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  4. Postmarket Drug Safety Information for Patients and Providers
  5. Isotretinoin Capsule Information
  1. Postmarket Drug Safety Information for Patients and Providers

Isotretinoin Capsule Information

Information on Isotretinoin

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane, and is sometimes referred to by its former brand name, Accutane. Isotretinoin is a prescription medication used to treat severe recalcitrant nodular acne.

While isotretinoin is beneficial for some patients, there are risks associated with this drug. Specifically, isotretinoin is highly teratogenic (i.e., causes severe birth defects) and, therefore, is approved for marketing only under a restricted-distribution risk evaluation and mitigation strategy (REMS), called the iPLEDGE REMS.

iPLEDGE REMS

The FDA iPLEDGE information page has moved. For updates related to the iPLEDGE REMS , visit the FDA iPLEDGE webpage.

The iPLEDGE Program was originally implemented in early 2005 and approved as the iPLEDGE REMS in 2010. It is a “shared system” program, meaning that it includes all FDA-approved isotretinoin. The goals of the iPLEDGE REMS are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions. It provides a centralized system for prescribers, pharmacies, and patients to manage patient risk, regardless of which isotretinoin product is being used.

FDA Warning: Don't Buy Accutane Over the Internet

FDA ALERT [7/2005]: Suicidal Thoughts or Actions: In addition to the strengthened risk management program, FDA continues to assess reports of suicide or suicide attempts associated with the use of isotretinoin. All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression. Patients should stop isotretinoin and they or their caregiver should contact their healthcare professional right away if the patient has any of the previously mentioned symptoms. Discontinuation of treatment may be insufficient and further evaluation may be necessary. [Action taken 8/12/2005 Labeling revision]

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

Isotretinoin is marketed under these names:

  • Absorica
  • Absorica LD
  • Accutane (not currently marketed in the US)
  • Amnesteem
  • Claravis
  • Myorisan
  • Zenatane

To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this sheet.

 FDA Warning:
Risks of Buying isotretinoin over the Internet

Isotretinoin is a potentially dangerous prescription medicine that should only be taken under the close supervision of your healthcare professional and pharmacist. If you are pregnant or may get pregnant, isotretinoin can cause birth defects, miscarriage, premature births, and death in babies. Buying this product over the Internet bypasses important procedures to ensure that patients can take this drug safely. When these procedures are ignored, isotretinoin can cause serious and harmful side effects. Patients taking isotretinoin may experience side effects including bad headaches, blurred vision, dizziness, nausea, vomiting, seizures, stroke, diarrhea, and muscle weakness. Additionally, serious mental health problems, such as depression and suicide, have been reported with isotretinoin use.

  • You should NEVER buy isotretinoin without first seeing your healthcare professional.
  • You should NEVER take isotretinoin if you are pregnant or trying to get pregnant or could accidentally become pregnant.
  • Some websites sell prescription drugs without a prescription. This is illegal and DANGEROUS.

Labeling and Regulatory History from Drugs@FDA

 

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