LIFITEGRAST

N/A

Manufactured by Bausch & Lomb Incorporated

29,776 FDA adverse event reports analyzed

Last updated: 2026-04-14

About LIFITEGRAST

LIFITEGRAST is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch & Lomb Incorporated. The most commonly reported adverse reactions for LIFITEGRAST include EYE IRRITATION, VISION BLURRED, DRUG INEFFECTIVE, EYE PAIN, INSTILLATION SITE PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LIFITEGRAST.

Top Adverse Reactions

EYE IRRITATION2,649 reports
VISION BLURRED2,566 reports
DRUG INEFFECTIVE1,536 reports
EYE PAIN1,386 reports
INSTILLATION SITE PAIN1,281 reports
DRY EYE1,131 reports
DYSGEUSIA1,088 reports
INSTILLATION SITE REACTION1,019 reports
OCULAR HYPERAEMIA663 reports
HEADACHE602 reports
LACRIMATION INCREASED601 reports
VISUAL IMPAIRMENT565 reports
PRODUCT DOSE OMISSION ISSUE435 reports
EYE PRURITUS423 reports
EYE DISCHARGE380 reports
HYPERSENSITIVITY368 reports
PRODUCT QUALITY ISSUE360 reports
PRODUCT USE COMPLAINT356 reports
PAIN330 reports
EYE DISORDER322 reports
OFF LABEL USE313 reports
NAUSEA289 reports
BURNING SENSATION270 reports
EYE SWELLING266 reports
DIZZINESS261 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS259 reports
CONDITION AGGRAVATED258 reports
PRODUCT CONTAINER ISSUE256 reports
DEATH252 reports
INSTILLATION SITE IRRITATION245 reports
OCULAR DISCOMFORT244 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION235 reports
FATIGUE219 reports
OVERDOSE215 reports
INSTILLATION SITE ERYTHEMA210 reports
PRURITUS202 reports
INCORRECT DOSE ADMINISTERED201 reports
PRODUCT USE ISSUE199 reports
MALAISE198 reports
FEELING ABNORMAL197 reports
SINUSITIS196 reports
TASTE DISORDER195 reports
INSTILLATION SITE PRURITUS188 reports
INSTILLATION SITE LACRIMATION179 reports
PHOTOPHOBIA177 reports
RASH177 reports
FOREIGN BODY SENSATION IN EYES173 reports
DYSPNOEA170 reports
PRODUCT PACKAGING QUANTITY ISSUE159 reports
COVID 19157 reports
DIARRHOEA156 reports
DRUG HYPERSENSITIVITY154 reports
ARTHRITIS152 reports
FALL152 reports
ACCIDENTAL EXPOSURE TO PRODUCT151 reports
COUGH142 reports
PNEUMONIA134 reports
ILLNESS132 reports
CATARACT128 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION127 reports
PRODUCT DOSE OMISSION125 reports
EYELID MARGIN CRUSTING124 reports
OROPHARYNGEAL PAIN124 reports
ANXIETY118 reports
INSTILLATION SITE DISCHARGE118 reports
BLINDNESS116 reports
HYPOACUSIS111 reports
INSOMNIA111 reports
THROAT IRRITATION110 reports
DRY MOUTH108 reports
DRUG INTOLERANCE106 reports
NASOPHARYNGITIS106 reports
RHINORRHOEA106 reports
PRODUCT DELIVERY MECHANISM ISSUE105 reports
PRODUCT STORAGE ERROR103 reports
ARTHRALGIA102 reports
ERYTHEMA101 reports
ABDOMINAL DISCOMFORT99 reports
NO ADVERSE EVENT99 reports
EYE INFECTION96 reports
PAIN IN EXTREMITY94 reports
MIGRAINE90 reports
BLOOD PRESSURE INCREASED87 reports
DISCOMFORT80 reports
PRODUCT USE IN UNAPPROVED INDICATION80 reports
URTICARIA80 reports
SWELLING OF EYELID79 reports
EYE INFLAMMATION78 reports
PRODUCT TASTE ABNORMAL77 reports
EXPIRED PRODUCT ADMINISTERED76 reports
INSTILLATION SITE SWELLING76 reports
INTENTIONAL PRODUCT USE ISSUE74 reports
EPISTAXIS73 reports
ILL DEFINED DISORDER72 reports
PRODUCT AFTER TASTE71 reports
SINUS DISORDER71 reports
VISUAL ACUITY REDUCED71 reports
VOMITING71 reports
GASTROOESOPHAGEAL REFLUX DISEASE70 reports
DRUG DOSE OMISSION69 reports

Report Outcomes

Out of 15,781 classified reports for LIFITEGRAST:

Serious 17.7%Non-Serious 82.3%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female11,783 (82.8%)
Male2,442 (17.2%)
Unknown3 (0.0%)

Reports by Age

Age 70152 reports
Age 71150 reports
Age 66148 reports
Age 61145 reports
Age 63140 reports
Age 68140 reports
Age 72138 reports
Age 74138 reports
Age 64133 reports
Age 67130 reports
Age 69126 reports
Age 65125 reports
Age 58123 reports
Age 60122 reports
Age 75120 reports
Age 76117 reports
Age 62111 reports
Age 80106 reports
Age 81104 reports
Age 77101 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with LIFITEGRAST?

This profile reflects 29,776 FDA FAERS reports that mention LIFITEGRAST. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LIFITEGRAST?

Frequently reported terms in FAERS include EYE IRRITATION, VISION BLURRED, DRUG INEFFECTIVE, EYE PAIN, INSTILLATION SITE PAIN, DRY EYE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures LIFITEGRAST?

Labeling and FAERS entries often list Bausch & Lomb Incorporated in connection with LIFITEGRAST. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.