artificial tears Side Effects
Also known as: Refresh, Systane
Analysis of 2,450 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
2,450
Death-Related
212
8.7% of reports
Hospitalizations
645
26.3% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 212 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| 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 |
| OFF LABEL USE | 10 |
| ACUTE RESPIRATORY FAILURE | 9 |
| DEHYDRATION | 9 |
| HYPOXIA | 9 |
| VOMITING | 9 |
| ASTHENIA | 8 |
| GASTROINTESTINAL HAEMORRHAGE | 8 |
| NAUSEA | 8 |
| CONFUSIONAL STATE | 7 |
Reactions in Hospitalization Reports
Top reactions in 645 reports where hospitalization was an outcome.
| 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 |
Nearby — Related Medications
What the FAERS Data Reveals About artificial tears Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 2,450 voluntary reports linked to artificial tears and its brand equivalents (Refresh, Systane), spanning 2004 through 2025. Of those, 212 (8.7%) listed death as an outcome and 645 (26.3%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 67% were female and 33% male; age distribution skews toward 45-64, with 454 reports in that bracket. The single most reported reaction is eye pain with 340 submissions, followed by eye irritation and headache.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.