Isotretinoin (Accutane)

What Is Isotretinoin (Accutane)?

Isotretinoin is the active ingredient in a prescription drug available under the brand names Sortret, Zenatane, Myorisane, Claravis, Amnesteem, and Absorica.
Doctors prescribe isotretinoin to treat a severe form of acne called recalcitrant nodular or cystic acne.
The Food and Drug Administration (FDA) originally approved isotretinoin as the brand name Accutane in 1982. Hoffmann La Roche manufactured it.
Hoffmann La Roche stopped making Accutane in 2009, partly due to numerous class action lawsuits filed against the company for birth defects caused by the drug.
In addition, plaintiffs' complaints included Crohn's disease, depression, suicide, and disabilities that caused them to miss work and lose wages.

Isotretinoin and Birth Defects

Today, women and men must agree to follow guidelines in iPLEDGE program before taking isotretinoin.
iPLEDGE requires that you and your doctor and pharmacist follow certain detailed steps to ensure your safety and prevent pregnancy while you are being treated with the drug.
Although requirements vary according to your gender and stage of life, iPLEDGE requires that people who are able to reproduce use two forms of birth control while taking isotretinoin.
Your doctor will enroll you in the iPLEDGE program. Then, before filling your prescription, your pharmacist will verify your enrollment and make sure you meet the program's requirements.

Isotretinoin and Hair Loss

One major side effect of isotretinoin is that it dries tissues, causing dry skin, cracked lips, dry mucous membranes, and dry scalp.
It may thin hair or cause it to become dry, brittle, and fragile.
This happens because isotretinoin slows down or blocks the production and secretion of the body's on own natural oils.
According to anecdotal reports, isotretinoin may not only thin hair on the head but also on the face, causing a loss of eyelashes and eyebrows.
Some people may become bald.
Although hair may regrow a few months after stopping isotretinoin, some people report that it took several years.
Others say isotretinoin caused permanent hair loss.

Isotretinoin Warnings

The FDA has issued two black-box warnings for isotretinoin.
One requires anyone taking it comply with the iPLEDGE program.
The second bans isotretinoin from being prescribed to women who are either pregnant or are able to become pregnant.
The FDA also cautions people who use isotretinoin that it can cause serious skin reactions, some of which can be life threatening.
You should not take isotretinoin if you are:
  • Pregnant or planning on getting pregnant
  • Allergic to isotretinoin or any other ingredients found in the drug
  • Allergic to soybean oil
  • Breastfeeding
Talk to your doctor before taking isotretinoin if you have:
  • Certain mood or mental conditions
  • Bone cancer
  • Soft or brittle bones and are prone to bone breaks (osteomalacia or osteoporosis)
  • Diabetes mellitus
  • Anorexia
  • High cholesterol

Pregnancy and Isotretinoin

Isotretinoin can cause severe birth defects and miscarriages. It should never be taken during pregnancy.
Isotretinoin passes into breast milk, so it also isn't safe to take while breastfeeding.

Isotretinoin (Accutane) Side Effects

Common Side Effects of Isotretinoin

  • Itching
  • Changes in nail and skin texture
  • Hair thinning and breakage
  • Dry mouth, nose, ears, throat, and anus
  • High triglycerides
  • Nausea
  • Weight loss

Serious Side Effects of Isotretinoin

  • Bone softening or brittleness or other bone disorders
  • Inflammation of liver or pancreas
  • Cataracts or other vision changes
  • Depression and suicide
  • Stroke

Isotretinoin (Accutane) Interactions

Tell your doctor all the medications you're taking.
This also includes prescription and over-the-counter medications, vitamins and other dietary supplements (nutritional shakes, protein powders, etc.), herbal remedies and any illegal and recreational drugs.
 Do not take isotretinoin if you are taking tetracycline antibiotics, such as doxycycline (Vibramycin) or demeclocycline (Declomycin, Declostatin, Ledermycin) or vitamin A.
Avoid taking isotretinoin if you're taking:
  • Acitretin (Soriatane, Neotigason)
  • Avage cream
  • Tazarotene (Fabior foam, Tazorac gel or cream)
Talk to your doctor about the risks and benefits of taking isotretinoin if you're using:
  • Any creams, washes, or lotions for acne, such as benzoyl peroxide or adapalene (Differin, Epiduo)
  • Phenytoin (Dilantin, Phenytek) or carbamazepine (Carbatrol, Tegretol, Equetro)
  • Corticosteroids, such as prednisone, prednisolone, or triamcinolone
  • The herbal treatments kava and black cohosh

Isotretinoin and Alcohol

You should avoid or limit drinking while taking isotretinoin.

Isotretinoin and Grapefruit Juice

The liver breaks down isotretinoin several different ways, one of them being the same as grapefruit juice.
Avoid grapefruit and the juice while you're taking isotretinoin.

Isotretinoin (Accutane) Dosage

Your doctor prescribes your dose and course of treatment based on your body weight.
Take isotretinoin quickly with a full glass of water, which prevents it from lodging in your esophagus and irritating it.
Some brands should be taken with food or milk.

Isotretinoin Overdose

If you suspect an overdose, you should contact a poison control center or emergency room immediately.
You can get in touch with a poison control center at (800) 222-1222.

Missed Dose of Isotretinoin

If you miss a dose of Isotretinoin, try to take it as soon as you remember.
If it's almost time for the next dose, just skip the missed dose and take your next dose as you normally would.
Don't take two doses of isotretinoin at the same time.

Isotretinoin Pictures

Accutane 10 mg, pink, oval, liquid filled
Accutane 40 mg, yellow, oval, liquid filled
Accutane 20 mg, maroon, oval, liquid filled
Amnesteem 10 mg, brown, oval,