Botulinum toxin (Botox)

What is botulinum toxin?

Botulinum toxin is a substance that reduces the activity of a targeted muscle by suppressing the release of acetylcholine, which carries the signal between nerve and muscle.¹² Its effect is on the muscle in the area where it is applied, and it is temporary.

This page is written not to present the treatment but to make it possible to assess it. As in every article in the non-surgical procedures section, four questions are asked: what this treatment is, what is claimed for it, how far its evidence reaches, and how the marketing language should be read.

How it differs from filler: Botulinum toxin does not add volume to tissue; it reduces muscle activity.² Filler adds volume. The two address different aims and do not stand in for one another.

The name: "Botox" is a brand name. In everyday speech it is used as though it were the name of every botulinum toxin treatment, but it is not the name of the active substance.³ The rest of this article uses the name of the substance.

Uses outside aesthetics: Severe migraine, focal muscle stiffness (spasticity) and excessive sweating are among this substance's areas of treatment.⁴ This article deals with its aesthetic use on facial lines; how those treatments are carried out does not belong here. Nor does a substance being used for another condition mean that every product is licensed in Türkiye for all of those areas.

What changes are expected, and what are not?

Lines on the face are not all of one kind. Lines that become marked on contraction and lines that are visible while the face is at rest are assessed separately.² Because the substance works through muscle activity, the change expected in lines of facial expression is more direct.

That distinction is not an absolute boundary. It is stated that lines present at rest can also respond, while deep, established lines may not respond fully to this substance alone.² Absolute statements such as "it only works on expression lines" or "it has no effect on established lines" are therefore not supported by the sources.

There are also things not to expect. A reduction in muscle activity is not the same result as removing excess skin or surgically repositioning tissue.¹² The position of the brow can change according to the balance between muscles, but that is not the equivalent of a lifting operation; forehead lift is a separate procedure with a separate aim.

That the effect is temporary is the starting point of any assessment. This is not a treatment that gives a permanent result.¹

What does the evidence on effectiveness show?

The effect of this substance on facial lines has been examined in randomised trials, and the evidence is broader than for many other aesthetic treatments. Even so, the figures depend on which product was studied, in which area, with which measure and over what period.

How is the effect measured in the studies?

In the studies, "success" is mostly defined as reaching a particular level on a line-severity scale, and who makes that assessment matters; the participant's own assessment and the physician's assessment are separate outcomes.

In a systematic review covering 65 randomised trials and 14,919 participants, the results for a particular dose arm compared with placebo in the lines between the brows are as follows. At week 4, the risk ratio for success as assessed by the participant was 19.45 (95 per cent confidence interval 8.60-43.99; 4 studies, 575 people), and for success as assessed by the physician 17.10 (10.07-29.05; 7 studies, 1,339 people). The review rates the certainty of both of these outcomes as moderate.⁵

These figures are not a success rate per person. A risk ratio shows how many times more likely success was reported in the treated group than in the placebo group; it does not say what an individual's result will be. The figures belong to a particular dose of a particular product and to the area between the brows alone; they cannot be generalised to all products and all areas of the face.

When does the effect start, and how long does it last?

Four separate things are being measured here and they should not be confused: the first change the person notices, the response detected on a scale, the loss of that response, and the time until the treatment is repeated.

A systematic review examining a single product in the upper face assessed 42 publications. Onset was reported, on the measures chosen, mostly at 2 to 3 days and in some studies at 24 hours. For duration, 18 studies gave findings at 4 months, 4 studies at 5 months, and 3 studies at 6 months or longer.⁶ That is not a single pooled duration; the measures the studies used differ from one another, such as mean duration, median duration, or the response persisting in at least half of the participants.

A single randomised trial becomes easier to read when it defines plainly how it measured duration. In a trial of 185 people examining the lines between the brows over 6 months, duration was measured as the time until a line that had eased returned to a moderate or severe level. By the investigator's assessment the median was 137 days in the treated group (95 per cent confidence interval 106-141) and 50 days in the placebo group (29-79). By the participant's assessment the same figures were 108 days (105-142) and 36 days (29-50).⁷

The difference between the two measurements arises from different scales giving different results within the same data set. The confidence intervals are not the shortest and longest durations individuals experienced.

Does the duration change with repeated treatments?

The data answering this question are limited and should be read carefully. In one trial, the median time to the first change noticed by participants in their diaries was 2 days (95 per cent confidence interval 2 to 3 days), and over the open follow-up period the duration was broadly maintained with repeated treatments.⁸

Being maintained does not mean lengthening. What that trial measured, moreover, is the time until re-treatment; that decision depends on the line becoming marked again and on the conditions of the trial protocol. Because the follow-up period was open-label and the make-up of the groups changed, the result does not support the conclusion that the biological duration of the effect keeps lengthening in the same person.⁸

How are authorisation and product licensing assessed in Türkiye?

There are two separate questions here and they do not stand in for one another. The first is who may carry out the treatment, the second whether the product used is licensed.

There is no separate regulation specific to botulinum toxin. How health services for aesthetic and cosmetic purposes are to be provided in private outpatient facilities is governed by the Regulation on Private Health Facilities Providing Outpatient Diagnosis and Treatment, dated 19 April 2025.⁹ That regulation repealed the previous one dated 2008; explanations resting on the earlier text are out of date.⁹

The provision in force requires three conditions together. Health services for aesthetic or cosmetic purposes may be provided within a medical centre, a polyclinic or a doctor's practice; within the competences physicians have acquired through their training curriculum or through a certificate; within the medical procedures permitted at the facility where they work; and provided that the physical space and minimum medical equipment defined for a polyclinic room are in place.⁹

What that means for a reader is this. The physician's competence and the facility's authorisation are separate things and both are required. A diploma alone, or a course certificate alone, does not show that all of these conditions are met.

This provision covers private outpatient diagnosis and treatment facilities. A complete list of authorisation by profession and title, for every type of institution, cannot be derived from this text.

How is it asked whether the product is licensed?

The question about the product is separate from the question about authorisation, and in Türkiye it has a concrete basis. In a letter dated 7 February 2024, the Turkish Medicines and Medical Devices Agency reports that counterfeits of licensed products have been found on the market and that unlicensed products said to contain botulinum toxin are being obtained outside the legal supply chain. The same document states that there has been a significant increase in cases of botulism reaching the Turkish Pharmacovigilance Centre, and lists risks of impurity, lack of sterility, the presence of particles, contamination and variation in dose in these products.¹⁰

The Agency writes that physicians should not use products other than licensed medicines.¹⁰ From a reader's point of view, the following can be asked:

• Is the product to be used licensed in Türkiye, and can its Summary of Product Characteristics be shown
• Is the proposed use included in that product's Summary of Product Characteristics
• Can the packaging, the expiry information and the record of legal supply be verified

A datamatrix code on medicine packaging is compulsory and can be checked through the Medicine Tracking System; the system gives access to the record, to any recall and to expiry information.¹¹ However, the same Agency document reports that counterfeit products use datamatrix codes copied from licensed ones.¹⁰ A code appearing in the system is therefore not on its own proof that a product is genuine.

What are the risks and unwanted effects?

The figures in this section belong to particular products, particular areas and particular sets of studies. A rate measured in one area cannot be carried over to another, and none of them is one person's risk.

Local effects

In a meta-analysis combining registration studies in the upper face, the findings seen more often in the treated group than with placebo during the first treatment period were drooping of the eyelid, sensory complaints in the eyelid, tightness of the skin, drooping of the brow, swelling of the eyelid and facial pain.¹² The study reports that these effects were mostly mild or moderate and temporary.¹²

Picking out only one of these and leaving the others unmentioned would be misleading. In a number of cells in the same study's table there is a mark indicating that the difference was not statistically significant rather than a figure; because that mark does not mean zero events, no rate can be derived from those cells.¹²

Where a general comparison is wanted, the estimate from the systematic review cited above can be used. The review reports a Peto odds ratio of 3.62 for major unwanted effects (95 per cent confidence interval 1.50-8.74; 8 studies, 1,390 people) and a risk ratio of 1.14 for any unwanted event (0.89-1.45; 8 studies, 1,388 people). The certainty of the first is moderate and of the second low.⁵ The major unwanted effects reported in the review were mainly drooping of the eyelid; that category is not synonymous with a threat to life.⁵

Where treatment is carried out in the lower face, change in the smile and in the function of the mouth is discussed in an anatomical review.¹³ That source explains the possibility; it does not measure its frequency. Rates reported for the upper face cannot be used for the lower face.

Spread beyond the site and emergency signs

The product information states that the substance can also have an effect on muscles distant from the area where it is applied, that difficulty in swallowing, speaking or breathing can develop in that situation, and that these signs call for urgent assessment.¹

That warning and the local effects above are not of the same frequency and should not be listed side by side. No frequency specific to this situation is given for aesthetic use on facial lines.¹

An active infection at the site of treatment, disorders of nerve and muscle, and any previous unwanted effect from this substance are further headings considered separately in the assessment.¹

Does a reduced effect always mean resistance?

It does not. Neutralising antibodies developed by the immune system against this substance can be measured, but detecting antibodies and the effect being lost clinically are not the same thing.

In a meta-analysis combining 33 studies across different indications, antibody formation was reported in 27 of 5,876 people who could be assessed; that is 0.5 per cent (95 per cent confidence interval 0.3-0.6). Sixteen people remained positive at the end of the study, 0.3 per cent (0.1-0.4). The spread of the estimates across indications runs from 0 to 1.4 per cent.¹⁴

The aesthetic groups are given separately. In the group with lines between the brows, antibody formation was reported in 3 of 810 people, 0.4 per cent (0-0.8). In the group with lines at the outer corner of the eye, no event was reported in 915 people; no confidence interval is given for that zero, and zero events is not proof that there is no risk. In neither aesthetic group was antibody positivity reported at the end of the study.¹⁴

The decisive point is this. Of the 27 people who developed antibodies, only 5 met the criterion for genuine secondary non-response, and those were in the medical indication groups.¹⁴ Neither "every repeat reduces the effect" nor "resistance never develops" is therefore supported by these data. Nor can a ranking of products on this point be derived from this source.

What is known about pregnancy and breastfeeding?

Pregnancy: The teratology information service in the United Kingdom states that the data on human pregnancy are limited and advises avoiding use for cosmetic purposes.⁴ That does not mean harm has been definitively shown; it means the data are insufficient.

Where treatment has been given before a pregnancy was recognised, the same source states that, in the absence of a systemic effect in the mother, the risk to the fetus is expected to be low and that the decision should be assessed for the individual.⁴ Unintended exposure does not in itself mean harm.

Breastfeeding: In the 15 September 2026 update of the institutional database assessing the passage of medicines into breast milk, it is stated that measurements in milk are limited to a single active substance and that in small samples undetectable or very low levels have been reported. The same record conveys that use is regarded as acceptable in the context of treating chronic migraine, while also including a case of swelling in an infant for which causation was not shown.¹⁵

An opinion given for one medical indication is not unconditional approval for all products and for aesthetic use. Neither "it is certainly safe" nor "you must stop breastfeeding" is supported by that record.

How should the marketing language be read?

A settled language of naming has grown up around this substance, and the names mostly say nothing about the content.

What does "baby Botox" mean?

In an institutional explanation, this name is described not as a separate substance or a separate procedure but as a name for a treatment given in a reduced amount.¹⁶ The content, in other words, is the same.

The name itself is not evidence of a safer, more natural or ageing-preventing result. No comparative evidence was found in this search showing that treatment offered under this name gives superior safety or a preventive effect compared with standard treatment.

Is "needle-free Botox" the same thing?

There is no evidence that the creams and devices offered under this name are the same as injection. An experimental topical gel formulation has been examined in a placebo-controlled trial;¹⁷ research on the subject has therefore not been absent. But a research formulation having been examined does not show that a product sold under this name has the same content, is licensed in Türkiye, or gives a result equivalent to injection.

For any such product this question can be asked: what is in it, what is its status in Türkiye, and is there a trial comparing it directly with injection.

Absolute claims

Expressions such as "permanent effect", "your expressions are definitely preserved" and "a non-surgical facelift" are not supported by the sources. The effect is temporary,¹ the duration varies with the measure and the product,⁶⁷ and a reduction in muscle activity is not the equivalent of a surgical lift.²

How should the numbers in this article be read?

No treatment schedule, dose, unit or number of sessions is given in this article. The aim of this section is not to describe a treatment but to show how the claims made for it can be assessed.

Every figure depends on which product it was obtained with, in which area and with which measure. A result measured in the lines between the brows cannot be carried over to the area around the eye, nor a duration obtained with one product to another product.

A risk ratio and an odds ratio are not a personal success rate. They come from comparing two groups and do not predict one person's result. A confidence interval is likewise not the shortest and longest duration individuals will experience.

The onset of the effect, the response detected on a scale, the loss of that response and the time until re-treatment are four separate measurements. A duration reported by one study cannot be compared with another's without knowing which definition it used.

Frequencies from different studies cannot be added together. A mark reading "not significant" in place of a figure in a table does not mean zero events.

The rate of antibody formation combines all indications and is not a personal risk for aesthetic use.

A number not being given for a risk in this article does not mean that the risk does not exist.

References

1. US Food and Drug Administration. OnabotulinumtoxinA prescribing information, revised October 2024. Accessed 25 September 2026. accessdata.fda.gov ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷

2. Small R. Botulinum toxin injection for facial wrinkles. Am Fam Physician. 2014;90(3):168-175. No DOI is recorded. PMID 25077722 ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶

3. American Society of Plastic Surgeons. Botulinum toxin. Accessed 25 September 2026. plasticsurgery.org ↩

4. UK Teratology Information Service. Exposure to botulinum toxin in pregnancy. Version 4.0, September 2023. Accessed 25 September 2026. uktis.org ↩ ↩² ↩³

5. Camargo CP, Xia J, Costa CS, et al. Botulinum toxin type A for facial wrinkles. Cochrane Database Syst Rev. 2021;7:CD011301. doi:10.1002/14651858.CD011301.pub2 ↩ ↩² ↩³

6. Nestor M, Cohen JL, Landau M, et al. Onset and duration of abobotulinumtoxinA for aesthetic use in the upper face: a systematic literature review. J Clin Aesthet Dermatol. 2020;13(12):E56-E83. pmc.ncbi.nlm.nih.gov ↩ ↩²

7. Ascher B, Rzany B, Kestemont P, et al. Liquid formulation of abobotulinumtoxinA: a 6-month, phase 3, double-blind, randomized, placebo-controlled study of a single treatment, ready-to-use toxin for moderate-to-severe glabellar lines. Aesthet Surg J. 2020;40(1):93-104. doi:10.1093/asj/sjz003 A corrigendum to this paper was published in 2021; it concerns the course of the response at rest over time and does not change the duration results reported here. doi:10.1093/asj/sjab111 ↩ ↩²

8. Wu Y, Fang F, Lai W, et al. Efficacy and safety of abobotulinumtoxinA for the treatment of glabellar lines in Chinese patients: a pivotal, phase 3, randomized, double-blind and open-label phase study. Aesthetic Plast Surg. 2023;47(1):351-364. doi:10.1007/s00266-022-03164-3 ↩ ↩²

9. Republic of Türkiye Ministry of Health. Regulation on Private Health Facilities Providing Outpatient Diagnosis and Treatment. Official Gazette, 19 April 2025, no. 32875; articles 6 and 38. Accessed 25 September 2026. antalyaism.saglik.gov.tr ↩ ↩² ↩³

10. Turkish Medicines and Medical Devices Agency, Department of Pharmacovigilance and Controlled Substances. On not using products containing botulinum toxin that are unlicensed in Türkiye. 7 February 2024. Accessed 25 September 2026. Copy of the agency document ↩ ↩² ↩³

11. Republic of Türkiye Ministry of Health. Medicine Tracking System Mobile, official application description. Accessed 25 September 2026. play.google.com ↩

12. Brin MF, De Boulle K, Liew S, et al. Safety and tolerability of onabotulinumtoxinA in the treatment of upper facial lines from global registration studies in 5298 participants: a meta-analysis. JAAD Int. 2024;14:4-18. doi:10.1016/j.jdin.2023.07.021 ↩ ↩² ↩³

13. Yi KH, Lee JH, Hu HW, et al. Novel anatomical guidelines for botulinum neurotoxin injection in the mentalis muscle: a review. Anat Cell Biol. 2023;56(3):293-298. doi:10.5115/acb.22.266 ↩

14. Jankovic J, Carruthers J, Naumann M, et al. Neutralizing antibody formation with onabotulinumtoxinA treatment from global registration studies across multiple indications: a meta-analysis. Toxins (Basel). 2023;15(5):342. doi:10.3390/toxins15050342 ↩ ↩² ↩³

15. National Institute of Child Health and Human Development. Botulinum toxins, therapeutic. Drugs and Lactation Database (LactMed). Last revised 15 September 2026. Accessed 25 September 2026. ncbi.nlm.nih.gov ↩

16. Cleveland Clinic. Baby botox. Institutional explanation, 10 February 2023. Accessed 25 September 2026. health.clevelandclinic.org ↩

17. Glogau R, Blitzer A, Brandt F, et al. Results of a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a botulinum toxin type A topical gel for the treatment of moderate-to-severe lateral canthal lines. J Drugs Dermatol. 2012;11(1):38-45. pubmed.ncbi.nlm.nih.gov ↩