Medical Botox: Every FDA-Approved Therapeutic Use
Reviewed for medical accuracy against our Medical Review Board · Last updated 22 August 2026
Part of Botox Guides: Basics, Dosing and Safety
Botox holds nine approved therapeutic indications in the United States, not one. They cover the bladder, chronic migraine, spasticity, cervical dystonia, underarm sweating, eyelid spasm and crossed eyes, and several are approved in children, one from age two. Three of the nine require you to have already tried and failed another medicine, and that gate is the thing worth knowing before you ask.
Most people think of this drug as cosmetic with a migraine exception. In fact the therapeutic label is far larger than the cosmetic one, the doses are up to twenty times higher, and these are the uses insurance actually pays for.
1. All nine approved uses, with doses
Straight from the BOTOX prescribing information. This is the complete list.
| Indication | Who | Labelled dose |
|---|---|---|
| Overactive bladder | Adults, after an anticholinergic has failed | 100 units, 20 sites in the detrusor |
| Incontinence from a neurologic condition | Adults with spinal cord injury or MS, after an anticholinergic has failed | 200 units, 30 sites |
| Neurogenic detrusor overactivity | Children 5 and older, after an anticholinergic has failed | 200 units, or 6 units/kg under 34 kg |
| Chronic migraine | Adults with 15 or more headache days a month, lasting 4 hours or longer | 155 units across 7 head and neck muscles |
| Spasticity | Patients 2 and older | Up to 400 units in adults, weight-based in children |
| Cervical dystonia | Adults, to reduce abnormal head position and neck pain | Individualised, lower if toxin-naive |
| Severe axillary hyperhidrosis | Adults, when topical agents have not worked | 50 units per armpit |
| Blepharospasm | Patients 12 and older, with dystonia | 1.25 to 2.5 units into each of 3 sites per eye |
| Strabismus | Patients 12 and older | Based on prism dioptre correction |
Two things jump out of that table. The first is the range: from 1.25 units into an eyelid to 400 units across a limb, a three-hundred-fold spread. The second is that children are included, from age two for spasticity and five for bladder function. This is not a cosmetic drug with a sideline.
2. The gate: three of them need you to fail another drug first
This is the most practically useful thing on the page, and it is easy to miss in the label's phrasing.
All three bladder indications are written for patients who have "an inadequate response to or are intolerant of an anticholinergic medication". The hyperhidrosis indication is written for sweating "that is inadequately managed by topical agents".
In plain terms: for these uses, Botox is not a first-line treatment and the label does not present it as one. You are expected to have tried something else and for it to have not worked.
What that means for you before you go anywhere near a clinic:
- Start the paper trail now. A documented trial of the first-line drug, and a documented reason it failed or could not be tolerated, is what your eventual claim rests on.
- Order matters. The same failed medication documented before you ask about Botox is worth more than the same failure recorded afterwards.
- Chronic migraine has a different kind of gate, a headache-day count rather than a failed drug, covered in the migraine guide.
3. What the label says it does NOT cover
The prescribing information carries a short Limitations of Use section, and both entries are things patients are routinely offered anyway.
| Not established for | What that means for you |
|---|---|
| Episodic migraine, meaning 14 headache days a month or fewer | If your headaches fall below the 15-day threshold, the evidence for this treatment does not cover you, and insurance will almost certainly decline |
| Hyperhidrosis anywhere other than the armpits | Palms, soles, scalp and face are all off-label. The label separately warns of hand weakness after palmar treatment and a drooping eyelid after facial treatment |
Neither is a prohibition. Off-label prescribing is legal and often reasonable. But "not established" means no registration trial supports it, so there is no labelled dose, no injection map and no published success rate, and your injector's judgement is the entire protocol.
4. The doses are not comparable to cosmetic
Anyone who has had their frown lines treated has had 20 units. Here is what therapeutic use looks like next to that.
| Use | Units | Times a frown line treatment |
|---|---|---|
| Frown lines (cosmetic) | 20 | 1x |
| Overactive bladder | 100 | 5x |
| Underarm sweating | 100 | 5x |
| Chronic migraine | 155 | Nearly 8x |
| Neurologic incontinence | 200 | 10x |
| Adult limb spasticity | Up to 400 | 20x |
The label also sets a ceiling that matters if you have more than one reason to be treated: in any three month interval, do not exceed 400 units in adults, or the lesser of 10 units per kilogram or 340 units in children.
That ceiling is a real constraint. Someone having 400 units for spasticity has no headroom for anything else in that window, cosmetic included. If you are treated for a medical condition and also want cosmetic treatment, that conversation has to happen with whoever holds the bigger prescription. Our units guide covers cosmetic dosing across every area.
5. Two products, two labels, one drug
Something that confuses almost everyone, including people who have had both: BOTOX and BOTOX Cosmetic are separate products with separate prescribing information, made by the same manufacturer from the same active ingredient.
- BOTOX carries the nine therapeutic indications above.
- BOTOX Cosmetic carries four: frown lines, crow's feet, forehead lines, and platysma bands in the neck, the last added in the October 2024 revision.
So a sentence like "Botox is approved for thirteen things" is technically true and practically useless, because no single vial is approved for all of them. When a clinic says a use is "approved", the useful question is which label they mean. Our comparison of cosmetic against medical Botox goes into the distinction in more depth.
6. Why these are the ones insurance pays for
Cosmetic treatment is not covered anywhere, ever. Therapeutic treatment frequently is, and the reason is exactly the structure of the label: a diagnosed condition, an on-label indication, and in several cases a documented failure of first-line therapy.
The two easiest to get funded are chronic migraine and severe axillary hyperhidrosis, because both have a crisp diagnostic gate that a claims reviewer can check: a headache-day count for one, a severity score plus a failed topical for the other. Both have their own guide on this site with the documentation each needs.
Where it gets harder is any use where a cosmetic benefit rides along. Masseter treatment for jaw clenching is the clearest example: it may genuinely be treating bruxism, and it also slims the face, and that ambiguity is what makes coverage difficult. We cover that specific fight in the masseter guide.
7. The cosmetic side effects of a medical dose
It is the same drug, so it does the same thing wherever it lands, and at therapeutic doses more of it lands.
The chronic migraine protocol puts 155 units through the frontalis, the corrugators, the procerus, the temples, the neck and the shoulders. Several of those are the muscles cosmetic treatment targets. So migraine patients routinely find their forehead lines soften as a side effect, and in the migraine trials eyelid ptosis occurred in 4% against under 1% on placebo, roughly the rate seen in cosmetic glabellar treatment. Our guide to a drooping eyelid after Botox applies just as much to a medical dose.
The reverse also holds and matters more. If you are already receiving therapeutic Botox, tell any cosmetic injector, because the 400 unit three-month ceiling is cumulative across everything, and because your response to the drug is already established.
8. The common off-label medical uses
Several therapeutic uses are widespread, reasonable, and not on the label. The distinction is worth knowing because it changes what evidence sits behind the dose you are quoted.
- TMJ disorder and bruxism, via the masseter. Common, and off-label. Covered in the masseter guide.
- Hyperhidrosis of the palms, soles, scalp or face. Explicitly not established, with named risks. See the hyperhidrosis guide.
- Episodic migraine, below the 15-day threshold. Not established.
- Platysmal band treatment for medical rather than cosmetic reasons. The cosmetic label covers platysma bands as of October 2024, which is a recent change; see the neck guide.
- Depression, sialorrhoea, anal fissure, achalasia and others, all with a literature behind them and none on this label.
None of that is a warning against them. It is a reason to ask who is injecting and how often they do that specific thing, since on an off-label use their experience is the protocol. Check the licence yourself with our 50 state verification guide.
9. Safety at therapeutic doses
Every botulinum toxin carries a boxed warning about the effect spreading beyond the injection site. At therapeutic doses it deserves more attention than it usually gets, and the label says why: the risk of these symptoms is probably greatest in children treated for spasticity, though they can occur in adults too, particularly where there is an underlying condition that predisposes to them.
The symptoms to know, from the warning itself: swallowing and breathing difficulties, generalised muscle weakness, double vision, drooping eyelid, slurred speech and loss of bladder control. They have been reported anywhere from hours to weeks after injection, and swallowing and breathing difficulties are described as potentially life threatening.
That is not a reason to decline a treatment your doctor recommends. It is the reason these doses are given by specialists in a clinical setting rather than at a med spa, and the reason any difficulty swallowing or breathing after an injection is an emergency rather than a side effect to wait out.
One more from the label worth flagging: aminoglycoside antibiotics, anticholinergics and anything else interfering with neuromuscular transmission can potentiate the effect, so a current and complete medication list is not a formality here.
10. What to ask before you agree
- Is my condition an on-label indication, or is this off-label? Both are legitimate, but I want to know.
- Does my indication require a documented failure of another treatment first, and is that in my notes?
- How many units, and where does that sit against the 400 unit three-month ceiling?
- Am I receiving any other botulinum toxin, cosmetic included? Ask this of yourself and answer it honestly.
- What are the cosmetic consequences of this dose, and where will they show?
- How many of this specific indication have you treated?
- What symptoms would mean I should seek urgent help, and what is the number after hours?
And the framing worth carrying in: for a medical indication you are choosing a clinician, not a clinic. The relevant credential is experience with your condition, not with faces.
Frequently asked questions
What medical conditions is Botox approved to treat?
Is medical Botox the same as cosmetic Botox?
Does insurance cover medical Botox?
Do I have to try another treatment before Botox?
How many units are used for medical Botox?
Can Botox treat episodic migraine?
Will medical Botox affect how I look?
Is Botox safe for children?
What are the off-label medical uses of Botox?
Who should give medical Botox injections?
Know the count before the quote. The unit count is half the bill, and a low per-unit rate recovered by a high unit count is the commonest way a deal is not one. How to tell.
Deciding which area, not how many units? Botox by facial area covers what each zone actually achieves, which four are FDA approved, and the things Botox cannot fix at all.
