FDA Adverse Events Reports (FAERS) Summary for COMBIGAN

These tables and charts are based on 7,068 total reports for COMBIGAN (BRIMONIDINE TARTRATE\TIMOLOL MALEATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 6,722 pharmaceutical company-submitted and non-U.S. FAERS reports and 346 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 346 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch COMBIGAN summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	EYE IRRITATION	601
2	EYE RED	588
3	EYE PAIN	515
4	FATIGUE	409
5	DRUG INEFFECTIVE	374
6	VISION BLURRED	370
7	INTRAOCULAR PRESSURE INCREASED	314
8	OFF LABEL USE	303
9	DIZZINESS	293
10	ITCHY EYES	288
11	HEADACHE	268
12	DIARRHEA	224
13	VISUAL IMPAIRMENT	217
14	FALL	209
15	WATERING EYES	204
16	LACK OF STRENGTH AND ENERGY (ASTHENIA)	203
17	DEATH	192
18	NAUSEA	184
19	SHORTNESS OF BREATH	177
20	CATARACT	170
21	GLAUCOMA	169
22	EYE SWELLING	168
23	HYPERSENSITIVITY	163
24	ACCIDENTAL EXPOSURE TO PRODUCT	160
25	DRY EYE	155
26	PAIN	145
27	ITCHING	145
28	INCORRECT DOSE ADMINISTERED	142
29	DROWSINESS	138
30	PRODUCT DOSE OMISSION ISSUE	137
31	DRY MOUTH	133
32	MALAISE	127
33	VISUAL ACUITY REDUCED	125
34	LOW BLOOD PRESSURE	123
35	WEIGHT DECREASED	118
36	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	117
37	PRODUCT STORAGE ERROR	117
38	RASH	117
39	FOREIGN BODY SENSATION IN EYES	111
40	SKIN REDNESS	110
41	COUGH	104
42	DRUG HYPERSENSITIVITY	104
43	JOINT PAIN	100
44	DECREASED APPETITE	100
45	CONSTIPATION	98
46	EYE DISCHARGE	98
47	HIGH BLOOD PRESSURE	97
48	INSOMNIA	96
49	PRODUCT CONTAINER ISSUE	96
50	PNEUMONIA	95
51	ERYTHEMA OF EYELID	92
52	PAIN IN EXTREMITY	92
53	DRUG DOSE OMISSION	90
54	MUSCULAR WEAKNESS	90
55	EYE DISORDER	87
56	FEELING ABNORMAL	85
57	PRODUCT DOSE OMISSION	85
58	BLINDNESS	82
59	GAIT DISTURBANCE	81
60	SENSITIVITY TO LIGHT	81
61	CONDITION AGGRAVATED	80
62	BLOOD PRESSURE DECREASED	78
63	CONFUSIONAL STATE	75
64	LOWER LIMBS SWELLING	74
65	URINARY TRACT INFECTION	74
66	BLINDNESS UNILATERAL	73
67	BLOOD PRESSURE INCREASED	73
68	PRODUCT QUALITY ISSUE	73
69	VOMITING	73
70	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	73
71	BACK PAIN	70
72	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	70
73	BALANCE DISORDER	66
74	EYE DISCOMFORT	66
75	PRODUCT DELIVERY MECHANISM ISSUE	65
76	EYELID OEDEMA	64
77	ABDOMINAL DISCOMFORT	63
78	ANEMIA	63
79	HEART RATE LOW (BRADYCARDIA)	63
80	DEPRESSION	63
81	CHRONIC KIDNEY DISEASE	62
82	ABDOMINAL PAIN UPPER	60
83	ACUTE KIDNEY INJURY	59
84	HEART RATE DECREASED	59
85	NO ADVERSE EVENT	59
86	ANXIETY	58
87	PRODUCT PACKAGING QUANTITY ISSUE	58
88	COMMON COLD	57
89	FAINTING	57
90	WEIGHT INCREASED	57
91	NUMBNESS	56
92	ATRIAL FIBRILLATION	55
93	EYE INFECTION	55
94	EYE INFLAMMATION	55
95	RUNNY NOSE	55
96	DRY SKIN	54
97	PINS AND NEEDLES	54
98	HAIR LOSS	53
99	BLOOD GLUCOSE INCREASED	53
100	CHEST PAIN	53

Latest Known Outcomes for Reactions Reported for COMBIGAN

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	3938
2	Patient has not recovered/symtoms have not resolved	1834
3	Patient recovered	1540
4	Patient is recovering/symptoms resolving	615
5	Patient died	272
6	Patient has recovered but has consequent health issues	40

Search all MedWatch and FAERS by keyword:

COMBIGAN Total Reports

Male	Female	Unknown	Total
2665	3970	433	7,068

Top Countries Reporting

	Country	Number of Reports
1	United States	5428
2	Canada	133
3	Brazil	84
4	France	81
5	Spain	40
6	Germany	36
7	Italy	30
8	Australia	23
9	United Kingdom	16
10	Hungary	13

Outcomes for Reports

Serious: 2834
Not Serious: 4230
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
Glaucoma
EYE DISCOMFORT
Intraocular pressure test
Intraocular pressure increased

Top Companies Reporting

ABBVIE

Safety-Related FDA Updates

FDA Approval Date: 2007-10-30

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 COMBIGAN 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.