Provide a valuable resource to your clients or customers by linking to this resource page. Just place the following link on your website.
Isotretinoin is a prescription oral retinoid indicated for severe recalcitrant nodular acne in nonpregnant patients age 12 and older. It is reserved for severe nodular acne that has not responded to conventional treatment, including systemic antibiotics. Isotretinoin is available only through the iPLEDGE REMS.
read more about isotretinoin ...Isotretinoin is a retinoid related to vitamin A. Its exact mechanism in severe nodular acne is not fully established. Treatment reduces sebaceous gland activity and sebum production and changes processes involved in acne formation.
Isotretinoin is used in nonpregnant patients age 12 and older with severe recalcitrant nodular acne. Patients who can become pregnant follow pregnancy testing and pregnancy prevention requirements before, during, and after treatment through the iPLEDGE REMS.
The recommended dose is 0.5 mg to 1 mg per kg per day in two divided doses with food for 15 to 20 weeks. Capsules are swallowed whole with a full glass of liquid. A second treatment course is not recommended until at least two months after the first course ends.
Isotretinoin carries a boxed warning for embryo-fetal toxicity and is contraindicated in pregnancy. Other serious concerns include psychiatric disorders, intracranial hypertension, severe skin reactions, pancreatitis, lipid abnormalities, liver toxicity, hearing impairment, inflammatory bowel disease, musculoskeletal effects, and eye disorders. Fasting lipids and liver tests are checked before treatment.
Isotretinoin treats severe recalcitrant nodular acne in nonpregnant patients age 12 and older.
The recommended range is 0.5 mg to 1 mg per kg per day in two divided doses with food.
It is a restricted safety program required for isotretinoin due to the severe embryo-fetal toxicity risk.
No. Isotretinoin is contraindicated in pregnancy due to the extremely high risk of severe birth defects.
iPLEDGE Risk Evaluation and Mitigation Strategy (REMS). https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/ipledge-risk-evaluation-and-mitigation-strategy-rems. Date Accessed October 5, 2026.
Isotretinoin Capsule Information. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/isotretinoin-capsule-information. Date Accessed October 5, 2026.
Isotretinoin Capsules Prescribing Information. https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1cf11710-f966-4529-8e08-02175f588bca. Date Accessed October 5, 2026.
Isotretinoin: MedlinePlus Drug Information. https://medlineplus.gov/druginfo/meds/a681043.html. Date Accessed October 5, 2026.
Isotretinoin. https://www.ncbi.nlm.nih.gov/books/NBK525949/. Date Accessed October 5, 2026.