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Accutane
Isotretinoin
$126.00
10mg · 3 × 30 capsules · 3 months supply
Generic· By Taro
$42.00 per month
Brand or generic
Generic packs carry the same active ingredient at the same strength.
Strength
How long a supply?
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Annual cost
$504a year at this pack size
Prescription required
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FDA boxed warningEmbryo-fetal toxicity – contraindicated in pregnancy
Isotretinoin Capsules can cause 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.
Because of the risk of embryo-fetal toxicity, Isotretinoin Capsules is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE REMS.
IN PREGNANCY
Isotretinoin Capsules
in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.
iPLEDGE REMS.
About Accutane
Overview
Accutane contains isotretinoin, a retinoid related to vitamin A. It is used to treat severe nodular acne in non-pregnant patients aged 12 years and older whose acne has not responded to conventional treatment, including oral antibiotics. Because it can cause significant adverse reactions, its use is reserved for these patients. Its exact action is unknown, but it reduces the activity and size of the skin’s oil glands, temporarily decreasing oil production.
What it treats
Severe nodular acne with multiple inflamed nodules at least 5 mm across that has not responded to conventional treatment, including systemic antibiotics, in non-pregnant patients aged 12 years and older.
Safety information
Side effects
Common side effects include dry or chapped lips, dry skin, dry eyes, nosebleeds, headache, back pain, joint pain, muscle and bone discomfort, skin inflammation, nose and throat inflammation, upper respiratory tract infections, and reduced visual sharpness. Blood tests may show increased creatine kinase, a muscle enzyme. Serious side effects require medical attention: • Stop treatment and contact a doctor if depression, suicidal thoughts, hallucinations, or aggressive or violent behaviour occur. • Stop treatment and contact a doctor for a severe skin reaction, abdominal pain, rectal bleeding, severe diarrhoea, or symptoms of inflammation of the pancreas. • Stop treatment and contact a doctor if hearing or vision problems develop. Decreased night vision may persist after treatment ends. • Other serious risks include increased pressure inside the skull, liver injury, severe allergic reactions, blood clots, stroke, seizures, blood cell abnormalities, and bone changes, including reduced bone density. Isotretinoin can also increase blood fats, including triglycerides and cholesterol. Regular blood fat checks and liver function tests before and during treatment are needed. Sexual problems, including erectile dysfunction, reduced sex drive and vaginal dryness, have been reported and may continue after treatment stops. Hair loss may also persist. Contact your doctor if these occur. Some reactions were reported after marketing, so their frequency and whether isotretinoin caused them cannot always be determined.
FDA boxed warning
Embryo-fetal toxicity – contraindicated in pregnancy
Isotretinoin Capsules can cause 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.
Because of the risk of embryo-fetal toxicity, Isotretinoin Capsules is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE REMS.
IN PREGNANCY
Isotretinoin Capsules
in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.
iPLEDGE REMS.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not take isotretinoin if you are pregnant or allergic to isotretinoin, vitamin A or any of its ingredients. Serious allergic reactions, including anaphylaxis, have occurred. Breastfeeding is not recommended during treatment. If you can become pregnant, pregnancy testing is required before, during and after treatment, and contraception requirements apply. Do not use isotretinoin together with tetracycline antibiotics because of the risk of increased pressure around the brain. Conditions requiring caution and monitoring include mental health disorders, abnormal blood fats, liver problems, hearing or vision changes, and bone or joint problems. Mental health assessment is needed before and during treatment. Blood fat levels need regular monitoring, and liver function tests are needed before and during treatment. Stop treatment and seek medical advice if depression, psychosis, suicidal thoughts or behaviour, or aggressive or violent behaviour develops. Treatment must also be stopped for serious skin reactions, symptoms of pancreatitis, abdominal pain, rectal bleeding or severe diarrhoea. Hearing or vision changes require stopping treatment and specialist assessment. Isotretinoin must be stopped if high triglyceride levels cannot be controlled.
Interactions
Avoid taking isotretinoin with vitamin A or tetracycline antibiotics. Tell your doctor if you take vitamin A supplements or a tetracycline antibiotic.
Using Accutane
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label ISOTRETINOIN CAPSULE [AUROBINDO PHARMA LIMITED] (DailyMed, retrieved 19 September 2026).
Patient information and references
Official and supporting information to read alongside advice from your prescriber or pharmacist.
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