SkinActive ingredient
Isotretinoin
Oral retinoid1 FDA label read
Isotretinoin is the only oral retinoid on this page and the only medication in this category with a boxed warning. That warning is about pregnancy: the label states that it must not be used by anyone who is pregnant or may become pregnant, because it causes severe birth defects.
Highlights of the labels
- Isotretinoin capsules
- Severe nodular acnecovers skin
- Supply
- Prescription only
- Generic
- 13 approved applications
- Boxed warning
- WARNING: EMBRYO-FETAL TOXICITY
FDA boxed warning
WARNING: EMBRYO-FETAL TOXICITY
In the Isotretinoin capsules label
- CONTRAINDICATED IN PREGNANCY Isotretinoin capsules can cause severe life-threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking any amount of isotretinoin capsules even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affected. If pregnancy occurs, discontinue isotretinoin capsules immediately and refer the patient to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.
A boxed warning is the most serious warning the FDA requires. This text is reproduced from the label.
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| Isotretinoin capsulesUpsher-Smith Laboratories, LLC | What its label approvesSevere nodular acneCovers skin | SupplyPrescription | Label version13 February 2026 |
How it works
Isotretinoin is the only medication on this page swallowed rather than applied to the skin, which is why its label describes effects on the body rather than on one patch of it. Read the wording below closely on one point: the label links clinical improvement to reduced sebum by saying the two occur in association, not by claiming one causes the other.
Mechanism of action, Isotretinoin capsules label
Isotretinoin is a retinoid, which when administered at the recommended dosage, inhibits sebaceous gland function and keratinization. Clinical improvement in nodular acne patients occurs in association with a reduction in sebum secretion. The decrease in sebum secretion is temporary and is related to the dose and duration of treatment with isotretinoin capsules and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation.
What the FDA approved it for
The approved uses, as worded in the label.
- Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.
- Isotretinoin capsules are retinoids indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater.
- Limitations of Use: If a second course of isotretinoin therapy is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of therapy.
Forms and strengths
The presentations and strengths listed in the label.
- Isotretinoin capsules, USP are available in 10 mg, 20 mg and 30 mg. 10 mg: Yellow, oblong, opaque, soft gelatin capsule, containing a yellow/orange viscous liquid, imprinted "570" in black ink. 20 mg: Pink, oblong, opaque, soft gelatin capsule, containing a yellow/orange viscous liquid, imprinted "571" in black ink.
- Capsules: 10 mg, 20 mg and 30 mg
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
- Recommended dosage for isotretinoin capsules is 0.5 to 1 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks
- Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of isotretinoin capsules in divided doses.
- Once daily dosing is not recommended.
- If a dose of isotretinoin capsules is missed, just skip that dose. Do not take two doses of isotretinoin capsules at the same time.
- Perform pregnancy tests prior to prescribing, each month during therapy, end of therapy, and one month after discontinuation.
- Prior to prescribing, perform fasting lipid profile and liver function tests.
Most common adverse reactions
The adverse reactions the label reports as most common.
Most common adverse reactions (incidence ≥ 5%) are: dry lips, dry skin, back pain, dry eye, arthralgia, epistaxis, headache, nasopharyngitis, chapped lips, dermatitis, increased creatine kinase, cheilitis, musculoskeletal discomfort, upper respiratory tract infection, reduced visual acuity.
Warnings and precautions
The warnings and precautions section of the label.
- Psychiatric Disorders (depression, psychosis, suicidal thoughts and behavior, and aggressive and/or violent behaviors): Prior to and during therapy assess for these conditions; stop if these conditions occur on therapy
- Intracranial Hypertension (Pseudotumor Cerebri): Avoid use with concomitant tetracyclines
- Serious Skin Reactions: Monitor for Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious skin reactions
- Acute Pancreatitis: If occurs, discontinue treatment
- Lipid Abnormalities (hypertriglyceridemia, low HDL, and elevation of cholesterol): Monitor lipid levels at regular intervals; stop if hypertriglyceridemia cannot be controlled
- Hearing Impairment: Discontinue and refer to specialized care
- Hepatotoxicity: Monitor liver function tests prior to and during therapy
- Inflammatory Bowel Disease: Discontinue for abdominal pain, rectal bleeding, or severe diarrhea
Contraindications
Situations in which the label states the medication must not be used.
Hypersensitivity to this product or any of its components
Drug interactions
Interactions the label singles out.
- Vitamin A: may cause additive adverse reactions
- Tetracyclines: avoid concomitant use
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to isotretinoin during pregnancy. Report any suspected fetal exposure during or 1 month after isotretinoin therapy immediately to the FDA via the MedWatch telephone number 1-800-FDA-1088 and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the internet (www.ipledgeprogram.com).
Generic or brand
Isotretinoin is dispensed almost entirely as generics in the United States. The original brand is no longer the reference point it once was, and the labels on this page come from a generic manufacturer.
The FDA label database lists 13 approved generic applications for this ingredient.
What affects the cost
Isotretinoin is generic, but access is governed by a risk management program that requires registration, pregnancy testing and monthly prescribing. That process, not the price of the capsules, is what shapes how people get it. This site does not link to sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programs. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Brand | Generic |
|---|---|---|
| per tablet, capsule or pen | Brand$38.05 (range $35.35 to $42.16, 270 listings) | Generic$2.18 (range $1.61 to $14.43, 2690 listings) |
Median of 2960 listings. Effective dates 2025-07-23 to 2026-07-22, file dated 2026-07-29.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- What does the boxed warning say?
- It concerns pregnancy. The label states that isotretinoin must not be used by patients who are or may become pregnant, and describes the severe birth defects associated with exposure. The full text of the warning is quoted on this page.
- Why is it harder to get than a cream?
- Because of that warning. Prescribing is tied to a risk management program with registration and pregnancy testing requirements. This page reports what the label says; it does not describe how to enroll or how to obtain the medication.
Other medications under skin
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Isotretinoin capsules
Upsher-Smith Laboratories, LLC. Label version 4, effective 13 February 2026.
Each stripe is one section of the label, each division in a stripe one entry in that section. The red bar marks a boxed warning.
Page last updated 23 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.