Over-the-counter medication · Ocular Lubricant
artificial tears
Also sold as Refresh, Systane. This medicine treats dry, irritated eyes.
Data updated 2026-05-15
- 2,450
- FDA reportsLightly reported
- 77% less
- Generic vs brandBig savings
- 12
- Recall records
What the data shows
artificial tears (Refresh) is an over-the-counter Ocular Lubricant, among the least-reported drugs the FDA tracks (2,450 FDA reports), whose generic runs roughly half the brand price or less (77% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
artificial tears (Refresh) is an over-the-counter Ocular Lubricant. This medicine treats dry, irritated eyes.
Artificial tears are eye drops that lubricate your eyes. They help relieve dryness and irritation.
Verify with FDA → · CMS NADAC pricing →
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
No specific warnings noted. Always follow your prescriber's instructions.
The sections below are summarized in plain English from artificial tears's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 2,450 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for artificial tears, by number of reports
- Eye Pain
Eye Pain
340 reports
- Eye Irritation
Eye Irritation
236 reports
- Headache
Headache
147 reports
- Fatigue
Fatigue
146 reports
- Vision Blurred
Vision Blurred
145 reports
- Pain 121
Pain
121 reports
- Nausea 112
Nausea
112 reports
- Ocular Hyperaemia 112
Ocular Hyperaemia
112 reports
- Diarrhoea 103
Diarrhoea
103 reports
- Dry Eye 103
Dry Eye
103 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for artificial tears each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where artificial tears sits
artificial tears has more FDA adverse-event reports than 16% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is artificial tears; the line is the median (50th percentile).
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
Reports Mentioning Death
212
8.7% of reports — not proof of cause
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 |
| 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 |
| 16 | FALL | 89 |
| 17 | ASTHENIA | 86 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
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?
What pregnancy or breastfeeding source fields are listed for artificial tears?
Has artificial tears been recalled?
Active Recalls
Lack of Assurance of Sterility
Preferred Pharmaceuticals, Inc.
Lack of Assurance of Sterility
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
K.C. Pharmaceuticals, Inc
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.
Related Medications in Ocular Lubricant
Other drugs grouped near artificial tears - same-class peers and common alternatives.
aflibercept
Eylea
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bevacizumab (ophthalmic)
Avastin
Avastin is a medicine that blocks a protein called vascular endothelial growth factor (VEGF).
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bimatoprost
Lumigan
Bimatoprost eye drops help lower pressure in the eye.
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brimonidine ophthalmic
Alphagan P
Alphagan P eye drops help lower pressure in the eye.
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brimonidine/timolol
Combigan
Combigan eye drops contain two medicines that lower pressure in the eye.
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for artificial tears: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 2,450.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 8.65%.
- finasteride Δ 0.02 pts · 56,567 reports · 5-Alpha Reductase Inhibitor 8.68%death share
- clarithromycin Δ 0.03 pts · 33,247 reports · Macrolide Antibiotic 8.69%death share
- primidone Δ 0.04 pts · 9,782 reports · Anticonvulsant (Barbiturate) 8.69%death share
- sulfasalazine Δ 0.04 pts · 76,270 reports · Disease-Modifying Antirheumatic Drug (DMARD) 8.69%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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 2,450 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 12 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: April 21, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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