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Isotretinoin

Isotretinoin is a retinoid capsule used to treat severe nodular acne that has not responded to other therapies, including antibiotics.

Brand names AbsoricaAmnesteemClaravisMyorisanZenatane +3 more
Drug class Retinoid
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 22 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record · 4
Isotretinoin at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Isotretinoin is a powerful oral retinoid (a vitamin A relative) that shrinks the skin’s oil glands, reserved for severe nodular acne that antibiotics have not cleared; on the market since the early 1980s and available as a generic, it can bring long-lasting remission. Almost everyone gets dry, chapped lips and dry skin; nosebleeds and achy joints are common but manageable. Its boxed warning concerns pregnancy, because even brief exposure can cause life-threatening birth defects, so anyone who can become pregnant must use two forms of contraception and test monthly under the iPLEDGE program. Mood changes, liver and blood fat effects, and bone changes in growing teens need regular monitoring.

Clinical pearls

  • Take each dose with a meal, ideally one with some fat, because an empty stomach sharply cuts how much you absorb.
  • Never combine it with doxycycline, minocycline or other tetracyclines, which raise the risk of dangerous pressure inside the skull.
  • Stop any vitamin A supplements, since they add to isotretinoin’s toxic effects, and go easy on alcohol, which raises triglycerides.
  • A progesterone-only minipill does not count as adequate birth control, and St. John’s wort can weaken hormonal methods.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Isotretinoin must never be taken during pregnancy. There is an extremely high risk of life-threatening birth defects if you become pregnant while taking this medication — even one dose, even for a very short time. Birth defects that have been documented include abnormalities of the face, eyes, ears, skull, brain, heart, and glands. Some affected babies have died. Because of this danger, isotretinoin is only available through a strictly controlled program called iPLEDGE. Only certified prescribers may write the prescription, only enrolled pharmacies may dispense it, and every patient must be registered. Patients who can become pregnant must have negative pregnancy tests before, during, and after treatment, and must use two forms of contraception at the same time. No more than a 30-day supply can be dispensed, and every refill requires a new prescription and new program authorization.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule
Earliest FDA record1982
Companies listing it with the FDA13
FDA label last updatedAug 19, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Isotretinoin, written from its FDA label.

What Isotretinoin is used for

▾

Isotretinoin is an oral retinoid capsule approved for one specific, serious indication across all supported products.

  • Absorica and Absorica LD: treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules 5 mm or larger, when conventional therapy including systemic antibiotics has failed
  • Accutane: treatment of severe recalcitrant nodular acne in non-pregnant patients when conventional therapies including systemic antibiotics have not worked
  • Amnesteem: treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older unresponsive to conventional therapy including systemic antibiotics
  • Claravis: treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older unresponsive to conventional therapy including systemic antibiotics
  • Isotretinoin capsules (generic): treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older who have not responded to conventional therapy including systemic antibiotics
  • All products: a second course should not begin until at least two months after completing the first course, because acne can keep improving after stopping treatment

How Isotretinoin works

▾

Isotretinoin is a retinoid — a synthetic compound closely related to vitamin A. It works primarily by reducing the size of the skin's oil-producing glands (sebaceous glands) and suppressing how much oil (sebum) they produce. It also inhibits the abnormal skin cell buildup (keratinization) that contributes to clogged pores and nodule formation. Clinical improvement in nodular acne tracks closely with this reduction in sebum output. The exact molecular mechanism is not fully understood, but the sebum-lowering effect is considered central to how it clears severe acne.

The reduction in sebum is dose- and duration-dependent — meaning higher doses and longer treatment tend to produce a larger and more sustained effect on oil gland activity.

Isotretinoin dosage

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Isotretinoin capsules are taken by mouth twice daily, typically for 15 to 20 weeks. Most brands (Accutane, Amnesteem, Claravis, and generic isotretinoin capsules) must be taken with food — absorption is dramatically higher with a high-fat meal compared to fasting. Absorica and Absorica LD may be taken without regard to meals, but their dosing differs from other brands, and Absorica and Absorica LD are not interchangeable with each other on a milligram-for-milligram basis.

  • Take twice daily — once-daily dosing is not recommended for any brand
  • If you miss a dose, skip it; never double up
  • Each prescription covers only 30 days; refills require a new prescription and new iPLEDGE authorization
  • Follow your prescriber's instructions exactly — do not adjust your dose on your own

Dosing details from the FDA-approved label

From the Isotretinoin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • ABSORICA (severe recalcitrant nodular acne)
    • 0.5 to 1 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks
    • Not substitutable with ABSORICA LD. Once daily dosing is not recommended. Swallow capsules whole with a full glass of liquid.
  • ABSORICA LD
    • 0.4 to 0.8 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks
    • Not substitutable with ABSORICA. Once daily dosing is not recommended. Swallow capsules whole with a full glass of liquid.
  • Adult patients with very severe disease (scarring or primarily manifested on the trunk) - ABSORICA
    • Dosage adjustments up to 2 mg/kg/day in divided doses, as tolerated
    • Maximum: 2 mg/kg/day
    • Adult patients only
  • Adult patients with very severe disease (scarring or primarily manifested on the trunk) - ABSORICA LD
    • Dosage adjustments up to 1.6 mg/kg/day in divided doses, as tolerated
    • Maximum: 1.6 mg/kg/day
    • Adult patients only
  • Amnesteem (severe recalcitrant nodular acne)
    • 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks
    • With food. Once daily dosing is not recommended. Swallow capsules whole with a full glass of liquid.
  • Adult patients with very severe disease (scarring or primarily manifested on the trunk) - Amnesteem
    • Dosage adjustments up to 2 mg/kg/day in divided doses with food, as tolerated
    • Maximum: 2 mg/kg/day
    • Adult patients only
  • Claravis
    • 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks
    • Once daily dosing is not recommended
  • Adult patients with very severe disease (scarring, trunk involvement) - Claravis
    • May increase dosage to 2 mg/kg/day in two divided doses with food
    • Maximum: 2 mg/kg/day
    • Adult patients only
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Evaluations Prior To Prescribing and Use of ABSORICA/ABSORICA LD: In patients who can get pregnant, only prescribe ABSORICA/ABSORICA LD after verification and documentation that they are not pregnant. See the Full Prescribing Information for the detailed requirements prior to prescribing ABSORICA/ABSORICA LD ( 2.1 , 8.3 ) Complete the following laboratory tests in all patients: fasting lipid profile and liver function tests. ( 2.1 ) ABSORICA is not substitutable with ABSORICA LD because of different bioavailability and recommended dosage. ( 2.2 , 5.3 ) Recommended dosage for (2.2 ): o ABSORICA is 0.5 to 1 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks ( 2.1 ) o ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks ( 2.1 ) Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of ABSORICA (1.6 mg/kg/day of ABSORICA LD) in divided doses. ( 2.1 ) Once daily dosing is not recommended. ( 2.1 ) If a dose of ABSORICA/ABSORICA LD is missed, just skip that dose. Do not take two doses of ABSORICA/ABSORICA LD at the same time. ( 2.1 ) 2.1 Evaluations Prior To Prescribing and Use of ABSORICA/ABSORICA LD In patients who can get pregnant, only prescribe ABSORICA/ABSORICA LD after verification and documentation that they are not pregnant [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 , 5.2 )]. For the detailed requirements prior to prescribing ABSORICA/ABSORICA LD, see Use in Specific Populations (8.3). Prior to ABSORICA / ABSORICA LD use in all patients, complete the following laboratory testing: A fasting lipid profile including triglycerides [see Warnings and Precautions ( 5.8 , 5.15 )] . Liver function tests [see Warnings and Precautions ( 5.10 , 5.15 )] . 2.2 Recommended Dosage ABSORICA is not substitutable with ABSORICA LD [see Warnings and Precautions ( 5.3 )]. The recommended dosage of: ABSORICA is 0.5 to 1 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks (see Table 1). ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks (see Table 2). To decrease the risk of esophageal irritation, instruct patients to swallow the capsules with a full glass of liquid. Swallow capsules whole.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Isotretinoin side effects

▾

The most common side effects — affecting many patients — involve dryness throughout the body.

Common side effects

  • Dry, chapped lips (very common)
  • Dry skin and dry eyes
  • Back pain and joint pain (arthralgia)
  • Nosebleeds (epistaxis)
  • Headache
  • Dry nose and increased sensitivity to sunburn
  • Elevated triglycerides (blood fat levels)
  • Dry, chapped lips (cheilitis) — very common and often the first thing patients notice
  • Fatigue and musculoskeletal discomfort

When to get medical help

  • Stop taking it and call your doctor right away if you feel depressed, have thoughts of hurting yourself, or notice sudden mood or behavior changes
  • Seek emergency care for severe headache, nausea, vomiting, or vision changes — these may signal dangerous pressure in the skull (pseudotumor cerebri)
  • Stop immediately and get medical help for severe abdominal pain, rectal bleeding, or bad diarrhea — signs of inflammatory bowel disease
  • Stop and see a doctor if you develop a severe skin reaction such as peeling, blistering, or a widespread rash — could be Stevens-Johnson syndrome or toxic epidermal necrolysis
  • Call your doctor if you notice yellowing of skin or eyes, unusual fatigue, or upper abdominal pain — signs of liver problems
  • Report any ringing in the ears (tinnitus) or hearing loss right away — may not resolve after stopping the drug
  • Stop and seek care if you have sharp abdominal pain that could indicate pancreatitis (inflamed pancreas)

Serious reactions requiring immediate attention include signs of depression or suicidal thoughts, severe headache with vision changes (possible brain pressure), severe skin reactions, abdominal pain with or without bleeding (possible bowel or pancreas problems), yellowing of the skin or eyes (liver), and any hearing changes or ringing in the ears.

Isotretinoin warnings and precautions

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Pregnancy is an absolute contraindication. Isotretinoin causes devastating, often fatal birth defects — affecting the brain, heart, face, ears, and other organs — even with brief exposure at any dose. All patients who can become pregnant must be enrolled in the iPLEDGE REMS program, use two forms of contraception simultaneously, and have monthly pregnancy tests. Breastfeeding is not recommended during treatment or for at least 8 days after the last dose.

  • Mental health: isotretinoin may cause depression, mood disturbances, psychosis, aggression, and rarely suicidal thinking or behavior. Patients and families should watch for mood changes and contact the prescriber immediately if they occur — stopping the drug may not be enough on its own
  • Brain pressure (pseudotumor cerebri / intracranial hypertension): severe headache, nausea, vomiting, or vision changes may signal dangerous pressure buildup inside the skull — stop the drug and see a neurologist; risk is higher when combined with tetracycline antibiotics
  • Pancreatitis: potentially fatal inflammation of the pancreas has been reported — stop immediately if you have severe abdominal pain
  • Liver damage: liver enzyme elevations occur in about 15% of patients; clinical hepatitis has been reported — regular liver function testing is required
  • Lipid changes: about 25% of patients develop markedly elevated triglycerides; 15% develop low HDL cholesterol — requires monitoring and dose adjustment or drug discontinuation if uncontrolled
  • Bone effects: decreases in bone mineral density have been reported, especially in adolescents; premature closure of bone growth plates and stress fractures have been seen — teens in high-impact sports face additional risk
  • Inflammatory bowel disease: symptoms can persist even after stopping the drug
  • Hearing loss: tinnitus and hearing impairment have been reported, sometimes persisting after treatment ends
  • Serious skin reactions: Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening skin peeling) have been reported — stop immediately if a severe skin reaction develops

Isotretinoin interactions

▾

Isotretinoin has several important interactions to know about before starting treatment.

  • Vitamin A supplements: isotretinoin is related to vitamin A — combining them multiplies toxic effects; avoid all vitamin A supplements during treatment
  • Tetracycline antibiotics (doxycycline, minocycline, tetracycline): combining these with isotretinoin significantly raises the risk of pseudotumor cerebri (dangerous brain pressure) — this combination must be avoided
  • Micro-dosed progesterone 'minipill' contraceptives: these are not reliable enough as birth control during isotretinoin therapy — two forms of contraception are required, and minipills are not an adequate primary method
  • St. John's Wort: this herbal supplement may reduce the effectiveness of hormonal contraceptives, which is dangerous given the mandatory pregnancy prevention requirements
  • Phenytoin (seizure medication): both phenytoin and isotretinoin can affect bone health — use together with caution
  • Systemic corticosteroids (e.g., prednisone): both can contribute to bone loss — use together with caution
  • Alcohol: can worsen triglyceride elevation; minimize alcohol intake during treatment

Interactions listed in the FDA-approved label

From the Isotretinoin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Vitamin A: Because of the relationship of isotretinoin to vitamin A, taking vitamin A supplements may cause additive toxic effects. Patients should be advised against taking vitamin supplements containing vitamin A.
  • Tetracyclines: Isotretinoin use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some involving concomitant use of tetracyclines. Concomitant treatment should be avoided.
  • Micro-dosed progesterone preparations (minipills without estrogen): May be an inadequate method of contraception during isotretinoin therapy. Patients who can become pregnant should select and commit to use two forms of effective contraception simultaneously, at least one of which must be a primary form.
  • Norethindrone/ethinyl estradiol (Ortho-Novum 7/7/7): Isotretinoin at 1 mg/kg/day did not induce clinically relevant changes in the pharmacokinetics of ethinyl estradiol and norethindrone or in serum levels of progesterone, FSH and LH. Consult the package insert of medications given concomitantly with hormonal contraceptives, since some medications may decrease their effectiveness.
  • St. John's Wort: A possible interaction with hormonal contraceptives has been suggested based on reports of breakthrough bleeding; pregnancies have been reported in users of combined hormonal contraceptives who also used St. John's Wort. Patients should be prospectively cautioned not to self-medicate with St. John's Wort.
  • Phenytoin: Isotretinoin has not been shown to alter the pharmacokinetics of phenytoin; phenytoin is known to cause osteomalacia, and no formal studies assessed an interactive effect on bone loss. Caution should be exercised when using these drugs together.
  • Systemic corticosteroids: Systemic corticosteroids are known to cause osteoporosis; no formal clinical studies assessed an interactive effect on bone loss with isotretinoin. Caution should be exercised when using these drugs together.
Read the label’s full interactions text

Drug Interactions Vitamin A: Because of the relationship of isotretinoin to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects. Tetracyclines: Concomitant treatment with isotretinoin and tetracyclines should be avoided because isotretinoin use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines. Micro-dosed Progesterone Preparations: Micro-dosed progesterone preparations (“minipills” that do not contain an estrogen) may be an inadequate method of contraception during isotretinoin therapy. Although other hormonal contraceptives are highly effective, there have been reports of pregnancy from patients who can become pregnant who have used combined oral contraceptives, as well as transdermal patch/injectable/implantable/vaginal ring hormonal birth control products. These reports are more frequent for patients who can become pregnant who use only a single form of contraception. It is not known if hormonal contraceptives differ in their effectiveness when used with isotretinoin. Therefore, it is critically important for patients who can become pregnant to select and commit to use two forms of effective contraception simultaneously, at least one of which must be a primary form (see PRECAUTIONS ). Norethindrone/ethinyl estradiol: In a study of 31 premenopausal female patients with severe recalcitrant nodular acne receiving Ortho-Novum ® 7/7/7 Tablets as an oral contraceptive agent, isotretinoin at the recommended dose of 1 mg/kg/day, did not induce clinically relevant changes in the pharmacokinetics of ethinyl estradiol and norethindrone and in the serum levels of progesterone, follicle-stimulating hormone (FSH) and luteinizing hormone (LH).

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿49 supplements and herbs with documented Isotretinoin interactions, ranked by severity Check Isotretinoin against a supplement or herb →

Before taking Isotretinoin

▾
  • Pregnancy: isotretinoin is absolutely contraindicated in pregnancy — do not take it if you are pregnant or may become pregnant without being enrolled in iPLEDGE and using two forms of contraception
  • Breastfeeding: not recommended during treatment or for at least 8 days after the last dose
  • History of depression or mental illness: tell your prescriber before starting — close monitoring for mood changes is required throughout treatment
  • Diabetes, obesity, high triglycerides, or family history of lipid disorders: these patients need more frequent blood lipid monitoring
  • Liver disease: liver function tests are required before and during treatment; existing liver disease warrants extra caution
  • Adolescents still growing: bone mineral density effects and premature growth plate closure are particular concerns in this age group
  • History of bone conditions (osteoporosis, osteomalacia, anorexia nervosa): prescribers should weigh risks carefully before prescribing
  • Contact lens wearers: dry eyes are very common — this may affect your ability to wear contacts comfortably
  • Blood donors: do not donate blood during treatment or for one month after stopping

Isotretinoin overdose

▾

In humans, taking too much isotretinoin has been associated with vomiting, flushing of the face, severely chapped lips, abdominal pain, headache, dizziness, and loss of coordination (ataxia). These symptoms have generally resolved quickly without lasting effects. However, because isotretinoin causes life-threatening birth defects at any dose, anyone who can become pregnant and experiences an overdose must be evaluated for pregnancy and receive counseling about contraception — and male patients should use a condom and avoid unprotected sex with anyone who could become pregnant for one month after an overdose. No one who has taken an overdose should donate blood for at least one month.

What Isotretinoin does in the body

▾

Isotretinoin's primary measurable effect on the body is a significant, dose-related reduction in sebum (skin oil) secretion. This effect is tied to how long treatment lasts and how high the dose is. The reduction in sebum happens because isotretinoin causes the skin's oil glands (sebaceous glands) to shrink in size and lose their ability to differentiate and function normally. This decrease in sebum output is temporary — it is not permanent — and it corresponds closely to the clinical clearing of nodular acne seen during treatment.

How your body processes Isotretinoin

▾

Isotretinoin is absorbed through the gut and its absorption is strongly influenced by food — taking it with a high-fat meal more than doubles the amount that enters your bloodstream compared to taking it on an empty stomach. Once absorbed, it binds tightly to proteins in the blood (more than 99.9% protein-bound, primarily to albumin). The body breaks it down into several active metabolites, primarily through liver enzymes (CYP2C8, 2C9, 3A4, and 2B6), and the drug and its breakdown products are excreted roughly equally in urine and feces. The elimination half-life (the time for blood levels to fall by half) is approximately 21 hours for isotretinoin itself, meaning it takes several days to fully clear after the last dose. Pharmacokinetics in adolescents aged 12 to 15 are similar to those in adults.

How to store Isotretinoin

▾

Store at 20° to 25°C (68° to 77°F). Protect from light.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

49

Supplements & herbs that interact with Isotretinoin

49 supplements and herbal products have documented interactions with Isotretinoin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 2
  • Moderate · 35
  • Minor · 12
ACTIVATED CHARCOAL Major VITAMIN A Major AFRICAN WILD POTATO Moderate ALFALFA Moderate ANGELICA ARCHANGELICA Moderate ARRACH Moderate BERGAMOT Moderate BISHOP'S WEED Moderate +41 more
Every supplement checked against Isotretinoin — ranked by severity The full interaction hub: 2 major · 35 moderate · 12 minor · every one linked to its full report. Check Isotretinoin against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

4

Nutrient depletion considerations

Isotretinoin has been associated with lower levels of 4 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Higher significance · 3
  • Moderate · 1
ACETYL-L-CARNITINE Insignificant Depletion L-CARNITINE Insignificant Depletion PROPIONYL-L-CARNITINE Insignificant Depletion FOLIC ACID Moderate Depletion
See the full Isotretinoin nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Isotretinoin: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Isotretinoin — the kind of thing our pharmacy team would talk through with you at the counter.

Why is there so much paperwork and testing before I can even get this prescription filled?

▾
Isotretinoin causes extremely serious birth defects — even one dose during pregnancy can cause devastating harm to a developing baby. Because of that risk, the FDA requires everyone — prescribers, pharmacies, and patients — to be registered in a mandatory safety program called iPLEDGE before the drug can be prescribed or dispensed. If you can become pregnant, you'll need pregnancy tests before starting, every month during treatment, and after you finish. It can feel like a lot of hoops, but the program exists to make sure this powerful medication is used as safely as possible.

Do I really need to take this with food every time?

▾
For most brands — including Accutane, Amnesteem, Claravis, and generic isotretinoin — yes, taking it with food is essential. Studies show that a fatty meal more than doubles the amount of drug your body actually absorbs. Taking it on an empty stomach can significantly reduce how well it works. Absorica and Absorica LD have slightly different instructions, so follow what your prescriber and the label say for your specific brand. As a rule of thumb: if your bottle says take with food, don't skip that step.

What side effects should I just expect, versus ones where I should call my doctor right away?

▾
Very dry lips, dry skin, dry eyes, and nosebleeds are common and expected — most patients experience at least some dryness. Back pain and joint aches are also fairly common, especially in teens. The serious ones to act on immediately: any signs of depression, dark thoughts, or major mood changes; severe headache with nausea or vision changes; bad abdominal pain or rectal bleeding; a severe skin rash with blistering or peeling; or any new hearing loss or ringing in your ears. Don't wait for your next scheduled visit if any of those happen — contact your doctor right away or go to the ER.

Can I take my doxycycline or other antibiotic at the same time as isotretinoin?

▾
No — not if it's a tetracycline-class antibiotic like doxycycline or minocycline. Combining isotretinoin with tetracyclines raises the risk of a dangerous condition called pseudotumor cerebri, where pressure builds up inside your skull. That's a serious risk. Make sure your prescriber knows about every medication you're taking, including supplements, before you start isotretinoin.

I've heard isotretinoin can affect your mood. Should I be worried?

▾
It's something to take seriously and watch for, but not a reason to panic. Some patients on isotretinoin have experienced depression, irritability, and in rare cases more serious psychiatric symptoms. Before you start, your prescriber will ask about your mental health history. During treatment, you and your family should stay alert for changes in mood, unusual sadness, feelings of hopelessness, or any thought of self-harm. If anything like that shows up, stop the medication and contact your doctor the same day — don't wait for your next appointment.

After I finish my course, will my acne stay gone?

▾
For many patients, yes — a single 15- to 20-week course has been shown to produce complete, long-lasting clearing. Some patients do need a second course, but if that happens, it should not start until at least two months after the first one ends, because your skin may keep improving even after you've stopped. Your prescriber will help you assess whether retreatment is needed based on how your skin responds over time.

Is Isotretinoin available over the counter?

▾
No. Isotretinoin is a prescription medicine: every Isotretinoin product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Isotretinoin first available?

▾
The earliest FDA record we hold for Isotretinoin is from 1982: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Isotretinoin was first used.

Who makes Isotretinoin?

▾
13 companies currently list Isotretinoin products in the FDA's NDC Directory, including Sun Pharmaceutical Industries, Inc., Amneal Pharmaceuticals NY LLC, Zydus Lifesciences Limited. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Isotretinoin on HelloPharmacist

📊Isotretinoin supplement interactions49 checked — ranked by severity 🌿Drug & Supplement CheckerIsotretinoin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Isotretinoin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Isotretinoin Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Isotretinoin forms and strengths (how it comes)

Isotretinoin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Absorica Absorica LD Accutane Amnesteem Claravis Zenatane
How this form is used
What it may be used for
  • Absorica and Absorica LD are indicated for severe recalcitrant nodular acne in non-pregnant patients aged 12 and older who have not responded to conventional therapy including systemic antibiotics
  • Accutane, Amnesteem, and Claravis are indicated for severe recalcitrant nodular acne in non-pregnant patients aged 12 and older unresponsive to conventional therapy including systemic antibiotics
  • Isotretinoin capsules (generic) are indicated for severe recalcitrant nodular acne in non-pregnant patients aged 12 and older who have not responded to conventional treatments including systemic antibiotics
  • A second course of any of these products should not begin until at least two months after completing the first course, as acne may continue to improve after stopping
Important instructions
  • Accutane, Amnesteem, Claravis, and Isotretinoin capsules should be taken twice daily with food — taking on an empty stomach significantly reduces how much is absorbed
  • Absorica and Absorica LD are taken twice daily without regard to meals, but should still be taken consistently as directed; note that Absorica and Absorica LD are not interchangeable with each other on a milligram-for-milligram basis
  • If a dose is missed, skip it and continue the normal schedule — do not take two doses at once
  • All brands must be dispensed with a Medication Guide, in no more than a 30-day supply, and each refill requires a new prescription and new iPLEDGE program authorization
Available strengths 10 strengths
8 mg 10 mg 16 mg 20 mg 24 mg 25 mg
Show 4 more strengths Show fewer strengths
30 mg 32 mg 35 mg 40 mg
239 FDA-listed product records ⓘ

Isotretinoin on the U.S. market: products, makers and brands

How Isotretinoin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

13 companies list 97 Isotretinoin product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 1982. Brand names on the directory include Absorica, Amnesteem, Claravis and 5 more; the rest are generics.

1
Dose forms ⓘ
13
Labelers (makers, repackagers, distributors)
7
Brand names
97
FDA-listed product records ⓘ
1982
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Sun Pharmaceutical Industries, Inc.16%
Amneal Pharmaceuticals NY LLC10%
Zydus Lifesciences Limited10%
Zydus Pharmaceuticals USA Inc.10%
Aurobindo Pharma Limited9%
Mayne Pharma8%
Other makers35%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Isotretinoin is used (Medicaid data)

A general measure of how commonly Isotretinoin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Isotretinoin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

239,122
Medicaid prescriptions filled (Q1–Q4 2025)
$47M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Isotretinoin prescribed? Of the 1,601 medications we measure, Isotretinoin ranks #365 by Medicaid prescriptions — more than 77% of them.

Where Isotretinoin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #365 of 1,601
#360 Cinacalcet 248,746 Rx #361 Insulin Degludec (rDNA... 246,402 Rx #362 Calcium Carbonate 245,920 Rx #363 Terconazole 242,416 Rx #364 Minoxidil 241,791 Rx #365 Isotretinoin 239,122 Rx #366 Gemfibrozil 236,607 Rx #367 Fluocinonide Topical 235,702 Rx #368 Fluocinonide 235,702 Rx #369 Heparin Injection 233,533 Rx #370 Heparin 233,533 Rx

Utilization by Isotretinoin product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 40 mg oral capsule is the most-dispensed Isotretinoin product — about 45% of these Medicaid prescriptions.

isotretinoin 40 MG Oral Capsule Most dispensed

107,776 Medicaid prescriptions (Q1–Q4 2025) 45% of Isotretinoin prescriptions shown $18.8M gross reimbursement (before rebates) ≈ $174 per prescription (gross)

Summed across the 14 of 46 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197845

isotretinoin 30 MG Oral Capsule

94,260 Medicaid prescriptions (Q1–Q4 2025) 39% of Isotretinoin prescriptions shown $18.8M gross reimbursement (before rebates) ≈ $199 per prescription (gross)

Summed across the 13 of 44 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 403930

isotretinoin 20 MG Oral Capsule

29,941 Medicaid prescriptions (Q1–Q4 2025) 13% of Isotretinoin prescriptions shown $4.4M gross reimbursement (before rebates) ≈ $147 per prescription (gross)

Summed across the 13 of 46 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197844

isotretinoin 10 MG Oral Capsule

3,843 Medicaid prescriptions (Q1–Q4 2025) 2% of Isotretinoin prescriptions shown $461,310 gross reimbursement (before rebates) ≈ $120 per prescription (gross)

Summed across the 13 of 46 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197843

isotretinoin 35 MG Oral Capsule

979 Medicaid prescriptions (Q1–Q4 2025) <1% of Isotretinoin prescriptions shown $939,584 gross reimbursement (before rebates) ≈ $960 per prescription (gross)

Summed across the 3 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1547565

isotretinoin 25 MG Oral Capsule

842 Medicaid prescriptions (Q1–Q4 2025) <1% of Isotretinoin prescriptions shown $572,739 gross reimbursement (before rebates) ≈ $680 per prescription (gross)

Summed across the 3 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1547561

Micronized isotretinoin 32 MG Oral Capsule

645 Medicaid prescriptions (Q1–Q4 2025) <1% of Isotretinoin prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $2,064 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2262725

Micronized isotretinoin 24 MG Oral Capsule

625 Medicaid prescriptions (Q1–Q4 2025) <1% of Isotretinoin prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $2,167 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2262717

Micronized isotretinoin 16 MG Oral Capsule

180 Medicaid prescriptions (Q1–Q4 2025) <1% of Isotretinoin prescriptions shown $304,358 gross reimbursement (before rebates) ≈ $1,691 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2262711

Micronized isotretinoin 8 MG Oral Capsule

31 Medicaid prescriptions (Q1–Q4 2025) <1% of Isotretinoin prescriptions shown $45,903 gross reimbursement (before rebates) ≈ $1,481 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2262729

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Isotretinoin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 63 of 214 listed Isotretinoin NDCs with Medicaid activity.

Compare Isotretinoin products

A representative set of FDA-listed product records for Isotretinoin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 81 of 97 products — FDA National Drug Code Directory. See every product, package size and price: browse all 97 Isotretinoin NDCs →

Isotretinoin side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Isotretinoin — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Isotretinoin are depression, inflammatory bowel disease, colitis ulcerative; about 56% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

49,172
Reports mentioning it
56%
Reported as serious
12
Distinct effects shown
Most reported effects
Depression
5,803
Inflammatory Bowel Disease
5,252
Colitis Ulcerative
3,808
Dry Skin
2,425
Suicidal Ideation
2,146
Pregnancy
2,080
Irritable Bowel Syndrome
2,015
Headache
1,993
Arthralgia
1,966
Anxiety
1,926
Age groups
Adult · 5,947Adolescent · 2,914Child · 125Elderly · 117Neonate · 64Infant · 39

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Isotretinoin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Isotretinoin FDA approval history

How Isotretinoin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Isotretinoin was first approved by the FDA in 1982 (Brand: ACCUTANE · Hoffmann La Roche); the first generic version was approved in 2002. It remains available in U.S. pharmacies today.

1982
Brand approved
Brand: ACCUTANE · Hoffmann La Roche
2002
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Isotretinoin recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 4 Isotretinoin recalls since July 2021, covering 5 product listings. All of them are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Apr 6, 2026 · Teva Pharmaceuticals USA, Inc
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
  • Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack… Lots: Lots#: 100067507, 100067508, Exp 07/31/2026 FDA record D-0521-2026 →
Ongoing Class II Feb 24, 2026 · MYLAN PHARMACEUTICALS INC
Failed Dissolution Specifications
  • Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6… Lots: Lot #: 3116110, 3116130, Exp. Date 07/2026 FDA record D-0399-2026 →
Ongoing Class II Jan 12, 2026 · Teva Pharmaceuticals USA, Inc
Superpotent and Subpotent
  • Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pa… Lots: Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 . FDA record D-0446-2026 →
  • Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pa… Lots: Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027 FDA record D-0445-2026 →
Ongoing Class II Mar 28, 2024 · Teva Pharmaceuticals USA, Inc
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
  • Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 059… Lots: Lot #: 100044259, Exp 06/30/2025. FDA record D-0439-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Isotretinoin RxCUI 6064 2 dose forms · 12 strengths
  2. Dose form (SCDF) Topical Gel RxCUI 377991 No current FDA listing
    Clinical drug / strength (SCD) 0.0005 MG/MG RxCUI 107436

Look up RxCUI 6064 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Isotretinoin costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule · Oral 40 mg $2.21 per capsule NDC details & price history
Capsule · Oral 30 mg $2.13 per capsule NDC details & price history
Capsule · Oral 20 mg $1.93 per capsule NDC details & price history
Capsule · Oral 10 mg $1.96 per capsule NDC details & price history
Capsule · Oral 25 mg $10.55 per capsule NDC details & price history
Capsule · Oral 32 mg $42.42 per capsule NDC details & price history
Capsule · Oral 24 mg $42.23 per capsule NDC details & price history
Capsule, Liquid Filled · Oral 10 mg $11.94 per capsule NDC details & price history
Capsule, Liquid Filled · Oral 40 mg $6.67 per capsule NDC details & price history
Capsule, Liquid Filled · Oral 20 mg $4.25 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Isotretinoin brand names

Isotretinoin is sold under 8 brand names in the FDA directory — Absorica, Amnesteem, Claravis, Myorisan and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Absorica Amnesteem Claravis Myorisan Zenatane Accutane Sotret Absorica LD

Who makes Isotretinoin: manufacturers and labelers

13 companies list Isotretinoin products with the FDA. By number of product records, the largest are Sun Pharmaceutical Industries, Inc., Amneal Pharmaceuticals NY LLC, Zydus Lifesciences Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Sun Pharmaceutical Industries, Inc. 16 Amneal Pharmaceuticals NY LLC 10 Zydus Lifesciences Limited 10 Zydus Pharmaceuticals USA Inc. 10 Aurobindo Pharma Limited 9 Mayne Pharma 8 Upsher-Smith Laboratories, LLC 8 Actavis Pharma, Inc. 6 BluePoint Laboratories 4 Dr. Reddy's Laboratories Limited 4 JG Pharma Inc. 4 Mylan Pharmaceuticals Inc. 4 Teva Pharmaceuticals USA, Inc. 4

Isotretinoin drug class (RxNorm)

Isotretinoin belongs to the Retinoid class.

Pharmacologic class Retinoid
Drug family (ATC) Retinoids for topical use in acne, Retinoids for treatment of acne

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Isotretinoin page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 19, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Isotretinoin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Isotretinoin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
22
Finished products in the current FDA directory
97
Companies listing them (makers, repackagers, distributors)
13
FDA labeler codes behind them ⓘ
16
Linked representative label ⓘ
Sun Pharmaceutical Industries, Inc.
Linked label effective
Aug 19, 2026
Composite sections available
27
Linked SPL Set ID
3ef0cff8-19c1-4441-b780-fca6c7ee1615
Linked SPL Document ID
a83b6e70-c01f-47c2-8aa3-e8c4148bafa6
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sun Pharmaceutical Industries, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →