artificial tears
Brand names: Refresh, Systane
Artificial tears are eye drops that lubricate your eyes. They help relieve dryness and irritation.
Drug Pricing (NADAC)
Brand Price
$0.76/unit
Generic Price
$0.17/unit
Generic Savings
77%
Generic Available
Yes (0 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats dry, irritated eyes.
Common side effects
Eye irritation, Blurred vision, Increased tears
Key warnings
There are no boxed warnings for this medication.
How It Works
Artificial tears work by adding moisture to your eyes. This helps to relieve dryness and discomfort. They act like your natural tears to keep your eyes lubricated.
How to Take It
Shake the bottle well before using. Put 1 or 2 drops in the affected eye(s). Use the drops as often as you need them.
Pregnancy & Breastfeeding
It is not known if artificial tears can harm an unborn baby. It is also not known if this medicine passes into breast milk.
Missed Dose
Since you use these drops as needed, you do not have to worry about a missed dose.
Storage
Store at room temperature.
Side Effects (from patient reports)
Based on 1,595 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 2,450 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
2,450
Death-Related Reports
212
Hospitalization Reports
645
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | EYE PAIN | 340 |
| 2 | EYE IRRITATION | 236 |
| 3 | HEADACHE | 147 |
| 4 | FATIGUE | 146 |
| 5 | VISION BLURRED | 145 |
| 6 | DRUG INEFFECTIVE | 133 |
| 7 | PAIN | 121 |
| 8 | NAUSEA | 112 |
| 9 | OCULAR HYPERAEMIA | 112 |
| 10 | DIARRHOEA | 103 |
| 11 | DRY EYE | 103 |
| 12 | DIZZINESS | 102 |
| 13 | DYSPNOEA | 102 |
| 14 | ANXIETY | 91 |
| 15 | OFF LABEL USE | 91 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
There are no boxed warnings for this medication.
Common Questions
How often can I use these drops?
Can I use these with contact lenses?
What if my eyes get worse?
Can children use these drops?
What if I accidentally swallow some of the drops?
How long does a bottle last once opened?
Can I use these drops for other eye problems?
What should I do if the bottle tip touches my eye?
Can I use these drops after eye surgery?
Are there preservatives in these drops?
What are the common side effects of artificial tears?
What drug class is artificial tears?
Is there a generic version of artificial tears?
Is artificial tears safe during pregnancy?
Has artificial tears been recalled?
Active Recalls
cGMP deviations and lack of assurance of sterility.
BRS Analytical Services, LLC
Non-Sterility
Alcon Research LLC
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Pharma Nobis LLC
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
K.C. Pharmaceuticals, Inc
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Global Pharma Healthcare Private Limited
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Global Pharma Healthcare Private Limited
CGMP Deviations: product held outside appropriate storage temperature conditions.
Family Dollar Stores, Llc.
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What the FDA Data Shows for artificial tears
The FDA label for artificial tears (sold under brand names such as Refresh, Systane) classifies it as an over-the-counter product in the Ocular Lubricant class. This medicine treats dry, irritated eyes. Official labeling lists 3 commonly reported side effects, including Eye irritation, Blurred vision, Increased tears.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,595 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.17 versus $0.76 for the brand — a 77% generic savings.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 9 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: April 21, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages