Accutane (isotretinoin) is one of the most effective acne treatments available, but it carries some of the most serious side effects of any prescription medication. The worst include severe birth defects if taken during pregnancy, psychiatric changes including depression and suicidal thoughts, liver damage, a rare condition that mimics a brain tumor, and vision problems that can occasionally become permanent. Most people complete treatment without experiencing these severe reactions, but understanding the risks is important before and during a course of the drug.
Birth Defects: The Most Dangerous Risk
Isotretinoin causes life-threatening birth defects in a developing fetus. This is not a small or theoretical risk. It is so dangerous that the FDA requires every patient, prescriber, and pharmacist to participate in a federal safety program called iPLEDGE before a single pill can be dispensed. The program exists for one reason: to prevent pregnancy during treatment.
If you can become pregnant, the iPLEDGE requirements include a pregnancy test in a medical setting before starting treatment, ongoing pregnancy tests throughout the course, and the use of two forms of contraception. If you don’t pick up your prescription within a seven-day window, you may need another pregnancy test before you can get it. These rules feel burdensome, but the birth defects isotretinoin causes (affecting the brain, heart, and face of the developing baby) are severe enough that miscarriage, stillbirth, and premature birth are also documented outcomes.
Depression, Anxiety, and Suicidal Thoughts
The link between isotretinoin and psychiatric side effects has been debated for decades, but the signal in safety data is hard to ignore. Between the drug’s launch in 1982 and May 2000, the FDA received reports of 37 patients in the U.S. who died by suicide while taking isotretinoin, 110 who were hospitalized for depression, suicidal thoughts, or suicide attempts, and 284 who experienced depression that didn’t require hospitalization. That’s 431 total reports in the FDA’s adverse event database, and isotretinoin ranked in the top 10 of all drugs for reports of depression and suicide attempts.
Researchers have noted several patterns that suggest the connection may be real: symptoms appear during treatment, improve when the drug is stopped, and in some cases return when a patient restarts it. Biological plausibility exists as well, since the drug affects vitamin A pathways throughout the body, including the brain. Not everyone who takes isotretinoin will experience mood changes, but any new sadness, crying spells, unusual fatigue, loss of appetite, social withdrawal, or difficulty concentrating during treatment is worth taking seriously and reporting to your prescriber immediately.
Liver Damage
Isotretinoin can elevate liver enzymes, which is why blood tests are required throughout treatment. In most cases, mild elevations resolve on their own without changing the dose. Moderate elevations sometimes require lowering the dose or temporarily stopping the drug, with liver values typically returning to normal within one to four weeks. In severe cases, treatment has to be discontinued entirely, though enzyme levels generally normalize within about two weeks after stopping.
Your prescriber will check your blood work at regular intervals specifically to catch these changes early. The risk is manageable with monitoring, but it’s one of the reasons you can’t simply take isotretinoin without medical supervision.
Inflammatory Bowel Disease
For years, isotretinoin was suspected of causing Crohn’s disease and ulcerative colitis. A large-scale global study has since clarified the picture: isotretinoin does not appear to increase the lifetime risk of Crohn’s disease at all. The data on ulcerative colitis is slightly more nuanced. There is a small, temporary spike in risk during the first six months of treatment, roughly double the baseline rate. But in absolute terms, this translates to about 5 additional cases of ulcerative colitis per 10,000 patients who start isotretinoin. After six months, the risk drops back to the same level as people who never took the drug.
If you have a family history of inflammatory bowel disease, this is worth discussing with your doctor. But for most people, the gastrointestinal risk is much smaller than it was once feared to be.
Increased Pressure Inside the Skull
One of the rarer but more frightening side effects is a condition called intracranial hypertension, sometimes referred to as pseudotumor cerebri. It causes symptoms that mimic a brain tumor: severe headaches, visual disturbances, nausea, and swelling of the optic nerve (papilledema). A review of safety databases identified 179 reported cases linked to isotretinoin use, with an average time from starting the drug to diagnosis of about 2.3 months.
The condition is typically reversible after stopping isotretinoin and receiving appropriate treatment. In one documented case, a 16-year-old patient developed papilledema and was found to have narrowing of brain structures, but the condition resolved completely after the drug was discontinued. The risk increases if isotretinoin is taken alongside certain antibiotics (particularly tetracyclines), so your prescriber will avoid those combinations. Persistent or worsening headaches, especially with vision changes, during treatment should not be brushed off.
Eye and Vision Problems
Isotretinoin shrinks oil-producing glands throughout your body, including the tiny glands in your eyelids that keep your eyes lubricated. This makes eye-related side effects quite common. In one prospective study of 55 patients, about 35% developed dry eye symptoms and 40% developed eyelid inflammation (blepharitis). Both conditions usually resolve within a month of finishing treatment.
The more concerning issue is that some of these effects can become permanent. Isotretinoin can trigger cell death in the eyelid’s oil glands, and in rare cases, chronic dry eye persists long after the drug is stopped. Vision changes related to how the retina processes light have also been documented. The drug appears to interfere with normal vitamin A activity in the eye, which can temporarily affect the electrical signals your retina sends to the brain. Night vision problems during treatment are a known consequence of this mechanism. For most patients, vision returns to normal after the course ends, but permanent dry eye remains a small but real possibility.
Bone and Joint Effects in Young Patients
Joint and muscle pain are common complaints during isotretinoin treatment, and for most people they’re temporary and tolerable. The more serious concern involves young patients whose bones are still growing. Isotretinoin has been linked to premature closure of growth plates in rare cases, which can permanently stop bone growth in the affected area. Published cases suggest the risk increases with younger age, higher doses, and longer treatment courses. One reported case involved an adolescent male athlete whose growth plates closed prematurely during a 4.5-month course at a standard dose.
This is an uncommon complication, but it’s particularly relevant for younger teenagers who haven’t finished growing. If your child is being considered for isotretinoin, the potential impact on bone development is something to weigh carefully.
The Early “Purge” Phase
While not dangerous, the initial worsening of acne catches many patients off guard and deserves mention. Roughly 5 to 20% of people experience a flare of their acne after starting isotretinoin, typically within the first month. It can also appear in the second month or when the dose is increased. This purge phase is temporary and doesn’t mean the drug isn’t working. It can, however, be discouraging and emotionally difficult, especially for someone already struggling with severe acne. Knowing it’s a normal possibility makes it easier to push through.
Cholesterol and Blood Lipid Changes
Isotretinoin commonly raises triglycerides and cholesterol levels during treatment. This is another reason blood work is monitored regularly. For most patients, lipid levels return to normal after the course is finished. In people who already have high cholesterol or a family history of lipid disorders, the elevation can be more pronounced and may require closer monitoring or dose adjustments.