Botox Cosmeticonabotulinumtoxina
According to the FDA label: BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication ( 1.1 ) Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate…
38,867 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Botox Cosmetic in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 20,319 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Off Label Use 5,780 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Therapeutic Response Decreased 3,691 reports
A report that a treatment seemed to work less well than before. Similar to drug ineffective and therapeutic product effect decreased.
Full definition in the glossary →- Product Preparation Error 3,261 reports
- Multiple Use Of Single-use Product 2,610 reports
Injection Site Pain 2,043 reports
Pain at the spot on the body where a medication was injected.
Full definition in the glossary →- Eyelid Ptosis 1,905 reports
- Wrong Technique In Drug Usage Process 1,462 reports
Headache 1,455 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Wrong Technique in Product Usage Process 1,265 reports
A report that the medication was used or administered with the wrong technique, such as an incorrect injection or inhaler method. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Injection Site Swelling 728 reports
Swelling at the spot where a medication was injected.
Full definition in the glossary →Swelling Face 641 reports
Swelling of the face, which can have many causes including allergic reactions.
Full definition in the glossary →- Facial Paresis 635 reports
Vision Blurred 622 reports
A loss of sharpness in vision, making things look out of focus.
Full definition in the glossary → See all drugs reporting this event →Dizziness 580 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
By Age Group
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Botox Cosmetic. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 37,686 |
| Other Serious | 938 |
| Hospitalization | 296 |
| Disability | 68 |
| Death | 29 |
| Life-Threatening | 24 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Botox Cosmetic. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 9 |
| 2005 | 22 |
| 2006 | 17 |
| 2007 | 25 |
| 2008 | 100 |
| 2009 | 43 |
| 2010 | 4,016 |
| 2011 | 1,280 |
| 2012 | 2,448 |
| 2013 | 2,257 |
| 2014 | 1,926 |
| 2015 | 2,052 |
| 2016 | 3,082 |
| 2017 | 2,331 |
| 2018 | 2,350 |
| 2019 | 2,418 |
| 2020 | 2,245 |
| 2021 | 3,268 |
| 2022 | 2,627 |
| 2023 | 3,043 |
| 2024 | 1,599 |
| 2025 | 1,376 |
| 2026 (partial) | 333 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026