This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.
Botox is the brand name for onabotulinumtoxina, a neuromuscular blocker. According to the FDA-approved 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 anticholine. FAERS contains 76,730 submissions naming this drug from 2004 through 2026; the top three reactions cited are drug ineffective, off label use, and therapeutic response decreased.
Most-Reported Reactions
Counts of the reactions most often cited in FAERS submissions that named Botox. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.
Patient Demographics
Patient sex and age across the FAERS submissions that named Botox. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.
By Sex
By Age Group
Severity Outcomes
Severity flags recorded across the 76,730 FAERS submissions that named Botox. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.
Submissions Per Quarter
Quarterly count of FAERS submissions that named Botox. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.
From the FDA-Approved Label
Excerpts from the official FDA-approved prescribing information for Botox. This is the authoritative source on indications, warnings, and known adverse reactions.
Indications
1 INDICATIONS AND USAGE 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 response to or are intolerant of an anticholinergic medication ( 1.1 ) Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. ( 1.2 ) Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer) ( 1.3 ) Treatment of spasticity in patients 2 years of age and older ( 1.4 ) Treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain ( 1. (continues in label)
Adverse Reactions (from label)
6 ADVERSE REACTIONS The following adverse reactions to BOTOX (onabotulinumtoxinA) for injection are discussed in greater detail in other sections of the labeling: Spread of Toxin Effects [see Warnings and Precautions ( 5.1 )] Serious Adverse Reactions with Unapproved Use [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Contraindications ( 4 ) a nd Warnings and Precautions ( 5.4 )] Increased Risk of Clinically Significant Effects with Pre-Existing Neuromuscular Disorders [see Warnings and Precautions ( 5.5 )] Dysphagia and Breathing Difficulties [see Warnings and Precautions ( 5.6 )] Pulmonary Effects of BOTOX in Patients with Compromised Respiratory Status Treated for Spasticity or for Detrusor Overactivity Associated with a Neurologic Condition [see Warnings and Precautions ( 5.7 )] Corneal Exposure and Ulceration in Patients Treated with BOTOX for Blepharospasm [see Warnings and Precautions ( 5.8 )] Retrobulbar Hemorrhages in Patients Treated with BOTOX for Strabismus [see Warnings and Precautions ( 5.9 )] Bronchitis and Upper Respiratory Tract Infections in Patients Treated for Spasticity [se e Warnings and Precautions ( 5. (continues in label)
AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.
