FDA label
What is Botox used for?
Botox contains botulinum toxin type a. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Botox lists 7 uses: Adult Bladder Dysfunction; Pediatric Detrusor Overactivity A ssociated with a Neurologic Condition; . 3 Chronic Migraine; . 4 Spasticity; and 3 more.
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Indications and Usage, quoted from the label by Sportpharm LLC (BLA103000). Cross-references to other label sections are left out.
Adult Bladder Dysfunction
Overactive Bladder
BOTOX for injection is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Detrusor Overactivity associated with a Neurologic Condition
BOTOX is indicated for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., SCI, MS) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Pediatric Detrusor Overactivity A ssociated with a Neurologic Condition
BOTOX is indicated for the 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.
. 3 Chronic Migraine
BOTOX is indicated for the prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer).
Limitations of Use
Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in seven placebo-controlled studies.
. 4 Spasticity
BOTOX is indicated for the treatment of spasticity in patients 2 years of age and older.
Limitations of Use
BOTOX has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture.
. 5 Cervical Dystonia
BOTOX is indicated for the treatment of adults with cervical dystonia, to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.
. 6 Primary Axillary Hyperhidrosis
BOTOX is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
Limitations of Use The safety and effectiveness of BOTOX for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive BOTOX for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.
Safety and effectiveness of BOTOX have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18.
. 7 Blepharospasm and Strabismus
BOTOX is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and older.
Source: DailyMed label, set id a6f42753-d31e-4b23-8da0-4b990fee4b38, version 1, effective February 2, 2026. NDC 85766-155, one of 3 listings for this product.
Questions
What is Botox used for?
The FDA label for Botox lists 7 uses: Adult Bladder Dysfunction; Pediatric Detrusor Overactivity A ssociated with a Neurologic Condition; . 3 Chronic Migraine; . 4 Spasticity; and 3 more.
What drug class is Botox?
FDA lists botulinum toxin type a in the Acetylcholine Release Inhibitor and Neuromuscular Blocker established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.