Suffering with severe acne is no walk in the park. Not only do you have to deal with the kind of debilitating acne that can scar and damage your skin, but you have to deal with the emotional and financial side effects as well. Severe acne can make your self-esteem plummet and may leave your wallet practically empty thanks to all of the acne medication that you’ve been purchasing in the hopes of finally clearing up your problem.

Systemic Retinoid for Moderate to Severe Acne

If you’ve been suffering from severe acne for some time now, it might be time to talk to your doctor or dermatologist about isotretinoin, a systemic acne drug approved by the FDA. Isotretinoin is the generic form of the brand name drugs Accutane®, Amnestreem®, Claravis®, and Sotret. This orally-administered drug is available by prescription only and is used for moderate to severe nodular acne that has failed to respond to other treatments (e.g., topical agents and oral antibiotics).Acne conglobata is characterized by large, interconnected cysts (nodules) that are filled with pus, often painful, and can lead to scarring.1,2

How Isotretinoin Works

Isotretinoin is an orally administered retinoid closely related to vitamin A. Although how isotretinoin works to relieve acne is not completely understood, it is believed to inhibit production of oil from the sebaceous glands which in turn reduces formation of inflammatory, scarring lesions. Patients typically take 0.5-1.0 mg per kg of body weight daily, and most improve within one treatment course of 20 weeks. Doses up to 2.0 mg/kg of body weight may be needed for especially severe cases, for as many as three courses of 20 weeks. Isotretinoin can provide prolonged relief and even complete remission of the condition in most patients for many months.1,2

iPledge Program to Help Avoid the Danger of Birth Defects

Isotretinoin can have some serious side effects, especially for fetuses of pregnant women. If you are a female of child-bearing age who has not gone through menopause (surgical or natural), you should know that isotretinoin can cause severe and life-threatening birth defects if you should become pregnant. That’s why if your dermatologist prescribes you Accutane, you must agree to use two effective forms of birth control to ensure that you won’t become pregnant. You’ll also be required to have two negative pregnancy tests before beginning treatment and once-monthly pregnancy tests during your isotretinoin treatment. You should not take this medication while breastfeeding.

In fact, isotretinoin is only available in the United States under a mandatory Food and Drug Administration program called iPledge. Both men and women who want to use isotretinoin must register in the program and sign documents stating that they understand the dangers of this medication and agree to use birth control as required. Doctors cannot prescribe isotretinoin and pharmacists cannot fill a prescription for it without registration in the iPledge program and verification of patient’s program participation.1

Other Possible Side Effects

Some side effects of isotretinoin include:

  • Achy joints (common)1
  • Acne flares in previously lesion-free areas (early-on in treatment for people with darker skin tones, but typically resolved as treatment continues)3
  • Angular cheilitis —inflammatory condition in corners of mouth (very common, often with staph infection)2
  • Arthritis (rare)2
  • Decreased high-density lipoproteins (HDLs, or “good” cholesterol)2
  • Depression (rare)2
  • Dry mouth (very common)2
  • Eczema-like dry skin (typically resolved with topical glucocorticoids)1,2
  • Eye inflammation1
  • Fungal infection around finger- or toenail (very rare)2
  • Grayish facial hue (from dry skin in people with darker skin tones)3
  • Hair loss (very rare, and reversible)2
  • Headaches (rare)2
  • Increased triglycerides (so-called “bad” cholesterol)2
  • Muscle pain (rare)1,2
  • Night blindness2
  • Nosebleeds (rare)2
  • Pruritus1

Experts suggest that blood lipid tests should be administered prior to prescribing isotretinoin because of the possible increased cardiovascular risk.2

Rare but serious and potentially fatal side effects include:

  • Acute pancreatitis. Since isotretinoin increases triglycerides in about 25% of those who take it, acute pancreatitis can be a significant concern.2 This is because triglyceride levels over 800 mg/µL can cause sudden inflammation in the pancreas.2 Often beginning with severe pain in the upper abdomen, symptoms may include swelling, fever, nausea, and vomiting.3 Acute pancreatitis can lead to serious complications involving organ failure and even death if bleeding occurs within the pancreas.3
  • Brain swelling. Caused by an accumulation of cerebrospinal fluid, the pressure inside the skull can cause headaches, nausea, vision impairment, and vomiting.1 There is an increased risk of this side effect if isotretinoin is used with the antibiotic tetracycline, which also can cause this brain swelling.2 Experts recommend never using the two drugs together.2
  • Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis. Life-threatening skin reactions characterized by fever, chills, aches, sore throat, stinging eyes, conjunctivitis , and joint pain one to three days before skin rash appears. Rash is followed by skin blisters, mouth and throat sores, and peeling skin. If you experience any of these symptoms, stop taking isotretinoin and seek medical attention immediately. These types of severe skin reactions, though extremely rare, can be fatal.5

However, for some acne sufferers, isotretinoin is the only medication that truly works. Be sure to ask your doctor or dermatologist any questions that you may have about isotretinoin before you start the treatment, and take note of all side effects that you may experience for safety’s sake.


Ogbru, Omudhome. Skin Center: isotretinoin, Sotret, Claravis, Amnesteem, (Accutane is no longer available). MedicineNet. [Online] July 13, 2010. [Cited: December 27, 2010.]
Wolff, Klaus and Johnson, Richard Allen. Fitzpatrick’s Color Atlas and Synopsis of Clinical Dermatology. 6. New York City : The McGraw-Hill Companies, 2009. ISBN 978-0-07-159975-7.
Davis, Erica C. and Callender, Valerie D. J Clin Aesthet Dermatol. 3(4): A Review of Acne in Ethnic Skin. [Online] April 2010. [Cited: December 27, 2010.]
National Digestive Diseases Information Clearinghouse. Pancreatitis. U.S. Department of Health and Human Services: National Institute of Diabetes and Digestive and Kidney Diseases. [Online] July 2008. [Cited: December 27, 2010.] NIH Publication No. 08–1596.
Biondi, Lorenzo. Hoffmann-La Roche Limited: Accutane (isotretinoin) - Association with Cases of Severe Skin Reactions - For the Public. Health Canada. [Online] February 11, 2010. [Cited: December 27, 2010.]
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