Roacutan: What is it? How does it work? Dosage, History, Side Effects and Warnings

The “Accutane,” as known in some parts of the world, was discovered in 1979 when it was administered for the first time to patients with severe acne.

Most of them reacted with a clear, dramatic, and permanent improvement in their acne symptoms.

It is a derivative of vitamin A (13-cis-retinoic acid) administered orally in pill form with a meal containing an adequate amount of fat, usually for 15-20 weeks (3.5-4.5 months). However, It is also sometimes prescribed in lower doses for up to six months or more.

It was initially recommended for people with severe acne who did not respond to other treatments but has gained popularity in the last 25 years and is prescribed more frequently for less severe acne.

This practice is controversial because Roacutan is a systemic medication that affects all body systems and can cause lifelong side effects for the user. Roatan does not need to be combined with other medicines.


Gerald Peck and collaborators at the NIH (National Institute of Health) in Bethesda, Maryland, first studied isotretinoin in patients with skin cell disorders.

They accidentally discovered that it also worked in patients with severe acne. Isotretinoin was registered in 1979, was launched in the United States in 1982 as Accutane, and was launched in Europe in 1985 as Roaccutane.


The Roche patent expired in 2002, and manufacturers began selling generic forms of the drug.

In June 2009, shortly after a jury awarded $ 33 million in damages to people who claimed Accutane caused intestinal disease, Roche decided to suspend the sale of the brand Accutane. The company cited decreasing sales as its reason.

How does roacutan or Accutane work?

Exactly how roacutan works at a cellular level is unknown, but we know it affects four ways acne develops.

It drastically reduces the size of the skin’s sebaceous glands (35% -58%) and reduces the amount of oil produced by these glands (around 80%).

The acne bacterium lives in the oil of the skin. Since the fat is drastically reduced, so is the amount of acne bacteria on the skin.

It decreases the speed with which the skin produces cells within the pore, which helps to prevent pores from clogging in the first place.

Although acne can worsen during the first month of Accutane use in approximately 30% of patients, the final results are usually dramatic.

Accutane works to achieve partial or complete clearance of acne in approximately 95% of people who complete a cycle, regardless of whether they have inflammatory or non-inflammatory acne.

Most people who take it experience a long-term remission of acne symptoms. Studies show relapse rates between 14.6% to 52%, with an average of about 1/3 of people sharing a relapse. In these cases, a second course is sometimes given.

This rate of relapse depends on the dose. Patients receiving a cumulative dose of 100-120 mg/kg obtain the best results and the lowest relapse rates. Patients who receive a lower dose relapse more frequently. The daily dosage depends on the patient’s weight; 0.5mg-2 mg/kg is typical.

Other factors that increase the chances of relapse are :

  • Male gender.
  • Severe acne
  • Do not take isotretinoin with an adequate amount of fat in your diet.
  • Hormonal imbalances such as polycystic ovary syndrome (PCOS) in women.


Low doses: Traditionally, most physicians prescribe high doses of at least 1 mg/kg/day for relatively short periods (15-20 weeks).

However, because many people develop roacutan severe side effects, more recently, doctors began testing lower doses of roacutan administered over a more extended period.

Initial data show that patients with mild to moderate acne can achieve long-term remission with significantly lower doses and, therefore, suffer fewer side effects 20-22, including a lower incidence of scarring.

For people with more severe acne, staying on a lower dose of Accutane for a more extended period until reaching the total cumulative dose of 120 mg/kg may be a way to produce a long-term remission with significantly fewer side effects.

Based on this initial research, the current recommendation is that the cumulative dose (the amount of roacutan that accumulates in the body) is the most critical factor that determines the success of the treatment.

Intermittent dosing: intermittent administration (taking Accutane only one week per month) produces fewer side effects but may not work. It has been studied twice.

In both studies, people who received an intermittent dose received a lower cumulative amount, so we do not know if the poorer results are due to intermittent administration of the drug or the lowest cumulative dose. The first study compared a periodic amount with a regular dose.

The researchers gave the patients in the intermittent dose group the same dose as the patients in the regular dose group, but only for one week of the month. This resulted in only ¼ of the cumulative dose after the end of the treatment.

This produced a slightly lower clearance of acne and more than three times the relapse rate of the regular dose group. The second study compared a similar intermittent dose for only one week of the month with a continuous low amount every day.

While the exact numbers were not reported, based on what we can deduce from the study, this resulted in approximately half the cumulative dose for the intermittent group compared to the continuous low dose group.

Both groups in this second study achieved a noticeable skin at the end of the treatment, but more people relapsed in the intermittent group21.

Side effects

Roatan is a systemic medication that affects the entire body. Side effects are numerous and widespread and affect almost all patients.

Side effects can be moderate and reversible, but they can be severe or long-term in some cases.

Some adverse effects:

  • Isotretinoin is associated with teratogenicity, resulting in severe congenital disabilities and spontaneous abortions.
  • Depression / Suicide: A causal association between isotretinoin and depression/suicide has not been found.
  • Inflammatory bowel disease: A causal association between isotretinoin and inflammatory bowel disease has not been found.
  • Celiac disease: A causal association between isotretinoin and celiac disease has not been found.
  • Bone density: To date, a causal association between isotretinoin and bone density problems has not been found in young patients who use isotretinoin in the short term.

Clinical research shows an extremely high risk of congenital disabilities if pregnant women take Roacutan.

Effects on the fetus:

The effects and risks of Accutane in the fetus are so severe that the FDA approved the iPledge program, which requires women of childbearing age to commit to using two forms of birth control while using roacutan.

However, despite warnings to women not to get pregnant while using roacutan, studies published in Canada, the Netherlands, and the United Kingdom report that 11-24 per 1,000 women become pregnant while taking Roaccutane.

This is lower than the pregnancy rate in the general population of these countries, which is about 50 per 1,000 women but remains unacceptably high, leading to tragic results.

Another study conducted in California analyzed pregnancy rates before and after implementing the iPledge program. Fortunately, they found lower pregnancy rates among women who used Accutane in California but found that the iPledge program had only modest results.

Before iPledge, 3.1 women in California for every 1000 who took the medication became pregnant, and after iPledge, this number dropped to 2.7.

The researchers found that most women who take isotretinoin rely on contraceptive methods that require considerable adherence to be effective.

Unfortunately, our results suggest that this adherence is not realistic for many women. Abstinence, condoms, and the contraceptive pill were mentioned as areas of non-adherence.

The iPledge program began with a program called SMART (System for managing teratogenicity related to Accutane) in 2000, which became the iPledge program in March 2006.

Topical isotretinoin:

Topical isotretinoin exists, but it does not produce the results of oral isotretinoin. It is mainly of historical importance in the treatment of acne.


Do not buy Accutane or Roaccutane on the Internet!

According to the FDA:

“Buying (Accutane) through the Internet bypasses essential procedures to ensure that patients can take this medication safely. Isotretinoin can cause severe and harmful side effects when these procedures are ignored. “

It would help if you NEVER bought Accutane (isotretinoin) without first consulting your healthcare professional.

You should NEVER take Accutane (isotretinoin) or any of the generic versions of Accutane if you are pregnant or trying to get pregnant or if you could become pregnant accidentally.

Some websites sell prescription drugs without a prescription. This is illegal and DANGEROUS.