Triage & Classification
Rule-based seriousness assessment, expectedness evaluation, and regulatory classification
ICSR-2026-04892
Adalimumab — Injection site reaction
Non-SeriousListed / Expected
Seriousness Assessment
Results in Death
No
Life-Threatening
No
Inpatient Hospitalization
No
Persistent Disability
No
Congenital Anomaly
No
Other Medically Important
No
Classification: Non-Serious — No seriousness criteria met
Expectedness Evaluation
TermListedReference
Injection site reaction
Yes
SmPC Section 4.8Erythema
Yes
SmPC Section 4.8Pruritus
Yes
SmPC Section 4.8Swelling
Yes
SmPC Section 4.8All reported terms are listed in the reference safety information