HYDRALAZINE\ISOSORBIDE DINITRATE: 106 Adverse Event Reports & Safety Profile
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106
Total FAERS Reports
10 (9.4%)
Deaths Reported
29
Hospitalizations
106
As Primary/Secondary Suspect
10
Life-Threatening
1
Disabilities
Active Ingredient: HYDRALAZINE HYDROCHLORIDE\ISOSORBIDE DINITRATE ·
First Report: 2013 · Latest Report: 20230101
What Are the Most Common HYDRALAZINE\ISOSORBIDE DINITRATE Side Effects?
#1 Most Reported
Hypotension
25 reports (23.6%)
#2 Most Reported
Cerebrovascular accident
16 reports (15.1%)
#3 Most Reported
Headache
15 reports (14.2%)
All HYDRALAZINE\ISOSORBIDE DINITRATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hypotension | 25 | 23.6% | 0 | 22 |
| Cerebrovascular accident | 16 | 15.1% | 0 | 14 |
| Fall | 15 | 14.2% | 0 | 15 |
| Headache | 15 | 14.2% | 0 | 0 |
| Mental disorder | 11 | 10.4% | 0 | 11 |
| Unresponsive to stimuli | 11 | 10.4% | 0 | 11 |
| Death | 10 | 9.4% | 10 | 0 |
| Confusional state | 8 | 7.6% | 0 | 8 |
| Dyspnoea | 8 | 7.6% | 0 | 0 |
| Fatigue | 7 | 6.6% | 0 | 0 |
| Mental status changes | 7 | 6.6% | 0 | 7 |
| Product prescribing error | 7 | 6.6% | 0 | 7 |
| Dizziness | 6 | 5.7% | 0 | 0 |
| Hypertension | 6 | 5.7% | 0 | 0 |
| Palpitations | 6 | 5.7% | 0 | 0 |
| Atrial fibrillation | 5 | 4.7% | 0 | 0 |
| Cardiomyopathy | 5 | 4.7% | 0 | 0 |
| Diabetic nephropathy | 5 | 4.7% | 0 | 0 |
| Essential hypertension | 5 | 4.7% | 0 | 0 |
| Hyperlipidaemia | 5 | 4.7% | 0 | 0 |
Who Reports HYDRALAZINE\ISOSORBIDE DINITRATE Side Effects? Age & Gender Data
Gender: 32.0% female, 68.0% male. Average age: 65.3 years. Most reports from: US. View detailed demographics →
Is HYDRALAZINE\ISOSORBIDE DINITRATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 1 | 0 | 0 |
| 2015 | 4 | 0 | 0 |
| 2016 | 4 | 1 | 1 |
| 2017 | 3 | 1 | 0 |
| 2018 | 3 | 2 | 0 |
| 2019 | 5 | 1 | 0 |
| 2020 | 1 | 0 | 0 |
| 2021 | 1 | 0 | 0 |
| 2022 | 1 | 0 | 0 |
| 2023 | 1 | 0 | 0 |
What Is HYDRALAZINE\ISOSORBIDE DINITRATE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 70 |
| Hypertension | 13 |
HYDRALAZINE\ISOSORBIDE DINITRATE vs Alternatives: Which Is Safer?
HYDRALAZINE\ISOSORBIDE DINITRATE vs HYDROCHLOROTHIAZIDE
HYDRALAZINE\ISOSORBIDE DINITRATE vs HYDROCHLOROTHIAZIDE\IRBESARTAN
HYDRALAZINE\ISOSORBIDE DINITRATE vs HYDROCHLOROTHIAZIDE\LISINOPRIL
HYDRALAZINE\ISOSORBIDE DINITRATE vs HYDROCHLOROTHIAZIDE\LOSARTAN
HYDRALAZINE\ISOSORBIDE DINITRATE vs HYDROCHLOROTHIAZIDE\METOPROLOL
HYDRALAZINE\ISOSORBIDE DINITRATE vs HYDROCHLOROTHIAZIDE\NEBIVOLOL
HYDRALAZINE\ISOSORBIDE DINITRATE vs HYDROCHLOROTHIAZIDE\OLMESARTAN MEDOXOMIL
HYDRALAZINE\ISOSORBIDE DINITRATE vs HYDROCHLOROTHIAZIDE\QUINAPRIL
HYDRALAZINE\ISOSORBIDE DINITRATE vs HYDROCHLOROTHIAZIDE\RAMIPRIL
HYDRALAZINE\ISOSORBIDE DINITRATE vs HYDROCHLOROTHIAZIDE\SPIRONOLACTONE
Official FDA Label for HYDRALAZINE\ISOSORBIDE DINITRATE
Official prescribing information from the FDA-approved drug label.