BUPIVACAINE\FENTANYL: 75 Adverse Event Reports & Safety Profile
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75
Total FAERS Reports
0
Deaths Reported
9
Hospitalizations
75
As Primary/Secondary Suspect
3
Life-Threatening
1
Disabilities
Active Ingredient: BUPIVACAINE HYDROCHLORIDE\FENTANYL CITRATE ·
First Report: 20150121 · Latest Report: 20250510
What Are the Most Common BUPIVACAINE\FENTANYL Side Effects?
#1 Most Reported
Exposure during pregnancy
22 reports (29.3%)
#2 Most Reported
Live birth
19 reports (25.3%)
#3 Most Reported
Bradycardia
19 reports (25.3%)
All BUPIVACAINE\FENTANYL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Exposure during pregnancy | 22 | 29.3% | 0 | 0 |
| Bradycardia | 19 | 25.3% | 0 | 0 |
| Live birth | 19 | 25.3% | 0 | 1 |
| Drug ineffective | 16 | 21.3% | 0 | 0 |
| Hypotension | 16 | 21.3% | 0 | 1 |
| Blood pressure decreased | 9 | 12.0% | 0 | 0 |
| Maternal exposure during pregnancy | 9 | 12.0% | 0 | 5 |
| Hypoaesthesia | 5 | 6.7% | 0 | 1 |
| Toxicity to various agents | 5 | 6.7% | 0 | 3 |
Who Reports BUPIVACAINE\FENTANYL Side Effects? Age & Gender Data
Gender: 98.6% female, 1.4% male. Average age: 34.5 years. Most reports from: US. View detailed demographics →
Is BUPIVACAINE\FENTANYL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2015 | 1 | 0 | 0 |
| 2017 | 1 | 0 | 1 |
| 2018 | 3 | 0 | 1 |
| 2019 | 2 | 0 | 0 |
| 2020 | 5 | 0 | 0 |
| 2021 | 6 | 0 | 0 |
| 2022 | 6 | 0 | 1 |
| 2023 | 3 | 0 | 0 |
| 2025 | 2 | 0 | 1 |
What Is BUPIVACAINE\FENTANYL Used For?
| Indication | Reports |
|---|---|
| Labour pain | 18 |
| Product used for unknown indication | 18 |
Official FDA Label for BUPIVACAINE\FENTANYL
Official prescribing information from the FDA-approved drug label.