ADALIMUMAB-AQVH: 75 Adverse Event Reports & Safety Profile
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75
Total FAERS Reports
1 (1.3%)
Deaths Reported
8
Hospitalizations
75
As Primary/Secondary Suspect
Prescription
Status
FDA Application: 761216 ·
First Report: 20131030 · Latest Report: 20250810
What Are the Most Common ADALIMUMAB-AQVH Side Effects?
#1 Most Reported
Accidental exposure to product
32 reports (42.7%)
#2 Most Reported
Product dose omission issue
21 reports (28.0%)
#3 Most Reported
Device malfunction
18 reports (24.0%)
All ADALIMUMAB-AQVH Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Accidental exposure to product | 32 | 42.7% | 0 | 0 |
| Product dose omission issue | 21 | 28.0% | 0 | 0 |
| Device malfunction | 18 | 24.0% | 0 | 0 |
| No adverse event | 8 | 10.7% | 0 | 0 |
| Product quality issue | 7 | 9.3% | 0 | 0 |
| Product complaint | 6 | 8.0% | 0 | 0 |
| Device leakage | 5 | 6.7% | 0 | 0 |
| Drug ineffective | 5 | 6.7% | 1 | 2 |
Who Reports ADALIMUMAB-AQVH Side Effects? Age & Gender Data
Gender: 72.4% female, 27.6% male. Average age: 45.8 years. Most reports from: US. View detailed demographics →
Is ADALIMUMAB-AQVH Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 1 | 0 | 0 |
| 2023 | 10 | 0 | 1 |
| 2024 | 30 | 0 | 1 |
| 2025 | 5 | 0 | 0 |
What Is ADALIMUMAB-AQVH Used For?
| Indication | Reports |
|---|---|
| Rheumatoid arthritis | 24 |
| Product used for unknown indication | 22 |
| Crohn's disease | 13 |
Official FDA Label for ADALIMUMAB-AQVH
Official prescribing information from the FDA-approved drug label.