PROBUCOL: 157 Adverse Event Reports & Safety Profile
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157
Total FAERS Reports
71 (45.2%)
Deaths Reported
88
Hospitalizations
157
As Primary/Secondary Suspect
1
Life-Threatening
1
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
FDA Application: 017535 ·
First Report: 200907 · Latest Report: 20240129
What Are the Most Common PROBUCOL Side Effects?
#1 Most Reported
Disease progression
57 reports (36.3%)
#2 Most Reported
Type iia hyperlipidaemia
56 reports (35.7%)
#3 Most Reported
Liver injury
17 reports (10.8%)
All PROBUCOL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Disease progression | 57 | 36.3% | 56 | 13 |
| Type iia hyperlipidaemia | 56 | 35.7% | 55 | 12 |
| Liver injury | 17 | 10.8% | 13 | 14 |
| Cholecystitis acute | 14 | 8.9% | 13 | 14 |
| Abdominal pain | 13 | 8.3% | 13 | 13 |
| Hypotension | 13 | 8.3% | 13 | 13 |
| Nausea | 13 | 8.3% | 13 | 13 |
| Pleural effusion | 13 | 8.3% | 13 | 13 |
| Pneumonia | 7 | 4.5% | 5 | 5 |
| Drug ineffective | 5 | 3.2% | 0 | 3 |
| Therapeutic product effect incomplete | 5 | 3.2% | 0 | 0 |
Who Reports PROBUCOL Side Effects? Age & Gender Data
Gender: 31.5% female, 68.5% male. Average age: 63.1 years. Most reports from: KR. View detailed demographics →
Is PROBUCOL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 1 | 1 |
| 2010 | 2 | 1 | 1 |
| 2011 | 8 | 2 | 6 |
| 2012 | 8 | 1 | 8 |
| 2013 | 15 | 3 | 15 |
| 2014 | 15 | 2 | 15 |
| 2015 | 26 | 3 | 22 |
| 2017 | 2 | 0 | 0 |
| 2018 | 3 | 1 | 2 |
| 2019 | 1 | 0 | 0 |
| 2022 | 1 | 0 | 1 |
| 2023 | 2 | 0 | 1 |
| 2024 | 1 | 0 | 1 |
What Is PROBUCOL Used For?
| Indication | Reports |
|---|---|
| Type iia hyperlipidaemia | 62 |
| Cerebral infarction | 58 |
| Hypercholesterolaemia | 14 |
| Hyperlipidaemia | 12 |
PROBUCOL vs Alternatives: Which Is Safer?
PROBUCOL vs PROCAINAMIDE
PROBUCOL vs PROCAINE
PROBUCOL vs PROCARBAZINE
PROBUCOL vs PROCHLORPERAZINE
PROBUCOL vs PROCHLORPERAZINE EDISYLATE
PROBUCOL vs PROCRIT
PROBUCOL vs PROCYCLIDINE
PROBUCOL vs PROGESTERONE
PROBUCOL vs PROGRAF
PROBUCOL vs PROHANCE
Official FDA Label for PROBUCOL
Official prescribing information from the FDA-approved drug label.