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
Plain-language summary, compiled from the cited regulatory records
Isotretinoin is a medication classified as a retinoid for topical use in acne [1]. It is approved for the treatment of severe recalcitrant nodular acne [1]. Nodules are defined as inflammatory lesions measuring 5 mm or greater in diameter, which may become suppurative or hemorrhagic [1]. The term "severe" indicates a large number of nodules, rather than just a few or several [1]. Due to significant potential adverse effects, isotretinoin capsules are typically reserved for patients with severe nodular acne who have not responded to other treatments [1].
In the past 12 months, there have been 3,087 adverse event reports associated with isotretinoin [2]. Common adverse reactions reported include depression and dry skin [2].
This is not medical advice. Consult a qualified healthcare professional.
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
Severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. The prescriber must consider that there is no other appropriate effective treatment before initiation of isotretinoin therapy.
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
1 INDICATIONS AND USAGE Isotretinoin capsules 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, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Isotretinoin capsules 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, isotretinoin capsules 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 isotretinoin 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.
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) · PL556120041 · revised May 29, 2026
- [2]Health Canada (DPD) · 00582344 · revised March 3, 2026
- [3]FDA DailyMed · 08529687-26b2-41… · revised February 13, 2026 [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.