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Roaccutane in Acne: Dosage, Benefits and Side Effects

Updated on December 10, 2010

Oral Isotretinoin, developed by Roche in 1982 and named Accutane (in USA), was declared a miracle drug for the sufferers of severe nodular and cystic Acne as soon as it was launched. In 2009 the company cited "business reasons" and discontinued its production and marketing in USA. Isotretinoin is still widely available outside USA as Roaccutane and other cheaper brand names e.g Oratane, Attractin, Sonion, Arynoin, Isotret, Decutan, Isotane etc. Oral Isotretinoin is a prescription medicine which is now commonly used to treat severe and persistent forms of Acne. And Low grade Persistent Acne that is resistant to other treatment.

Treatment with Topical agents and systemic antibiotics is first tried because the safety profile of Roaccutane is questionable at best. Isotretinoin by mouth is instituted in refractory cases and when the risk of scarring is high. Also when acne becomes a source of psychological distress. In any case the risks and benefits must be weighed before you decide to start a course of Roaccutane.

Why the manufacture and distribution was discontinued in USA is a foggy subject. But the FDA had shown concern about the under-reported cases of pregnancy and abortion during the course of treatment with Isotretinoin. Isotretinoin is highly teratogenic. The risk of congenital malformations while using oral Isotretinoin is about 30%. So, the first and most important precaution for Roaccutane use in women of child-bearing age is contraception.

Although Acne isn't the only indication for the prescription of oral Isotretinoin (Other uses include: treatment of Acne Rosacea, Hydradenitis suppurativa, Psoriasis, Xeroderma Pigmentosum, Neuroblastoma etc), Acne is the commonest reason why Roaccutane is a familiar name and is used so much.


Conventionally, Roaccutane is given in high doses for the treatment of severe or resistant Acne. About 0.5 to 2 mg/kg/day is given with meals to aid absorption. The ideal blood levels of the medication cannot be achieved otherwise because the molecule of isotretinoin has to bind with plasma proteins to become part of the system. This dosage is continued until a cumulative dose of 120-140mg/kg is reached. This usually takes between 5 to 7 months. There are a number of regimens in practice. Some take the bull by the horns, and start with the highest doses. Others start with lower doses and build up to higher levels as the body gets used to the drug. I suggest that you start with lower levels, so that you and Roaccutane start cohabiting nicely! But first get your blood work-up done.

Another valid option is the newfangled low-dose regimen (or even ultra-low-dose regimen!). Low dose regimen means that you take about half the amount of oral Isotretinoin usually prescribed in a high dose regimen. This approach is gaining popularity for the simple fact that its effective without causing severe and serious side effects: Its safer. If you prefer this option, discuss it with a qualified dermatologist. You will be taking 0.2 to 0.4 mg/kg/day of Roaccutane.

Blood Tests Before You Begin....

  1. A Complete Blood Count
  2. Liver Enzymes
  3. Coagulation Profile
  4. Serum Lipid Levels

You should also repeat the liver enzymes test in the middle and at the end of your course of treatment.

Does It Actually Work?

Yes, it does. However there are exceptions to the rule. About 40% of people treated with oral Isotretinoin completely remit, and are cured for life. 40% have a milder form of Acne again, that is managed with topical agents with ease. And 20% relapse badly enough to need another course of oral Isotretinoin, with improved chances of a cure with subsequent courses.

Roaccutane is a toxic substance, but its toxicity can be minimized with proper care and vigilance. A rule of thumb is to avoid everything which contains or is a derivative of Vitamin A in your diet.

How Does It Work?

How Isotretinoin actually works is a mystery. But possible explanations for its effectiveness in treating and curing Acne are its actions on the sebaceous glands that produce oil, and set the stage for Propioniobacterium Acnes to colonize and cause infection. Roaccutane causes atrophy of these glands as well as having a direct bactericidal action on the P.Acnes.

Side Effects of Oral Isotretinoin:

The toxicity of Isotretinoin is dose dependent. So the higher the dose, the more side-effects you'll encounter.

The commonest side-effects of Roaccutane include:

  1. Dry/Chapped lips: The commonest side effect of Oral isotretinoin is cracking of the lips. It gets really really bad, so to avoid it, start using Vaseline or simple Petroleum Jelly on your lips right away.
  2. Myalgia and Arthralgia (muscle and joint pains. These go away with time, and aren't inflammatory in nature)
  3. Acne flare-up: Most Roaccutane users experience a transient period of increased break-outs and an increase in the number of acne lesions. This effect is part of the package and you just have to lump it. the good news is that its TRANSIENT!
  4. Dryness of the skin, mouth and eyes: The skin and mucous membranes become over-dried during the course of treatment. This isn't a serious issue. especially if you deal with it correctly. Apply a generous amount of a good moisturizer daily. Use a soap-free face-wash. Instill a few drops of a tear-substitute twice or thrice a day. Increase your fluid intake.
  5. Headaches: Headaches are common with oral retinoid intake. Most occur as a result of dry eyes. So keep your eyes moist at all times. These headaches usually disappear with OTC pain blockers. A more serious form of headache is the rare (1%) Benign Intracranial Hypertension. BIH is an increase in the pressure inside the skull. Get an eye examination done if the pain persists despite popping a few painkillers. You will have to discontinue isotretinoin therapy if you are prone to this. 
  6. Nose-bleeds: A substantial percentage of Roaccutane users report having nose-bleeds spontaneously, or with minor trauma. This is a result of an increased tendency to bleed with the use of Roaccutane. These bleeds are usually mild and stop with minimal fuss. Use saline nasal drops or vaseline to avoid a bloody nose.
  7. Thinning and peeling of skin.
  8. Flushing
  9. Brittle nails.
  10. Thinning of hair and diffuse hair loss. Thinning of hair may be temporary but it can persist even after the drug is discontinued.
  11. Increased fragility of skin: Minor trauma causes bruises. Skin is easily injured.
  12. Conjunctivitis.
  13. Intolerance to Contact Lenses: avoid wearing your contact lenses during the course of Roaccutane.
  14. Raised liver enzymes: Since Isotretinoin is metabolized in the liver.
  15. Hyperlipidemia: the fat-levels in the blood rise in response to treatment, be careful with your diet.
  16. A drop in libido/Erectile dysfunction. (uncommon but possible)

Rare Adverse Effects

This is a list of very uncommon side effects, but they do happen. So keep in mind the possibility, however slim, that they may occur.


  • Problems with night vision
  • Cataracts
  • Optic neuritis
  • Menstrual disturbances
  • Inflammatory bowel disease
  • Pancreatitis
  • Hepatitis
  • Corneal opacities
  • Papilloedema
  • Benign intracranial hypertension
  • Tendon calcification
  • Psychosis
  • Depression

Despite its many risks and disadvantages, Roaccutane remains popular amidst controversy. And why not? Any sufferer of the uncomfortable condition called Acne will tell you that the pain of disfigurement hurts more than the threat of a few uncommon side-effects combined!


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    • profile image


      4 years ago

      is the acne permanantly gone after this treatment...!!!!!

    • etna5678 profile imageAUTHOR

      Yasmeen Anwer 

      6 years ago from Lahore, Pakistan

      Dear Nada,

      A few lesions after completing the regimen are not uncommon.

      You can use a topical retinoid or topical antibiotic for mild bouts...Repeating the course depends on your current skin condition. I'd say you visit your dermatologist for a detailed plan of action.

    • profile image


      6 years ago

      If I used. Roacctane and I took the full course but after a while few acnes appear can I take the medication again for one month?

    • profile image


      6 years ago

      found it informative.good hub

    • profile image


      7 years ago


      thank u so much for these info .. concise and helpful .. specially the predicted MOA of isotretinoin wich is for me was binding to retinol receptors and that's it .. now i can say deeper info has been added .. :)

    • profile image


      7 years ago

      Nice blog. just pasing by :)

      You may also include its -ve effect on foetus as another side-effect.


    • etna5678 profile imageAUTHOR

      Yasmeen Anwer 

      7 years ago from Lahore, Pakistan

      Thanks Nayothara! :)

    • Nayothara profile image


      7 years ago

      Awesome keep wring. Love this.


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