IGURATIMOD: 286 Adverse Event Reports & Safety Profile
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286
Total FAERS Reports
51 (17.8%)
Deaths Reported
179
Hospitalizations
286
As Primary/Secondary Suspect
28
Life-Threatening
4
Disabilities
First Report: 20061025 · Latest Report: 20250615
What Are the Most Common IGURATIMOD Side Effects?
#1 Most Reported
Interstitial lung disease
26 reports (9.1%)
#2 Most Reported
Pneumocystis jirovecii pneumonia
20 reports (7.0%)
#3 Most Reported
Pneumonia bacterial
13 reports (4.5%)
All IGURATIMOD Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Interstitial lung disease | 26 | 9.1% | 10 | 18 |
| Pneumocystis jirovecii pneumonia | 20 | 7.0% | 5 | 18 |
| Pneumonia bacterial | 13 | 4.6% | 4 | 10 |
| Off label use | 12 | 4.2% | 3 | 5 |
| Pneumonia | 10 | 3.5% | 4 | 6 |
| Covid-19 | 9 | 3.2% | 2 | 9 |
| Lymphoproliferative disorder | 9 | 3.2% | 0 | 4 |
| Stomatitis | 9 | 3.2% | 1 | 4 |
| Condition aggravated | 8 | 2.8% | 2 | 4 |
| Hepatic function abnormal | 8 | 2.8% | 1 | 5 |
| Herpes zoster | 8 | 2.8% | 0 | 5 |
| Pancytopenia | 8 | 2.8% | 3 | 4 |
| Pyrexia | 8 | 2.8% | 1 | 7 |
| Varicella zoster pneumonia | 8 | 2.8% | 0 | 6 |
| Acute kidney injury | 7 | 2.5% | 1 | 7 |
| Acute respiratory distress syndrome | 7 | 2.5% | 4 | 7 |
| Anaemia | 7 | 2.5% | 1 | 6 |
| Bacteraemia | 7 | 2.5% | 0 | 6 |
| Drug interaction | 7 | 2.5% | 0 | 3 |
| Listeriosis | 7 | 2.5% | 0 | 7 |
Who Reports IGURATIMOD Side Effects? Age & Gender Data
Gender: 71.6% female, 28.4% male. Average age: 67.9 years. Most reports from: JP. View detailed demographics →
Is IGURATIMOD Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 1 | 0 | 1 |
| 2013 | 2 | 1 | 1 |
| 2014 | 9 | 3 | 5 |
| 2015 | 16 | 8 | 7 |
| 2016 | 19 | 4 | 13 |
| 2017 | 23 | 6 | 14 |
| 2018 | 22 | 2 | 17 |
| 2019 | 30 | 4 | 21 |
| 2020 | 14 | 4 | 12 |
| 2021 | 15 | 3 | 12 |
| 2022 | 13 | 2 | 11 |
| 2023 | 12 | 0 | 9 |
| 2024 | 7 | 1 | 4 |
| 2025 | 3 | 0 | 0 |
What Is IGURATIMOD Used For?
| Indication | Reports |
|---|---|
| Rheumatoid arthritis | 189 |
| Product used for unknown indication | 53 |
| Dermatomyositis | 5 |
| Polyarthritis | 5 |
IGURATIMOD vs Alternatives: Which Is Safer?
IGURATIMOD vs ILOPERIDONE
IGURATIMOD vs ILOPROST
IGURATIMOD vs IMATINIB
IGURATIMOD vs IMBRUVICA
IGURATIMOD vs IMDEVIMAB
IGURATIMOD vs IMEGLIMIN
IGURATIMOD vs IMETELSTAT
IGURATIMOD vs IMIDAPRIL
IGURATIMOD vs IMIGLUCERASE
IGURATIMOD vs IMIPENEM
Official FDA Label for IGURATIMOD
Official prescribing information from the FDA-approved drug label.