FDA Adverse Events Reports (FAERS) Summary for LOTEMAX

These tables and charts are based on 3,973 total reports for LOTEMAX (LOTEPREDNOL ETABONATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 3,777 pharmaceutical company-submitted and non-U.S. FAERS reports and 196 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 196 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch LOTEMAX summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	EYE PAIN	487
2	EYE IRRITATION	434
3	OFF LABEL USE	351
4	VISION BLURRED	339
5	DRUG INEFFECTIVE	293
6	EYE RED	256
7	HEADACHE	198
8	FATIGUE	178
9	DRY EYE	167
10	NAUSEA	160
11	PAIN	158
12	PRODUCT USE IN UNAPPROVED INDICATION	153
13	VISUAL IMPAIRMENT	145
14	WATERING EYES	135
15	DIZZINESS	128
16	CONDITION AGGRAVATED	125
17	ITCHY EYES	120
18	EYE SWELLING	117
19	SHORTNESS OF BREATH	114
20	RASH	113
21	SENSITIVITY TO LIGHT	107
22	FOREIGN BODY SENSATION IN EYES	106
23	DIARRHEA	105
24	PRODUCT DOSE OMISSION ISSUE	103
25	INTRAOCULAR PRESSURE INCREASED	98
26	CATARACT	88
27	EYE DISCOMFORT	86
28	JOINT PAIN	84
29	ANXIETY	82
30	LACK OF STRENGTH AND ENERGY (ASTHENIA)	82
31	INSOMNIA	82
32	ITCHING	82
33	FALL	81
34	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	79
35	EYE DISCHARGE	76
36	MALAISE	74
37	CHRONIC KIDNEY DISEASE	73
38	EYE INFLAMMATION	71
39	PRODUCT QUALITY ISSUE	71
40	BACK PAIN	64
41	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	64
42	COMMON COLD	64
43	VOMITING	64
44	DEATH	63
45	HYPERSENSITIVITY	63
46	WEIGHT DECREASED	63
47	DRUG HYPERSENSITIVITY	62
48	EYE DISORDER	62
49	KIDNEY FAILURE	61
50	BLOOD PRESSURE INCREASED	60
51	HIGH BLOOD PRESSURE	60
52	PAIN IN EXTREMITY	59
53	PNEUMONIA	59
54	COUGH	58
55	VISUAL ACUITY REDUCED	57
56	SKIN REDNESS	56
57	PRODUCT USE ISSUE	55
58	DEPRESSION	54
59	URINARY TRACT INFECTION	52
60	GLAUCOMA	51
61	ACUTE KIDNEY INJURY	49
62	HAIR LOSS	49
63	FEELING ABNORMAL	49
64	INTENTIONAL PRODUCT USE ISSUE	49
65	SINUSITIS	48
66	DECREASED APPETITE	47
67	MUSCLE SPASMS	47
68	THROAT PAIN	46
69	THERAPY INTERRUPTED	45
70	EYELID PAIN	43
71	CONSTIPATION	42
72	WEIGHT INCREASED	42
73	DRUG DOSE OMISSION	41
74	BURNING SENSATION	40
75	EYE INFECTION	40
76	ANEMIA	39
77	CHEST PAIN	39
78	INJECTION SITE PAIN	39
79	DROWSINESS	39
80	FEVER	38
81	ABDOMINAL PAIN UPPER	37
82	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	37
83	NUMBNESS	37
84	INFECTION	37
85	HIVES	37
86	METALLIC OR ALTERED TASTE	36
87	PINS AND NEEDLES	36
88	CONJUNCTIVITIS	35
89	INCORRECT DOSE ADMINISTERED	35
90	RUNNY NOSE	35
91	BALANCE DISORDER	33
92	GASTROOESOPHAGEAL REFLUX DISEASE	33
93	INSTILLATION SITE PAIN	33
94	PRODUCT PRESCRIBING ERROR	33
95	EMOTIONAL DISTRESS	32
96	GAIT DISTURBANCE	32
97	PRODUCT PHYSICAL CONSISTENCY ISSUE	32
98	ABDOMINAL DISCOMFORT	31
99	BLOOD GLUCOSE INCREASED	31
100	EYELID OEDEMA	31

Latest Known Outcomes for Reactions Reported for LOTEMAX

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	2373
2	Patient has not recovered/symtoms have not resolved	1236
3	Patient recovered	838
4	Patient is recovering/symptoms resolving	389
5	Patient died	83
6	Patient has recovered but has consequent health issues	17

Search all MedWatch and FAERS by keyword:

LOTEMAX Total Reports

Male	Female	Unknown	Total
935	2871	167	3,973

Top Countries Reporting

	Country	Number of Reports
1	United States	3269
2	Canada	133
3	United Kingdom	20
4	Poland	19
5	Turkey	8
6	China	7
7	United Arab Emirates	5
8	South Korea	5
9	South Africa	5
10	Germany	4

Outcomes for Reports

Serious: 1406
Not Serious: 2566
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

Conjunctivitis allergic

Top Companies Reporting

BAUSCH AND LOMB

Safety-Related FDA Updates

FDA Approval Date: 1998-03-09

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 LOTEMAX 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.