Trade Name: Accutane
Other Name: 13-cis-Retinoic
Isotretinoin is an anti-cancer drug. Isotretinoin is classified as a retinoid.
(For more detail, see "How Isotretinoin Works" section below).
What Isotretinoin Is Used For:
- Being investigated for use treating various different cancers.
- Treatment of severe acne.
Note: If a drug has been approved for one use, physicians sometimes elect
to use this same drug for other problems if they believe it might be helpful.
How Isotretinoin Is Given:
- By mouth in the form of a soft gelatin capsule, capsule sizes are 10, 20 and 40mg.
- Protect capsules from light.
- Take capsules with a meal and a full glass of liquid.
- The amount of Isotretinoin you will receive depends on many factors, including your
height and weight, your general health or other health problems, and the type of
cancer you have. Your doctor will determine your dosage and schedule.
Side Effects of Isotretinoin:
Important things to remember about the side effects of Isotretinoin:
- Most people do not experience all of the side effects listed.
- Side effects are often predictable in terms of their onset and duration.
- Side effects are almost always reversible and will go away after treatment is complete.
- There are many options to help minimize or prevent side effects.
- There is no relationship between the presence or severity of side effects and the
effectiveness of the medication.
The following side effects are common (occurring in more than 30%) for patients
These are less common side effects (occurring in 10-29%) for patients receiving
Rare but serious possible side effects of Isotretinoin:
- Blood clots.
Blood clots rarely can lead to pulmonary embolus or stroke - potentially life-threatening
- Pancreatitis (inflammation of the pancreas) is a rare side effect. Mainly
noted in blood tests that return to normal after therapy is discontinued.
Rarely may be severe causing symptoms. Symptoms of acute pancreatitis include
pain in the upper abdomen that worsens with eating, swollen and tender abdomen,
nausea, vomiting, fever, and rapid pulse. If these symptoms occur notify your
health care professional immediately.
- A very serious side effect that has been observed in patients that have taken medications
similar to Isotretinoin for treatment of leukemia, is called APL differentiation
syndrome. This syndrome is a reaction between the drug and the leukemia. It is preventable
with proper monitoring and immediate treatment. This syndrome produces fever,
difficulty breathing, weight gain, lung and heart problems. It is generally
treated with high-dose steroids. Be sure to let your health care professional know
if you experience fever of 100.5F or 38C, difficulty breathing, or sudden weight
Not all side effects are listed above, some that are rare (occurring in less than
10% of patients) are not listed here. However, you should always inform your
health care provider if you experience any unusual symptoms.
When To Contact Your Doctor or Health Care Provider:
Contact your health care provider immediately, day or night, if you should experience
any of the following symptoms:
- Shortness of breath, wheezing, difficulty breathing, closing up of the throat, swelling
of facial features, hives (possible allergic reaction)
- Fever of 100.4 F (38 C) or higher, chills (possible signs of infection)
- Having thoughts or feeling like you may want to harm yourself or others
- Difficulty breathing, sudden weight gain, swelling, vision changes
- Severe abdominal pain
The following symptoms require medical attention, but are not emergency situations.
Contact your health care provider within 24 hours of noticing any of the following:
- Black or tarry stools, or blood in your stools or urine
- Unusual bleeding or bruising
- Abdominal cramping
- Nausea (interferes with ability to eat and unrelieved with prescribed medications)
- Vomiting (more than 4-5 episodes within a 24-hour period)
- Diarrhea (more than 4-6 episodes in a 24-hour period)
- Mouth sores (painful redness, swelling or ulcers)
- Extreme fatigue (inability to perform self-care activities)
- Anxiety, changes in thinking or mood, confusion, difficulty concentrating or trouble
sleeping, aggressive or violent behavior, or suicidal thoughts.
- Depressed (interfering with your ability to carry on your regular activities)
- Ringing in the ears, problems with hearing
- Yellowing of the skin or eyes
Always inform your health care provider if you experience any unusual symptoms.
- Before starting Isotretinoin treatment, make sure you tell your doctor about any
other medications you are taking (including prescription, over-the-counter, vitamins,
herbal remedies, etc.). Do not take aspirin, or products containing aspirin
unless your doctor specifically permits this.
- Do not take vitamin A supplements. Vitamin A in high doses has many of the
same side effects as Isotretinoin. Taking both together may increase your
chance of getting side effects.
- Do not receive any kind of immunization or vaccination without your doctor's approval
while taking Isotretinoin.
- Inform your health care professional if you are pregnant or may be pregnant prior
to starting this treatment. Pregnancy category X (Isotretinoin may cause fetal harm
when given to a pregnant woman. Isotretinoin must not be given to a pregnant
woman or a woman who intends to become pregnant. If a woman becomes pregnant
while taking Isotretinoin, the medication must be stopped immediately and the woman
given appropriate counseling).
- Because of the extremely high risk that a deformed infant can result if pregnancy
occurs while taking Isotretinoin in any amount even for short periods of time, for
both men and women: Do not conceive a child (get pregnant) while taking Isotretinoin.
Two methods of effective contraception are recommended for women of childbearing
potential, unless absolute abstinence is the chosen method. Discuss with your
doctor when you may safely become pregnant or conceive a child after therapy.
- Do not breast feed while taking Isotretinoin.
Isotretinoin Self Care Tips:
- Take Isotretinoin at about the same time every day along with a meal that includes
- Avoid grapefruit juice
- Avoid wearing contact lenses if you have dry or irritated eyes
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed
- You may be at risk of infection so try to avoid crowds or people with colds, and
report fever or any other signs of infection immediately to your health care provider.
- Wash your hands often.
- To reduce nausea, take anti-nausea medications as prescribed by your doctor, and
eat small, frequent meals.
- To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times
a day with 1/2 to 1 teaspoon of baking soda and/or 1/2 to 1 teaspoon of salt mixed
with 8 ounces of water.
- When you start taking Isotretinoin, you may experience headache, loss of night vision,
sleepiness or eyesight changes. Use caution when driving or engaging in tasks
requiring alertness until response to drug is known.
- Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.
- In general, drinking alcoholic beverages should be kept to a minimum or avoided
completely. You should discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition.
- If you experience symptoms or side effects, be sure to discuss them with your health
care team. They can prescribe medications and/or offer other suggestions that
are effective in managing such problems.
Monitoring and Testing While Taking Isotretinoin:
You will be monitored regularly by your health care professional while you are taking
Isotretinoin to monitor side effects and check your response to therapy. For
women of childbearing age, a pregnancy test is required one week prior to beginning
this therapy and every month during treatment. Blood counts and lipid (fats,
cholesterol) levels and liver function all need to be analyzed before treatment
begins and regularly during treatment. These are measured through blood tests.
How Isotretinoin Works:
Retinoids are drugs that are relatives of vitamin A. Retinoids control normal
cell growth, cell differentiation (the normal process of making cells different
from each other), and cell death during embryonic development and in certain tissues
later in life. Retinoids effects on the cells are controlled by receptors
on the nucleus of each cell (nuclear receptors).
There are two major classes of retinoid nuclear receptors: retinoic acid receptors
(RAR) and retinoid-X-receptors (RXR). There are also subtypes within each
class. Each of these types of receptors has different functions in different
tissues. The different retinoid drugs work by binding to different receptors;
which, in turn, affect cell growth and differentiation.
Retinoids are relatively new types of anti-cancer drugs. They have been used
alone or in combination to treat a variety of cancers such as skin cancers, cutaneous
T-cell lymphoma, acute promyelocytic leukemia, lung cancer, breast cancer, ovarian
cancer, bladder cancer, kidney cancer, and head and neck cancers. Retinoids
have also been used experimentally in an attempt to prevent certain types of cancer.
There is ongoing research to determine their role in both cancer treatment and prevention.
Retinoids have been associated with side effects such as skin problems (dryness,
peeling, itching, sun sensitivity), reversible elevation in liver enzymes, temporary
abnormal lipid levels, low thyroid levels (hypothyroidism), and headaches.
Taking supplemental doses of vitamin A may increase the side effects. Vitamin
supplementation should be discussed with your physician.
Note: We strongly encourage you to talk with your health care professional
about your specific medical condition and treatments. The information contained
in this website is meant to be helpful and educational, but is not a substitute
for medical advice.