Skip to content
Breathing, swallowing or vision problems: call the emergency services (15 or 112 in France).

Masseter Botox: jaw muscle injections, what is known

The masseter is the muscle that clenches the jaw. When it is very developed, it widens the lower face, and some people want to reduce it with botulinum toxin. In France, no product label provides for this use: it is off-label. Recent trials exist, but follow-up remains limited. Here are the facts.

The jaw is one of the eleven areas of our "why and how" atlas of botulinum toxin, added because the question comes up often. This page explains the role of the masseter, what is known about treating it with botulinum toxin, why it is an off-label use in France, and what its limits are. It does not replace a consultation.

Why talk about the masseter?

The masseter is a powerful muscle on each side of the face, between the cheekbone and the angle of the jaw. It is used to clench the teeth and to chew. When it is very developed, this is called masseter hypertrophy or prominence: it forms a bulge near the angle of the jaw and widens the lower face1,3.

Botulinum toxin relaxes the injected muscle; in the masseter, this relaxation also leads to a gradual reduction in its volume, which explains the reduction in width observed in some trials1,3. A phase 3 trial published in 2026, funded by the manufacturer of the toxin studied, measured a mean reduction in lower face width of about 5 mm on day 90, compared with no change on placebo3.

What the toxin does not do: it does not change the jaw bone and does not act on sagging skin or fat in the lower face. It is not a guaranteed way to change the shape of the face: results vary widely from one person and one study to another2.

When is the toxin used?

There are no official criteria in France, since no label provides for this area. Recent trials concern adults whose masseter is rated "marked" or "very marked" on an assessment scale3. The 2013 Cochrane review noted that benign masseter hypertrophy is an uncommon condition of uncertain cause; the trials it looked for had to concern hypertrophy confirmed by clinical and radiological examination1.

The contraindications in the labels apply whatever the area: allergy to the toxin or to a component of the product, a generalised disorder of the muscles and of the junction between nerve and muscle (myasthenia gravis, Lambert-Eaton syndrome), an infection at the injection site5,6. Treatment is not recommended during pregnancy or breastfeeding5,6.

Which toxin for the masseter?

Approval status in France: Masseter / jaw
ToxinStatus in France
Long-acting botulinum toxin (type A)No aesthetic indication for this area in the SmPCs in force in France: off-label use, to be discussed with your doctor
Short-acting botulinum toxin (serotype E)No aesthetic indication for this area in the SmPCs in force in France: off-label use, to be discussed with your doctor

The type A toxins approved for aesthetic use in France cover frown lines and, depending on the product, crow’s feet and forehead lines6,7. None provides for the masseter. The short-acting botulinum toxin (serotype E) is approved for frown lines only, in the European Union and in Canada5,8. For this area, any injection is therefore off-label in France. In the United States, the manufacturer of a type A toxin announced on 4 August 2026 that its application for this area had been accepted for review by the FDA; at the date of that press release, the use was therefore not approved there4.

Status as of 9 October 2026: no French label provides for the masseter6. In the United States, an application was accepted for review in August 2026, according to the manufacturer4.

Is it right for me?

Your doctor will first try to find out whether the width of your jaw is really due to the muscle, rather than to the bone or the tissues of the cheek. They will ask whether you clench your teeth or have jaw pain, and will take into account your medical history, your treatments and any pregnancy plans.

They will also explain the limits of the data: few trials, variable results, no optimal protocol defined2. The neighbouring areas are covered on the pages about the chin and about the neck and platysma bands.

Questions to ask your doctor: is this treatment off-label? Is my jaw wide because of the muscle? What result is reasonable, and after how long? Could my chewing be affected? What happens if I stop?

Onset and duration

No label gives an onset or duration for this area. In the 2026 phase 3 trial, 51.2% of treated people had an improvement of at least two grades on day 90, compared with 2.2% on placebo, and the improvement was maintained up to day 1803. The 2026 meta-analysis already observes a benefit at week 4, but stresses the need for trials with longer follow-up2.

How onset works in general is explained on the page about how long botulinum toxin takes to work.

What are the risks in this area?

In the 2026 phase 3 trial, most side effects were mild, non-serious and resolved3. The most common treatment-related side effect was a chewing problem (jaw fatigue or pain, weaker chewing), in 3.5% of treated people compared with none on placebo3. The injection-site reactions described in the labels (pain, swelling, small bruise) are possible5. Since the masseter is used for chewing, this is a question to ask your doctor before the injection; the page on difficulty chewing after a masseter injection explains how long it lasts and what to do.

As with any botulinum toxin injection, difficulty swallowing, speaking or breathing requires immediate medical attention5. If something unexpected happens after a jaw injection, the page on the jaw after an injection helps you find your way.

Key points

  • The masseter is used to clench the teeth; when very developed, it widens the lower face1,3.
  • No French label provides for this area: injection is off-label5,6.
  • Recent trials show a short-term effect, with variable results and limited follow-up2,3.
  • In the United States, an application was accepted for review in August 2026, according to the manufacturer4.

Frequently asked questions

  • Is botulinum toxin injection into the masseter approved in France?

    No. No French botulinum toxin label provides for the masseter: the type A toxins approved for aesthetic use cover frown lines and, depending on the product, crow’s feet and the forehead6,7, and the short-acting toxin covers frown lines only5. In the United States, an application for this area was accepted for review in August 2026, according to the manufacturer’s press release4.

  • What do studies on the masseter show?

    In 2013, a Cochrane review found no controlled trial meeting its criteria1. Since then, placebo-controlled trials have been published. A 2026 meta-analysis of five trials and 536 participants concludes that there is a short-term improvement in masseter prominence and muscle thickness, with results that vary widely from one study to another and no optimal protocol defined2.

  • How long does the effect last in the masseter?

    No label says, since this use is not included in any label. In a phase 3 trial published in 2026, the main effect was measured on day 90 and the improvement was maintained up to day 1803. The 2026 meta-analysis highlights the lack of trials with longer follow-up2. This is a question to discuss with your doctor.

Sources

  1. 1.Fedorowicz Z. et al., botulinum toxin for masseter hypertrophy, Cochrane review, 2013 (opens in a new tab) — Cochrane Database of Systematic Reviews
  2. 2.Machado G.F. et al., botulinum toxin for masseter hypertrophy: systematic review and meta-analysis, Journal of Plastic, Reconstructive & Aesthetic Surgery, 2026 (opens in a new tab) — Journal of Plastic, Reconstructive & Aesthetic Surgery
  3. 3.Sun J. et al., type A botulinum toxin for masseter muscle prominence: placebo-controlled phase 3 trial, Aesthetic Surgery Journal, 2026 (manufacturer-funded study) (opens in a new tab) — Aesthetic Surgery Journal (Oxford University Press)
  4. 4.Manufacturer press release (AbbVie) on a FDA filing for masseter prominence, 4 August 2026 (opens in a new tab) — AbbVie (manufacturer)
  5. 5.Summary of product characteristics of the serotype E botulinum toxin approved in the European Union (EPAR annex I) (opens in a new tab) — European Commission (Union Register of medicinal products)
  6. 6.SmPC of a type A botulinum toxin approved for aesthetic use in France (BDPM, CIS 68150775) (opens in a new tab) — French public medicines database (BDPM)
  7. 7.SmPC of a type A botulinum toxin approved for aesthetic use in France (BDPM, CIS 61592762) (opens in a new tab) — French public medicines database (BDPM)
  8. 8.Canadian product monograph of the serotype E botulinum toxin (authorization date: 2026-06-22) (opens in a new tab) — Health Canada
Book an appointmentSOS after an injection