Jeuveau: cosmetic use, side effects and what its FDA label says

Jeuveau is a prescription botulinum toxin injection. Its FDA-approved label covers one cosmetic use: the frown lines between the brows, called glabellar lines, in adults.¹

Here is what the label says about the side effects seen in trials, who shouldn't have it and the boxed warning. It gives no dose. Whether Jeuveau is right for you is a question for a clinician.

What it is

Jeuveau (prabotulinumtoxinA-xvfs) is a botulinum toxin product. The FDA says these products are injectable drugs that work by keeping muscles from tightening, so the wrinkles don't show as much. They are not dermal fillers.²

What the label says it is for

The label says Jeuveau is for the temporary improvement in the appearance of moderate to severe glabellar lines in adults, and that it isn't approved for spasticity or any condition other than glabellar lines.¹ For any other area, ask what the use is based on. The label says safety and effectiveness haven't been established in pediatric patients.¹

Side effects seen in trials

The label reports two placebo-controlled trials in which 492 people received Jeuveau and 162 received placebo. Eyelid ptosis was 2% with Jeuveau and none with placebo. Upper respiratory tract infection was 3% with Jeuveau and 1% with placebo, and a raised white blood cell count 1% and none. Headache was reported by 12% with Jeuveau and 13% with placebo.¹

In two one-year trials with repeat treatments, 922 people were enrolled and the median number of treatments was three. The label says the pattern of adverse events was similar to the single-dose trials.¹ It adds that most adverse reactions occur within the first week and are generally transient, though they may last several months or longer.¹

These are the label's trial figures. The label says rates from one drug's trials can't be directly compared with those of another drug, and may not reflect what happens in practice.¹

The boxed warning

Like every botulinum toxin, Jeuveau has a boxed warning about distant spread of toxin effect. Its effects may spread from the injection site and cause symptoms consistent with botulinum toxin effects, reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening, and deaths have been reported.¹

Who shouldn't have it

The label says Jeuveau must not be used by people with a known allergy to any botulinum toxin preparation or any of its components, or with an infection at the proposed injection site.¹ On pregnancy, it says the limited data in pregnant women are insufficient to inform a risk. In rats, no effects on the developing fetus were seen at up to 12 times the maximum recommended human dose.¹ Tell your provider if you are pregnant, planning a pregnancy or breastfeeding.

Units and other brands

The label says Jeuveau's units are specific to its preparation and assay method, and can't be compared with, or converted into, the units of other botulinum toxin products.¹ A price per unit for Jeuveau isn't comparable with another brand's. Our comparison of the five brands covers this.

At the clinics we list

424 of the 7,475 med spas we list name Jeuveau among their brands. Naming a brand doesn't tell you what a clinic stocks or uses, so ask.³

Which licensed professionals may inject depends on your state. See our guide to choosing a Botox provider, which applies to any botulinum toxin.

Here is what to bring to a consultation.

Cost

We don't give prices on this page. Our Botox cost guide explains how clinics quote, per unit.

Common questions