logo
Call (203) 954-9293

Botox for the Masseter Muscle

by | Sep 27, 2026 | Plastic Surgery

Here is now the process of an official fda indication and process to approve too for the Masseter Muscle.
What is the Masseter and why do people have it injected?
Masseter Botox involves injecting a neurotoxin into the large chewing muscle at the jaw angle. It relaxes the muscle to relieve teeth grinding, jaw clenching, and TMJ tension, while gradually shrinking the muscle bulk to slim and contour a square lower jawline.

How It Works and Treatment Details
    • Dosage: Usually requires 15 to 50 units per side depending on muscle strength and goals.
    • Timeline: Initial relief from tension starts in a few days, but visible facial slimming takes 4 to 6 weeks as the muscle shrinks.
    • Duration: Results last about 3 to 6 months before repeat injections are needed.
    • Cost: Typically ranges from $300 to $900 per session depending on provider pricing and total units used.
Benefits and Side Effects
    • Medical Benefits: Reduces bruxism (teeth grinding), tension headaches, and TMJ-related jaw pain.
    • Cosmetic Benefits: Creates a softer, more tapered, V-shaped lower face profile.
    • Potential Risks: Temporary jaw fatigue, minor chewing weakness, or rare localized smile changes if misplaced.

    FDA Accepts Application for Botox to Treat Masseter Muscle Prominence

    Aug 5, 2026 | Injectibles | 0  |

    FDA Accepts Application for Botox to Treat Masseter Muscle Prominence

    If approved, the neurotoxin would be the first indicated for the temporary improvement of marked to very marked masseter muscle prominence in the United States.

    Allergan Aesthetics, an AbbVie company, announced that the Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked masseter muscle prominence.

    If approved, Botox Cosmetic would become the first and only neurotoxin indicated for this condition in the US. This would also mark the fifth aesthetic indication for the product, according to the company.

    Masseter muscle prominence can contribute to the appearance of a wider or more square lower face. The submission addresses patient interest in non-surgical facial contouring to achieve improved jawline definition, shape, and a more slimming jawline overall.

    “This submission builds on the depth and versatility of Botox Cosmetic and reflects our continued investment in advancing aesthetic medicine,” says Darin Messina, SVP, head of aesthetics research and development at AbbVie, in a release. “At Allergan Aesthetics, our approach to innovation includes both developing new treatment options and continuing to expand the potential of established products.”

    The submission is supported by two Phase 3 clinical studies, M21-416 and M21-417, which both met their primary endpoints. According to the company, the studies demonstrated statistically significant improvements in the severity of masseter muscle prominence compared with a placebo. The safety profile remained consistent with established uses, and no new safety signals were identified.

    Patient satisfaction was also recorded during the trials. Twice as many patients treated with Botox Cosmetic reported they were “very satisfied” or “satisfied” compared with those who received a placebo.

    “Patients are increasingly seeking overall facial assessments with non-surgical options to address aesthetic needs for the lower face,” says a coordinating clinical investigator, in a release. “As facial assessment continues to evolve beyond individual treatment areas, this indication would further broaden the clinical utility of Botox Cosmetic, if approved, by providing an important new treatment option.”