BUPARLISIB: 95 Adverse Event Reports & Safety Profile
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95
Total FAERS Reports
12 (12.6%)
Deaths Reported
53
Hospitalizations
95
As Primary/Secondary Suspect
8
Life-Threatening
1
Disabilities
Active Ingredient: BUPARLISIB HYDROCHLORIDE ·
First Report: 20120207 · Latest Report: 20231107
What Are the Most Common BUPARLISIB Side Effects?
#1 Most Reported
Hyperglycaemia
13 reports (13.7%)
#2 Most Reported
Diarrhoea
11 reports (11.6%)
#3 Most Reported
Product use in unapproved indication
10 reports (10.5%)
All BUPARLISIB Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hyperglycaemia | 13 | 13.7% | 0 | 3 |
| Diarrhoea | 11 | 11.6% | 0 | 4 |
| Alanine aminotransferase increased | 10 | 10.5% | 0 | 0 |
| Depression | 10 | 10.5% | 0 | 1 |
| Product use in unapproved indication | 10 | 10.5% | 3 | 9 |
| Anxiety | 9 | 9.5% | 0 | 1 |
| Asthenia | 8 | 8.4% | 0 | 4 |
| Fatigue | 8 | 8.4% | 0 | 3 |
| Rash | 8 | 8.4% | 0 | 1 |
| Nausea | 7 | 7.4% | 0 | 2 |
| Aspartate aminotransferase increased | 6 | 6.3% | 0 | 0 |
| Mucosal inflammation | 6 | 6.3% | 2 | 3 |
| Neutropenia | 6 | 6.3% | 1 | 1 |
| Rash maculo-papular | 6 | 6.3% | 1 | 1 |
| Anaemia | 5 | 5.3% | 0 | 1 |
| Febrile neutropenia | 5 | 5.3% | 1 | 2 |
| Pruritus | 5 | 5.3% | 0 | 2 |
| Stomatitis | 5 | 5.3% | 1 | 1 |
| Transaminases increased | 5 | 5.3% | 0 | 4 |
Who Reports BUPARLISIB Side Effects? Age & Gender Data
Gender: 57.4% female, 42.6% male. Average age: 62.0 years. Most reports from: US. View detailed demographics →
Is BUPARLISIB Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 1 |
| 2013 | 4 | 2 | 3 |
| 2014 | 14 | 0 | 12 |
| 2015 | 11 | 0 | 7 |
| 2016 | 2 | 1 | 2 |
| 2017 | 4 | 0 | 4 |
| 2018 | 7 | 2 | 7 |
| 2022 | 7 | 3 | 6 |
| 2023 | 12 | 3 | 10 |
What Is BUPARLISIB Used For?
| Indication | Reports |
|---|---|
| Breast cancer metastatic | 16 |
| Basal cell carcinoma | 6 |
| Her-2 positive breast cancer | 6 |
| Squamous cell carcinoma of head and neck | 6 |
| B-cell lymphoma | 5 |
| Neoplasm malignant | 5 |
Official FDA Label for BUPARLISIB
Official prescribing information from the FDA-approved drug label.