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Oral isotretinoin therapy for acne vulgaris

Cindy Owen, MD
Section Editors
Robert P Dellavalle, MD, PhD, MSPH
Moise L Levy, MD
Mark V Dahl, MD
Deputy Editor
Abena O Ofori, MD


Oral isotretinoin (13-cis retinoic acid) is effective for the treatment of severe recalcitrant nodular acne. However, isotretinoin is associated with multiple adverse effects and is teratogenic. Thus, it must be used with appropriate caution in selected patients.

This topic will discuss clinical use of oral isotretinoin and related safety concerns. The pathogenesis, clinical manifestations, diagnosis, and conventional treatment of acne vulgaris are discussed separately. (See "Pathogenesis, clinical manifestations, and diagnosis of acne vulgaris" and "Hormonal therapy for women with acne vulgaris" and "Treatment of acne vulgaris".)


Oral isotretinoin counteracts the pathogenic factors that contribute to the development of acne vulgaris [1,2]. Therapy leads to shrinkage of sebaceous glands and a marked attenuation of sebum secretion. The decrease in sebum results in the inhibition of the sebum-dependent bacterium Cutibacterium (formerly Propionibacterium) acnes, which is a key promoter of inflammation in acne vulgaris. Oral isotretinoin also inhibits comedogenesis by fostering keratinocyte differentiation and by normalizing desquamation.


Oral isotretinoin is effective for the treatment of acne vulgaris [3-10]. The first study to show the benefit of oral isotretinoin was a case series of 14 patients with treatment-resistant severe acne [3]. After four months of treatment, 13 out of 14 patients experienced complete clearance of their disease.

Indications — In the United States, the Food and Drug Administration (FDA) approved usage of oral isotretinoin only for severe, recalcitrant, nodular acne. "Severe, recalcitrant, nodular acne" is defined as acne with many (greater than 5 mm) inflammatory nodules that is unresponsive to conventional therapy, including systemic antibiotics.

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Literature review current through: Dec 2017. | This topic last updated: Aug 29, 2017.
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