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U.S. Department of Health and Human Services

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Historical Information on Isotretinoin (marketed as Accutane)

 

Many of these items are out-of-date.
For current information on Accutane (isotretinoin), click on Isotretinoin (marketed as Accutane) Capsule Information

 

 

Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.

 

Contact FDA

1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

Mail to: MedWatch 5600 Fishers Lane

Rockville, MD 20857