Isotretinoin remains one of the most effective therapies for severe and recalcitrant acne, yet its use is accompanied by well-established risks, most notably embryo-fetal toxicity.1 To mitigate these risks, the US Food and Drug Administration (FDA) implemented the iPLEDGE program in 2005, later formalized as a Risk Evaluation and Mitigation Strategy (REMS) in 2010.2 As a shared system encompassing all isotretinoin products, iPLEDGE provides a centralized framework for prescribers, pharmacies, and patients to ensure safe use across diverse clinical settings.
In February 2026, the FDA approved modifications to the iPLEDGE REMS aimed at reducing administrative burden while maintaining safety.2 These updates introduce greater flexibility in pregnancy testing—allowing, at the prescriber’s discretion, the use of at-home pregnancy tests during and after treatment—while preserving the requirement for pre-treatment testing in a medical setting. Additional changes include elimination of certain documentation requirements for patients who cannot become pregnant, removal of dispensing time restrictions for this population, and streamlined processes for repeat pregnancy testing when prescription pickup windows are missed. Collectively, these changes reflect an effort to balance patient access, workflow efficiency, and continued risk mitigation.
Despite these regulatory updates, significant variability persists in how dermatologists approach isotretinoin prescribing, monitoring, and counseling in everyday practice. Clinical decisions regarding dosing strategies, laboratory monitoring, contraceptive counseling, procedural precautions, and long-term safety considerations are often guided by a combination of evidence, experience, and individual patient factors.
To better understand current expert perspectives in this evolving landscape, Practical Dermatology polled dermatologists with extensive experience in isotretinoin therapy on 10 critical questions, aiming to highlight areas of consensus and variation in clinical practice and to provide practical insights for clinicians navigating isotretinoin management today.
What is a more important consideration with isotretinoin: daily or cumulative dose?
Lawrence Eichenfield, MD (LE): Daily dose! Both are important; in the end result, the cumulative dose is key, but modulating the daily dose makes a huge impact in side effects and toleration. The experience is different for many users at moderate vs high doses per day.
John Barbieri, MD, MBA, FAAD (JB): Cumulative dose, based on a cohort study that found higher cumulative dosage may potentially reduce risk of acne relapse and isotretinoin retrial.3
Linda Stein Gold, MD (LSG): I treat for a minimum of 20 weeks, but I stop treatment based on clinical response.
Jonette Keri, MD, PhD (JK): Cumulative, as I have done it that way for years, but is not an absolute.
Elizabeth (Lisa) Swanson, MD, FAAD (ES): Cumulative dose!
Dawn Eichenfield, MD, PhD (DE): Both are important, but you might get more side effects with higher daily doses.
How do you decide when to stop a course of isotretinoin, and what do you recommend (topicals, etc) when the treatment is finished?
ES: When the patient has reached the target cumulative dose and is 100% clear of acne, then the course is done. I define 100% clear as no new acne the last month of treatment. Some people do 2 months of clear skin, but I still do 1 month. I do not prescribe a topical when the treatment is finished, but I know a lot of people recommend tretinoin after the course. If it is a female and she is doing her second course of isotretinoin, I encourage (OCPs) contraceptive pills or spironolactone to help prevent recurrence afterward.
LE: I stop when the patient is generally clear without lesions for a month, with a general target of 120-150 mg/kg cumulative dosing. Post-treatment, my default is: “Enjoy the ride of clear skin.” I recommend sun protection if there is post-inflammatory erythema and perhaps a topical retinoid for small scar management.
JK: I tell patients I use two endpoints: cumulative dose (usually 150-220 mg/kg but occasionally higher) and no significant acne for 2 months.
DE: I tell families that we try to get to the recommended amount but that the goal is to treat to being clear for about a month or two. Post-treatment, I talk about post-inflammatory erythema and hyperpigmentation. Some patients like to start a retinoid if tolerated.
LSG: The patient should be clear for a minimum of 1 to 2 months.
JB: The patient should be clear for 2 to 3 months, with at least a 120- to 220-mg/kg cumulative dose. I do not do any therapy once people stop because many have a goal of long-term clearance.
How important is utilizing formulations that are food dependent?
DE: I discuss that taking with food will help with absorption. We may select certain formulations if the patient is having issues with some of the more generic/standard formulations.
LSG: If a patient cannot take isotretinion with food (a fatty meal), I feel that the lidose isotretinoin formulations are important to maximize bioavailability of the drug and efficacy.
JK: In my patient population, the food-independent formulations can require prior authorizations that take time, so I usually go with what insurance will pay. Getting the medication is more important than food-independent or -dependent form.
LE: My default is to explain that taking “with food” maximizes absorption, and to not be as selective as I might of formulations that minimize problems due to having a huge variation in insurers/payors, which makes substitution standard.
ES: The generics need to be taken with fatty food, and I find that is relatively easy for teenagers to do (especially the boys). There is a version that does not need to be taken with fatty food and it is wonderful, but it is hard to access.
JB: We can overcome poor absorption with a higher dose (I choose a daily dose based on side effects), but it can be nice in some patients and is better if easy to access.
What labs should be followed and when?
JB: I would argue no labs are needed, but baseline and peak-dose lipids and ALT are sufficient.4-6
LSG: I do a full panel of labs at baseline and at the conclusion of treatment; pregnancy test are monthly; and liver function tests and lipid panel at 2 to 3 months and with any dose change.
ES: I do an alanine aminotransferase (ALT) test and triglyerides at baseline and after 2 months. That is it.
LE: I like baseline liver function tests (LFTs) and lipids, and I repeat them at 1 month and in the event of significant dose changes. At the standard “highest dose” we use, we will not standardly repeat after that unless symptoms issues/illness. Of course, pregnancy tests monthly are important.
JK: I do baseline labs—lipids, comprehensive metabolic panel (CMP), and occasionally complete blood count (CBC). I know you do not need a CBC, but there are some patients for whom I check this for other reasons. I check at baseline, usually at 2 months, and then with each increased dose. I probably should just do LFTs not CMP, but sometimes we just click CMP, to be honest.
DE: Generally, we use baseline LFTs and lipids, and repeat at 1 month and with significant dose increases. Sometimes, there may be shared decision making with families regarding how often we decide to check labs. Pregnancy tests are always mandatory monthly!
Is abstinence a sufficient precaution?
JK: Yes, but with careful counseling. It is always a risk, but in the 12- to 13-year-old or lesbian patient, etc. Again, there is still the risk.
LSG: Only if they have never been sexually active.
LE: It is, of course, with full, complete abstinence. The issue is: can we be assured of abstinence if a patient declares it is sufficient? This becomes an important medical judgement. Emergency contraception is discussed if abstinence is chosen in California.
JB: 100%. The pregnancy rate is higher with combined oral contraception use/male latex condoms than with abstinence based on the iPLEDGE data. If we are going to say abstinence is not sufficient, then we also should not allow combined oral contraceptives (COCs) as a contraception option.
DE: Yes, abstinence is the best contraception (for people who are truly abstinent!). I do discuss emergency contraception with females, especially if this is being chosen.
ES: I think so, as long as you are really talking to your patients about the importance of it and the importance of not getting pregnant, but the most important thing is: no babies on this medicine.
Who should be responsible for contraceptive counseling/prescribing?
ES: The clinician. This is not something for the medical assistants to be doing.
DE: I regularly prescribe and counsel regarding OCPs for acne management and for contraceptive use with isotretinoin.
LSG: If a patient is sexually active and in need of birth control, I prefer that they see gynecology.
JB: Collaborative care between the dermatologist, primary care physician, gynecologist is important. I prescribe COCs regularly for my patients as they are FDA-approved for acne treatment and for contraception.
LE: I am comfortable prescribing and counseling OCPs both for acne management and for contraceptive use with isotretinoin. Most of our pediatric/adolescent/young adult practice providers are comfortable with it as well.
JK: The physician/provider giving the medication should be responsible for both.
How young is too young for prescribing isotretinoin?
LE: No age. I have prescribed it for toddlers!
ES: I do not think there is a specific age, but they need to be able to swallow pills. If I see a 10-year-old with scarring acne, I will talk about isotretinoin.
JK: There are case reports for acne in ages 5 to 6 months. It depends on scarring and severity.
DE: We regularly use retinoids for younger ages.
LSG: I generally prescribe it for patients aged 12 and up. I have used it in younger patients if significant scarring was present.
JB: Any age if they are otherwise a good candidate.
What procedures are safe while on isotretinoin and which ones are not?
ES: Tough question! Lasers seem safe. Waxing is definitely not safe. I typically tell my patients to wait on any piercings or tattoos until they are finished with the isotretinoin.
JK: Most procedures that are not deep chemical peels, deep dermabrasion, or deep resurfacing can be done. I caution against wisdom tooth removal and rhinoplasty—wait.
LE: Follow the published guideline we were part of several years ago regarding dermatologic procedures.7
DE We follow the JAMA Dermatology 2017 guidelines regarding procedures during isotretinoin.7
LS: I follow the recent procedure paper from the American Society for Dermatologic Surgery (ASDS).8
JB: Any procedure that does not cause substantial skin trauma.
What do you counsel regarding alcohol intake while on isotretinoin?
LE: Push for no alcohol as a standard. Explain to college-age patients that no (or minimal) exposure is important to minimize problems.
JB: It is fine to drink in moderation. There is no evidence that isotretinoin affects the liver meaningfully.5-6,9
JK: Teenagers: no alcohol. Adults: avoid, but they can have a drink on weekends/special occasions and don’t overdo it.
DE: We recommend no alcohol (especially if you are not allowed to drink alcohol) and minimizing hepatotoxic medications.
LSG: I advise moderation and explain that the drug is metabolized in the liver and use with alcohol can lead to severe stress on the liver.
ES: Everything in moderation.
How do you address questions regarding premature closure of growth plates?
JB: This does not appear to be an issue with respect to final adult height.10,11
LSG: There have been cases of premature closure of the growth plates on isotretinoin for acne at standard dosing; however, this is rare. I discuss the risks and benefits in adolescent patients.
LE: Reassurance! Explain the data in more detail if needed (including two good papers last and this year showing no differences in height with or without isotretinoin).10,11
ES: I say that this issue stems from the long-term use of isotretinoin for genetic skin conditions. I do not worry about growth when treating teens for 6 months for acne.
DE: A lot of new publications suggest that isotretinoin does not cause premature closure of growth plates, and we do reference these articles.
JK: Don’t worry for routine acne. It is the neuroblastoma or epidermolytic hyperkeratosis (EHK) kids we worry about.
References
1. Khera KS. Maternal toxicity of drugs and metabolic disorders—a possible etiologic factor in the intrauterine death and congenital malformation: a critique on human data. Crit Rev Toxicol. 1987;17(4):345-375. https://doi.org/10.3109/10408448709029326
2. iPLEDGE Risk Evaluation and Mitigation Strategy (REMS). US Food and Drug Administration. Updated February 10, 2026. Accessed April 2, 2026. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/ipledge-risk-evaluation-and-mitigation-strategy-rems
3. Lai J, Barbieri JS. Acne relapse and isotretinoin retrial in patients with acne. JAMA Dermatol. 2025;161(4):367-374. https://doi.org/10.1001/jamadermatol.2024.5416
4. Xia E, Han J, et al. Isotretinoin laboratory monitoring in acne treatment: a Delphi consensus study. JAMA Dermatol. 2022;158(8):942-948. https://doi.org/10.1001/jamadermatol.2022.2044
5. Barbieri JS, Shin DB, Wang S, Margolis DJ, Takeshita J. The clinical utility of laboratory monitoring during isotretinoin therapy for acne and changes to monitoring practices over time. J Am Acad Dermatol. 2020;82(1):72-79. https://doi.org/10.1016/j.jaad.2019.06.025
6. Affleck A, Jackson D, Williams HC, Chavez P, Albrecht J. Is routine laboratory testing in healthy young patients taking isotretinoin necessary: a critically appraised topic. Br J Dermatol. 2022;187(6):857-865. https://doi.org/10.1111/bjd.21840
7. Spring LK, Krakowski AC, et al. Isotretinoin and timing of procedural interventions: a systematic review with consensus recommendations. JAMA Dermatol. 2017;153(8):802-809. https://doi.org/10.1001/jamadermatol.2017.2077
8. Waldman A, Bolotin D, et al. ASDS Guidelines Task Force: consensus recommendations regarding the safety of lasers, dermabrasion, chemical peels, energy devices, and skin surgery during and after isotretinoin use. Dermatol Surg. 2017;43(10):1249-1262. https://doi.org/10.1097/DSS.0000000000001166
9. Affleck A, Jackson D, Williams HC, Chavez P, Albrecht J. Is routine laboratory testing in healthy young patients taking isotretinoin necessary: a critically appraised topic. Br J Dermatol. 2022;187(6):857-865. https://doi.org/10.1111/bjd.21840
10. Cole HL, Barbieri JS, Shen LY. Pediatric isotretinoin use for acne is not associated with meaningful effects on adult height: a retrospective cohort study using TriNetX. J Am Acad Dermatol. 2026;94(4):1219-1221. https://doi.org/10.1016/j.jaad.2025.11.054
11. Xu KK, Aghazadeh N, Tebben P, Todd A, Tollefson M, Barbieri JS. The effect of isotretinoin treatment for acne vulgaris on height in adolescents: a retrospective cohort study using the Rochester Epidemiology Project. J Am Acad Dermatol. 2025;93(6):1464-1470. https://doi.org/10.1016/j.jaad.2025.08.009
John Barbieri, MD, MBA, FAAD
n
Director, Advanced Acne Therapeutics Clinic, Brigham and Women’s Hospital Boston, MA
Dawn Eichenfield, MD, PhD
n
Dermatologist, Rady Children’s Hospital-San Diego
n
Assistant Clinical Professor of Dermatology, University of California San Diego School of Medicine
Lawrence Eichenfield, MD
n
Chief of Pediatric and Adolescent Dermatology,
Rady Children’s Hospital-San Diego
n
Professor of Dermatology and Pediatrics and Vice-Chair of Department of Dermatology, University of California San Diego School of Medicine
Jonette Keri, MD, PhD
n
Chief of Dermatology Service, Miami VA Hospital
Miami, FL
Linda Stein Gold, MD
n
Director of Dermatology Clinical Research, Henry Ford Health System
Detroit, MI
Elizabeth (Lisa) Swanson, MD, FAAD
n
Board-certified dermatologist and Pediatric Dermatologist, Ada West Dermatology
Boise, ID
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