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Aczone Acne Treatment Review: Is it Safe?

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Aczone is a newly approved antibiotic topical gel for the management of acne. While this medication is somewhat effective in treating acne, the side effects may outweigh the benefits. Find out more below.

Aczone is an antibiotic treatment for acne approved for use in acne treatments by the FDA in 2008. But is this new topical acne treatment as safe and effective as the manufacturer would have you believe? There is some question about the effectiveness and safety of this popular anti-acne treatment.

One Boy’s Story

In the summer of 2011, a young teen boy from San Francisco started taking the prescription medication ACZone as a remedy to treat his acne. The boy took the medication for a few months, then he began to show signs of severe depression combined with suicidal thoughts. After his parents found out the boy was facing these complications, they took him off of the medication. However, it was too late. The boy committed suicide just a few days after he stopped using ACZone.

In January 2013, his parents filed a lawsuit against the manufacturer of Aczone, Allergan, and Amerisource Bergen, citing fraud, breach of warranty, misleading labeling, and improper marketing. The family claims that the manufacturer downplayed the risks associated with the drug and did not report all possible side effects in the medical literature or to doctors prescribing the medication.

It is possible that this topical acne treatment is as dangerous as these parents claim? Learn more about the controversial medication Aczone below.

What is Aczone?

Aczone is a brand name of the topical antibiotic medication dapsone. This topical gel fights acne by reducing the number of P. acnes bacteria on the skin. Studies have found that individuals with acne have more P. acne bacteria on their skin than individuals without acne. Applying a targeting antibiotic to the skin can kill the bacteria, which typically works to improve the condition of the skin.

According to clinical trials, dapsone gel containing 5 percent dapsone was able to eliminate or significantly reduce acne within 41 percent of patients in 12 weeks. Comparatively, the control group saw a 33 percent acne recovery in 12 weeks. Just like any other medication, Aczone has side effects. Learn more about the possible side effects below.

Why Antibiotics are Used for Acne

Antibiotics are a popular and somewhat effective acne treatment because they target the source of acne (or at least the visible source). Studies have shown that individuals with acne have a higher number of P. acnes bacteria on the skin and in the intestines. P. acnes bacteria is linked to an increased number of breakouts on the skin. Antibiotics can treat acne by eliminating these bacteria, as well as all other bacteria. 

Doctors typically do not recommend that patients use antibiotic acne treatments for more than a few weeks, in case they lower their immune system or build up a tolerance to the antibiotics. However, some patients use antibiotic acne treatments for years. In most cases, topical antibiotic treatments have fewer side effects than oral treatments. 

Common Aczone Side Effects

According to the Aczone website, common side effects of topical Aczone include redness, dry skin, peeling skin, yellow skin, and oily skin. One less-common side effect listed on the website is the possibility of the medication causing hemolytic anemia (the breakdown of red blood cells). The website states that this side effect is ordinarily caused by oral dapsone and is not expected to be a problem with topical dapsone. Some patients experienced a severe sore throat after applying the topical gel.

According to the FDA, in clinical trials; the most common side effects were redness, dryness, oiliness, and skin peeling. About 36 percent of patients had at least one of these side effects in clinical trials.

Rare Aczone Side Effects

The parents of the boy who committed suicide soon after starting Aczone treatments claimed that the medication was responsible for the condition and subsequent death of their child. According to clinical trials, severe depression and suicidal thoughts can be a rare complication of the medication. The rare side effects of dapsone topical cream are listed below:

Serious Complications of Aczone
  • Suicidal thoughts
  • Vomiting
  • Abdominal pain
  • Pancreatitis
  • Depression
  • Psychosis

According to clinical trials, in a study of 2372 patients using Aczone gel, 9 had severe depression and 2 suffered from psychosis. In the same group of around 2000 patients using the gel, 5 percent had cold-like symptoms, 3 percent caught an upper respiratory tract infection, 1 percent caught the flu, 6 percent had headaches, and 1 percent had fevers. 1 patient had severe facial swelling, which caused the patient to quit the clinical trial.

Could Aczone Cause Suicide?

According to the clinical trials, there were about 3-4 serious psychosis-related side effects that occurred in patients using topical Aczone. These clinical trials took place over a period of 12 weeks. Although the medication is not meant to be taken for longer than 12 weeks at a time, it is possible that the longer someone uses the medication, the more likely they are to suffer serious consequences of the medication- including suicidal thoughts.

The boy who committed suicide used Aczone for about 8 weeks before he began to show signs of suicidal thoughts and severe depression. According to data from the FDA during the clinical trials for this topical treatment, suicide is definitely a possible side effect. It is somewhat rare, but about 1-3 percent of patients in the clinical trials had some form of mental side effect from the topical gel. It is entirely possible that the boy in the lawsuit died as a result of using the topical gel.

The Dangers of Medication for Acne

All medications have side effects. Many popular acne medications have severe side effects. Accutane, for example, can cause miscarriage, fertility problems, or birth defects. Antibiotics can have serious side effects like the depressive effects of Aczone, or they can cause other long-term side effects due to a total reduction in beneficial bacteria on the skin.

There is some evidence that long-term antibiotic use makes the skin worse once treatments are stopped because there are no longer any beneficial bacteria to fight acne bacteria on the skin. Oral antibiotic treatments for acne are even worse for a person’s health. Although acne is a frustrating condition, the side effects of treatments like Aczone are far worse.

Luckily, there are alternative acne treatments that can help eliminate acne without the dangerous side effects of conventional medical treatments.

Alternative Acne Treatments

There are literally thousands of acne treatments out there. Some are more bizarre than others, like the urine acne treatment method. The trouble with acne is that scientists are not quite sure why some people are more prone to acne than others. Most people with acne have a higher prevalence of the P. acnes bacteria on their skin, but researchers do not know why that is, or what necessarily helps control skin bacteria levels. Some treatment methods are more likely to work better than others for your particular skin. Skin types vary wildly, and what works for your friend may not work for you.

Some people find their acne caused by excessively dry skin, while others find it caused by oily skin. Some acne is related to extreme sensitivity to perfumes, makeup, or dyes, while another acne is food-related.

However, no matter the cause of your specific acne, the following treatment methods have been scientifically proven to help reduce acne on a variety of skin types without dangerous side effects.


Probiotics for acne is kind of the opposite of antibiotics. This theory believes that by adding beneficial bacteria, your body becomes better equipped to fight off invading bacteria, including the bacteria that cause acne. According to a review of the theory by the State University of New York in 2011, the link between acne and intestinal health is a connection that has been studied for over 70 years. In studies, patients with acne are more likely to be constipated and have an imbalance of bacteria in the intestines. Supplementing with oral probiotics could restore the bacterial balance and prevent future acne outbreaks.

Omega 3s

Another theory surrounding the origin of modern acne is the prevalence of unhealthy fats in the modern diet. Most of the fats consumed in the American diet are omega 6 fats, which come from vegetable oils. An imbalance of omega 6 fats in the body can lead to an increase in inflammation, which could contribute to the development of acne. In studies, patients who take omega 3 supplements have varied responses in the condition of their acne. While some patients do not respond to omega 3 oil at all, some patients show a full recovery in just a few weeks. In a 2012 study conducted by California State Polytechnic University, over half of patients supplementing with omega 3 oils showed significant improvement after 12 weeks.

Vitamins and Minerals

A deficiency of vitamins and minerals could also contribute to the presence of acne on a person’s skin. Vitamins and minerals are the building blocks used to help the body function properly. A lack of vitamins and minerals could lead to unhealthy skin and higher levels of acne bacteria and breakouts. Studies have linked the following vitamins to the prevalence of acne on the skin:

Vitamin A: Vitamin A is the one vitamin that is clearly linked to skin health. Many acne medications and skin treatments contain vitamin A to boost the overall health of the skin. Vitamin A is a necessary nutrient to ensure you have healthy, acne-free skin.

Vitamin E: Vitamin E is a necessary vitamin for the development of healthy skin. According to research, you cannot absorb enough vitamin A without the right amount of vitamin E in your diet. This means that to boost vitamin A levels, you also need to take vitamin E.

Selenium: Selenium is an antioxidant mineral that affects the levels of the enzyme glutathione peroxidase in the body. This enzyme can prevent acne from forming. In a study from 1984, researchers found that many people with acne had low vitamin E and glutathione peroxidase levels.

Zinc: According to research, zinc is responsible for preventing testosterone from turning into DHT. DHT contributes to the production of sebum and keratin, which are leading causes of acne. In a French study from 1989, it was found that supplementing with effervescent zinc and zinc gluconate was able to reduce acne in study participants.

Herbal Supplements

There are a few herbs that have been shown to boost the health of a person’s skin and fight acne. The most documented herb for improving acne is gum guggul. This extract is able to clear nodulocystic acne. In a study of 20 patients published in the Journal of “Dermatology” in 1994, it was found that supplementing with gum guggul was more effective than the antibiotic treatment Tetracycline for clearing acne.

Aczone: A Dangerous Acne Drug

Although the deadly risks for Aczone are rare, about 15 percent of individuals taking the medications have some risk of developing serious side effects- either mental or physical. Considering that the effectiveness rate of this medication is less than 50 percent, it does not seem quite worth the risk to try the medication. Before taking Aczone, or any antibiotic treatment for acne- look at all the safety information and risks before using it to clear your acne.

Even if you are not afraid of the side effects, with an efficiency rating lower than 50 percent, there are many side-effect-free, natural treatments that you can try that are just as, and even more, effective than conventional medical treatments. Acne is not serious enough to risk dangerous side effects like depression, suicide, and psychosis from conventional treatment methods.





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