DIHYDRALAZINE: 151 Adverse Event Reports & Safety Profile
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151
Total FAERS Reports
9 (6.0%)
Deaths Reported
64
Hospitalizations
151
As Primary/Secondary Suspect
4
Life-Threatening
First Report: 19950228 · Latest Report: 20211201
What Are the Most Common DIHYDRALAZINE Side Effects?
#1 Most Reported
Foetal exposure during pregnancy
47 reports (31.1%)
#2 Most Reported
Patent ductus arteriosus
33 reports (21.9%)
#3 Most Reported
Off label use
26 reports (17.2%)
All DIHYDRALAZINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Foetal exposure during pregnancy | 47 | 31.1% | 7 | 10 |
| Patent ductus arteriosus | 33 | 21.9% | 0 | 11 |
| Off label use | 26 | 17.2% | 0 | 21 |
| Premature baby | 24 | 15.9% | 0 | 1 |
| Exposure during pregnancy | 20 | 13.3% | 0 | 3 |
| Dizziness | 19 | 12.6% | 0 | 10 |
| Maternal exposure during pregnancy | 18 | 11.9% | 0 | 4 |
| Toxic epidermal necrolysis | 18 | 11.9% | 0 | 18 |
| Acute graft versus host disease in skin | 17 | 11.3% | 0 | 17 |
| Atrial septal defect | 17 | 11.3% | 0 | 11 |
| Ventricular septal defect | 17 | 11.3% | 0 | 11 |
| Aorta hypoplasia | 14 | 9.3% | 0 | 11 |
| Coarctation of the aorta | 13 | 8.6% | 0 | 9 |
| Seizure | 13 | 8.6% | 0 | 11 |
| Product use issue | 12 | 8.0% | 0 | 12 |
| Shone complex | 12 | 8.0% | 0 | 9 |
| Supravalvular aortic stenosis | 12 | 8.0% | 0 | 10 |
| Congenital muscle absence | 11 | 7.3% | 1 | 0 |
| Congenital vas deferens absence | 11 | 7.3% | 1 | 0 |
| Heart disease congenital | 11 | 7.3% | 0 | 9 |
Who Reports DIHYDRALAZINE Side Effects? Age & Gender Data
Gender: 49.3% female, 50.7% male. Average age: 32.2 years. Most reports from: DE. View detailed demographics →
Is DIHYDRALAZINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 8 | 0 | 7 |
| 2009 | 9 | 0 | 0 |
| 2010 | 3 | 0 | 3 |
| 2015 | 1 | 0 | 1 |
| 2016 | 1 | 0 | 1 |
| 2017 | 6 | 1 | 0 |
| 2021 | 1 | 0 | 0 |
What Is DIHYDRALAZINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 75 |
| Hypertension | 45 |
| Foetal exposure during pregnancy | 8 |
DIHYDRALAZINE vs Alternatives: Which Is Safer?
DIHYDRALAZINE vs DIHYDROCODEINE
DIHYDRALAZINE vs DIHYDROERGOTAMINE
DIHYDRALAZINE vs DILANTIN
DIHYDRALAZINE vs DILAUDID
DIHYDRALAZINE vs DILTIAZEM
DIHYDRALAZINE vs DIMENHYDRINATE
DIHYDRALAZINE vs DIMETHICONE
DIHYDRALAZINE vs DIMETHICONE\LOPERAMIDE
DIHYDRALAZINE vs DIMETHINDENE
DIHYDRALAZINE vs DIMETHYL
Official FDA Label for DIHYDRALAZINE
Official prescribing information from the FDA-approved drug label.