Key takeaways:
Accutane (isotretinoin) is an effective acne treatment option. However, it’s important for clinicians to have open conversations with patients about monitoring for potential adverse effects.
Monitoring should include pregnancy testing, as well as liver function tests (LFTs) and lipid panels. Drug interaction assessments are also vital to prevent serious adverse effects.
The iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program is designed to prevent fetal exposure and harm from isotretinoin. The FDA has approved updates that clinicians can incorporate into their dermatology practice settings.
Isotretinoin is approved for the treatment of severe nodular and/or inflammatory acne, acne conglobata, and recalcitrant acne. The American Academy of Dermatology recommends isotretinoin when first-line topical and oral medications aren’t effective, or when acne causes psychosocial burden.
While isotretinoin is an effective acne pharmacotherapy treatment option for the estimated 50 million Americans with acne, it’s important to be sure it’s prescribed safely. Here we’ll review baseline testing and monitoring recommendations for patients taking isotretinoin.
Note: The brand-name Accutane is discontinued. It’s still available as a generic medication and under different brand names. However, clinicians and patients still commonly refer to the acne medication as Accutane.
Discuss adverse effects
Accutane causes a variety of mild adverse effects that don’t necessarily need monitoring. But setting patients’ expectations prior to treatment can go a long way in helping them cope once side effects do arise. It’s also helpful to let them know that most side effects resolve with time after treatment discontinuation.
Common side effects can include:
Cheilitis
Dry skin
Dry eyes
Nasal dryness and nosebleeds
Photosensitivity
Hair loss
Serious adverse effects
In addition to keratinocytes, isotretinoin affects a number of cell types, such as myocytes, hepatocytes, and neural crest cells. Due to its effects on these cell types, isotretinoin has been linked to a number of severe adverse effects.
Serious side effects can include:
Acute pancreatitis
Hepatotoxicity
Hypertriglyceridemia and hyperlipidemia
Hearing abnormalities
Inflammatory bowel disease
Osteoporosis
Psychiatric disorders
Pseudotumor cerebri
Stevens-Johnson syndrome
Toxic epidermal necrolysis
A thorough medical and pharmacologic history is critical to ensure there are no contraindications to treatment prior to starting. But prioritizing time in the visit for counseling on side effects and fielding patient questions are also important.
Assess drug interactions
Prior to starting treatment with isotretinoin, it’s important to check for drug interactions. Patients should avoid:
Vitamin A supplements, which could lead to hypervitaminosis A
Tetracyclines, such as doxycycline (Oracea), which can increase the risk of developing intracranial hypertension
With oral contraceptives being a common choice for preventing pregnancy while taking Accutane, it’s particularly key to check for potential interactions with birth control pills. For example, the popular herbal product St. John’s wort is a cytochrome P450 inducer that can make oral contraceptives less effective. That makes it an especially important product for patients to avoid.
Encourage your patients to maintain a current list of their prescription and over-the-counter medications and supplements, so your team can screen for any interactions before patients begin treatment. When in doubt, consult your local or health system pharmacist for guidance.
Review iPLEDGE REMS updates
Due to teratogenicity, pregnancy is a contraindication to isotretinoin. This makes preventing pregnancy, and thus fetal toxicity, critical while patients are taking Accutane. A threshold dose is not known, but birth defects have been reported after short-term exposure.
The iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program is intended to reduce the risk of fetal harm from isotretinoin. It restricts distribution of isotretinoin and mandates patient education and commitment to contraception.
Part of this pre-treatment education should center on the importance of two forms of contraception for individuals who can become pregnant, as well as requirements for pregnancy testing (more on this below).
In February 2026, the FDA approved changes to the safety program, which will take effect in August 2026. Changes include the following:
During and after isotretinoin treatment, patients can use at-home pregnancy tests.
Clinicians aren’t required to document monthly counseling in the REMS for patients who can’t become pregnant. However, they should still be counseled at enrollment.
Good to know: Patients must still complete their initial (pre-treatment) pregnancy tests in medical facilities before starting treatment with isotretinoin.
Baseline testing
Prior to initiating treatment with isotretinoin, certain baseline testing should be performed. The recommendations below are for individuals without any underlying medical conditions. Clinical judgment should be exercised to individualize testing.
Pregnancy
As mentioned, preventing fetal harm is paramount. The iPLEDGE REMS program requires two negative pregnancy tests prior to initiation of treatment, 30 days apart.
LFTs
Experts recommend checking liver function tests (LFTs) prior to starting isotretinoin. Typically, alanine aminotransferase (ALT) is recognized as a more specific indicator of liver damage than aspartate aminotransferase (AST). But research indicates that isotretinoin may also affect AST levels, so many clinicians check both prior to treatment.
Lipids
Isotretinoin can have mild effects on the lipid profile, including elevations in total cholesterol, triglycerides, and low-density lipoprotein (LDL) levels. It’s also been associated with lower high-density lipoprotein (HDL) levels. Typically, these lipid panel changes are mild. Accutane tends to have a greater impact on triglycerides.
Mental health
There is mixed evidence on whether isotretinoin may raise the risk of psychiatric disorders, but it remains a boxed warning in the label. And thus, it remains important to perform mental health screenings.
Recommendations include screening for any personal or family history of psychiatric disorder, mood disturbance, or aggression. Available screening tools include the patient health questionnaire-2 (PHQ-2) and PHQ-9. Prescribers are also recommended to review “Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Isotretinoin,” which can be downloaded from the iPLEDGE website.
The table below highlights the most important baseline labs and screenings to perform before starting isotretinoin.
Test | Timing |
|---|---|
Pregnancy | Two negative pregnancy tests 30 days apart performed in a medical facility prior to treatment initiation |
LFTs: ALT | Within 1 month prior to treatment initiation |
Fasting lipid panel: Triglycerides | Within 1 month prior to treatment initiation |
Mental health screening | Prior to treatment initiation |
Monitoring during treatment
With all that isotretinoin treatment requires, patients might find the process overwhelming. It can help to schedule regular check-ins to see how well they’re tolerating the medication. Some people may benefit from adjusting the dosing. These are also good opportunities to review recommendations for administration, such as taking the medication with food, not donating blood, and not sharing pills.
You’ll also need to continue testing for the markers you screened for prior to treatment. Below are recommendations for ongoing monitoring during treatment.
Pregnancy
Monthly pregnancy testing is required during treatment with isotretinoin, and again after treatment has been discontinued. As mentioned in the iPLEDGE REMS program update, patients have the option of using at-home tests for this.
LFTs
Mild elevations in liver enzymes during isotretinoin treatment are more likely to occur in the first 3 months. However, it’s rare for patients to experience drug-induced hepatitis. Currently, there is insufficient evidence to suggest who may be at higher risk.
In addition to ALT testing at peak dose, it’s important to monitor for clinical signs and symptoms of hepatic injury.
Triglycerides
Hypertriglyceridemia also has a higher risk of occurring within the first 3 months of starting isotretinoin. For this reason, the recommendation is to monitor triglycerides at peak dose, similar to monitoring ALT levels. For individuals with risk factors for hypertriglyceridemia, such as Type 2 diabetes, obesity, and metabolic syndrome, more frequent monitoring may be warranted.
Mental health
It’s important to screen for symptoms of depression, mood disturbance, psychosis, or aggression at each visit. If any new psychiatric signs or symptoms develop, further evaluation is warranted. Treatment with isotretinoin may need to be discontinued, depending on the individual situation.
The table below reviews labs and assessments for clinicians to perform during Accutane treatment.
Test | Timing |
|---|---|
Pregnancy | • Monthly pregnancy test during treatment |
LFTs: ALT | Test at peak dose |
Fasting lipid panel: Triglycerides | Test at peak dose |
Mental health | Monthly screenings |
The bottom line
While isotretinoin is an effective acne medication, it does require baseline testing and monitoring for adverse effects. These include fetal harm prevention and elevated liver function tests (LFTs) and lipid panel assessments. Screening for drug interactions is also a critical part of the treatment plan.
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