PROPIVERINE: 85 Adverse Event Reports & Safety Profile
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85
Total FAERS Reports
7 (8.2%)
Deaths Reported
40
Hospitalizations
85
As Primary/Secondary Suspect
12
Life-Threatening
1
Disabilities
First Report: 2002 · Latest Report: 20241101
What Are the Most Common PROPIVERINE Side Effects?
#1 Most Reported
Pulmonary embolism
14 reports (16.5%)
#2 Most Reported
Confusional state
12 reports (14.1%)
#3 Most Reported
Electrocardiogram st-t segment abnormal
11 reports (12.9%)
All PROPIVERINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pulmonary embolism | 14 | 16.5% | 0 | 1 |
| Confusional state | 12 | 14.1% | 0 | 12 |
| Dyspnoea exertional | 11 | 12.9% | 0 | 0 |
| Electrocardiogram st-t segment abnormal | 11 | 12.9% | 0 | 0 |
| Urinary incontinence | 10 | 11.8% | 0 | 1 |
| Aggression | 9 | 10.6% | 0 | 0 |
| Bradycardia | 9 | 10.6% | 0 | 9 |
| Diabetes mellitus | 9 | 10.6% | 0 | 0 |
| Dyslalia | 9 | 10.6% | 0 | 9 |
| Dysstasia | 9 | 10.6% | 0 | 0 |
| Fall | 9 | 10.6% | 0 | 9 |
| Fluid retention | 9 | 10.6% | 0 | 0 |
| Loss of consciousness | 9 | 10.6% | 0 | 0 |
| Malaise | 9 | 10.6% | 0 | 0 |
| Metabolic acidosis | 9 | 10.6% | 0 | 9 |
| Multiple sclerosis | 9 | 10.6% | 0 | 0 |
| Mydriasis | 9 | 10.6% | 0 | 9 |
| Neuroleptic malignant syndrome | 9 | 10.6% | 0 | 0 |
| Oedema peripheral | 9 | 10.6% | 0 | 0 |
| Restlessness | 9 | 10.6% | 0 | 0 |
Who Reports PROPIVERINE Side Effects? Age & Gender Data
Gender: 62.1% female, 37.9% male. Average age: 60.3 years. Most reports from: DE. View detailed demographics →
Is PROPIVERINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2002 | 1 | 0 | 1 |
| 2011 | 1 | 0 | 1 |
| 2013 | 1 | 0 | 0 |
| 2014 | 4 | 0 | 3 |
| 2015 | 5 | 0 | 2 |
| 2016 | 9 | 0 | 7 |
| 2017 | 2 | 0 | 1 |
| 2018 | 5 | 3 | 2 |
| 2020 | 13 | 0 | 0 |
| 2021 | 1 | 0 | 0 |
| 2022 | 1 | 0 | 1 |
| 2023 | 1 | 0 | 1 |
| 2024 | 2 | 0 | 0 |
What Is PROPIVERINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 49 |
| Suicide attempt | 6 |
| Hypertonic bladder | 5 |
Official FDA Label for PROPIVERINE
Official prescribing information from the FDA-approved drug label.