Accutane is a brand-name version of the drug isotretinoin. The brand is no longer available in the United States. However, the generic version of isotretinoin and other brand-name versions, such as Absorica, are still available.
Isotretinoin is used to treat a type of severe acne called nodular acne. Nodular acne causes red, swollen, tender lumps to form in the skin. If untreated, nodular acne can lead to permanent scarring.
Your doctor will only prescribe isotretinoin when other treatments, including antibiotics, haven’t helped your nodular acne. While isotretinoin can help treat nodular acne, it can also cause many side effects. Some of these effects can be serious, especially if the drug is taken during pregnancy.
The mild side effects of isotretinoin can include:
- dry skin
- chapped lips
- dry eyes
- dry nose that may lead to nosebleeds
These side effects may go away on their own. If they don’t go away or if they become a problem, call your doctor.
The more serious side effects of isotretinoin can have long-term or permanent effects. However, apart from increased cholesterol and joint and muscle problems, these side effects are all quite rare.
Isotretinoin can increase the levels of fats and cholesterol in your blood. During your treatment, your doctor may suggest regular blood tests to check your fat and cholesterol levels. You’re at higher risk of these problems if you:
- have diabetes
- are obese
- have metabolic syndrome
- drink alcohol
This side effect, if you have it, typically goes away when you finish your treatment with isotretinoin.
Joint and muscle problems
Tell your doctor if you plan to do hard physical activity during treatment with isotretinoin. Isotretinoin can cause pain in your bones, joints, muscles, and ligaments. It can also stunt the growth of long bones in teens, which could have permanent effects. If you have any of the following symptoms, call your doctor right away:
- new back pain
- new joint pain
- broken bone
If you break a bone, be sure to tell all of the healthcare providers that care for you that you take isotretinoin.
If you have muscle weakness, with or without pain, stop taking isotretinoin and call your doctor right away. Muscle weakness can be a sign of serious muscle damage and could be a permanent effect.
Pressure on your brain
Rarely, isotretinoin can cause increased pressure on the brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking isotretinoin and call your doctor right away if you have any of these symptoms:
- severe headache
- blurry vision
- nausea and vomiting
If you have either of these symptoms, call 911 right away:
Although rare, a rash caused by isotretinoin can be serious. Stop using isotretinoin and call your doctor right away if you have any of the following symptoms:
- conjunctivitis (pink eye)
- a rash with fever
- blisters on your arms, legs, or face
- peeling skin
- sores in your mouth, throat, nose, or eyes (on the lid or the eye itself)
Isotretinoin can damage your internal organs. These organs include your liver, pancreas, intestines, and esophagus (the tube connecting your mouth and stomach). The damage may not get better even after you stop taking isotretinoin.
This side effect is rare. Still, stop taking isotretinoin and call your doctor right away if you have any of the following symptoms:
- severe pain in your stomach, chest, or lower abdomen
- trouble swallowing or pain during swallowing
- new or worsening heartburn
- bleeding from your rectum
- yellowing of your skin or the whites of your eyes
- dark urine
Isotretinoin can cause serious hearing problems in rare cases. Stop using isotretinoin and call your doctor right away if your hearing gets worse or if you have ringing in your ears. Any hearing loss may be permanent.
Vision and eye problems
Isotretinoin can cause vision problems such as blurry vision, double vision, and tunnel vision. This drug can also reduce your ability to see in the dark. Vision problems may fix themselves after you stop taking the drug or the damage may be permanent.
Isotretinoin can cause your eyes to produce more tears than normal. If you wear contact lenses, you may have trouble wearing them while taking isotretinoin. Like the other vision problems, this problem may go away after your stop treatment or it may be permanent.
All of these vision and eye problems are rare. Nevertheless, stop taking isotretinoin and call your doctor right away if you have problems with your vision, an increased amount of tears, or painful or constant eye dryness.
Isotretinoin can cause serious allergic reactions in rare cases. Stop taking isotretinoin and call your doctor if you have a rash, red patches, or bruises on your legs or a fever. If you have any of the following symptoms, stop taking isotretinoin and call 911 or go to the nearest emergency room:
- swelling in your face or mouth
- trouble breathing
Diabetes and other blood sugar problems
Isotretinoin may cause blood sugar problems, including diabetes. Call your doctor if you have any of the following symptoms:
- severe thirst
- urinating more often
- blurry vision
- increased tiredness
These may be diabetic symptoms caused by the drug. This effect is rare, though.
Low red blood cell levels
Another rare, serious side effect is a decrease in blood cell levels. Low levels of red blood cells can cause problems such as anemia. Call your doctor if you have any of the following symptoms:
- extreme tiredness
- coldness in your hands and feet
- pale skin
Low white blood cell levels
Low levels of white blood cells raise your risk of infections. Call your doctor if you have any of the following symptoms:
- frequent infections
This side effect is rare.
Mental health issues
Rarely, isotretinoin can cause serious mental health problems. These include depression, psychosis (losing touch with reality), and suicidal thoughts or actions. Stop using isotretinoin and call your doctor right away if you have any of the following symptoms:
- increased feelings of sadness
- crying spells
- loss of interest in activities you enjoy
- sleeping too much or trouble sleeping
- acting more irritable, angry, or aggressive than usual
- changes in appetite or weight
- lack of energy
- withdrawal from friends or family
- trouble concentrating
- feelings of worthlessness or guilt
- thoughts of hurting yourself or taking your own life
- hallucinations (seeing or hearing things that are not real)
If you’re a female who is pregnant or trying to become pregnant, you must avoid using isotretinoin. Taking isotretinoin during pregnancy carries an extremely high risk of severe birth defects. This is true if the drug is used in any amount and even for short periods of time.
If you become pregnant during treatment with isotretinoin, stop taking the drug right away. A gynecologist can then give you further evaluation and counseling.
Isotretinoin can cause birth defects such as:
- abnormalities of the face, eyes, ears, and skull
- problems with the central nervous system, cardiovascular system, and thymus and parathyroid glands
- reduced IQ
Miscarriages and premature births have also been reported with use of isotretinoin.
The iPLEDGE Program
Because of the risks it carries for pregnancies, isotretinoin can be prescribed only under a special restricted distribution program called iPLEDGE. This program is approved by the Food and Drug Administration. Both males and females who take isotretinoin need to discuss this program with their doctor. Doctors who prescribe isotretinoin and pharmacies that dispense isotretinoin must be registered and activated with the iPLEDGE Program. Female patients who receive isotretinoin must be registered and meet all of the requirements of iPLEDGE.
The requirements for the iPLEDGE are strict. If you’re a female who can become pregnant, you must have two negative urine or blood pregnancy tests before starting isotretinoin. The second pregnancy test must be done in a lab specified by your doctor. The program also requires females to choose and agree to use two forms of effective birth control at the same time. This precaution goes along with the third requirement. That is, you must agree not to become pregnant while using isotretinoin and for one month before or after treatment.
At least one of the birth control methods must be a primary form of birth control. Examples of these forms are tubal ligation (having your tubes tied), an IUD, and hormonal birth control. Another approach is for your partner to have a vasectomy.
The only exceptions to this requirement are if you have chosen not to have intercourse with a male (abstinence) or have had a hysterectomy (surgery to remove your uterus).
To find out more about the iPLEDGE program, ask your doctor or pharmacist.
As you can see, there are many risks linked with isotretinoin use. If you have more questions about these side effects, talk with your doctor. Questions you may ask include:
- Are there certain side effects that I may be at higher risk for?
- How can I reduce my risk of side effects?
- What can I do to manage side effects?
- How long do you think my treatment with isotretinoin will last?
- Are there other drugs I can take that may cause fewer or less-serious side effects?
Your doctor can help you decide if isotretinoin is the right drug for you. They can also help you manage any side effects you have.