Hydralazine hydrochloride: adverse event reports filed with FDA

2,488

reports as suspect product

0% of all reports · about 111 a year

260

reports, 12 months to June 2026

275 in the 12 months before

85.6%

marked serious by the reporter

10.6% across the class

9%

record death among outcomes, as reported

224 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Hydralazine hydrochloride reports recording the termmedian drug in arteriolar vasodilator

1. Anti-neutrophil cytoplasmic antibody positive vasculitis23.7%589
2. Dyspnoeashortness of breath7.8%195
3. Drug ineffectivethe medicine did not work as expected7%173
4. Lupus-like syndromelupus-like symptoms6.8%168
5. Acute kidney injurysudden loss of kidney function5.4%134
6. Hypertensionhigh blood pressure5.2%130
7. Diarrhoealoose or frequent stools5.2%129
8. Glomerulonephritis rapidly progressive5.1%126
9. Arthralgiajoint pain5%124
10. Off label useused for a purpose or in a way not on the label4.9%122
11. Nauseafeeling sick4.7%118
12. Coughcough4.7%117
13. Headachehead pain4.4%110
14. Glomerulonephritis4.4%109
15. Pulmonary renal syndrome4.2%104
16. Rashskin rash4.2%104
17. Drug hypersensitivityan allergic-type reaction to a medicine4.1%102
18. Pulmonary alveolar haemorrhage4.1%101
19. Malaisegeneral feeling of being unwell4%99
20. Completed suicidedeath by suicide3.9%98
21. Abdominal discomfortstomach discomfort3.9%96
22. Cardiac failure congestivecongestive heart failure3.7%91
23. Abdominal pain upperupper stomach pain3.6%90
24. Hepatic steatosisfatty liver3.4%84
25. Therapeutic product effect decreased3.3%82
26. Lupus nephritis3.1%78
27. Vasculitisinflammation of blood vessels3.1%78
28. Renal impairmentreduced kidney function3.1%77
29. Exposure during pregnancythe medicine was taken during pregnancy3.1%76
30. Maternal exposure during pregnancythe mother took the medicine during pregnancy3.1%76

Top 30 of 486 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the arteriolar vasodilator class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 43,259 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 79.3% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 2,488 reports.

Drugs most often listed in the same reports

Other products listed in reports where Hydralazine hydrochloride is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the arteriolar vasodilator class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Hydralazine hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (6,812) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.