GUADECITABINE: 81 Adverse Event Reports & Safety Profile
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81
Total FAERS Reports
29 (35.8%)
Deaths Reported
52
Hospitalizations
81
As Primary/Secondary Suspect
6
Life-Threatening
First Report: 20160123 · Latest Report: 20211018
What Are the Most Common GUADECITABINE Side Effects?
#1 Most Reported
Febrile neutropenia
21 reports (25.9%)
#2 Most Reported
Neutropenia
16 reports (19.8%)
#3 Most Reported
Thrombocytopenia
12 reports (14.8%)
All GUADECITABINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Febrile neutropenia | 21 | 25.9% | 3 | 17 |
| Neutropenia | 16 | 19.8% | 2 | 9 |
| Anaemia | 12 | 14.8% | 5 | 9 |
| Thrombocytopenia | 12 | 14.8% | 1 | 5 |
| Constipation | 11 | 13.6% | 1 | 8 |
| Neutrophil count decreased | 9 | 11.1% | 6 | 6 |
| Abdominal pain | 8 | 9.9% | 2 | 8 |
| Fatigue | 8 | 9.9% | 4 | 4 |
| Platelet count decreased | 8 | 9.9% | 5 | 6 |
| Sepsis | 8 | 9.9% | 8 | 5 |
| Back pain | 7 | 8.6% | 1 | 7 |
| Nausea | 7 | 8.6% | 2 | 2 |
| Pneumonia | 7 | 8.6% | 4 | 7 |
| Urinary tract infection | 7 | 8.6% | 0 | 7 |
| Vomiting | 7 | 8.6% | 5 | 5 |
| White blood cell count decreased | 7 | 8.6% | 1 | 3 |
| Hyponatraemia | 6 | 7.4% | 3 | 4 |
| Injection site reaction | 6 | 7.4% | 2 | 2 |
| Pelvic pain | 6 | 7.4% | 0 | 6 |
| Pyrexia | 6 | 7.4% | 0 | 5 |
Who Reports GUADECITABINE Side Effects? Age & Gender Data
Gender: 28.8% female, 71.2% male. Average age: 61.4 years. Most reports from: US. View detailed demographics →
Is GUADECITABINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2016 | 1 | 0 | 1 |
| 2017 | 5 | 1 | 4 |
| 2018 | 17 | 8 | 17 |
| 2019 | 23 | 8 | 21 |
| 2020 | 6 | 3 | 5 |
| 2021 | 4 | 0 | 0 |
What Is GUADECITABINE Used For?
Official FDA Label for GUADECITABINE
Official prescribing information from the FDA-approved drug label.