URAPIDIL: 1,680 Adverse Event Reports & Safety Profile
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1,680
Total FAERS Reports
204 (12.1%)
Deaths Reported
1,072
Hospitalizations
1,680
As Primary/Secondary Suspect
212
Life-Threatening
30
Disabilities
First Report: 19970425 · Latest Report: 20250818
What Are the Most Common URAPIDIL Side Effects?
#1 Most Reported
Acute kidney injury
187 reports (11.1%)
#2 Most Reported
Fall
150 reports (8.9%)
#3 Most Reported
Hypotension
148 reports (8.8%)
All URAPIDIL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Acute kidney injury | 187 | 11.1% | 14 | 125 |
| Fall | 150 | 8.9% | 5 | 134 |
| Hypotension | 148 | 8.8% | 4 | 99 |
| Hyperkalaemia | 78 | 4.6% | 23 | 18 |
| Drug ineffective | 77 | 4.6% | 9 | 61 |
| Hyponatraemia | 69 | 4.1% | 22 | 42 |
| Bradycardia | 66 | 3.9% | 3 | 41 |
| Toxic epidermal necrolysis | 63 | 3.8% | 49 | 57 |
| Condition aggravated | 61 | 3.6% | 6 | 16 |
| Dizziness | 60 | 3.6% | 0 | 54 |
| Rash maculo-papular | 60 | 3.6% | 0 | 19 |
| Hepatic cytolysis | 59 | 3.5% | 1 | 18 |
| Hypertension | 56 | 3.3% | 7 | 46 |
| Off label use | 55 | 3.3% | 25 | 27 |
| Thrombocytopenia | 53 | 3.2% | 1 | 16 |
| Confusional state | 52 | 3.1% | 0 | 35 |
| Coma | 51 | 3.0% | 16 | 25 |
| Eosinophilia | 49 | 2.9% | 0 | 8 |
| Vomiting | 47 | 2.8% | 0 | 34 |
| Diarrhoea | 45 | 2.7% | 1 | 41 |
Who Reports URAPIDIL Side Effects? Age & Gender Data
Gender: 49.8% female, 50.2% male. Average age: 67.5 years. Most reports from: FR. View detailed demographics →
Is URAPIDIL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 2 | 0 | 2 |
| 2007 | 8 | 0 | 8 |
| 2008 | 3 | 0 | 3 |
| 2010 | 5 | 0 | 5 |
| 2011 | 5 | 2 | 4 |
| 2012 | 6 | 2 | 6 |
| 2013 | 16 | 2 | 12 |
| 2014 | 50 | 8 | 41 |
| 2015 | 84 | 8 | 67 |
| 2016 | 76 | 3 | 68 |
| 2017 | 151 | 5 | 112 |
| 2018 | 143 | 5 | 100 |
| 2019 | 148 | 11 | 101 |
| 2020 | 225 | 72 | 142 |
| 2021 | 142 | 36 | 41 |
| 2022 | 50 | 12 | 16 |
| 2023 | 102 | 9 | 50 |
| 2024 | 75 | 1 | 47 |
| 2025 | 16 | 0 | 9 |
What Is URAPIDIL Used For?
| Indication | Reports |
|---|---|
| Hypertension | 949 |
| Product used for unknown indication | 424 |
| Essential hypertension | 24 |
| Blood pressure increased | 13 |
| Dysuria | 12 |
| Hypertensive crisis | 10 |
| Angina pectoris | 9 |
| Foetal exposure during pregnancy | 9 |
| Gestational hypertension | 9 |
| Hypertensive emergency | 8 |
URAPIDIL vs Alternatives: Which Is Safer?
URAPIDIL vs UREA
URAPIDIL vs URIDINE TRIACETATE
URAPIDIL vs UROFOLLITROPIN
URAPIDIL vs URSODIOL
URAPIDIL vs USTEKINUMAB
URAPIDIL vs USTEKINUMAB-STBA
URAPIDIL vs VADADUSTAT
URAPIDIL vs VALACYCLOVIR
URAPIDIL vs VALBENAZINE
URAPIDIL vs VALBENAZINE DITOSYLATE
Official FDA Label for URAPIDIL
Official prescribing information from the FDA-approved drug label.