Botox for crow's feet and forehead lines: what the FDA label covers

Botox Cosmetic is approved for crow's feet and forehead lines. Its FDA-approved label lists four areas in adults: frown lines between the brows, lateral canthal lines (crow's feet) at the outer corners of the eyes, forehead lines and platysma bands in the neck.¹

Here is what the label says about the eye and forehead areas, the side effects seen in trials and the boxed warning. It gives no dose and no injection plan. Whether to have Botox is for you and a clinician.

What the label covers

The label says Botox Cosmetic is for the temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity, and of moderate to severe forehead lines associated with frontalis muscle activity, in adults.¹ The plastic surgeons' society names frown lines, forehead creases and crow's feet near the eyes as the most commonly treated areas.²

Areas the label doesn't list, such as a brow lift, are uses without a label statement behind them, so ask what the plan is based on.

Side effects seen in trials

For crow's feet, the label reports two placebo-controlled trials: 526 people received Botox Cosmetic and 530 received placebo. The reaction reported more often with Botox was eyelid edema, in 1% against none.¹

For forehead lines, the label reports trials in which forehead lines were treated together with frown lines, in 665 people on Botox Cosmetic and 315 on placebo. Headache was reported by 9% and 5%, eyelid ptosis (a drooping eyelid) by 2% and none, brow ptosis by 2% and none, and skin tightness by 2% and none.¹ The label found no additional reactions when the forehead, frown lines and crow's feet were treated at the same time.¹

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, Botox Cosmetic has a boxed warning about distant spread of toxin effect. Its effects may spread from the injection site and cause symptoms such as weakness, double vision, drooping eyelids, trouble swallowing or speaking, and breathing difficulties, reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening, and deaths have been reported.¹

What med spas offer

Three in five med spas we list offer Botox: 4,468 of 7,475. That doesn't tell you who injects or which areas they treat, so ask.³ Which licensed professionals may inject depends on your state; see our guide to choosing a Botox provider.

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