FDA Adverse Events Reports (FAERS) Summary for LATISSE

These tables and charts are based on 10,842 total reports for LATISSE (BIMATOPROST) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 10,758 pharmaceutical company-submitted and non-U.S. FAERS reports and 84 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 84 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch LATISSE summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with LATISSE (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	2651
2	LOSS OF EYELASH OR EYEBROW HAIR	1660
3	EYE RED	1589
4	ERYTHEMA OF EYELID	1106
5	EYE IRRITATION	1106
6	ITCHY EYES	1048
7	WRONG TECHNIQUE IN DRUG USAGE PROCESS	778
8	EYELIDS PRURITUS	623
9	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	592
10	EYE SWELLING	523
11	INCORRECT DOSE ADMINISTERED	520
12	EYELID OEDEMA	485
13	TRICHORRHEXIS	446
14	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	443
15	EYELID IRRITATION	418
16	SKIN HYPERPIGMENTATION	394
17	DRY EYE	380
18	SKIN REDNESS	369
19	EYE PAIN	330
20	THERAPEUTIC RESPONSE DECREASED	323
21	HYPERSENSITIVITY	319
22	BLEPHARAL PIGMENTATION	306
23	VISION BLURRED	267
24	SKIN DISCOLOURATION	253
25	EYE DISCHARGE	219
26	DRUG ADMINISTERED AT INAPPROPRIATE SITE	209
27	HAIR GROWTH ABNORMAL	207
28	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	205
29	OFF LABEL USE	201
30	ITCHING	196
31	WATERING EYES	194
32	SCLERAL HYPERAEMIA	155
33	EYELID PAIN	142
34	HEADACHE	140
35	SWELLING OF EYELID	122
36	BLEPHARITIS	119
37	HORDEOLUM	96
38	PRODUCT QUALITY ISSUE	96
39	EYE DISCOMFORT	91
40	EXPIRED PRODUCT ADMINISTERED	88
41	EYELID EXFOLIATION	85
42	BURNING SENSATION	84
43	RASH	84
44	ABNORMAL SENSATION IN EYE	83
45	FOREIGN BODY SENSATION IN EYES	82
46	VISUAL IMPAIRMENT	82
47	IRIS HYPERPIGMENTATION	81
48	SKIN IRRITATION	79
49	DRUG DOSE OMISSION	77
50	EYE INFECTION	77
51	EYE DISORDER	76
52	APPLICATION SITE REDNESS	73
53	DRUG HYPERSENSITIVITY	70
54	TRICHIASIS	69
55	ACCIDENTAL EXPOSURE TO PRODUCT	67
56	EYELID SKIN DRYNESS	67
57	DARK CIRCLES UNDER EYES	66
58	DRY SKIN	65
59	DRUG ADMINISTRATION ERROR	63
60	CONJUNCTIVITIS	61
61	EYELASH DISCOLOURATION	61
62	EYELID MARGIN CRUSTING	60
63	BLEPHAROSPASM	56
64	EYELID DISORDER	56
65	EYELID THICKENING	55
66	EYE COLOUR CHANGE	51
67	APPLICATION SITE ITCHING	50
68	EYELASH CHANGES	50
69	APPLICATION SITE PAIN	49
70	HAIR TEXTURE ABNORMAL	49
71	EYELID RASH	48
72	GROWTH OF EYELASHES	48
73	PRODUCT ADMINISTERED AT INAPPROPRIATE SITE	48
74	DROOPY EYELID	46
75	ASTHENOPIA	45
76	EYELID SENSORY DISORDER	43
77	SKIN PEELING	42
78	EXPIRED DRUG ADMINISTERED	41
79	FACIAL SWELLING	41
80	VISUAL ACUITY REDUCED	41
81	LID SULCUS DEEPENED	40
82	PRODUCT DOSE OMISSION ISSUE	40
83	PRODUCT PACKAGING QUANTITY ISSUE	40
84	SENSITIVITY TO LIGHT	39
85	ADVERSE EVENT	38
86	APPLICATION SITE DISCOLOURATION	37
87	EYE INFLAMMATION	36
88	EYELID SWELLING	36
89	SWELLING	36
90	MUSCLE TWITCHING	35
91	THERAPEUTIC PRODUCT EFFECT DECREASED	35
92	HIVES	35
93	HAIR LOSS	34
94	IRIS DISORDER	34
95	PAIN	34
96	ADVERSE DRUG REACTION	33
97	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	33
98	CATARACT	32
99	DRUG EFFECT INCREASED	31
100	ACNE	30

Latest Known Outcomes for Reactions Reported for LATISSE

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	5686
2	Patient recovered	1727
3	Patient has not recovered/symtoms have not resolved	1633
4	Patient is recovering/symptoms resolving	441
5	Patient has recovered but has consequent health issues	11
6	Patient died	3

Search all MedWatch and FAERS by keyword:

LATISSE Total Reports

Male	Female	Unknown	Total
96	10176	570	10,842

Top Countries Reporting

	Country	Number of Reports
1	United States	7378
2	Canada	13
3	Brazil	2
4	Puerto Rico	2
5	Australia	1
6	Israel	1

Outcomes for Reports

Serious: 283
Not Serious: 10559
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Product used for unknown indication
Growth of eyelashes
LOSS OF EYELASH OR EYEBROW HAIR
Hair growth abnormal
Brow ptosis

Top Companies Reporting

ABBVIE

Safety-Related FDA Updates

LATISSE ( BIMATOPROST) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with LATISSE? Rate LATISSE at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

This report, created by AskaPatient.com, is derived from the cases for LATISSE reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.