Isotretinoin (Accutane) – Controversial, But Excellent For Stubborn And Serious Cases Of Acne

Isotretinoin is an effective acne treatment in the retinoid family, which means it is a derivative of a synthetic form of vitamin A.  Specifically how it works in fighting acne is not fully understood, but doctors do know that it works to alter DNA transcription which enables this drug to reduce the size of sebaceous glands, thereby reducing their oil production.  Isotretinoin acne treatment also makes dead skin cells less “sticky” which means they won’t clog pores as easily.  While the drug’s effect on oil production is temporary, researchers have stated that acne control can be “complete and prolonged” after using this medication.

This drug is intended for use by those with severe cystic acne and nodules.  Isotretinoin is considered a “last resort” in the quest to cure acne.  After virtually all over the counter acne treatments have failed to really work and a person seeks professional skin care, a dermatologist will usually prescribe less harsh acne skin care products – topicals and antibiotics – before considering isotretinoin.

Because isotretinoin is taken orally, it can successfully treat body acne, scalp acne, and back acne as well as facial acne.

Company Information

Accutane, the original brand name for isotretinoin, was developed by Hoffman-La Roche and released to the public in 1982.  The medication is now produced by various companies including Barr Labs (Claravis), Ranbaxy Pharmaceuticals (Sotret), and Genpharm (Amnesteem).  According to some websites, Roche Laboratories has discontinued distribution of Accutane in the United States as of mid-2009.  The company still sells Roaccutane in Europe and elsewhere, and the other brands of isotretinoin are still available in the United States as of the time of this writing.

Product Specifications

Isotretinoin is a prescription acne medication that is sold under various brand names.  The most well-known of these names are Accutane in the United States and Roaccutane in Europe and other parts of the world, while other brand names include Amnesteem, Claravis, and Sotret.  Isotretinoin can only be prescribed by a doctor, and your physician or dermatologist will decide which specific version of isotretinoin to prescribe.

This medication comes in the form of gel capsules which are taken orally on a dosage schedule set by your doctor.  According to the Food and Drug Administration’s website, only 10mg capsules are now sold though 20mg and 40mg were once commonly prescribed.  In addition to the active ingredient, isotretinoin, the capsules contain beeswax, soybean oil flakes, vegetable and soybean oil, glycerin, parabens, and artificial colors.

According to Accutane’s patient insert, which can be viewed in its entirety on the Roche USA website, isotretinoin should be taken for “15 to 20 weeks” and will “result in complete and prolonged remission of disease in many patients.”  If the patient and physician decide that a second course of therapy is needful, “it should not be initiated until at least 8 weeks” after finishing the first course.  This is because some people have continued “to improve while off Accutane.”

While high doses of natural vitamin A showed promise as an acne home treatment as early as the 1930s, the synthetic form – called retinoic acid – has shown itself to be a much more effective and efficient treatment of acne.  The high doses of vitamin A necessary to treat acne meant that many people were suffering toxic overdoses of the vitamin.  Isotretinoin, however, includes many side effects.

The list of side effects to taking isotretinoin is lengthy.  They include depression, thoughts of suicide, psychosis, and aggressive or violent behaviors.  Patients and their family members need to be aware of the signs of depression and other psychiatric disorders.  If any signs develop, the patient should stop taking isotretinoin and talk with his doctor.  It’s important to note that discontinuing the doses of isotretinoin “may be insufficient” in reversing the psychiatric effects.

Other side effects of isotretinoin include acute pancreatitis, intracranial hypertension, elevated lipid levels and liver enzymes, hearing impairment – which may “persist after therapy has been discontinued” – vision impairment, and inflammatory bowel disease.

Accutane has been prescribed as a teenage acne treatment in persons as young as 12 years old, though anyone who has “not completed skeletal growth” needs to be aware of special warnings.  Some evidence suggests that “long-term, high-dose, or multiple courses of therapy with isotretinoin” may reduce a person’s bone density in the spine, hips, and elsewhere.  Though its direct link to isotretinoin has not been established, “spontaneous reports of osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures have been seen in the Accutane population.”  Other adverse effects on the skeletal system may also occur.

Isotretinoin must not be taken by those who are pregnant or breastfeeding.  Because this drug “causes serious birth defects,” miscarriage, and/or premature birth if taken by pregnant women, patients taking Accutane or any generic brand of isotretinoin must agree to take part in a program called iPLEDGE.  Among other stipulations, requirements of the program include undergoing monthly pregnancy tests throughout the course of treatment, committing to using two forms of birth control for one month before beginning isotretinoin therapy, during the entire course of treatment, and for one month after the last dose of iostretinoin.  If a patient becomes pregnant while taking this medication, she must stop all doses of isotretinoin immediately.  The pregnancy is required to be reported to the Food and Drug Administration’s MedWatch and to the iPLEDGE pregnancy registry.

A small amount of isotretinoin is present in the semen of male patients.  It is not known if this has a definite effect on the development of a fetus, but in the 20 years that Accutane has been marketed four instances of “defects compatible with features of retinoid exposed fetuses” have been reported in babies of male isotretinoin patients.

Patients must not donate blood during isotretinoin therapy nor for one month afterward.

The list of potentially adverse drug interactions includes vitamin A, tetracyclines, micro-dosed progesterone preparations, norethindrone/ethinyl estradiol, St. John’s wort, phenytoin, and systemic corticosteroids.  The possible effect of each of these drugs varies.  Full information is available in the isotretinoin patient insert, which can be viewed here:

Where to Buy Accutane-like Medications

Isotretinoin is available only from a pharmacy with a doctor’s prescription.  It cannot be sold in stores and should never be purchased over the internet.


The cost of a single 30-day prescription of isotretinoin will depend greatly on whether you have insurance.  With insurance, the cost can be as low of $5, but without insurance, the cost can be as high as $200.

Return Policy

Because it is a prescription medication, isotretinoin cannot be returned after purchase.


Isotretinoin is often considered the best acne cure available today.  Many people believe that after completing one, or perhaps two, courses of isotretinoin treatment, they will have no more acne – ever.  How does it work, though, in getting rid of acne and keeping acne gone for the long term?  I looked at a large number of user reviews and ratings to see what real experiences people are having.  Is isotretinoin the acne cure or the acne curse?

According to many, isotretinoin “does a good job of reducing oil.”  Reducing or eliminating oil goes a long way in healing many types of acne, but isotretinoin is said to be the best acne help for cystic, nodular, and other very severe acne.  According to one reviewer, isotretinoin “cleared up my BIG cyst pimples on my back and chest after 1 month.”  Since these severe forms of acne often don’t respond to treatment, this is undoubtedly exciting for anyone who suffers from them.

Many Accutane users post enthusiastic reviews with comments like “I’m clear!” “Acne completely cleared,” and “Fantastic stuff.”  I did not find anyone who said their skin did not improve during treatments.  Yet does it really work to keep acne under control once treatment is finished?

One lady writes that her husband used isotretinoin “about 10 years or more ago and hasn’t had a breakout since.”  As amazing as that is, it is not what every isotretinoin-user experiences.  Another user says that she has “suffered from numerous painful cysts” for 14 years and has taken a complete course of isotretinoin “three different times.”  Her results are not as good – she writes that it “cleared skin during treatment … but breakouts came back after I finished each course.”  A third reviewer had a middle-of-the-road experience:  “My skin cleared and stayed clear for months after the treatment, but now, about one year later my acne has returned.”  Though it is a strong and powerful medication that can have a dramatic effect on bad acne, each individual is going to respond differently.

Any look at the pros and cons of Accutane or other isotretinoin brands would logically start with the multitude of potential side effects and “very serious health risks.”  Isotretinoin has more drug side effects than any other acne blemish control system.  Of course, this doesn’t automatically rule out the potential good that it can do for acne prone skin.  It does, however, mean that isotretinoin warrants a closer review than your average, run-of-the-mill acne system.

Most reviewers of isotretinoin report experiencing extremely “dry skin and peeling,” sometimes accompanied by “flaky scalp,” “weak hair,” and even “hair loss.”  The dryness often extends to the eyes, leaving users with “really dry, red eyes” that can adversely affect vision and make the person unable to continue wearing contact lenses.  Several comments I read said people were having “dry sinuses” that caused “occasional nosebleeds” for some and “constant nosebleeds” for others.  The dryness has also led some to experience “facial redness” that is unrelated to the acne redness they experienced before beginning treatment.

At the same time, some have written that they “have had basically no adverse effects,” and at least one says, “Side effects are no where near as bad as I had read.”  Even those with numerous complaints write that they’re thrilled with the results of seeing their acne problems disappear.  Can isotretinoin be your last acne solution?  Each person must carefully compare the potential benefits with the potential problems of isotretinoin and then decide whether the risks are worth the possible cure.