INFLIXIMAB-AXXQ: 723 Adverse Event Reports & Safety Profile
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723
Total FAERS Reports
22 (3.0%)
Deaths Reported
99
Hospitalizations
723
As Primary/Secondary Suspect
19
Life-Threatening
16
Disabilities
Prescription
Status
FDA Application: 761086 ·
First Report: 2020 · Latest Report: 20250925
What Are the Most Common INFLIXIMAB-AXXQ Side Effects?
#1 Most Reported
Product storage error
144 reports (19.9%)
#2 Most Reported
Off label use
137 reports (18.9%)
#3 Most Reported
Circumstance or information capable of leading to medication error
99 reports (13.7%)
All INFLIXIMAB-AXXQ Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Product storage error | 144 | 19.9% | 0 | 1 |
| Off label use | 137 | 19.0% | 9 | 41 |
| Circumstance or information capable of leading to medication error | 99 | 13.7% | 0 | 1 |
| Drug ineffective | 57 | 7.9% | 2 | 5 |
| Infusion related reaction | 51 | 7.1% | 4 | 10 |
| Dyspnoea | 45 | 6.2% | 3 | 10 |
| Rash | 43 | 6.0% | 1 | 3 |
| Intercepted product administration error | 41 | 5.7% | 0 | 0 |
| Fatigue | 38 | 5.3% | 2 | 5 |
| Pain | 38 | 5.3% | 3 | 6 |
| Headache | 35 | 4.8% | 3 | 6 |
| Arthralgia | 34 | 4.7% | 1 | 5 |
| Pruritus | 32 | 4.4% | 2 | 3 |
| Diarrhoea | 28 | 3.9% | 0 | 7 |
| Crohn's disease | 24 | 3.3% | 2 | 11 |
| Hypersensitivity | 24 | 3.3% | 2 | 2 |
| Pyrexia | 24 | 3.3% | 1 | 3 |
| Abdominal pain | 23 | 3.2% | 0 | 10 |
| Nasopharyngitis | 23 | 3.2% | 1 | 3 |
| Ill-defined disorder | 22 | 3.0% | 2 | 3 |
Who Reports INFLIXIMAB-AXXQ Side Effects? Age & Gender Data
Gender: 57.9% female, 42.1% male. Average age: 49.8 years. Most reports from: US. View detailed demographics →
Is INFLIXIMAB-AXXQ Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2020 | 6 | 1 | 1 |
| 2021 | 34 | 0 | 4 |
| 2022 | 93 | 4 | 23 |
| 2023 | 75 | 3 | 15 |
| 2024 | 69 | 2 | 10 |
| 2025 | 27 | 3 | 5 |
What Is INFLIXIMAB-AXXQ Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 376 |
| Crohn's disease | 141 |
| Rheumatoid arthritis | 58 |
| Colitis ulcerative | 50 |
| Ankylosing spondylitis | 21 |
| Psoriatic arthropathy | 12 |
| Hidradenitis | 10 |
| Colitis | 9 |
| Sarcoidosis | 7 |
| Exposure during pregnancy | 6 |
INFLIXIMAB-AXXQ vs Alternatives: Which Is Safer?
INFLIXIMAB-AXXQ vs INFLIXIMAB-DYYB
INFLIXIMAB-AXXQ vs INFLIXIMAB-QBTX
INFLIXIMAB-AXXQ vs INFLIXIMAB, RECOMBINANT
INFLIXIMAB-AXXQ vs INFLUENZA A VIRUS A/CALIFORNIA/7/2009 LIVE ANTIGEN\INFLUENZA A VIRUS A/TEXAS/50/2012 LIVE ANTIGEN\INFLUENZA B VIRUS B/BRISBANE/60/2008 LIVE ANTIGEN\INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 LIVE ANTIGEN
INFLIXIMAB-AXXQ vs INFLUENZA VIRUS VACCINE
INFLIXIMAB-AXXQ vs INFLUENZA VIRUS VACCINE QUADRIVALENT TYPE A+B
INFLIXIMAB-AXXQ vs INGENOL MEBUTATE
INFLIXIMAB-AXXQ vs INLYTA
INFLIXIMAB-AXXQ vs INOTERSEN
INFLIXIMAB-AXXQ vs INOTUZUMAB OZOGAMICIN
Official FDA Label for INFLIXIMAB-AXXQ
Official prescribing information from the FDA-approved drug label.