ROXADUSTAT: 100 Adverse Event Reports & Safety Profile
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100
Total FAERS Reports
17 (17.0%)
Deaths Reported
50
Hospitalizations
100
As Primary/Secondary Suspect
19
Life-Threatening
2
Disabilities
First Report: 19911111 · Latest Report: 20250501
What Are the Most Common ROXADUSTAT Side Effects?
#1 Most Reported
Off label use
14 reports (14.0%)
#2 Most Reported
Renal impairment
9 reports (9.0%)
#3 Most Reported
Haemoglobin increased
9 reports (9.0%)
All ROXADUSTAT Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 14 | 14.0% | 6 | 5 |
| Gastrointestinal haemorrhage | 9 | 9.0% | 0 | 9 |
| Haemoglobin increased | 9 | 9.0% | 1 | 0 |
| Renal impairment | 9 | 9.0% | 0 | 1 |
| Hyperkalaemia | 8 | 8.0% | 1 | 2 |
| Product use issue | 7 | 7.0% | 3 | 2 |
| Shunt occlusion | 7 | 7.0% | 1 | 3 |
| Bronchopulmonary aspergillosis | 5 | 5.0% | 0 | 5 |
| Central hypothyroidism | 5 | 5.0% | 0 | 3 |
| Diarrhoea | 5 | 5.0% | 1 | 1 |
| Hypertension | 5 | 5.0% | 0 | 1 |
| Influenza | 5 | 5.0% | 0 | 5 |
| Nausea | 5 | 5.0% | 2 | 0 |
| Pancytopenia | 5 | 5.0% | 0 | 5 |
Who Reports ROXADUSTAT Side Effects? Age & Gender Data
Gender: 54.6% female, 45.4% male. Average age: 60.7 years. Most reports from: JP. View detailed demographics →
Is ROXADUSTAT Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 2 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2015 | 1 | 0 | 0 |
| 2016 | 9 | 1 | 9 |
| 2017 | 4 | 0 | 4 |
| 2018 | 1 | 0 | 1 |
| 2019 | 2 | 1 | 0 |
| 2020 | 7 | 2 | 4 |
| 2021 | 21 | 8 | 9 |
| 2022 | 14 | 0 | 8 |
| 2023 | 7 | 1 | 6 |
| 2024 | 14 | 1 | 5 |
| 2025 | 1 | 0 | 1 |
What Is ROXADUSTAT Used For?
| Indication | Reports |
|---|---|
| Nephrogenic anaemia | 57 |
| Anaemia | 15 |
| Product used for unknown indication | 15 |
| Chronic kidney disease | 5 |
ROXADUSTAT vs Alternatives: Which Is Safer?
ROXADUSTAT vs ROXICODONE
ROXADUSTAT vs ROXITHROMYCIN
ROXADUSTAT vs ROZANOLIXIZUMAB
ROXADUSTAT vs ROZANOLIXIZUMAB-NOLI
ROXADUSTAT vs RUBIDIUM RB-82
ROXADUSTAT vs RUCAPARIB
ROXADUSTAT vs RUCAPARIB CAMSYLATE
ROXADUSTAT vs RUFINAMIDE
ROXADUSTAT vs RUPATADINE
ROXADUSTAT vs RUXOLITINIB
Official FDA Label for ROXADUSTAT
Official prescribing information from the FDA-approved drug label.