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Lifitegrast (Xiidra): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
50 mg/mL
Brand names:
Active ingredient:

Patient information: uses, side effects, how to take - Lifitegrast

What is lifitegrast ophthalmic solution?

Lifitegrast ophthalmic solution is a prescription eye drop solution used to treat the signs and symptoms of dry eye disease (DED). It is not known if lifitegrast ophthalmic solution is safe and effective in children under 17 years of age.

Do not use lifitegrast ophthalmic solution:

  • If you are allergic to lifitegrast or any of the other ingredients in lifitegrast ophthalmic solution, see "What are the ingredients in lifitegrast ophthalmic solution?"

Before you use lifitegrast ophthalmic solution, tell your doctor if you:

  • are using any other eye drops
  • wear contact lenses
  • are pregnant or plan to become pregnant. It is not known if lifitegrast ophthalmic solution will harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if lifitegrast ophthalmic solution passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use lifitegrast ophthalmic solution.

How should I use lifitegrast ophthalmic solution?

See the complete Instructions for Use at the end of this Patient Information leaflet for detailed instructions about the right way to use lifitegrast ophthalmic solution.

  • Use lifitegrast ophthalmic solution as your doctor tells you.
  • Use one drop of lifitegrast ophthalmic solution in each eye, two times each day, about 12 hours apart.
  • Use lifitegrast ophthalmic solution right away after opening. Throw away the single-dose container and any unused solution after you have applied the dose to both eyes. Do not save any unused lifitegrast ophthalmic solution for later.

What are the possible side effects of lifitegrast ophthalmic solution?

The most common side effects of lifitegrast ophthalmic solution include eye irritation, discomfort, or blurred vision when the drops are applied to the eyes, and an unusual taste sensation (dysgeusia).

Seek medical care immediately if you get any symptoms of wheezing, difficulty breathing, or swollen tongue.

These are not all the possible side effects of lifitegrast ophthalmic solution.

Tell your doctor if you have any side effects that bother you. You may report side effects to FDA at 1-800-FDA-1088.

How should I store lifitegrast ophthalmic solution?

  • Store lifitegrast ophthalmic solution at room temperature between 20°C to 25°C (68°F to 77°F).
  • Store lifitegrast ophthalmic solution in the original foil pouch to protect it from light.
  • Do not open the lifitegrast ophthalmic solution foil pouch until you are ready to use the eye drops.
  • Return unused single-dose containers to their original foil pouch to protect from excessive light exposure.

Keep lifitegrast ophthalmic solution and all medicines out of the reach of children.

General information about the safe and effective use of lifitegrast ophthalmic solution.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or doctor for information about lifitegrast ophthalmic solution that is written for health professionals. Do not use lifitegrast ophthalmic solution for a condition for which it was not prescribed. Do not give lifitegrast ophthalmic solution to other people, even if they have the same symptoms you have. It may harm them.

What are the ingredients in lifitegrast ophthalmic solution?

Active ingredient: lifitegrast

Inactive ingredients: sodium chloride, dibasic sodium phosphate anhydrous, sodium thiosulfate pentahydrate, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection.

For more information, go to www.aurobindousa.com or call 1-866-850-2876.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Dispense with Patient Information and Instructions for Use available at: https://www.aurobindousa.com/medication-guides/

Distributed by:

Aurobindo Pharma USA, Inc.

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Manufactured by:

Eugia Pharma Specialities Limited

Hyderabad - 500032

India

Revised: September 2023

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 215063 · View the label on DailyMed

Revision date stated in the text: September 2023

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Lifitegrast

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Lymphocyte Function-Associated Antigen-1 Antagonist
Active ingredient Lifitegrast 50 mg/mL
Dosage form For solution
Route Ophthalmic
Marketing status listed in the FDA NDC Directory
Company (applicant) EUGIA PHARMA
FDA approval ANDA 215063Abbreviated New Drug Application (ANDA) – generic drug Approved November 7, 2023
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
50 mg/mL – 0.2 ml in 1 ampule / 5 in 1 pouch / 60 in 1 carton NDC 59651-450-05

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.