Isotretinoin

SFDA Saudi Arabia — SFDA human drug list

US FDA United States — FDA approvals (Drugs@FDA)

Canada Canada — marketed products (Health Canada)

Prices — United States and England

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

• US FDA 11 Aug 2026 ABSORICA — safety-related labeling change
  Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
• US FDA 11 Aug 2026 ABSORICA LD — safety-related labeling change
  Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
• MHRA 31 Oct 2023 Isotretinoin (Roaccutane▼): introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of age
  We have strengthened the safe use of isotretinoin through the introduction of additional oversight of the initiation of isotretinoin in patients under 18 years and through improved assessment and monitoring of mental health and sexual function issues. We ask healthcare professionals to review these new measures and supporting materials and integrate them into their clinical practice when referring patients and when prescribing or dispensing isotretinoin.
• MHRA 26 Apr 2023 Isotretinoin (Roaccutane▼): new safety measures to be introduced in the coming months, including additional oversight on initiation of treatment for patients under 18 years
  The Isotretinoin Expert Working Group of the Commission on Human Medicines has made recommendations to strengthen the safety of isotretinoin treatment. Recommendations include new warnings, the need for consistent monitoring requirements for psychiatric side effects, the introduction of new monitoring requirements for sexual side effects, and additional oversight of the initiation of treatment for patients younger than 18 years.
• MHRA 16 Nov 2020 Isotretinoin (Roaccutane▼): contribute to expert review
  A review is being undertaken by the Medicines and Healthcare products Regulatory Agency with advice from the Commission on Human Medicines and the Isotretinoin Expert Working Group due to concerns about the possible association between isotretinoin and suspected psychiatric and sexual disorders. We invite patients and their families, healthcare professionals, researchers and organisations to contribute views and information to the review.
• MHRA 26 Aug 2020 Isotretinoin (Roaccutane▼): reminder of important risks and precautions
  We remind healthcare professionals that isotretinoin should only be used for severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Prescription of isotretinoin should be supervised by specialist dermatologists with a full understanding of the potential risks and monitoring requirements.
• MHRA 26 Oct 2017 Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased libido
  Cases of sexual dysfunction, predominantly involving erectile dysfunction and decreased libido, have been reported rarely in patients taking oral isotretinoin for severe acne.
• MHRA 19 Dec 2014 Isotretinoin (Roaccutane): reminder of possible risk of psychiatric disorders
  Warn patients and family, monitor patients for signs of depression
• MHRA 11 Dec 2014 Isotretinoin: risk of serious skin reactions
  Erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis reported in association with isotretinoin - may result in hospitalisation, disability, life-threatening events, or death.

All safety entries for isotretinoin →

Combinations containing Isotretinoin

• Erythromycin + isotretinoin