MID-VOLUME · FEMALE-LED

lifitegrast Side Effects

lifitegrast (also sold as Xiidra) sits MID-VOLUME #265 of 524 by FAERS report count. Lead signal: FEMALE-LED - 83% of sex-coded reports are female (11,783 F / 2,442 M). Demographics and serious-outcome tables follow.

Data updated 2026-05-15

15,783
FAERS reports

FDA Adverse Event Reporting System extract for lifitegrast. Stamp set WATCHLIST · DEATH-MARKED · HOSP-LIGHT. How figures are compiled.

lifitegrast reporting skew - 83% of sex-coded reports are female (11,783 F / 2,442 M). Volume band MID-VOLUME #265 of 524 by FAERS report count; caseload WATCHLIST.

Mid-book FAERS page for lifitegrast (Xiidra) (15,783 reports). Signature FEMALE-LED. Dominant age band on file: 45-64. Educational reference only.

Counts from the openFDA FAERS extract (2015–2025). Stamps WATCHLIST · DEATH-MARKED · HOSP-LIGHT · FEMALE-LED.

EYE IRRITATION leads 2,649 of 15,783 reports

EYE IRRITATION
2,649
VISION BLURRED
2,566
EYE PAIN
1,386
INSTILLATION SITE PAIN
1,281
DRY EYE
1,131
DYSGEUSIA
1,088
INSTILLATION SITE REACTION
1,019
OCULAR HYPERAEMIA
663
HEADACHE
602
LACRIMATION INCREASED
601
VISUAL IMPAIRMENT
565
EYE PRURITUS
423
EYE DISCHARGE
380
HYPERSENSITIVITY
368
PRODUCT QUALITY ISSUE
360
PRODUCT USE COMPLAINT
356
PAIN
330
EYE DISORDER
322

FEMALE-LED reporters · age peak 45-64

Female-led reporters (83% of sex-coded rows)

Female 11,783 (83%)
Male 2,442 (17%)
Unknown 3

Age peak 45-64 (1,693 reports)

0-17 40 (1%)
18-44 544 (11%)
45-64 1,693 (35%)
65-74 1,344 (28%)
75+ 1,231 (25%)

FAERS filings rising toward 2025

15
16
17
18
19
20
21
22
23
24
25

Reactions in Death Reports

Death appears on 283 reports (1.8% - MARKED). Reactions below co-occur in those rows only.

Reaction Reports
DEATH 252
FALL 5
HEADACHE 4
PNEUMONIA 4
ARTHRALGIA 3
BREAST CANCER 3
BREAST CANCER METASTATIC 3
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 3
SPEECH DISORDER 3
ACUTE KIDNEY INJURY 2
CARDIAC FAILURE CONGESTIVE 2
CEREBROVASCULAR ACCIDENT 2
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 2
DIABETES MELLITUS 2
DIARRHOEA 2
DYSPHAGIA 2
EYE PAIN 2
HEPATIC FAILURE 2

Reactions in Hospitalization Reports

Hospitalization is lighter here (615). Reactions in that subset:

Reaction Reports
PNEUMONIA 90
FALL 62
FEELING ABNORMAL 51
ARTHRITIS 50
PLATELET COUNT DECREASED 47
BLOOD FOLATE DECREASED 43
HEADACHE 40
HOSPITALISATION 40
DYSPNOEA 38
COVID-19 36
MALAISE 36
WHITE BLOOD CELL COUNT DECREASED 36
PAIN 32
DIZZINESS 30
NAUSEA 27
VISION BLURRED 27
DIARRHOEA 25
How to read lifitegrast FAERS figures (WATCHLIST · DEATH-MARKED · HOSP-LIGHT)

FAERS holds 15,783 voluntary reports linked to lifitegrast (Xiidra), 2015-2025. Death is listed on 283 (1.8%). Hospitalization appears on 615 (3.9%). Top co-reported indication: Product Used For Unknown Indication.

Mid-volume extract - treat DEATH-MARKED · HOSP-LIGHT as signal-detection rates next to 83% of sex-coded reports are female (11,783 F / 2,442 M).

Read with lifitegrast

Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-LIGHT stamps.