FDA Adverse Events Reports (FAERS) Summary for BOTOX COSMETIC

These tables and charts are based on 38,692 total reports for BOTOX COSMETIC (ONABOTULINUMTOXINA) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 38,639 pharmaceutical company-submitted and non-U.S. FAERS reports and 53 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 53 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch BOTOX COSMETIC summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	20281
2	OFF LABEL USE	5733
3	THERAPEUTIC RESPONSE DECREASED	3690
4	PRODUCT PREPARATION ERROR	3261
5	MULTIPLE USE OF SINGLE-USE PRODUCT	2610
6	INJECTION SITE PAIN	2041
7	DROOPY EYELID	1902
8	WRONG TECHNIQUE IN DRUG USAGE PROCESS	1462
9	HEADACHE	1444
10	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	1265
11	INJECTION SITE SWELLING	728
12	FACIAL SWELLING	640
13	FACIAL PARESIS	635
14	VISION BLURRED	618
15	PRODUCT PREPARATION ISSUE	580
16	DIZZINESS	577
17	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	562
18	THERAPEUTIC RESPONSE SHORTENED	500
19	NAUSEA	485
20	PRODUCT STORAGE ERROR	455
21	PRODUCT QUALITY ISSUE	429
22	POOR QUALITY PRODUCT ADMINISTERED	420
23	INJECTION SITE REDNESS	404
24	EYE SWELLING	399
25	DIFFICULTY SWALLOWING	378
26	RASH	376
27	SHORTNESS OF BREATH	372
28	FATIGUE	371
29	PAIN	364
30	NUMBNESS	352
31	SKIN REDNESS	342
32	ANXIETY	323
33	INFLUENZA LIKE ILLNESS	319
34	INJECTION SITE RASH	310
35	BROW PTOSIS	298
36	EYELID OEDEMA	298
37	MUSCULAR WEAKNESS	298
38	PINS AND NEEDLES	297
39	ITCHING	291
40	HIVES	291
41	HYPERSENSITIVITY	269
42	DRUG EFFECT INCOMPLETE	266
43	INCORRECT DOSE ADMINISTERED	240
44	BURNING SENSATION	236
45	BRUISE	235
46	INJECTION SITE BRUISING	232
47	DOUBLE VISION	225
48	SWELLING	216
49	LACK OF STRENGTH AND ENERGY (ASTHENIA)	213
50	SKIN TIGHTNESS	211
51	FEELING ABNORMAL	207
52	SKIN WRINKLING	204
53	DRY EYE	200
54	MALAISE	194
55	NECK PAIN	181
56	THERAPEUTIC PRODUCT EFFECT DECREASED	180
57	VISUAL IMPAIRMENT	179
58	INJECTION SITE MASS	172
59	MIGRAINE	166
60	INJECTION SITE ITCHING	164
61	MUSCLE SPASMS	163
62	EYE PAIN	162
63	VOMITING	157
64	FEVER	155
65	DRY MOUTH	150
66	PALPITATIONS	142
67	WATERING EYES	139
68	FACIAL PAIN	137
69	POOR QUALITY DRUG ADMINISTERED	135
70	SPEECH DISORDER	134
71	SKIN DISORDER	132
72	INJECTION SITE URTICARIA	130
73	EYE RED	130
74	FACIAL ASYMMETRY	129
75	MUSCLE TWITCHING	127
76	VERTIGO	127
77	DIARRHEA	122
78	EYELID SWELLING	122
79	INSOMNIA	121
80	HOARSE VOICE	117
81	INJECTION SITE REACTION	112
82	LIP SWELLING	111
83	FACIAL PARALYSIS	105
84	LACK OF DRUG EFFECT	102
85	NUMBNESS IN THE MOUTH	101
86	PERIORBITAL OEDEMA	98
87	MUSCLE PAIN	97
88	MUSCULOSKELETAL STIFFNESS	96
89	SWELLING OF EYELID	96
90	EYE IRRITATION	95
91	THROAT TIGHTNESS	92
92	THROAT PAIN	91
93	DISCOMFORT	90
94	HEAD DISCOMFORT	89
95	TREMOR	89
96	ACCIDENTAL EXPOSURE TO PRODUCT	88
97	DRUG HYPERSENSITIVITY	88
98	RINGING IN THE EARS	88
99	INFLUENZA	85
100	WEIGHT DECREASED	85

Latest Known Outcomes for Reactions Reported for BOTOX COSMETIC

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	27044
2	Patient has not recovered/symtoms have not resolved	3475
3	Patient recovered	3134
4	Patient is recovering/symptoms resolving	1103
5	Patient has recovered but has consequent health issues	29
6	Patient died	20

Search all MedWatch and FAERS by keyword:

BOTOX COSMETIC Total Reports

Male	Female	Unknown	Total
2211	29911	6570	38,692

Top Countries Reporting

	Country	Number of Reports
1	United States	30265
2	Canada	68
3	United Kingdom	4
4	Ireland	3
5	Puerto Rico	3
6	South Africa	3
7	Australia	2
8	Colombia	1
9	EU	1
10	France	1

Outcomes for Reports

Serious: 1062
Not Serious: 37630
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

Skin wrinkling
Product used for unknown indication
Skin cosmetic procedure
Face lift
Lip cosmetic procedure

Top Companies Reporting

ABBVIE

Safety-Related FDA Updates

BOTOX COSMETIC (OnabotulinumtoxinA) Biological Drug:
Public Citizen petitioned the FDA urging that the warning on the labeling of Botox and related drugs be strengthened to make it clear that the drugs are associated with systemic iatrogenic botulism Safety-related Labeling Changes

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

BOTOX COSMETIC (OnabotulinumtoxinA) Biological Drug:
Adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction; Cases of dry eye have been reported when the injection is in or near the orbicularis oculi muscle Safety-related Labeling Changes

Have experience (good or bad) with BOTOX COSMETIC? Rate BOTOX COSMETIC 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 BOTOX COSMETIC 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.