LOW-VOLUME · SEX-BALANCED
artificial tears Side Effects
artificial tears (also sold as Refresh, Systane) is a LOW-VOLUME FAERS extract #441 of 524 by FAERS report count. Still opens on SEX-BALANCED: 67% of sex-coded reports are female (1,600 F / 776 M).
Data updated 2026-05-15
- 2,450
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
artificial tears reporting skew - 67% of sex-coded reports are female (1,600 F / 776 M). Volume band LOW-VOLUME #441 of 524 by FAERS report count; caseload SIGNAL.
Thinner FAERS extract for artificial tears (Refresh) (2,450 reports #441 of 524 by FAERS report count). 67% of sex-coded reports are female (1,600 F / 776 M). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2004–2025). Stamps SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
EYE PAIN leads 340 of 2,450 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (454 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (212 reports, 8.7%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 84 |
| CARDIAC ARREST | 16 |
| HYPOTENSION | 14 |
| RESPIRATORY FAILURE | 14 |
| URINARY TRACT INFECTION | 14 |
| FALL | 13 |
| PNEUMONIA | 13 |
| SEPSIS | 13 |
| PYREXIA | 12 |
| ACUTE KIDNEY INJURY | 11 |
| SEPTIC SHOCK | 11 |
| ACUTE RESPIRATORY FAILURE | 9 |
| DEHYDRATION | 9 |
| HYPOXIA | 9 |
| VOMITING | 9 |
| ASTHENIA | 8 |
| GASTROINTESTINAL HAEMORRHAGE | 8 |
| NAUSEA | 8 |
| CONFUSIONAL STATE | 7 |
Reactions in Hospitalization Reports
Hospitalization mid-share (645, 26.3%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| FALL | 55 |
| DYSPNOEA | 49 |
| PNEUMONIA | 48 |
| FATIGUE | 47 |
| PAIN | 45 |
| ASTHENIA | 44 |
| NAUSEA | 41 |
| DIARRHOEA | 40 |
| VOMITING | 40 |
| PYREXIA | 37 |
| HEADACHE | 35 |
| HYPOTENSION | 35 |
| URINARY TRACT INFECTION | 35 |
| DEHYDRATION | 33 |
| DIZZINESS | 33 |
| ACUTE KIDNEY INJURY | 32 |
| ANAEMIA | 32 |
| HOSPITALISATION | 31 |
| CONSTIPATION | 28 |
| SEPSIS | 28 |
How to read artificial tears FAERS figures (SIGNAL · DEATH-HEAVY · HOSP-MID)
FAERS holds 2,450 voluntary reports linked to artificial tears (Refresh, Systane), 2004-2025. Death is listed on 212 (8.7%). Hospitalization appears on 645 (26.3%). Top co-reported indication: Product Used For Unknown Indication.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with artificial tears
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 2,439 FAERS cases (Δ 11 lighter vs artificial tears); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,425 FAERS cases (Δ 25 lighter vs artificial tears); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,477 FAERS cases (Δ 27 heavier vs artificial tears); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,477 FAERS cases (Δ 27 heavier vs artificial tears); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 53.5 pp vs artificial tears's DEATH-HEAVY): CASELOAD · HOSP-MID.
artificial tears stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload SIGNAL and the label guide.