Botox for migraines and sweating: what the FDA label covers

Botox has medical uses apart from smoothing wrinkles. Its separate FDA-approved label, the one for Botox rather than Botox Cosmetic, lists chronic migraine and severe underarm sweating among them.¹

Here is what the label says about each, the side effects seen in trials and the boxed warning. It gives no dose or injection plan. Whether either is right for you is a question for a doctor who knows your history.

Chronic migraine

The label lists Botox for preventing headaches in adults with chronic migraine, which it defines as 15 or more days a month with headache lasting 4 hours a day or longer.¹ It states that safety and effectiveness haven't been established for preventing episodic migraine, meaning 14 or fewer headache days a month.¹

In two placebo-controlled trials, 687 people received Botox and 692 received placebo. Neck pain was reported by 9% on Botox and 3% on placebo, headache by 5% and 3%, migraine by 4% and 3%, eyelid ptosis (a drooping eyelid) by 4% and under 1%, bronchitis by 3% and 2%, and facial paresis (weakness) by 2% and none. Injection site pain was 3% and 2%, and high blood pressure 2% and 1%.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

Severe underarm sweating

The label lists Botox for severe primary axillary hyperhidrosis, meaning heavy underarm sweating, in adults when topical agents haven't managed it.¹ Its safety and effectiveness for sweating in other areas haven't been established. The label warns that hand muscle weakness and a drooping eyelid may occur in people treated for sweating of the palms and the face.¹

The most common reactions in the label's sweating studies were injection site pain and bleeding, sweating in other areas, sore throat and flu-like illness.¹

The boxed warning

Like every botulinum toxin, Botox has a boxed warning about distant spread of toxin effect. Its effects may spread from the injection site and cause 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

Who shouldn't have it

The label says Botox must not be used by people who are allergic to any botulinum toxin product or its components, or who have an infection at the proposed injection site.¹ On pregnancy, it says that based on animal data it may cause fetal harm, and that there are no adequate data in pregnant women.¹ Tell your provider if you are pregnant, planning a pregnancy or breastfeeding.

The label also lists other medical uses, among them overactive bladder, spasticity, neck muscle spasms, eyelid spasms and crossed eyes. We don't cover those here.¹

What to ask

These are medical treatments, and the label's uses are specific. 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. Insurance and payment are covered in our guide to paying for med spa treatments.

Common questions