isotretinoin
Brand names: Accutane, Absorica
Isotretinoin capsules are a strong medicine used to treat severe acne. It helps clear up acne when other treatments haven't worked.
Drug Pricing (NADAC)
Brand Price
$35.67/unit
Generic Price
$1.69/unit
Generic Savings
95%
Generic Available
Yes (13 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Isotretinoin capsules treat severe nodular acne.
Common side effects
Dry skin, Dry lips, Dry nose
Key warnings
Isotretinoin capsules can cause severe birth defects.
How It Works
Isotretinoin is related to vitamin A. It works by reducing the amount of oil released by oil glands in your skin. It also helps to reduce inflammation and prevent clogged pores.
How to Take It
Take isotretinoin capsules with a meal. The usual dose is 0.5 to 1 mg per kg of body weight per day, divided into two doses. Take it for 15 to 20 weeks. Your doctor may change your dose based on how well it's working and any side effects you have.
Pregnancy & Breastfeeding
Isotretinoin capsules can cause very serious birth defects. Do not take this medicine if you are pregnant or plan to become pregnant. Use two forms of birth control while taking isotretinoin capsules and for one month after stopping.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store at room temperature (68° to 77°F) and protect from light.
Side Effects (from patient reports)
Based on 29,012 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 47,513 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2000–2025.
Total Reports
47,513
Death-Related Reports
878
Hospitalization Reports
4,281
Top Indication
Acne
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DEPRESSION | 5,699 |
| 2 | INFLAMMATORY BOWEL DISEASE | 5,252 |
| 3 | COLITIS ULCERATIVE | 3,796 |
| 4 | DRY SKIN | 2,325 |
| 5 | SUICIDAL IDEATION | 2,113 |
| 6 | PREGNANCY | 2,074 |
| 7 | IRRITABLE BOWEL SYNDROME | 2,015 |
| 8 | HEADACHE | 1,943 |
| 9 | ARTHRALGIA | 1,909 |
| 10 | ANXIETY | 1,884 |
| 11 | UNINTENDED PREGNANCY | 1,882 |
| 12 | PRODUCT DOSE OMISSION ISSUE | 1,727 |
| 13 | CROHN^S DISEASE | 1,676 |
| 14 | EXPOSURE DURING PREGNANCY | 1,584 |
| 15 | LIP DRY | 1,534 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Isotretinoin capsules can cause severe birth defects. You must not take this medicine if you are pregnant or may become pregnant. You must use two forms of birth control while taking isotretinoin capsules. If you get pregnant while taking isotretinoin capsules, stop taking it right away and see a doctor.
Known Drug Interactions
Micro-dosed Progesterone Preparations: Micro-dosed progesterone preparations ("minipills" that do not contain an estrogen) may be an inadequate method of contraception during isotretinoin capsules therapy. Norethindrone/ethinyl estradiol: In a study of 31 premenopausal female patients with severe recalcitrant nodular acne receiving OrthoNovum ® 7/7/7 Tablets as an oral contraceptive agent, isotretinoin capsules 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 progester...
Mechanism: This drug can interfere with 'mini-pills' that only contain progesterone, making them less reliable for preventing pregnancy.
What to do: You should use a more effective form of birth control or two different methods to ensure you do not become pregnant.
Drug Interactions Vitamin A: Because of the relationship of isotretinoin capsules to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects.
Mechanism: Both of these are forms of Vitamin A, and taking them together can cause the vitamin to build up to toxic levels.
What to do: Avoid taking any vitamin supplements that contain Vitamin A while you are on this medicine.
Norethindrone/ethinyl estradiol: In a study of 31 premenopausal female patients with severe recalcitrant nodular acne receiving OrthoNovum ® 7/7/7 Tablets as an oral contraceptive agent, isotretinoin capsules 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).
Mechanism: Studies show that isotretinoin does not change the levels of estradiol in your body. It does not interfere with how this hormone is processed.
What to do: These drugs can be taken together safely. No special monitoring or dose changes are required.
Norethindrone/ethinyl estradiol: In a study of 31 premenopausal female patients with severe recalcitrant nodular acne receiving OrthoNovum ® 7/7/7 Tablets as an oral contraceptive agent, isotretinoin capsules 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).
Mechanism: Isotretinoin does not affect the amount of norethindrone in your blood or how well it works. It does not seem to change the effectiveness of this hormone.
What to do: You can take these medications together as prescribed. No dose adjustments are typically necessary.
Phenytoin : Isotretinoin capsules have not been shown to alter the pharmacokinetics of phenytoin in a study in seven healthy volunteers. Phenytoin is known to cause osteomalacia. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between phenytoin and isotretinoin capsules.
Mechanism: Both drugs may have an effect on bone strength, though it is not certain if taking them together increases the risk of bone loss.
What to do: Talk to your doctor about monitoring your bone health if you need to take both of these medicines.
Common Questions
Can I take vitamin A supplements while taking isotretinoin capsules?
Can I donate blood while taking isotretinoin capsules?
What should I do if I experience depression while taking isotretinoin capsules?
Can I have laser treatments or waxing while taking isotretinoin capsules?
How often will I see my doctor while taking isotretinoin capsules?
Can I drink alcohol while taking isotretinoin capsules?
What is the iPLEDGE program?
How long does it take for isotretinoin capsules to work?
What happens if I stop taking isotretinoin capsules early?
Can isotretinoin capsules cure my acne?
What are the common side effects of isotretinoin?
Does isotretinoin interact with other medications?
What drug class is isotretinoin?
Is there a generic version of isotretinoin?
Is isotretinoin safe during pregnancy?
Has isotretinoin been recalled?
Active Recalls
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Teva Pharmaceuticals USA, Inc
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What the FDA Data Shows for isotretinoin
The FDA label for isotretinoin (sold under brand names such as Accutane, Absorica) classifies it as a prescription-only medication in the Systemic Retinoid class. Isotretinoin capsules treat severe nodular acne. Official labeling lists 4 commonly reported side effects, including Dry skin, Dry lips, Dry nose.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 29,012 voluntary reports. The database also lists 7 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $1.69 versus $35.67 for the brand — a 95% generic savings.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: June 26, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages