Prescription medication · LFA-1 Antagonist (Ophthalmic)
lifitegrast
Also sold as Xiidra. Xiidra treats the signs and symptoms of dry eye disease.
Data updated 2026-05-15
- 15,783
- FDA reportsModerately reported
- $11.23
- Brand price (NADAC)
lifitegrast (Xiidra) is a prescription LFA-1 Antagonist (Ophthalmic). Xiidra treats the signs and symptoms of dry eye disease.
Xiidra is an eye drop medicine used to treat dry eye disease. It helps reduce inflammation that causes dry eyes.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$11.23/unit
Generic Available
Yes (1 manufacturer)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Xiidra treats the signs and symptoms of dry eye disease.
Common side effects
Irritation where the drops are placed, A bad taste in your mouth, Blurry vision
Key warnings
You should not take Xiidra if you are allergic to lifitegrast or any of the other ingredients.
The sections below are summarized in plain English from lifitegrast's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Xiidra blocks a protein on the surface of cells that causes inflammation. By blocking this protein, Xiidra can reduce inflammation in the eyes. This helps to improve the symptoms of dry eye disease.
How to Take It
Use one drop of Xiidra in each eye twice a day, about 12 hours apart. Use a new single-use container each time. Remove contact lenses before using Xiidra. You can put your contacts back in 15 minutes after using the drops.
This is a plain-language summary of lifitegrast's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
There is not enough information about using Xiidra during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if Xiidra passes into breast milk, so discuss with your doctor if you are breastfeeding.
This is a plain-language summary of lifitegrast's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose of Xiidra, use it as soon as you remember. Then, continue with your regular schedule.
This is a plain-language summary of lifitegrast's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Xiidra at room temperature, between 68°F and 77°F, and keep the single-use containers in the original foil pouch.
Side Effects (from patient reports)
Based on 15,783 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for lifitegrast, by number of reports
- Eye irritation
Eye irritation
2,649 reports
- Blurred vision
Blurred vision
2,566 reports
- Eye pain
Eye pain
1,386 reports
- Pain where the drops are placed
Pain where the drops are placed
1,281 reports
- Dry eye
Dry eye
1,131 reports
- Bad taste
Bad taste
1,088 reports
- Reaction where the drops are placed 1,019
Reaction where the drops are placed
1,019 reports
- Eye redness 663
Eye redness
663 reports
- Headache 602
Headache
602 reports
- Increased tearing 601
Increased tearing
601 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 lifitegrast 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 lifitegrast sits
lifitegrast has more FDA adverse-event reports than 49% 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 lifitegrast; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 15,783 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2015–2025.
Total Reports
15,783
Reports Mentioning Death
283
1.8% of reports — not proof of cause
Hospitalization Reports
615
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | EYE IRRITATION | 2,649 |
| 2 | VISION BLURRED | 2,566 |
| 4 | EYE PAIN | 1,386 |
| 5 | INSTILLATION SITE PAIN | 1,281 |
| 6 | DRY EYE | 1,131 |
| 7 | DYSGEUSIA | 1,088 |
| 8 | INSTILLATION SITE REACTION | 1,019 |
| 9 | OCULAR HYPERAEMIA | 663 |
| 10 | HEADACHE | 602 |
| 11 | LACRIMATION INCREASED | 601 |
| 12 | VISUAL IMPAIRMENT | 565 |
| 14 | EYE PRURITUS | 423 |
| 15 | EYE DISCHARGE | 380 |
| 16 | HYPERSENSITIVITY | 368 |
| 17 | PRODUCT QUALITY ISSUE | 360 |
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
You should not take Xiidra if you are allergic to lifitegrast or any of the other ingredients. Allergic reactions can be severe.
Common Questions
What is the strength of Xiidra?
How often should I use Xiidra?
Can I use Xiidra with contact lenses?
What should I do with the leftover solution in the container?
What if I experience severe side effects?
Can children use Xiidra?
Is Xiidra safe for elderly patients?
What are the inactive ingredients in Xiidra?
What does Xiidra look like?
How is Xiidra supplied?
What are the common side effects of lifitegrast?
What drug class is lifitegrast?
Is lifitegrast safe during pregnancy?
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What the FDA Data Shows for lifitegrast
The FDA label for lifitegrast (sold under brand names such as Xiidra) classifies it as a prescription-only medication in the LFA-1 Antagonist (Ophthalmic) class. Xiidra treats the signs and symptoms of dry eye disease. Official labeling lists 3 commonly reported side effects, including Irritation where the drops are placed, A bad taste in your mouth, Blurry vision.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 15,783 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS.
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, 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: November 21, 2024
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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