FDA Adverse Events Reports (FAERS) Summary for ALPHAGAN P

These tables and charts are based on 6,066 total reports for ALPHAGAN P (BRIMONIDINE TARTRATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 5,828 pharmaceutical company-submitted and non-U.S. FAERS reports and 238 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 238 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch ALPHAGAN P summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	417
2	EYE RED	403
3	EYE IRRITATION	380
4	EYE PAIN	318
5	INTRAOCULAR PRESSURE INCREASED	299
6	VISION BLURRED	296
7	FATIGUE	284
8	OFF LABEL USE	269
9	DIZZINESS	225
10	HEADACHE	216
11	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	215
12	SHORTNESS OF BREATH	197
13	ITCHY EYES	192
14	VISUAL IMPAIRMENT	191
15	HYPERSENSITIVITY	186
16	DIARRHEA	185
17	LACK OF STRENGTH AND ENERGY (ASTHENIA)	180
18	DEATH	166
19	GLAUCOMA	165
20	FALL	164
21	DRUG HYPERSENSITIVITY	155
22	NAUSEA	151
23	DRY EYE	146
24	CATARACT	131
25	PNEUMONIA	128
26	PAIN	126
27	RASH	126
28	CONDITION AGGRAVATED	122
29	SKIN REDNESS	122
30	MALAISE	121
31	INCORRECT DOSE ADMINISTERED	120
32	EYE SWELLING	119
33	VISUAL ACUITY REDUCED	114
34	COUGH	113
35	ITCHING	113
36	DROWSINESS	112
37	PRODUCT STORAGE ERROR	109
38	JOINT PAIN	107
39	WATERING EYES	105
40	ANEMIA	96
41	EYE DISORDER	95
42	FEVER	95
43	VOMITING	95
44	LOW BLOOD PRESSURE	93
45	PRODUCT DOSE OMISSION ISSUE	93
46	PAIN IN EXTREMITY	92
47	BLOOD PRESSURE INCREASED	89
48	HIGH BLOOD PRESSURE	89
49	CORNEAL OPACITY	88
50	ACUTE KIDNEY INJURY	86
51	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	86
52	URINARY TRACT INFECTION	86
53	ABDOMINAL PAIN	85
54	DRUG DOSE OMISSION	85
55	ACCIDENTAL EXPOSURE TO PRODUCT	84
56	DRY MOUTH	84
57	EYE DISCHARGE	82
58	BACK PAIN	81
59	CHRONIC KIDNEY DISEASE	81
60	DECREASED APPETITE	81
61	CONSTIPATION	80
62	WEIGHT DECREASED	79
63	INSOMNIA	77
64	BLINDNESS	76
65	KIDNEY FAILURE	71
66	FOREIGN BODY SENSATION IN EYES	69
67	LOWER LIMBS SWELLING	68
68	PRODUCT DOSE OMISSION	68
69	PRODUCT CONTAINER ISSUE	64
70	ATRIAL FIBRILLATION	62
71	FEELING ABNORMAL	62
72	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	62
73	DRUG INTOLERANCE	61
74	CONJUNCTIVITIS	60
75	ERYTHEMA OF EYELID	59
76	GAIT DISTURBANCE	59
77	TREATMENT FAILURE	59
78	ANXIETY	58
79	DEPRESSION	57
80	SENSITIVITY TO LIGHT	57
81	PRODUCT QUALITY ISSUE	57
82	SINUSITIS	57
83	PALPITATIONS	56
84	BLINDNESS UNILATERAL	55
85	STROKE	55
86	RUNNY NOSE	55
87	HAIR LOSS	54
88	MUSCULAR WEAKNESS	54
89	ABDOMINAL PAIN UPPER	53
90	BLOOD GLUCOSE INCREASED	53
91	NASAL CONGESTION	53
92	CONFUSIONAL STATE	52
93	DEHYDRATION	52
94	BALANCE DISORDER	51
95	CHEST PAIN	51
96	LOSS OF CONSCIOUSNESS	49
97	WEIGHT INCREASED	49
98	PRODUCT PACKAGING QUANTITY ISSUE	48
99	FAINTING	48
100	MEMORY IMPAIRMENT	47

Latest Known Outcomes for Reactions Reported for ALPHAGAN P

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	3780
2	Patient has not recovered/symtoms have not resolved	1665
3	Patient recovered	1562
4	Patient is recovering/symptoms resolving	648
5	Patient died	272
6	Patient has recovered but has consequent health issues	50

Search all MedWatch and FAERS by keyword:

ALPHAGAN P Total Reports

Male	Female	Unknown	Total
2111	3577	378	6,066

Top Countries Reporting

	Country	Number of Reports
1	United States	4641
2	Japan	301
3	Canada	154
4	France	86
5	Brazil	64
6	Germany	46
7	Australia	39
8	South Korea	28
9	Spain	25
10	United Kingdom	25

Outcomes for Reports

Serious: 2866
Not Serious: 3200
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
Intraocular pressure increased
Open angle glaucoma

Top Companies Reporting

ABBVIE

Safety-Related FDA Updates

FDA Approval Date: 2005-08-19

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 ALPHAGAN P 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.