Drug

Lotilaner Ophthalmic Solution

68 flagged reaction(s) · 3,888 total co-reports · max PRR 49.4

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Eye Irritation	404	49.4	56.7	signal
2	Eye Discharge	68	45.3	46.3	signal
3	Product Prescribing Issue	123	41.2	42.8	signal
4	Ocular Hyperaemia	266	38.8	42.3	signal
5	Eye Pruritus	172	35.5	37.5	signal
6	Ocular Discomfort	55	34.4	35.1	signal
7	Eye Pain	227	27.9	30.1	signal
8	Lacrimation Increased	116	26.4	27.4	signal
9	Eye Swelling	107	19.6	20.3	signal
10	Exposure Via Skin Contact	60	18.0	18.3	signal
11	Photophobia	49	17.8	18.1	signal
12	Therapy Interrupted	178	17.5	18.5	signal
13	Product Use Complaint	33	14.4	14.6	signal
14	Madarosis	23	13.3	13.4	signal
15	Eye Inflammation	18	12.9	13.0	signal
16	Dry Eye	90	12.6	12.9	signal
17	Vision Blurred	232	11.5	12.4	signal
18	Product Packaging Quantity Issue	16	9.9	10.0	signal
19	Device Breakage	54	9.3	9.5	signal
20	Eye Infection	15	9.1	9.1	signal
21	Product Use Issue	230	8.3	8.9	signal
22	Extra Dose Administered	45	7.6	7.7	signal
23	Wrong Technique In Product Usage Process	193	6.5	6.8	signal
24	Therapy Cessation	43	5.7	5.8	signal
25	Vitreous Floaters	8	5.6	5.6	signal
26	Therapeutic Response Decreased	48	5.4	5.5	signal
27	Accidental Exposure To Product	78	5.3	5.4	signal
28	Paraesthesia Oral	11	5.2	5.2	signal
29	Product Packaging Issue	7	5.1	5.1	signal
30	Eye Haemorrhage	10	5.1	5.1	signal
31	Product Storage Error	62	4.9	4.9	signal
32	Conjunctivitis	13	4.8	4.8	signal
33	Dermatitis Contact	8	4.8	4.8	signal
34	Condition Aggravated	212	4.8	5.0	signal
35	Therapeutic Product Effect Incomplete	46	4.4	4.5	signal
36	Burning Sensation	41	4.0	4.0	signal
37	Therapy Non-responder	26	3.9	4.0	signal
38	Diplopia	15	3.9	3.9	signal
39	Brain Fog	8	3.7	3.7	signal
40	Photosensitivity Reaction	9	3.7	3.7	signal
41	Device Delivery System Issue	14	3.6	3.6	signal
42	Hypoaesthesia Oral	8	3.6	3.6	signal
43	Visual Impairment	64	3.5	3.6	signal
44	Drug Hypersensitivity	101	3.5	3.6	signal
45	Eye Disorder	17	3.5	3.5	signal
46	Inability To Afford Medication	5	3.4	3.4	signal
47	Oral Discomfort	7	3.4	3.4	signal
48	Intentional Dose Omission	13	3.2	3.2	signal
49	Swelling Face	30	3.1	3.1	signal
50	Product Physical Issue	9	3.1	3.1	signal
51	Dermatitis	9	2.9	2.9	signal
52	Pharyngeal Swelling	4	2.8	2.8	no signal
53	Swollen Tongue	12	2.6	2.6	signal
54	Device Leakage	16	2.6	2.6	signal
55	Product Dose Omission In Error	10	2.5	2.5	signal
56	Lip Swelling	12	2.4	2.5	signal
57	Eyelid Oedema	4	2.3	2.3	no signal
58	Inappropriate Schedule Of Product Administration	56	2.1	2.2	signal
59	Skin Irritation	12	1.8	1.8	no signal
60	Intraocular Pressure Increased	3	1.6	1.6	no signal
61	Skin Burning Sensation	15	1.4	1.4	no signal
62	Device Issue	18	1.4	1.4	no signal
63	Device Difficult To Use	12	1.2	1.2	no signal
64	Drug Effective For Unapproved Indication	5	1.2	1.2	no signal
65	Product Administered At Inappropriate Site	3	1.1	1.1	no signal
66	Incorrect Dose Administered By Device	4	1.1	1.1	no signal
67	Injection Site Urticaria	3	0.8	0.8	no signal
68	Product Complaint	3	0.8	0.8	no signal