiovascular drug with reported associations with antineutrophil cytoplasmic antibody-associated vasculitis.
  • Previous case reports suggest a link, necessitating further investigation into the risk profile of hydralazine.

Purpose of the Study:

  • To evaluate the risk of developing vasculitis in older adults prescribed hydralazine.
  • To compare this risk against the use of angiotensin-converting enzyme inhibitors (ACE) or angiotensin receptor blockers (ARB).

Main Methods:

  • A population-based, retrospective cohort study involving adults aged 66+ in Ontario, Canada.
  • Data from January 2008 to December 2021 were analyzed using overlap-weighted Cox proportional hazards regression.
  • Vasculitis diagnosis was determined via ICD-10 codes, comparing new hydralazine users with ACE/ARB users.

Main Results:

  • The study included 583,136 adults; 40,748 received hydralazine and 542,388 received ACE or ARB.
  • Hydralazine use showed a slightly higher risk of vasculitis (HR 1.19, 95% CI 1.04-1.37), with an absolute risk difference of 0.3%.
  • This increased risk was not statistically significant when accounting for the competing risk of death.

Conclusions:

  • While case reports exist, hydralazine-associated vasculitis is rare in the general population.
  • The study suggests hydralazine use is unlikely to pose a clinically meaningful increased risk of vasculitis in older adults.
  • The findings support cautious but continued use of hydralazine when indicated for cardiovascular conditions.