Yes — dry eye has been reported as a side effect of Lifitegrast in FDA adverse-event reports (FAERS) and product labeling. It is among the more frequently reported events for this medication. These are voluntary reports, so they show what's been reported, not how often it happens.
Reported adverse reactions
ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity [see Contraindications (4) ] The most common adverse reactions (incidence 5% to 25%) following the use of lifitegrast were instillation-site irritation, dysgeusia and decreased visual acuity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc., at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov./medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In five clinical trials of DED conducted with lifitegrast ophthalmic solution, 1401 patients received at least one dose of lifitegrast (1287 of which received lifitegrast 5%). The majority of patients (84%) had less than or equal to 3 months of treatment exposure. One hundred-seventy patients were exposed to lifitegrast for approximately 12 months. The majority of the treated patients were female (77%). The most common adverse reactions reported in 5% to 25% of patients were instillation-site irritation, dysgeusia, and reduced visual acuity. Other adverse reactions reported in 1% to 5% of the patients were blurred vision, conjunctival hyperemia, eye irritation, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus, and sinusitis. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of lifitegrast. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Rare serious cases of hypersensitivity, including anaphylactic reaction, bronchospasm, respiratory distress, pharyngeal edema, swollen tongue, urticaria, allergic conjunctivitis, dyspnea, angioedema, and allergic dermatitis have been reported. Eye swelling and rash have also been reported [see Contraindications (4) ].
Yes — dry eye has been reported as a side effect of Lifitegrast in FDA adverse-event reports (FAERS) and/or its labeling. These are voluntary reports, so they show what's been reported, not how often it happens.
How common is dry eye with Lifitegrast?
dry eye is among the more frequently reported events for Lifitegrast in FAERS. Reporting volume isn't a true incidence rate — check the prescribing information for documented frequencies.
What should I do if I have dry eye while taking Lifitegrast?
Don't stop a prescribed medication on your own. Tell your prescriber or pharmacist — they can tell you whether it's expected, whether it needs attention, and what to do next.
Informational only, drawn from FDA adverse-event reporting (FAERS) and labeling — not medical advice, and not proof a medication caused an effect. Talk to your clinician or pharmacist about any side effect.
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