Botox: what it is, what the label says, what to ask

MedSpaGrades editorial teamUpdated 22 Oct 20264 sources checkedHow we write

Botox is a brand name of a prescription medicine called onabotulinumtoxinA. Botox Cosmetic is the version approved for cosmetic use. It is injected into muscle to temporarily improve how certain facial lines look. This page says what the FDA-approved label and the FDA say about it. It does not say whether you should have it.

What it is

Botulinum toxin products are injectable drugs that work by keeping muscles from tightening, so the wrinkles do not show as much, according to the FDA. The medicine is made from a bacterium. The FDA says it comes from the same bacteria that cause botulism, but that the amounts used for cosmetic purposes are purified and many orders of magnitude smaller.

Botox is one brand. The FDA names Botox, Dysport, Xeomin and Jeuveau as approved to treat facial wrinkles. The American Society of Plastic Surgeons (ASPS) also lists Daxxify. They are not dermal fillers. Fillers are gel-like substances that add smoothness or fullness, and the FDA regulates them as medical devices. The FDA also says that using fillers together with Botox has not been evaluated in a controlled clinical study.

What it is approved for

The Botox Cosmetic label says it is indicated in adults for the temporary improvement in the look of four things: moderate to severe frown lines between the eyebrows, crow's feet at the corners of the eyes, forehead lines, and vertical bands in the neck. The label's wording is "glabellar lines", "lateral canthal lines", "forehead lines" and "platysma bands".

The label says the safety and effectiveness of Botox Cosmetic have not been established in children.

How long it takes and how long it lasts

The label says the medicine starts to relax the injected muscles one to two days after injection, and that the effect increases in intensity during the first week. For frown lines, it says the effect lasts approximately 3 to 4 months. The label gives that figure for frown lines. Ask your provider what to expect for other areas. The American Society for Dermatologic Surgery (ASDS), a society of dermatologists who do surgery, says the effects of neuromodulators typically last about three months.

ASDS also says a physician must tell you if any neuromodulator is being used off-label, meaning in a way that was not part of its FDA approval.

The label also says the safety and effectiveness of dosing Botox Cosmetic more often than every 3 months have not been clinically evaluated. How often a person returns is a decision for the provider and you.

What the studies showed

The label reports two identical studies of frown lines. They enrolled healthy adults aged 18 to 75 with frown lines of at least moderate severity. Each person was treated once with Botox Cosmetic (405 people) or with placebo (132 people). An investigator then rated the lines at maximum frown. At day 30, the lines were rated none or mild in 80% of the treated people (325 of 405) and in 3% of the placebo group (4 of 132). At day 90, the figures were 48% and 2%. At day 120, 25% of treated people were rated none or mild.

This is what happened to the people in two studies, for frown lines only, under trial conditions. It is not a promise about what will happen to you. Results depend on the person, the area and the provider.

We do not show before-and-after photos on this page. If a clinic shows you photos, ask how long after treatment they were taken, whether the person was the same age and skin type as you, and whether they were edited.

Risks and side effects

The Medication Guide says Botox and Botox Cosmetic can cause serious side effects that can be life threatening. These are problems breathing or swallowing, and a spread of the toxin's effect beyond the injection site. It says the problems can happen hours, days or weeks after an injection, and that death can happen as a complication of severe swallowing or breathing problems. The label's boxed warning says the risk is probably greatest in children treated for spasticity, but can also occur in adults. People who already have swallowing or breathing problems have the highest risk, according to the Medication Guide.

Other side effects listed in the Medication Guide include discomfort or pain at the injection site, tiredness, headache, neck pain, eye problems (double or blurred vision, drooping or swollen eyelids, dry eyes), drooping eyebrows, and allergic reactions. In the frown-line studies, droopy eyelid was reported in 3% of treated people (13 of 405) and in none of the placebo group. The FDA says that in rare cases injections have resulted in double vision, dry eyes, or difficulty swallowing or breathing.

The label says Botox Cosmetic must not be used by people with a known allergy to any botulinum toxin product or to anything in the formulation, or when there is an infection at the planned injection site.

You can report a side effect to the FDA at 1-800-FDA-1088.

Pregnancy and breastfeeding

The FDA says cosmetic use is not recommended while pregnant or breastfeeding. The label says there are no adequate data on its use in pregnant women and no data on whether it is present in breast milk. The Medication Guide says it is not known whether Botox can harm an unborn baby or pass into breast milk. If you are pregnant, may become pregnant or are breastfeeding, say so at the consultation.

Who gives it

Botox Cosmetic is a prescription medicine. Which licensed professionals may inject it, and under whose supervision, depends on the state. See our Arizona page for one state and our guide to who may inject for how to check. The questions below are good ones to ask whoever offers it.

What it costs

We do not give prices on this page. ASPS says the cost of botulinum toxin injections varies with factors such as how advanced the lines are, how aggressively you want to treat them, and so the amount of product used, plus the expertise of the person treating you, the time the treatment takes and the geographic location. Our cost guide covers how clinics quote prices and what to ask.

Common questions