SULBACTAM: 130 Adverse Event Reports & Safety Profile
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130
Total FAERS Reports
35 (26.9%)
Deaths Reported
44
Hospitalizations
130
As Primary/Secondary Suspect
14
Life-Threatening
First Report: 19940627 · Latest Report: 20220501
What Are the Most Common SULBACTAM Side Effects?
#1 Most Reported
Drug ineffective
25 reports (19.2%)
#2 Most Reported
Foetal exposure during pregnancy
14 reports (10.8%)
#3 Most Reported
Tachycardia
11 reports (8.5%)
All SULBACTAM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 25 | 19.2% | 8 | 10 |
| Foetal exposure during pregnancy | 14 | 10.8% | 2 | 0 |
| Abdominal pain | 11 | 8.5% | 10 | 0 |
| Cardiac arrest | 11 | 8.5% | 11 | 2 |
| Tachycardia | 11 | 8.5% | 9 | 2 |
| Nausea | 10 | 7.7% | 10 | 1 |
| Stevens-johnson syndrome | 10 | 7.7% | 8 | 8 |
| Abdominal distension | 9 | 6.9% | 9 | 0 |
| Anuria | 9 | 6.9% | 1 | 1 |
| Candida infection | 9 | 6.9% | 0 | 0 |
| Chills | 9 | 6.9% | 9 | 0 |
| Hepatic lesion | 9 | 6.9% | 9 | 0 |
| Off label use | 9 | 6.9% | 3 | 2 |
| Rash | 9 | 6.9% | 6 | 7 |
| Thrombosis | 9 | 6.9% | 9 | 0 |
| C-reactive protein increased | 8 | 6.2% | 0 | 0 |
| Cardiac septal defect | 8 | 6.2% | 0 | 0 |
| Condition aggravated | 8 | 6.2% | 2 | 5 |
| Kidney duplex | 8 | 6.2% | 0 | 0 |
| Stillbirth | 8 | 6.2% | 2 | 2 |
Who Reports SULBACTAM Side Effects? Age & Gender Data
Gender: 37.4% female, 62.6% male. Average age: 55.5 years. Most reports from: CN. View detailed demographics →
Is SULBACTAM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 3 | 2 | 1 |
| 2005 | 6 | 6 | 6 |
| 2007 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2014 | 4 | 2 | 0 |
| 2017 | 2 | 1 | 0 |
| 2018 | 3 | 1 | 1 |
| 2019 | 11 | 0 | 9 |
| 2020 | 2 | 0 | 1 |
| 2021 | 5 | 0 | 5 |
| 2022 | 2 | 0 | 1 |
What Is SULBACTAM Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 36 |
| Pneumonia | 10 |
| Infection | 9 |
| Foetal exposure during pregnancy | 8 |
| Anti-infective therapy | 5 |
| Evidence based treatment | 5 |
SULBACTAM vs Alternatives: Which Is Safer?
SULBACTAM vs SULFACETAMIDE
SULBACTAM vs SULFADIAZINE
SULBACTAM vs SULFADIAZINE\TRIMETHOPRIM
SULBACTAM vs SULFAMETHOXAZOLE
SULBACTAM vs SULFAMETHOXAZOLE\TRIMETHOPRIM
SULBACTAM vs SULFANILAMIDE
SULBACTAM vs SULFASALAZINE
SULBACTAM vs SULFATHIAZOLE
SULBACTAM vs SULFISOMIDINE
SULBACTAM vs SULFUR
Official FDA Label for SULBACTAM
Official prescribing information from the FDA-approved drug label.