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Updated on September 22, 2021

Accutane Uses, Risks & Side Effects

What is Accutane?

Accutane, the brand name for the drug isotretinoin, is a medication used to treat severe nodular acne. The drug is reserved for patients who have failed other therapies such as antibiotics or other conventionally used acne medications.

Accutane is a retinoid, similar to retinoic acid and retinol (vitamin A), that helps treat many skin conditions. Acne develops when sebaceous glands produce too much sebum in the skin, which consists of oils, wax, and cholesterol. Accutane works by inhibiting sebaceous gland function and keratinization to prevent acne formation.

Accutane pill

Accutane is available in 10, 20 and 40 milligram (mg) soft gel capsules taken by mouth. The dose is typically 0.5 to 1 mg per kilogram (kg) of your body weight per day. It is also important to take the drug with food to increase its absorption into the body. Doses are given twice a day over 15 to 20 weeks, and most patients are in complete remission at the end.

Over two million people have been prescribed Accutane to treat severe acne.

- American Osteopathic College of Dermatology (AOCD)

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Risks of Accutane

Accutane can cause severe birth defects, so you cannot take it if you are pregnant or planning to become pregnant. iPLEDGE is an online patient monitoring system created to help prevent fetal exposure to the drug. Patients who are prescribed Accutane must sign up for the iPLEDGE program to receive their medication.

If you have reproductive potential, you must meet several requirements to receive an Accutane prescription. For example, two methods of contraceptives must be used one month before, during, and one month after drug use. Additionally, two pregnancy tests are conducted and must be negative before you can be prescribed the drug. Each month of use, you must have a negative pregnancy test to continue receiving the prescription.

Serious birth defects can occur if using Accutane while pregnant. Documented cases include:

  • Skull abnormalities
  • Eye abnormalities
  • Central nervous system abnormalities
  • Thymus gland abnormality
  • Parathyroid hormone deficiencies
  • Cardiovascular abnormalities

In some cases, death has resulted from these abnormalities. There is also an increased risk of spontaneous abortions, and premature births have occurred.

Accutane may cause psychosis, depression and, rarely, suicide attempts, suicidal ideation, suicide, and aggressive or violent behaviors. Before beginning treatment, talk with your doctor about any prior mental health history. If you experience any mental health symptoms during therapy, contact your doctor immediately. Signs of depression to be aware of while taking Accutane include:

  • Hopelessness
  • Sad or depressed mood
  • Feelings of worthlessness or guilt
  • Fatigue
  • Suicidal attempts or thoughts
  • Restlessness or irritability
  • Loss of interest in activities
  • Difficulty concentrating
  • Changes in sleep patterns
  • Loss of appetite
  • Changes in weight

Pseudotumor cerebri is a condition in which the pressure around your brain increases. This can occur in patients taking Accutane in conjunction with the antibiotic tetracycline. Speak with your doctor if you develop these symptoms:

  • Headache
  • Papilledema (swelling of the optic nerve)
  • Nausea and vomiting
  • Visual disturbances

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Side Effects of Accutane

Many side effects can occur while taking Accutane. The more common and less severe include:

  • Skin rash
  • Bone or joint pain, or broken bones
  • Dry lips, mouth, and skin
  • Nosebleeds
  • Redness, itching, or burning of the eyes

More serious side effects that can occur while taking Accutane include:

  • Stomach problems — organ damage can occur in the liver, pancreas, intestines, and esophagus. Acute pancreatitis can result from using Accutane; seek medical attention if you have severe abdominal pain, chills, nausea, vomiting, fever or constipation.
  • Vision problems — the drug may affect your ability to see in the dark. It may also make your eyes dry, making wearing contacts difficult.
  • Hearing problem — if you have ringing in your ears or your hearing gets worse, contact your doctor.
  • Blood sugar problems — monitor your blood sugar levels during therapy, particularly if you have diabetes, as the drug may affect them.
  • Lipid problems — Accutane can raise lipid levels in the blood. Blood work will be done while taking the drug to monitor levels of fats and cholesterol.
  • Allergic reactions — if you have an allergy to food dyes, inform your doctor as you may react negatively to the drug. Seek emergency medical attention immediately if you develop a swollen face, hives, or have difficulty breathing.

It is important to wear sunscreen regularly to ensure Accutane is working properly. During the first two to three weeks of treatment, your skin will be more sensitive to damage from sun, wind, or cold weather. So, avoid exposing your skin to the sun by wearing protective clothing and hats.

Is Accutane Addictive?

Accutane has not been shown to be addictive. Talk with your doctor if you have any concerns about the drug and alternate options that may be available.

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Resources

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American Osteopathic College of Dermatology. “Accutane.” AOCD, https://www.aocd.org/page/Accutane

Food and Drug Administration. “Accutane label.” FDA, Jan. 2010, https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018662s060lbl.pdf

iPLEDGE. “About Isotrentinoin.” iPLEDGE, https://www.ipledgeprogram.com/iPledgeUI/aboutDrug.u

Makrantonaki, E., Ganceviciene, R., Zouboulis, C. “An update on the role of the sebaceous gland in the pathogenesis of acne.” Dermato-Endocrinology, Jan.-Mar. 2011, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3051853/

Mayo Clinic. “Isotretinoin (Oral Route).” Mayo Clinic, Feb. 2020, https://www.mayoclinic.org/drugs-supplements/isotretinoin-oral-route/proper-use/drg-20068178

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