Botox (OnabotulinumtoxinA) Monograph – Approval History, Indications, & More

Published: August 08, 2025

Botox (onabotulinumtoxinA), most commonly associated with reducing facial wrinkles, has wider uses beyond aesthetic enhancements. Botox has several FDA-approved uses, including for overactive bladder, headaches, overactivity, and more. Today we are taking a look at Botox’s many uses and exploring the drug’s approval history, appearances in guidelines, and indications.

Medication Overview:

Brand Name: Botox
Generic Name: OnabotulinumtoxinA
Treatment for: Overactive Bladder, Urinary Incontinence, Neurogenic Detrusor, Overactivity, Headaches, Spasticity, Cervical Dystonia, Severe Axillary Hyperhidrosis, Blepharospasm, Strabismus
Manufacturer: Allergan

Indicated Condition	Indication	Age	Date Approved
Overactive Bladder	For the 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.	Adults	January 2013
Urinary Incontinence	For the 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.	Adults	August 2011
Neurogenic Detrusor Overactivity	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.	Children 5 years and older	February 2021
Headaches	Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer).	Adults	October 2010
Spasticity	For the treatment of spasticity in patients 2 years of age and older.	Patients 2 years and older	May 2010 (upper limb, adults); January 2016 (lower limb); June 2019 (upper limb, pediatric); October 2019 (lower limb, pediatric); July 2020 (spasticity, pediatric)
Cervical Dystonia	For the treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain.	Adults	December 2000
Severe Axillary Hyperhidrosis	For the treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients.	Adults	July 2004
Blepharospasm	For the treatment of blepharospasm associated with dystonia in patients 12 years of age and older	Patients 12 years and older	December 1989
Strabismus	For the treatment of strabismus in patients 12 years of age and older.	Patients 12 years and older	December 1989

Warnings and Precautions:

Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur.
Potency Units of Botox are not interchangeable with other preparations of botulinum toxin products.
Potential serious adverse reactions after Botox injections for unapproved uses.
Concomitant neuromuscular disorder may exacerbate clinical effects of treatment.
Use with caution in patients with compromised respiratory function.
Corneal exposure and ulceration due to reduced blinking may occur with Botox treatment of blepharospasm.
Retrobulbar hemorrhages and compromised retinal circulation may occur with Botox treatment of strabismus.
Bronchitis and upper respiratory tract infections in patients treated for spasticity.
Urinary tract infections in patients treated for OAB.
Urinary retention: Post-void residual urine volume should be monitored in patients treated for OAB or adult detrusor overactivity associated with a neurologic condition who do not catheterize routinely, particularly patients with multiple sclerosis or diabetes mellitus.

Dosage and Administration:

Follow indication-specific dosage and administration recommendations.

In a 3 month interval, do not exceed a total dose of:
- Adults: 400 Units
- Pediatrics: the lesser of 10 Units/kg or 340 Units

See Preparation and Dilution Technique for instructions on Botox reconstitution, storage, and preparation before injection.

Overactive Bladder: Recommended total dose 100 Units, as 0.5 mL (5 Units) injections across 20 sites into the detrusor.
Adult Detrusor Overactivity associated with a Neurologic Condition: Recommended total dose 200 Units, as 1 mL (~6.7 Units) injections across 30 sites into the detrusor.
Pediatric Detrusor Overactivity associated with a Neurologic Condition: 0.5 mL injections across 20 sites into the detrusor. Greater than or equal to 34 kg: Recommended total dose is 200 Units Less than 34 kg: Recommended total dose is 6 Units/kg.
Chronic Migraine: Recommended total dose 155 Units, as 0.1 mL (5 Units) injections per each site divided across 7 head/neck muscles.
Adult Upper Limb Spasticity: Recommended total dose up to 400 Units divided among affected muscles.
Adult Lower Limb Spasticity: Recommended total dose 300 Units to 400 Units divided across ankle and toe muscles.
Pediatric Upper Limb Spasticity: Recommended total dose 3 Units/kg to 6 Units/kg (maximum 200 Units) divided among affected muscles.
Pediatric Lower Limb Spasticity: Recommended total dose 4 Units/kg to 8 Units/kg (maximum 300 Units) divided among affected muscles.
Cervical Dystonia: Base dosing on the patient’s head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history; use lower initial dose in botulinum toxin naïve patients.
Axillary Hyperhidrosis: 50 Units per axilla.
Blepharospasm: 1.25 Units-2.5 Units into each of 3 sites per affected eye.
Strabismus: The dose is based on prism diopter correction or previous response to treatment with Botox.

Contraindications:

Botox is contraindicated:

In patients who are hypersensitive to any botulinum toxin product or to any of the components in the formulation.
In the presence of infection at the proposed injection site(s).
For intradetrusor injection in patients with a urinary tract infection; or in patients with urinary retention or post-void residual (PVR) urine volume >200 mL who are not routinely performing clean intermittent self-catheterization (CIC).
Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
Infection at the proposed injection site.
Intradetrusor Injections: Urinary tract infection or urinary retention.

Drug Interactions:

Patients receiving concomitant treatment of Botox and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of Botox may be potentiated.

Aminoglycosides and Other Agents Interfering with Neuromuscular Transmission: Co-administration of Botox and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated.

Anticholinergic Drugs: Use of anticholinergic drugs after administration of Botox may potentiate systemic anticholinergic effects.

Other Botulinum Neurotoxin Products: The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

Muscle Relaxants: Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of Botox.

Adverse Reactions:

Spread of toxin effects
Serious adverse reactions with unapproved use
Hypersensitivity reactions
Increased risk of clinically significant effects with pre-existing neuromuscular disorders
Dysphagia and breathing difficulties
Pulmonary effects of Botox in patients with compromised respiratory status treated for spasticity or detrusor overactivity associated with a neurologic condition
Corneal exposure and ulceration in patients treated with Botox for blepharospasm
Retrobulbar hemorrhages in patients treated with Botox for strabismus
Bronchitis and upper respiratory tract infections in patients treated for spasticity
Autonomic dysreflexia in patients treated for detrusor overactivity associated with a neurologic condition
Urinary tract infections in patients with overactive bladder
Urinary retention in patients treated for bladder dysfunction

The most common adverse reactions ≥5% and >placebo, if applicable) are:

OAB: urinary tract infection, dysuria, urinary retention
Adult detrusor overactivity associated with a neurologic condition: urinary tract infection, urinary retention
Pediatric detrusor overactivity associated with a neurologic condition: urinary tract infection, leukocyturia, bacteriuria
Chronic migraine: neck pain, headache
Adult spasticity: pain in extremity
Pediatric spasticity: upper respiratory tract infection
Cervical dystonia: dysphagia, upper respiratory infection, neck pain, headache, increased cough, flu syndrome, back pain, rhinitis
Axillary hyperhidrosis: injection site pain and hemorrhage, non-axillary sweating, pharyngitis, flu syndrome

Examples of onabotulinumtoxinA in Guidelines:

Management of Headache

Veterans Health Administration / Department of Defense, 2023

“We suggest onabotulinumtoxinA injection for the prevention of chronic migraine.”
“We suggest against abobotulinumtoxinA or onabotulinumtoxinA injection for the prevention of episodic migraine.”

Diagnosis and Treatment of Interstitial Cystitis/Bladder Pain Syndrome

American Urological Association, 2022

“Intradetrusor onabotulinumtoxinA may be administered if other treatments have not provided adequate improvement in symptoms and quality of life. Patients must be willing to accept the possibility that intermittent self-catheterization may be necessary.”

Non-Neurogenic Male Lower Urinary Tract Symptoms

European Association of Eurology, 2025

“Offer bladder wall injections of onabotulinumtoxinA (100 U) to patients with overactive bladder/urgency urinary incontinence refractory to medical therapy.”

Please note: This article is current as of August 7, 2025. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.