Quick overview
Accutane is a brand name for isotretinoin, an oral retinoid used for severe acne. In the United States, isotretinoin can only be dispensed under the FDA REMS iPLEDGE program due to a high risk of serious birth defects if taken during pregnancy. If you are new to this therapy, review U.S. legal and program requirements first, then read how to take it safely in How to take isotretinoin and what to avoid in Interactions.
U.S. legal and program requirements
In the USA, isotretinoin is prescription-only and regulated by the iPLEDGE REMS program.
- Enrollment in iPLEDGE is required for patients, prescribers, and pharmacies.
- Patients who can become pregnant must use two forms of contraception or practice abstinence as specified, have two negative pregnancy tests before the first fill, then monthly negative tests, plus one test after therapy ends. Only a 30-day supply is dispensed at a time.
- Patients who cannot become pregnant must also enroll and meet monthly authorization steps before each refill.
- Telemedicine is allowed if the prescriber and pharmacy comply with iPLEDGE and state laws.
- Buying isotretinoin online or importing it without a valid U.S. prescription is illegal.
- Do not donate blood during treatment and for at least 30 days after the last dose to prevent exposure in pregnant recipients.
These safeguards are federal requirements. Some states may impose additional rules on labs, telehealth, or dispensing windows.
Tell your prescriber before starting
Share your full medical history and all medicines you take. Be sure to mention if you have or have had any of the following:
- Pregnancy, trying to conceive, or plans to become pregnant; or if you are breastfeeding
- Liver disease or a history of abnormal liver tests
- Pancreatitis or very high triglycerides
- Depression, other mental health conditions, past suicide attempt, psychosis, or a family history of serious mental health disorders
- Osteoporosis, osteomalacia, or other bone problems
- Inflammatory bowel disease (e.g., Crohn disease, ulcerative colitis)
- Heart disease
- High cholesterol or high triglycerides
- Diabetes or prediabetes
- Any allergy to isotretinoin, vitamin A, retinoids, parabens, dyes, foods, or preservatives
How to take isotretinoin
Isotretinoin in the U.S. is supplied as capsules. Swallow capsules whole with water. Do not crush, chew, or open them.
Take exactly as prescribed, usually once or twice daily. Taking with a meal helps absorption. Some brands (for example, Absorica/Absorica LD) are formulated to be less dependent on high-fat meals, but follow your product-specific directions.
Stay consistent: take doses at the same times each day. Do not take more than directed.
Pediatric use: specialists may prescribe isotretinoin to adolescents with severe acne when benefits outweigh risks. If prescribed for a younger patient, additional monitoring applies.
Overdose: call your local emergency number or the U.S. Poison Help line at 1-800-222-1222 immediately.
Need help with timing or side effects? See Monitoring and precautions.
If you miss a dose
If you remember the missed dose with enough time before the next scheduled dose, take it. If your next dose is due in less than about 4 hours, take skip the missed dose and resume your regular schedule. Do not double up.
Interactions
Avoid the following because they can significantly increase risks:
- Vitamin A supplements or multivitamins high in vitamin A
Other interactions to discuss with your prescriber:
- Tetracycline antibiotics (e.g., doxycycline, tetracycline) due to risk of increased intracranial pressure
- Progestin-only birth control (the mini-pill) which may be less reliable for those who can become pregnant
- St. John's wort (may reduce effectiveness of hormonal birth control)
- Systemic steroids such as prednisone or cortisone
- Medicines for seizures
- Warfarin and other anticoagulants
- Orlistat
- Topical acne products that dry or irritate skin (benzoyl peroxide, salicylic acid, strong astringents)
- Photosensitizing drugs, including some sulfa medications
- Alcohol, which can worsen triglycerides and liver strain
This list does not include every possible interaction. Always provide a complete list of prescription medicines, OTC drugs, supplements, and herbals to your health care professional, and mention alcohol, nicotine, or recreational drug use.
Monitoring and precautions
You may notice acne flares during the first weeks. Monthly follow-ups are standard to track progress, side effects, pregnancy testing when applicable, and lab results (lipids and liver enzymes).
- Mood and mental health: stop the medicine and call your prescriber right away if you experience depression, anxiety, unusual anger, or thoughts of self-harm.
- Vision changes: night vision may decline; stop the drug and see an eye doctor if you notice visual changes. Contact lenses may feel uncomfortable due to dryness.
- Sun sensitivity: minimize sun exposure; wear protective clothing and broad-spectrum sunscreen. Avoid tanning beds and sun lamps.
- Cosmetic procedures: avoid waxing, dermabrasion, and most laser skin treatments during therapy and for at least 6 months after the last dose due to scarring risk.
- Blood sugar: if you have diabetes or insulin resistance, monitor glucose more closely and report changes.
- Do not donate blood while taking isotretinoin and for 30 days after the final dose.
- Never share this medication with anyone.
For items that can interact with sun or skin dryness, review Interactions.
Possible side effects
Serious effects - get medical help promptly
- Allergic reactions: hives, rash, itching, swelling of the face, lips, tongue, or throat; trouble breathing
- Severe headache, dizziness, fainting, slurred speech, trouble swallowing, vision changes (blurred, double, or reduced night vision)
- Chest pain or irregular heartbeat
- Severe stomach pain, persistent nausea or vomiting, or bad upper abdominal pain (could signal pancreatitis)
- Severe diarrhea
- Hearing loss or ringing in the ears
- Yellowing of the skin or eyes, dark urine, unusual bruising or bleeding (possible liver or blood problems)
- Marked increase in thirst or urination
- Muscle weakness with or without pain
- New or worsening depression, loss of interest in usual activities, irritability, aggression, or thoughts of self-harm
- Changes in the menstrual cycle or facial swelling
Common, usually less serious
- Chapped or cracked lips
- Dry skin, nose, or mouth; mild headache
- Facial flushing
- Hair thinning or increased fragility
Report persistent or bothersome effects to your prescriber. For steps to reduce dryness and sun sensitivity, see Monitoring and precautions.
Alternatives and similar medicines
Alternatives depend on acne severity, skin type, and patient factors. Discuss with a dermatologist before changing therapy.
- Other isotretinoin brands/generics: Absorica/Absorica LD, Claravis, Amnesteem, Myorisan, Zenatane (same active ingredient; absorption and formulation may differ)
- Topical retinoids: adapalene (OTC and Rx), tretinoin, tazarotene
- Topical agents: benzoyl peroxide, clindamycin-benzoyl peroxide combinations, azelaic acid, salicylic acid
- Oral antibiotics for moderate to severe inflammatory acne: doxycycline, minocycline, sarecycline (short-term courses; avoid combining with isotretinoin)
- Hormonal options for those who can become pregnant: combined oral contraceptives approved for acne; spironolactone (off-label for acne)
- Procedural options: intralesional corticosteroid injections for nodules; light or photodynamic therapy in selected cases
When isotretinoin is clearly indicated for severe nodular acne, alternatives may be less effective but can be used when isotretinoin is contraindicated or declined. For cost comparisons, see prices.
Approximate prices in the USA (USD)
Out-of-pocket costs vary widely by brand, dose, insurance, and pharmacy. The figures below are rough cash estimates for a 30-day supply unless noted. Your costs may be much lower with insurance or discount programs.
- Isotretinoin generics (e.g., Claravis, Myorisan, Zenatane): about $150 to $400 per month depending on dose
- Absorica/Absorica LD (brand): often higher, roughly $300 to $700+ per month depending on dose
- Topical adapalene (OTC 0.1%): about $12 to $30 per tube
- Tretinoin cream/gel (Rx): about $40 to $150 per tube
- Doxycycline or minocycline generics: commonly $10 to $40 per month
- Spironolactone: about $5 to $30 per month
- Combined oral contraceptives: about $10 to $50 per month
- Typical monthly labs and required pregnancy tests (where applicable): often $10 to $50+ per test depending on setting
Tip: Ask your prescriber about pharmacy shopping, manufacturer copay cards (for brands), and independent labs to reduce costs. Never attempt to bypass iPLEDGE or import isotretinoin; see legal requirements.
Storage and handling
- Keep out of reach of children.
- Store at room temperature (59 to 86 F or 15 to 30 C) in a dry place, away from excess heat and light.
- Do not use after the expiration date; follow local guidance for safe disposal.