FDA approved Absorica (isotretinoin) for Severe Recalcitrant Nodular AcneFDA approved new acne drug Absorica for severe cases

FDA From the archive Source published May 25, 2012 Summary added June 16, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider reserving Absorica for severe nodular acne unresponsive to conventional therapy; monitor pregnancy and lipids.

The FDA has approved Absorica (isotretinoin) for the treatment of severe recalcitrant nodular acne in non-pregnant patients aged 12 years and older with multiple inflammatory nodules 5 mm or greater. Because of significant adverse reactions, Absorica is reserved for patients who are unresponsive to conventional therapy, including systemic antibiotics. The approval is based on a double-blind, randomized trial comparing Absorica to another isotretinoin product, though specific efficacy data are not available in the label. Clinicians should note that Absorica is not substitutable with Absorica LD due to different bioavailability and dosing. A second course is not recommended before a two-month waiting period, as acne may continue to improve after a 15 to 20-week course.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Not reported in label.

Indication & Patient Population

Absorica is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. It is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.

Dosing & Administration

The recommended dosage of Absorica is 0.5 to 1 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks. Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day in divided doses. Once daily dosing is not recommended. If a dose is missed, skip that dose; do not take two doses at the same time. Prior to prescribing, perform pregnancy testing, fasting lipid profile, and liver function tests. Pregnancy tests should be performed monthly during therapy, at end of therapy, and one month after discontinuation.

Key Clinical Trial Data

The effectiveness of Absorica for the treatment of severe recalcitrant nodular acne in patients 12 years and older is based on a double-blind, randomized, parallel group trial (Study 1) in subjects with severe recalcitrant nodular acne who received Absorica or another isotretinoin capsule product under fed conditions. Specific efficacy results are not available in the label.

Warnings & Contraindications

Absorica is contraindicated in pregnant patients. Because of significant adverse reactions, it is reserved for patients unresponsive to conventional therapy. Laboratory monitoring includes pregnancy testing, fasting lipid profile, and liver function tests. If a second course is needed, a two-month waiting period is recommended. Long-term use has not been studied.

Place in Therapy

Absorica is a retinoid reserved for severe recalcitrant nodular acne unresponsive to conventional therapy including systemic antibiotics. It is not a first-line treatment. A second course requires a two-month waiting period due to potential continued improvement after the initial course.

The FDA has approved a new drug called Absorica (isotretinoin) to treat severe nodular acne. This type of acne causes large, painful bumps under the skin. Absorica is for patients aged 12 and older who have not gotten better with other treatments, including antibiotics. Because of serious side effects, it is only for people with severe acne that has not responded to standard therapy.

The approval was based on a study that compared Absorica to another isotretinoin product. However, the specific results are not available in the drug label. It is important to know that Absorica is not the same as Absorica LD. They have different doses and are not interchangeable. Also, a second course of treatment is not recommended until at least two months after the first course, because acne may continue to improve after the initial 15 to 20 week treatment.

This approval means there is a new option for people with severe acne that has not improved with other treatments. However, Absorica can cause serious side effects, including birth defects, depression, and liver problems. It is only available through a special program that requires regular blood tests and pregnancy monitoring for women who can become pregnant.

If you have severe acne, talk to your doctor about whether Absorica might be right for you. Your doctor can help you understand the risks and benefits and decide if this treatment is appropriate for your situation.

What this means for you:

Absorica is a new option for severe acne, but it has serious risks and is only for those who haven't improved with other treatments.

Study Details

Study typeFda approval

PublishedMay 2012

View Original Abstract ↓

1 INDICATIONS AND USAGE ABSORICA and ABSORICA LD are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use : If a second course of ABSORICA/ABSORICA LD therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see Dosage and Administration (2.2) ]. ABSORICA and ABSORICA LD are retinoids indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. (1) Limitations of Use: If a second course of ABSORICA/ABSORICA LD therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy. (1)

FDA approved Absorica (isotretinoin) for Severe Recalcitrant Nodular AcneFDA approved new acne drug Absorica for severe cases

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FDA approved Absorica (isotretinoin) for Severe Recalcitrant Nodular AcneFDA approved new acne drug Absorica for severe cases

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Clinical research that matters. Delivered to your inbox.

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