FDA approved Xeomin (incobotulinumtoxinA) for Chronic Sialorrhea in Patients 2 Years and OlderFDA approved Xeomin to treat chronic drooling in adults and children

FDA From the archive Source published July 30, 2010 Summary added July 2, 2026 DOI ↗ Editorial oversight: Dr. Ji-eun Park, MD · Brain, Mind & Pain

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Key Takeaway

Consider Xeomin for chronic sialorrhea in patients 2 years and older, with weight-based dosing and a minimum 16-week retreatment interval.

The FDA has approved Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea in patients 2 years of age and older, according to the prescribing label. This marks the first approval of a botulinum toxin for chronic drooling in this broad age range. The recommended dose for adults is 100 Units per session, divided between the parotid and submandibular glands. For pediatric patients, dosing is weight-based, with a 3:2 ratio between parotid and submandibular glands, and ultrasound guidance is recommended. Retreatment should occur no sooner than every 16 weeks. Xeomin is already approved for upper limb spasticity, cervical dystonia, blepharospasm, and upper facial lines. The approval provides a new treatment option for patients with chronic sialorrhea, a condition that can significantly impact quality of life.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

XEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent. It inhibits the release of acetylcholine from presynaptic nerve terminals, thereby reducing muscle activity and glandular secretions.

Indication & Patient Population

XEOMIN is indicated for the treatment of chronic sialorrhea in patients 2 years of age and older. It is also indicated for upper limb spasticity in adults and pediatric patients 2 to 17 years of age (excluding spasticity caused by cerebral palsy), cervical dystonia in adults, blepharospasm in adults, and temporary improvement in the appearance of upper facial lines (glabellar lines, horizontal forehead lines, and lateral canthal lines) in adults.

Dosing & Administration

For chronic sialorrhea in adults, the recommended total dose is 100 Units per treatment session: 30 Units per parotid gland and 20 Units per submandibular gland. For pediatric patients, the dose is based on body weight, administered in a 3:2 ratio into the parotid and submandibular glands, respectively. Ultrasound guidance is recommended. Retreatment should be no sooner than every 16 weeks. For other indications, dosing varies; see label for details. Reconstituted XEOMIN is for intramuscular or intraglandular injection only, and should be used within 24 hours when stored in a refrigerator (2°C to 8°C).

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

XEOMIN provides a treatment option for chronic sialorrhea in patients aged 2 years and older, filling a need for pharmacologic management of excessive drooling. Its use should be individualized based on patient weight and response, with attention to dosing intervals and injection technique.

The FDA has approved Xeomin (incobotulinumtoxinA) to treat chronic sialorrhea, also known as chronic drooling, in patients 2 years of age and older. This is the first time a botulinum toxin has been approved for this condition in both adults and children. Chronic drooling can be caused by conditions like cerebral palsy, Parkinson's disease, or other neurological disorders. It can lead to skin irritation, social embarrassment, and a lower quality of life.

Xeomin is injected into the salivary glands to reduce saliva production. For adults, the recommended dose is 100 Units per session, divided between the parotid and submandibular glands. For children, the dose is based on weight, with a 3:2 ratio between the parotid and submandibular glands. Ultrasound guidance is recommended to help place the injections accurately. Retreatment should happen no sooner than every 16 weeks.

Xeomin is already approved for other conditions like upper limb spasticity, cervical dystonia, blepharospasm, and frown lines. This new approval gives patients with chronic drooling another treatment option. However, it is not a cure. The effects are temporary, and repeat injections are needed.

If you or your child has chronic drooling, talk to your doctor about whether Xeomin might be a good option. Your doctor can help you weigh the benefits and risks based on your specific health situation.

What this means for you:

Xeomin is a new FDA-approved injection to reduce chronic drooling in people age 2 and older.

Study Details

Study typeFda approval

PublishedJul 2010

View Original Abstract ↓

1 INDICATIONS AND USAGE XEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of: Chronic sialorrhea in patients 2 years of age and older ( 1.1 ) Upper limb spasticity in adults ( 1.2 ) Upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy ( 1.2 ) Cervical dystonia in adults ( 1.3 ) Blepharospasm in adults ( 1.4 ) the appearance of upper facial lines in adults: moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity ( 1.5 ) moderate to severe horizontal forehead lines associated with frontalis muscle activity ( 1.5 ) moderate to severe lateral canthal lines associated with orbicularis oculi muscle activity ( 1.5 ) 1.1 Chronic Sialorrhea XEOMIN is indicated for the treatment of chronic sialorrhea in patients 2 years of age and older. 1.2 Upper Limb Spasticity Upper Limb Spasticity in Adult Patients XEOMIN is indicated for the treatment of upper limb spasticity in adult patients. Upper Limb Spasticity in Pediatric Patients, Excluding Spasticity Caused by Cerebral Palsy XEOMIN is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. 1.3 Cervical Dystonia XEOMIN is indicated for the treatment of cervical dystonia in adult patients. 1.4 Blepharospasm XEOMIN is indicated for the treatment of blepharospasm in adult patients. 1.5 Upper Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines) XEOMIN is indicated in adult patients for the temporary improvement in the appearance of upper facial lines: moderate to severe glabellar lines (GL) associated with corrugator and/or procerus muscle activity moderate to severe horizontal forehead lines (HFL) associated with frontalis muscle activity moderate to severe lateral canthal lines (LCL) associated with orbicularis oculi muscle activity.

FDA approved Xeomin (incobotulinumtoxinA) for Chronic Sialorrhea in Patients 2 Years and OlderFDA approved Xeomin to treat chronic drooling in adults and children

Study Details

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FDA approved Xeomin (incobotulinumtoxinA) for Chronic Sialorrhea in Patients 2 Years and OlderFDA approved Xeomin to treat chronic drooling in adults and children

Study Details

Intravenous tenecteplase improves functional outcomes but increases hemorrhage risk in non-large vessel occlusion acute ischemic stroke

Tenecteplase improves stroke recovery but increases bleeding risk in late treatment window

Clinical research that matters. Delivered to your inbox.

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