Reported signals
0xygen
Registration status unknownDrugalgemeen
46,871
reports (FAERS)
67.8%
reported as serious
5,576
fatal reports (11.9%)
30
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]
Infusion site pain
36.5 [34.2–39.1]
Pulmonary arterial hypertension
30.6 [28.6–32.7]
Oxygen saturation decreased
26.1 [25.2–27.2]
Pulmonary hypertension
23.6 [22.2–25.2]
Dyspnoea exertional
21.0 [20.0–22.1]
Hypoxia
16.4 [15.5–17.4]
Chronic obstructive pulmonary disease
14.5 [13.8–15.3]
Productive cough
12.5 [11.8–13.3]
Fluid retention
12.1 [11.5–12.8]
Therapy non-responder
10.0 [9.3–10.6]
Dyspnoea
9.1 [8.9–9.3]
Cough
8.2 [7.9–8.4]
Respiratory failure
7.9 [7.5–8.4]
Nasal congestion
7.5 [7.0–8.0]
Epistaxis
7.5 [7.1–7.9]
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
Infusion site pain
Pulmonary arterial hypertension
Oxygen saturation decreased
Pulmonary hypertension
Dyspnoea exertional
Hypoxia
Chronic obstructive pulmonary disease
Productive cough
Recall history · 0 on record
No recalls on record.
Compare within ALGEMEEN
Source & citation
HealthProves. 0xygen — reported signals. Retrieved 2026-07-05. Source: openFDA (FAERS). healthproves.com/0xygen/
FAERS46,871 records
Retrieved2026-07-05
MethodROR / disproportionality