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lifitegrast

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Brand names: Xiidra

LFA-1 Antagonist (Ophthalmic) Rx

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 →

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.

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.

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.

Missed Dose

If you miss a dose of Xiidra, use it as soon as you remember. Then, continue with your regular schedule.

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 13,921 FDA adverse event reports.

Eye irritation
2,649
Blurred vision
2,566
The medicine is not working
1,536
Eye pain
1,386
Pain where the drops are placed
1,281
Dry eye
1,131
Bad taste
1,088
Reaction where the drops are placed
1,019
Eye redness
663
Headache
602

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

Death-Related Reports

283

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
3 DRUG INEFFECTIVE 1,536
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
13 PRODUCT DOSE OMISSION ISSUE 435
14 EYE PRURITUS 423
15 EYE DISCHARGE 380

Reactions in Death Reports

DEATH 252
FALL 5
PRODUCT DOSE OMISSION ISSUE 5
HEADACHE 4
PNEUMONIA 4
ARTHRALGIA 3
BREAST CANCER 3
BREAST CANCER METASTATIC 3
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 3
OFF LABEL USE 3

Reactions in Hospitalization Reports

PNEUMONIA 90
FALL 62
DRUG INEFFECTIVE 60
PRODUCT DOSE OMISSION ISSUE 55
FEELING ABNORMAL 51
ARTHRITIS 50
PLATELET COUNT DECREASED 47
BLOOD FOLATE DECREASED 43
HEADACHE 40
HOSPITALISATION 40

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?
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 most commonly reported side effects of lifitegrast include Irritation where the drops are placed, A bad taste in your mouth, Blurry vision. Based on 13,921 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
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.
Is lifitegrast safe during pregnancy?
There is not enough information about using Xiidra during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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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 13,921 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

All federal data sources used on this page