Reported signals
adalimumab
Registration status unknownDrugalgemeen
715,350
reports (FAERS)
51.4%
reported as serious
26,384
fatal reports (3.7%)
10
signals above threshold
2026-07
last updated
Signal ranking · ROR
What stands out in the reports.
On the labelNew signalUnknown & frequent
Symptom
0.1110100
ROR [95% CI]
Rheumatoid arthritis
14.4 [14.2–14.5]
Joint swelling
7.2 [7.1–7.3]
Psoriasis
7.0 [6.9–7.1]
Injection site pain
5.7 [5.7–5.8]
Arthralgia
4.1 [4.0–4.1]
Nasopharyngitis
3.8 [3.7–3.8]
Incorrect dose administered
3.3 [3.2–3.3]
Pain in extremity
2.7 [2.6–2.7]
Pain
2.6 [2.6–2.7]
Drug ineffective
2.3 [2.3–2.3]
Rash
1.8 [1.8–1.9]
Fatigue
1.6 [1.6–1.6]
Malaise
1.5 [1.5–1.5]
Headache
1.4 [1.4–1.4]
Diarrhoea
1.2 [1.2–1.2]
ROR = reporting odds ratio (log scale). A value above 1 means the symptom is reported more often for this product than for all other products combined. This measures how much it stands out in reports — not cause, not risk.
Interpretation
Summary not yet available — will be auto-generated.
Label versus report
On the label
No signals currently mapped to the label.
Newly reported
Rheumatoid arthritis
Joint swelling
Psoriasis
Injection site pain
Arthralgia
Nasopharyngitis
Incorrect dose administered
Pain in extremity
Recall history · 0 on record
No recalls on record.
Compare within ALGEMEEN
Source & citation
HealthProves. adalimumab — reported signals. Retrieved 2026-07-05. Source: openFDA (FAERS). healthproves.com/adalimumab/
FAERS715,350 records
Retrieved2026-07-05
MethodROR / disproportionality