Drug Information: Isotretinoin – Accutane Part 2

What side effects can this medication cause?

Isotretinoin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • red, cracked, and sore lips
  • dry skin, eyes, mouth, or nose
  • nosebleeds
  • changes in skin color
  • peeling skin, especially on the palms and soles
  • changes in the nails
  • slowed healing of cuts or sores
  • bleeding or swollen gums
  • hair loss or unwanted hair growth
  • sweating
  • flushing
  • voice changes
  • tiredness
  • cold symptoms

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • headache
  • blurred vision
  • dizziness
  • upset stomach
  • vomiting
  • seizures
  • slow or difficult speech
  • weakness or numbness of one part or side of the body
  • stomach pain
  • chest pain
  • difficulty swallowing or pain when swallowing
  • new or worsening heartburn
  • diarrhea
  • 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
  • painful or constant dryness of the eyes
  • unusual thirst
  • frequent urination
  • trouble breathing
  • fainting
  • fast or pounding heartbeat
  • fever
  • rash
  • red patches or bruises on the legs
  • swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs

Isotretinoin may cause the bones to stop growing too soon in teenagers. Talk to your child’s doctor about the risks of giving this medication to your child.

Isotretinoin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

  • vomiting
  • flushing
  • severe chapped lips
  • stomach pain
  • headache
  • dizziness
  • loss of coordination

Anyone who has taken an overdose of isotretinoin should know about the risk of birth defects caused by isotretinoin and should not donate blood for 1 month after the overdose. Pregnant woman should talk to their doctors about the risks of continuing the pregnancy after the overdose. Women who can become pregnant should use two forms of birth control for 1 month after the overdose. Men whose partners are or may become pregnant should use condoms or avoid sexual contact with that partner for 1 month after the overdose because isotretinoin may be present in the semen.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to isotretinoin.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand name(s):

  • Accutane®
  • Amnesteem®
  • Claravis®
  • Sotret®

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