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Accutane Side Effects


Accutane side effects will be divided into three groups as shown below.A black box warning means that medical studies and clinical trials have shown that the drug in question has a significant risk of serious or possibly even life-threatening adverse effects. It is the strongest warning that the Food & Drug Administration (FDA) requires and is so called because of the black border around the warning on drug package inserts.

Accutane Chemical Structure


Black Box Warning

Women who are or may become pregnant must NOT use Accutane even for a short time because of the high risk of very severe birth defects.

Here is a breakdown of Accutane side effects and the frequency with which they occur.

Frequently Occur:

  • dry skin, eyes, nose and/or mouth
  • voice changes
  • flushing
  • sweating
  • skin peeling, especially on the palms and soles of feet
  • bleeding or swollen gums
  • red, cracked, and sore lips
  • nosebleeds
  • changes in skin color
  • tiredness
  • cold symptoms
  • cuts and sores taking longer to heal
  • changes in the nails

Sometimes Occur:

  • headache
  • swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
  • chest pain
  • blurred vision
  • painful or constant dryness of the eyes
  • upset stomach
  • dizziness
  • vomiting
  • seizures
  • slow or difficult speech
  • weakness or numbness of one part or one side of the body
  • stomach pain
  • difficulty swallowing or pain when swallowing
  • new or worsening heartburn
  • rectal bleeding
  • yellowing of the skin or eyes
  • dark colored urine
  • back, bone, joint or muscle pain
  • muscle weakness
  • difficulty hearing
  • ringing in the ears
  • vision problems
  • unusual thirst
  • frequent urination
  • trouble breathing
  • fainting
  • fast or pounding heartbeat
  • fever
  • rash
  • red patches or bruises on the legs
  • diarrhea

Rarely Occur:

  • suicidal ideation
  • attempted suicide
  • suicide
  • aggressive and/or violent behaviors
  • Accutane also has some other serious warnings that you should be aware of just in case you plan on taking this medication. Accutane can cause:

    • depression
    • psychosis


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    Drug Manufacturer Information

    Roche Laboratories Inc.
    340 Kingsland Street
    Nutley, NJ 07110-1199
    973-235-5000

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    April 28, 2009

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