Isotretinoin
Active ingredient · 2 therapeutic classes
Sold as CLARUS · EPURIS · ACCUTANE · ABSORICA LD
- Drug class
- Retinoids For Topical Use In Acne
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 35
- FDA reports (12 mo)
- 3,087
Overview
Isotretinoin is an active pharmaceutical ingredient in the Retinoids For Topical Use In Acne group (D10AD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 21 | May 29, 2026 |
| CA Canada | Health Canada | 12 | March 3, 2026 |
| US United States | FDA | 2 | February 13, 2026 |
GBUnited Kingdom· MHRA
21 products
Uses
Isotrex Cream is indicated for the topical treatment of mild to moderate acne vulgaris especially if comedones are predominant. The cream is particularly suitable for patients with dry skin.
How to take
CACanada· Health Canada
12 products
Uses
ACCUTANE™ (isotretinoin) is indicated for the treatment of: • Severe Nodular and/or Inflammatory Acne • Acne Conglobata • Recalcitrant Acne Because of significant side effects associated with its use, ACCUTANE should be reserved for patients where the conditions listed above are unresponsive to conventional first line therapies.
ACCUTANE should only be prescribed by physicians knowledgeable in the use of retinoids systemically, who understand the risk of teratogenicity in females of child bearing age and who are experienced in counselling young adults for whom ACCUTANE is generally indicated (see
How to take
USUnited States· FDA
2 products
Uses
INDICATIONS AND USAGE
Severe Recalcitrant Nodular Acne Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic.
"Severe," by definition, 2 means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.
In addition, isotretinoin capsules are indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.
Drug interactions
Known interactions involving Isotretinoin. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL194940069 · revised November 3, 2017
- [2]Health Canada (DPD) · 00582344 · revised March 3, 2026
- [3]FDA DailyMed · 0114567b-3bac-49… · revised June 26, 2024 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.