Accutane (Isotretinoin) is a powerful oral retinoid medication used to treat severe nodular acne that hasn't responded to other treatments, including oral antibiotics.

What Is Accutane?

Accutane is the original brand name for Isotretinoin, a prescription medication in the retinoid (Vitamin A derivative) drug class. It was originally manufactured by Roche and received FDA approval for severe recalcitrant nodular acne. The Accutane brand was discontinued in 2009, but the medication lives on through several generic versions:

• Claravis (Teva)
• Amnesteem (Mylan)
• Myorisan
• Zenatane (Zydus)
• Absorica / Absorica LD (Sun Pharma) — a micronized formulation with improved absorption

Isotretinoin is not a controlled substance, but it is heavily restricted through the iPLEDGE REMS program — a federal risk management program that both patients and prescribers must enroll in before the medication can be prescribed or dispensed. This program exists primarily to prevent pregnancies during treatment, due to the extremely high risk of severe birth defects.

What Is Accutane Used For?

FDA-Approved Use

Isotretinoin is FDA-approved for one specific indication:

• Severe recalcitrant nodular acne — acne that forms deep, painful cysts and nodules and hasn't improved with conventional treatments including systemic antibiotics like Doxycycline or Minocycline.

Off-Label Uses

Doctors sometimes prescribe Isotretinoin off-label for other conditions, including:

• Moderate acne that hasn't responded to other treatments
• Rosacea
• Folliculitis
• Hidradenitis suppurativa
• Certain skin cancers (prevention of squamous cell carcinoma in high-risk patients)

How Is Accutane Taken?

Isotretinoin comes as oral capsules in various strengths: 10 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg. Absorica also comes in micronized capsules (8 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg).

Key dosing details:

• Typical dose: 0.5 to 1.0 mg/kg/day (for example, a 150-pound person might take 30-60 mg per day)
• Cumulative target: 120-150 mg/kg over the full course
• Treatment duration: Usually 15 to 20 weeks (about 4-5 months)
• Take with food: Standard capsules should be taken with a high-fat meal for best absorption. Absorica/Absorica LD can be taken without food.
• Swallow whole — do not crush or chew the capsules.

Your dermatologist may start you at a lower dose and gradually increase it to minimize the initial acne flare that some patients experience. For details on how the medication works in your body, see our guide on how Accutane works.

Who Should Not Take Accutane?

Isotretinoin is not safe for everyone. It is contraindicated in the following situations:

• Pregnancy or planned pregnancy — Isotretinoin causes severe birth defects. It is classified as Category X, meaning the risks far outweigh any potential benefit. This is the reason for the iPLEDGE program.
• Breastfeeding — Not recommended for nursing mothers.
• Allergy to Isotretinoin or its ingredients — Some formulations contain parabens or soybean oil.
• Concurrent tetracycline use — Taking Doxycycline, Minocycline, or other tetracyclines with Isotretinoin dramatically increases the risk of pseudotumor cerebri (dangerous pressure in the skull).
• Excess Vitamin A intake — Isotretinoin is a Vitamin A derivative; additional supplementation can cause toxicity.

Patients with a history of depression, mental health conditions, high cholesterol, liver disease, or diabetes should discuss these carefully with their doctor before starting treatment. Monthly blood work is required to monitor liver function and lipid levels. For a complete guide to Accutane side effects, see our detailed breakdown.

How Much Does Accutane Cost?

Cost varies widely depending on insurance coverage, dose, and where you fill your prescription:

• Generic Isotretinoin (cash price): $200 to $500+ per month without insurance
• With discount coupons (GoodRx, etc.): As low as $40-$90 per month
• Brand Absorica: $700-$900+ per month without insurance
• With insurance: Most plans cover generic Isotretinoin, often with prior authorization. Copays vary but are typically $10-$75/month with commercial insurance.

Insurance companies usually require prior authorization and may enforce step therapy — meaning you need to show that you've tried and failed other treatments first (topical retinoids like Adapalene or Tretinoin, oral antibiotics, etc.).

For detailed strategies on reducing costs, see our guide to saving money on Accutane. Absorica also offers a manufacturer savings card at absorica.com for commercially insured patients.

The iPLEDGE Program: What You Need to Know

Every patient taking Isotretinoin in the United States must be enrolled in iPLEDGE, regardless of age or sex. Here's what that involves:

• Registration — Your doctor, pharmacy, and you must all be registered in the system.
• Monthly verification — You must log in to the iPLEDGE website or call in each month to answer questions and confirm compliance.
• Pregnancy testing — Patients who can become pregnant must have two negative pregnancy tests before starting and monthly tests throughout treatment.
• Two forms of contraception — Required for patients who can become pregnant (or documented abstinence).
• 7-day fill window — Once authorized, you have 7 days to pick up your prescription.
• No blood donation — During treatment and for one month after stopping.

Final Thoughts

Accutane (Isotretinoin) remains one of the most effective medications for severe acne, with the potential to produce long-lasting or even permanent clearance in many patients. But it comes with significant requirements — the iPLEDGE program, monthly lab work, and a list of side effects that need careful monitoring.

If your doctor has recommended Isotretinoin, come prepared: understand the commitment, the monitoring schedule, and your options for managing costs. And when it's time to fill your prescription, Medfinder can help you find a pharmacy with Accutane in stock.