Is Botox® Safe?

woman receiving botox injection

The Bottom Line

Botox®, Dysport®, and Xeomin® injections are popular cosmetic procedures. These injections contain a small amount of botulinum toxin. This is the same toxin that causes botulism, but these products contain much less of the toxin than is needed to cause disease in humans.

botox syringe botulinum toxin BTX

The Full Story

Whether you agree with it or not, our society promotes the appearance and preservation of youth and beauty. In the era of dating apps, Zoom calls, and social media influencers, many people choose to undergo cosmetic surgical procedures to enhance certain features of their natural appearance.

In 2020, over 16 billion dollars was spent on cosmetic procedures in the United States, and more than 15 million cosmetic procedures were performed. Breast augmentations, breast lifts, and buttock augmentation with fat grafting (“Brazilian Butt Lift” or “BBL”) were among the most popular cosmetic surgical procedures, according to the American Society of Plastic Surgeons. Chemical peels, laser hair removal, and botulinum toxin type A injections, were also popular. These and other minimally invasive cosmetic procedures represent 85% of the total cosmetic procedures performed in 2020. Overall, administration of botulinum toxin type A, including Botox®, Dysport®, and Xeomin® was the most popular minimally invasive cosmetic procedure performed in the United States in 2020.

Botulinum toxin type A is a specific medical formulation of botulinum toxin. This toxin is produced by selected species of Clostridium bacteria, including Clostridium botulinum, which are found throughout our environment. In humans, the toxin binds to nerve cells and prevents the release of certain chemicals that are involved in muscle contraction. In the presence of botulinum toxin, muscle cells are unable to contract, and they become paralyzed. When botulinum toxin type A is injected for cosmetic purposes, this muscle paralysis results in a temporary decrease in wrinkles and frown lines. The medical use of botulinum toxin type A dates back to the 1940’s, when injections of the toxin were used as a treatment for strabismus (crossed eyes). Since then, the toxin has been used to treat muscle spasticity and excessive salivation in addition to cosmetic conditions. There are several formulations of botulinum toxin type A that are approved by the United States Food and Drug Administration (FDA) for cosmetic use, including Botox®, Dysport®, and Xeomin®.

Botulinum toxin is also the cause of botulism, a dangerous and life-threatening disease in humans. Foodborne botulism occurs after the consumption of botulism toxin in foods that have not been processed correctly. This most commonly occurs after ingestion of home-canned foods, as incorrect canning procedures can promote toxin growth and proliferation. Honey consumption by infants is a recognized cause of infant botulism, since more than half of all honey products may contain Clostridium botulinum. For this reason, infants should not consume honey for the first 12 months of life. Wound botulism can occur when open sores or cuts are contaminated with Clostridium botulinum bacteria. Intestinal botulism is a rare form of botulism that generally occurs in people with Crohn’s disease or other gastrointestinal illness. All forms of botulism can cause severe symptoms including profound muscle weakness, double vision, and difficulty swallowing. If untreated, the disease can progress to respiratory failure and death. Even with treatment, the signs and symptoms of botulism can last for months and may result in permanent complications. There is an antidote for botulism called botulinum antitoxin. The antitoxin does not reverse muscle paralysis or other symptoms that have already occurred, but it can prevent the development of additional signs or symptoms of the disease.

Botulinum toxin is a very potent poison, and exposure to small amounts of the toxin can cause severe disease in humans. The Centers for Disease Control and Prevention (CDC) considers botulism to be a high-priority bioterrorism agent. Even though botulism exposure is dangerous in small amounts, the amounts used for cosmetic procedures are significantly smaller than the amounts needed to cause disease in humans. For this reason, it is extremely rare for people to experience signs and symptoms of botulism after receiving injections of the medical formulations of botulinum toxin.

While rarely reported, botulism can occur in individuals who receive excessively high doses of botulinum toxin type A for medical or cosmetic purposes, as well as those who receive injections of unlicensed products. These unlicensed products are not meant for use in humans and may contain significantly higher doses of botulinum toxin type A than Botox®, Dysport®, or Xeomin®. Because of this, people should never receive injections of unlicensed botulinum toxin type A products.

Some people participate in “Botox parties” where a group of people get together in a home or hotel room to get cosmetic injections of botulinum toxin type A. While this might sound like a fun way to look fabulous, there are risks associated with getting injections at such parties. The individuals performing the injections might be inexperienced, or even unlicensed, the product could be counterfeit or not FDA-approved, the environment might not be clean to the standards of a medical office, and there might not be resources available on site if you have a bad reaction to the injection. These parties are illegal in some states.

If you experience adverse or unexpected signs or symptoms after receiving botulinum toxin type A, contact poison control immediately for guidance. Help is available online or by calling 1-800-222-1222. Both options are free, confidential, and available 24 hours a day.


Kelly Johnson-Arbor, MD
Medical Toxicologist

Poisoned?

Call 1-800-222-1222 or

HELP ME online

Prevention Tips

  • Use search tools provided by the American Society of Plastic Surgeons or the American Academy of Dermatology to find a board-certified and experienced plastic surgeon or dermatologist to perform cosmetic injections of botulinum toxin type A.
  • Avoid the use of botulinum toxin type A products that are unlicensed or not approved by the United States Food and Drug Administration (FDA).
  • Avoid “Botox parties” where injections are done in homes or hotel rooms.  While these parties may be legal (depending on the state), injections should only be performed by trained and licensed medical professionals using FDA-approved products.
  • Do not feed honey to infants less than 12 months of age.

This Really Happened

A physician injected botulinum toxin type A into himself and 3 other patients for cosmetic purposes. The label on the injection bottle indicated that the product was designed for laboratory use only and was not meant for use in humans. Several days later, the doctor and his patients were admitted to a hospital with symptoms of botulism including severe weakness and difficulty breathing. They received botulinum antitoxin, and all recovered after prolonged hospitalizations of up to 104 days. A sample vial of the laboratory-grade botulinum toxin used in the injections was tested and was found to contain enough toxin to kill thousands of humans.


For More Information

Botulinum Toxin (American Society of Plastic Surgerons)

Botulism (Centers for Disease Control and Prevention)


References

American Society of Plastic Surgeons. 2020 Plastic Surgery Statistics Report. Accessed March 21, 2022.

Arnon SS, Schechter R, Inglesby TV, Henderson DA, Bartlett JG, Ascher MS, Eitzen E, Fine AD, Hauer J, Layton M, Lillibridge S, Osterholm MT, O'Toole T, Parker G, Perl TM, Russell PK, Swerdlow DL, Tonat K; Working Group on Civilian Biodefense. Botulinum toxin as a biological weapon: medical and public health management. JAMA. 2001 Feb 28;285(8):1059-70. 

Bai L, Peng X, Liu Y, Sun Y, Wang X, Wang X, Lin G, Zhang P, Wan K, Qiu Z. Clinical analysis of 86 botulism cases caused by cosmetic injection of botulinum toxin (BoNT). Medicine (Baltimore). 2018 Aug;97(34):e10659.

Carruthers A, Carruthers J. History of the cosmetic use of Botulinum A exotoxin. Dermatol Surg. 1998 Nov;24(11):1168-70.

Chertow DS, Tan ET, Maslanka SE, Schulte J, Bresnitz EA, Weisman RS, Bernstein J, Marcus SM, Kumar S, Malecki J, Sobel J, Braden CR. Botulism in 4 adults following cosmetic injections with an unlicensed, highly concentrated botulinum preparation. JAMA. 2006 Nov 22;296(20):2476-9.

Healthline. Are Botox parties safe? Accessed March 21, 2022.

Rosen HE, Kimura AC, Crandall J, Poe A, Nash J, Boetzer J, Tecle S, Mukhopadhyay R, Mcauley K, Kasirye O, Garza A, Shahkarami M, Chaturvedi V, Kiang D, Vidanes J, Mccoy K, Barcellos M, Derby T, Jain S, Vugia DJ. Foodborne Botulism Outbreak Associated With Commercial Nacho Cheese Sauce From a Gas Station Market. Clin Infect Dis. 2020 Apr 10;70(8):1695-1700.

Schantz EJ, Johnson EA. Botulinum toxin: the story of its development for the treatment of human disease. Perspect Biol Med. 1997 Spring;40(3):317-27.

Sobel J. Botulism. Clin Infect Dis. 2005 Oct 15;41(8):1167-73.

Swerdlow DL, Tonat K; Working Group on Civilian Biodefense. Botulinum toxin as a biological weapon: medical and public health management. JAMA. 2001 Feb 28;285(8):1059-70.

Vosloo MN, Opperman CJ, Geyer HDW, Setshedi GM, Allam M, Kwenda S, Ismail A, Khumalo ZTH, Brink AJ, Frean JA, Rossouw J. First confirmed case of infant botulism in Africa, caused by a dual-toxin-producing Clostridium botulinum strain. Int J Infect Dis. 2021 Feb;103:164-166.

Poisoned?

Call 1-800-222-1222 or

HELP ME online

Prevention Tips

  • Use search tools provided by the American Society of Plastic Surgeons or the American Academy of Dermatology to find a board-certified and experienced plastic surgeon or dermatologist to perform cosmetic injections of botulinum toxin type A.
  • Avoid the use of botulinum toxin type A products that are unlicensed or not approved by the United States Food and Drug Administration (FDA).
  • Avoid “Botox parties” where injections are done in homes or hotel rooms.  While these parties may be legal (depending on the state), injections should only be performed by trained and licensed medical professionals using FDA-approved products.
  • Do not feed honey to infants less than 12 months of age.

This Really Happened

A physician injected botulinum toxin type A into himself and 3 other patients for cosmetic purposes. The label on the injection bottle indicated that the product was designed for laboratory use only and was not meant for use in humans. Several days later, the doctor and his patients were admitted to a hospital with symptoms of botulism including severe weakness and difficulty breathing. They received botulinum antitoxin, and all recovered after prolonged hospitalizations of up to 104 days. A sample vial of the laboratory-grade botulinum toxin used in the injections was tested and was found to contain enough toxin to kill thousands of humans.