Lifitegrast Ophthalmic
Lifitegrast ophthalmic solution is an eye drop used to treat the signs and symptoms of dry eye disease.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Lifitegrast Ophthalmic: Patient Information Guide
A plain-language walkthrough of Lifitegrast Ophthalmic — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Lifitegrast ophthalmic solution is used to treat dry eye disease. Here is the full supported use:
- Xiidra (lifitegrast ophthalmic solution) 5%: treats both the signs (what a doctor observes on examination) and the symptoms (what you feel, such as dryness, irritation, or discomfort) of dry eye disease (DED)
⚙️How it works▾
Dry eye disease involves inflammation on the surface of the eye. Lifitegrast works by attaching to a protein called LFA-1 on immune cells (white blood cells called leukocytes). Normally, LFA-1 links up with a molecule called ICAM-1, which may be overproduced on the cornea and conjunctiva (the surfaces of the eye) in dry eye disease. This link activates T-cells — immune cells that drive inflammation — and sends them into eye tissue. By blocking LFA-1 from connecting to ICAM-1, lifitegrast may interrupt this inflammatory chain reaction. The precise mechanism in dry eye disease is not fully understood.
💊How it's taken▾
Xiidra comes in single-use eye drop containers. The general dosing schedule is one drop in each eye twice a day, about 12 hours apart. Each single-dose container should be used for one administration (both eyes) and then discarded immediately — do not save a partly used container.
- Remove contact lenses before using the drops
- Wait at least 15 minutes after using the drops before putting contact lenses back in
- Follow your prescriber's specific instructions and the directions on your prescription label
🤒Side effects — in detail▾
The most commonly reported side effects with lifitegrast eye drops (occurring in 5–25% of patients in clinical trials) include:
- Irritation or discomfort at the site where the drop is placed
- An unusual or altered taste in the mouth (dysgeusia) — a recognized quirk of this drop
- Temporarily reduced visual acuity (sharpness of vision) right after instillation
- Blurred vision
- Eye redness (conjunctival hyperemia)
- Eye irritation, itching, or discomfort
- Increased tearing or eye discharge
- Headache or sinusitis
Serious but rare reactions — including severe allergic responses such as anaphylaxis, throat or tongue swelling, difficulty breathing, hives, and skin rashes — have been reported after approval. Stop using Xiidra and seek emergency care immediately if any of these occur.
⚠️Warnings & precautions▾
- Serious allergic reactions (hypersensitivity): Rare cases of anaphylaxis, bronchospasm (airway tightening), throat and tongue swelling, respiratory distress, hives, and severe skin reactions have been reported. Anyone with a known allergy to lifitegrast or any formulation ingredient must not use Xiidra.
- Eye swelling and rash: These have also been reported after the product was approved and should prompt you to contact your doctor.
- Contact lens use: Contact lenses must be removed before each dose; they can be reinserted 15 minutes after the drops are used.
🔀What it interacts with▾
The FDA label for Xiidra does not describe specific drug, food, or supplement interactions.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy: Do not use Xiidra if you are allergic to lifitegrast or any ingredient in the product
- Pregnancy: No human data are available; high-dose animal studies at exposures far above what people get from eye drops showed some fetal concerns — talk to your doctor about the risks and benefits
- Breastfeeding: It is unknown whether lifitegrast passes into human milk; because absorption from eye drops is very low, discuss with your doctor whether to continue breastfeeding
- Children under 17: Safety and effectiveness have not been established — Xiidra is not recommended for this age group
- Older adults: No differences in safety or effectiveness have been seen compared to younger adults; no special precautions are noted
🔬Pharmacokinetics — how your body processes it▾
After twice-daily use of Xiidra eye drops, the amount of lifitegrast that reaches the bloodstream is very low. In a clinical study, only about 1 in 5 patients had detectable blood levels of the drug, and even those levels were very small. This low systemic (whole-body) absorption is one reason the risk of body-wide side effects from the eye drops is considered minimal.
📦How to store it▾
Store at 20 to 25°C (68 to 77°F) . Store single-dose containers in the original foil pouch.
📄 Written from Lifitegrast Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Lifitegrast Ophthalmic
3 supplements and herbal products have documented interactions with Lifitegrast Ophthalmic in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 2
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Lifitegrast Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.
What is Xiidra actually for — is it just artificial tears? ▾
Why do I get a weird taste in my mouth after using the drops? ▾
How long do I have to use Xiidra before it starts working? ▾
Can I wear my contact lenses while using Xiidra? ▾
Is it safe to use Xiidra while pregnant or breastfeeding? ▾
What should I do if I have an allergic reaction to Xiidra? ▾
Is Lifitegrast Ophthalmic available over the counter? ▾
When was Lifitegrast Ophthalmic first available? ▾
Who makes Lifitegrast Ophthalmic? ▾
💬 Answers drafted from Lifitegrast Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Lifitegrast Ophthalmic comes
Lifitegrast Ophthalmic is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Eye drops
How this form is used
- Xiidra is used to treat the signs and symptoms of dry eye disease (DED)
- Xiidra: instill one drop into each eye twice daily, approximately 12 hours apart
- Xiidra: use a single-dose container for each administration and discard it immediately after use in both eyes — do not reuse
- Xiidra: remove contact lenses before using the drops and wait at least 15 minutes before reinserting them
📊 Lifitegrast Ophthalmic across the U.S. market
How Lifitegrast Ophthalmic appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Lifitegrast Ophthalmic is used
A general measure of how commonly Lifitegrast Ophthalmic is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Lifitegrast Ophthalmic is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Lifitegrast Ophthalmic prescribed? Of the 1,596 medications we measure, Lifitegrast Ophthalmic ranks #495 by Medicaid prescriptions — more than 69% of them.
Utilization by Lifitegrast Ophthalmic product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
lifitegrast 50 MG/ML Ophthalmic Solution
Summed across the 2 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1801835
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Lifitegrast Ophthalmic, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 14 listed Lifitegrast Ophthalmic NDCs with Medicaid activity.
🔍 Compare Lifitegrast Ophthalmic products
A representative set of FDA-listed product records for Lifitegrast Ophthalmic — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Eye drops | ||||
| 50 mg/mL | Ophthalmic | Aurobindo Pharma Limited | ANDA | View NDC → |
| 50 mg/mL | Ophthalmic | Bausch & Lomb Incorporated × 2 listings | NDA | View NDC → |
| 50 mg/mL | Ophthalmic | Novartis Pharmaceuticals Corporation × 3 listings | NDA | View NDC → |
| 50 mg/mL | Ophthalmic | Takeda Pharmaceuticals America, Inc. | NDA | View NDC → |
Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Lifitegrast Ophthalmic NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Lifitegrast Ophthalmic — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Lifitegrast Ophthalmic in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Lifitegrast Ophthalmic went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1801820 1 dose form · 1 strength
-
Dose form (SCDF) Ophthalmic Solution RxCUI 1801834In current FDA listingsClinical drug / strength (SCD) 50 MG/MLRxCUI 1801835
Look up RxCUI 1801820 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Lifitegrast Ophthalmic is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Lifitegrast Ophthalmic belongs to the Lymphocyte Function-Associated Antigen-1 Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 3 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Bausch & Lomb Incorporated is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.