Prescription medication · Systemic Retinoid
isotretinoin
Also sold as Accutane, Absorica. Isotretinoin capsules treat severe nodular acne.
Data updated 2026-05-15
- 47,513
- FDA reportsOften reported
- 7
- InteractionsFew interactions
- 95% less
- Generic vs brandHuge savings
- 5
- Recall records
What the data shows
isotretinoin (Accutane) is a prescription Systemic Retinoid, reported at a middle-of-the-pack volume (47,513 FDA reports), whose generic costs a fraction of the brand (about 95% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
isotretinoin (Accutane) is a prescription Systemic Retinoid. Isotretinoin capsules treat severe nodular acne.
Isotretinoin capsules are a strong medicine used to treat severe acne. It helps clear up acne when other treatments haven't worked.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from isotretinoin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of isotretinoin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of isotretinoin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of isotretinoin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature (68° to 77°F) and protect from light.
Side Effects (from patient reports)
Based on 47,513 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for isotretinoin, by number of reports
- Feeling sad or hopeless
Feeling sad or hopeless
5,699 reports
- Inflammation of the intestines
Inflammation of the intestines
5,253 reports
- Ulcers in the large intestine
Ulcers in the large intestine
3,796 reports
- Skin is rough and flaky
Skin is rough and flaky
2,326 reports
- Thoughts of killing yourself 2,112
Thoughts of killing yourself
2,112 reports
- Being pregnant 2,074
Being pregnant
2,074 reports
- Stomach pain and bloating 2,015
Stomach pain and bloating
2,015 reports
- Pain in your head 1,944
Pain in your head
1,944 reports
- Joint pain 1,909
Joint pain
1,909 reports
- Feeling worried or nervous 1,884
Feeling worried or nervous
1,884 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for isotretinoin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where isotretinoin sits
isotretinoin has more FDA adverse-event reports than 72% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is isotretinoin; the line is the median (50th percentile).
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
Reports Mentioning Death
878
1.8% of reports — not proof of cause
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 |
| 13 | CROHN^S DISEASE | 1,676 |
| 14 | EXPOSURE DURING PREGNANCY | 1,584 |
| 15 | LIP DRY | 1,534 |
| 16 | ADVERSE DRUG REACTION | 1,439 |
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...
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Teva Pharmaceuticals USA, Inc
Failed Dissolution Specifications
MYLAN PHARMACEUTICALS INC
Superpotent and Subpotent
Teva Pharmaceuticals USA, Inc
Superpotent and Subpotent
Teva Pharmaceuticals USA, Inc
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Teva Pharmaceuticals USA, Inc
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 47,513 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 5 recall records 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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