SINTILIMAB: 652 Adverse Event Reports & Safety Profile
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652
Total FAERS Reports
61 (9.4%)
Deaths Reported
225
Hospitalizations
652
As Primary/Secondary Suspect
68
Life-Threatening
26
Disabilities
First Report: 2017 · Latest Report: 20250915
What Are the Most Common SINTILIMAB Side Effects?
#1 Most Reported
Myelosuppression
127 reports (19.5%)
#2 Most Reported
Nausea
77 reports (11.8%)
#3 Most Reported
Rash
72 reports (11.0%)
All SINTILIMAB Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Myelosuppression | 127 | 19.5% | 2 | 63 |
| Nausea | 77 | 11.8% | 4 | 8 |
| Rash | 72 | 11.0% | 6 | 12 |
| Vomiting | 68 | 10.4% | 3 | 8 |
| Off label use | 64 | 9.8% | 13 | 29 |
| Hypothyroidism | 62 | 9.5% | 3 | 2 |
| Diarrhoea | 61 | 9.4% | 3 | 7 |
| Fatigue | 60 | 9.2% | 4 | 3 |
| Anaemia | 59 | 9.1% | 2 | 7 |
| Pyrexia | 51 | 7.8% | 1 | 15 |
| Therapy partial responder | 51 | 7.8% | 1 | 0 |
| Thrombocytopenia | 51 | 7.8% | 3 | 3 |
| Hypertension | 48 | 7.4% | 2 | 1 |
| Leukopenia | 45 | 6.9% | 1 | 1 |
| Neutropenia | 45 | 6.9% | 2 | 6 |
| Decreased appetite | 41 | 6.3% | 4 | 6 |
| Platelet count decreased | 41 | 6.3% | 2 | 17 |
| Alanine aminotransferase increased | 40 | 6.1% | 1 | 0 |
| Aspartate aminotransferase increased | 39 | 6.0% | 1 | 0 |
| White blood cell count decreased | 39 | 6.0% | 1 | 13 |
Who Reports SINTILIMAB Side Effects? Age & Gender Data
Gender: 35.0% female, 65.0% male. Average age: 57.6 years. Most reports from: CN. View detailed demographics →
Is SINTILIMAB Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2017 | 2 | 0 | 0 |
| 2018 | 1 | 0 | 0 |
| 2019 | 6 | 3 | 3 |
| 2020 | 20 | 1 | 6 |
| 2021 | 31 | 3 | 12 |
| 2022 | 49 | 4 | 22 |
| 2023 | 53 | 2 | 31 |
| 2024 | 115 | 3 | 70 |
| 2025 | 52 | 0 | 32 |
What Is SINTILIMAB Used For?
| Indication | Reports |
|---|---|
| Gastric cancer | 91 |
| Hepatocellular carcinoma | 70 |
| Lung neoplasm malignant | 33 |
| Colorectal cancer metastatic | 30 |
| Hepatic cancer | 24 |
| Lung adenocarcinoma | 19 |
| Tumour thrombosis | 19 |
| Adenocarcinoma gastric | 18 |
| Non-small cell lung cancer | 18 |
| Lung squamous cell carcinoma stage iii | 15 |
SINTILIMAB vs Alternatives: Which Is Safer?
SINTILIMAB vs SIPONIMOD
SINTILIMAB vs SIPULEUCEL-T
SINTILIMAB vs SIROLIMUS
SINTILIMAB vs SIRUKUMAB
SINTILIMAB vs SITAGLIPTIN
SINTILIMAB vs SOAP
SINTILIMAB vs SODIUM
SINTILIMAB vs SODIUM BICARBONATE
SINTILIMAB vs SODIUM BICARBONATE\SODIUM
SINTILIMAB vs SODIUM BORATE
Official FDA Label for SINTILIMAB
Official prescribing information from the FDA-approved drug label.