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.

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 →

Compare with Another Drug → Full Side Effects Report →

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.

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

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.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for lifitegrast each year to the FDA Adverse Event Reporting System (FAERS).

01,0002,0003,000 20152016201720182019202020212022202320242025 966

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.

fewest reports most reports

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

Female 11,783 (83%)
Male 2,442 (17%)

Age Distribution

0–17 40
18–44 544
45–64 1,693
65–74 1,344
75+ 1,231

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

DEATH 252
FALL 5
HEADACHE 4
PNEUMONIA 4
ARTHRALGIA 3
BREAST CANCER 3
BREAST CANCER METASTATIC 3
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 3
SPEECH DISORDER 3
ACUTE KIDNEY INJURY 2

Reactions in Hospitalization Reports

PNEUMONIA 90
FALL 62
FEELING ABNORMAL 51
ARTHRITIS 50
PLATELET COUNT DECREASED 47
BLOOD FOLATE DECREASED 43
HEADACHE 40
HOSPITALISATION 40
DYSPNOEA 38
COVID-19 36

Source: 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?
Xiidra contains 50 mg/mL of lifitegrast.
How often should I use Xiidra?
Use one drop in each eye twice a day, about 12 hours apart.
Can I use Xiidra with contact lenses?
No, remove your contact lenses before using Xiidra. You can put them back in 15 minutes after using the drops.
What should I do with the leftover solution in the container?
Throw away the single-use container immediately after using it, even if there is solution left.
What if I experience severe side effects?
Contact your doctor immediately if you experience any severe side effects or allergic reactions.
Can children use Xiidra?
The safety and effectiveness of Xiidra in children under 17 years old have not been studied.
Is Xiidra safe for elderly patients?
Yes, studies have not shown any differences in safety or effectiveness between elderly and younger adult patients.
What are the inactive ingredients in Xiidra?
The inactive ingredients are sodium chloride, sodium phosphate dibasic anhydrous, sodium thiosulfate pentahydrate, and water for injection. Sodium hydroxide and/or hydrochloric acid are used to adjust the pH.
What does Xiidra look like?
Xiidra is a sterile, clear, colorless to slightly brownish-yellow solution.
How is Xiidra supplied?
Xiidra comes in a foil pouch containing 5 single-use containers. Each carton contains 60 single-use containers.
What are the common side effects of lifitegrast?
The registry lists Irritation where the drops are placed, A bad taste in your mouth, Blurry vision among the most-reported FAERS reaction terms for lifitegrast. The compiled record contains 15,783 FDA adverse-event reports. These counts are not an individual symptom assessment.
What drug class is lifitegrast?
lifitegrast belongs to the LFA-1 Antagonist (Ophthalmic) drug class. It requires a prescription (Rx). Xiidra treats the signs and symptoms of dry eye disease.
What pregnancy or breastfeeding source fields are listed for lifitegrast?
The FDA label for lifitegrast contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

Other drugs grouped near lifitegrast - same-class peers and common alternatives.

Compare lifitegrast vs aflibercept side-by-side →

Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for lifitegrast: 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.

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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 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: November 21, 2024

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.

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