Prescription medicine
Acitretin First approved as Soriatane
Acitretin (Soriatane) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $2.59 per acitretin 10 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the acitretin FDA label on DailyMed (effective August 5, 2026, Sigmapharm Laboratories, LLC); the NDA 19821 record on Drugs@FDA; every acitretin label on DailyMed.
Highlights of the record
FDA label of August 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
AND WARNINGS:.
Pregnancy Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. Acitretin also must not be used by females who may not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation of treatment. Acitretin is a metabolite of etretinate (TEGISON), and major human fetal abnormalities have been reported with the administration of acitretin and etretinate. Potentially, any fetus exposed can be affected. Clinical evidence has shown that concurrent ingestion of acitretin and ethanol has been associated with the formation of etretinate, which has a significantly longer elimination half-life than acitretin. Because the longer elimination half-life of etretinate would increase the duration of teratogenic potential for female patients, ethanol must not be ingested by female patients of childbearing potential either during treatment with acitretin or for 2 months after cessation of therapy. This allows for elimination of acitretin, thus removing the substrate for transesterification to etretinate. The mechanism of the metabolic process for conversion of acitretin to etretinate has not been fully defined. It is not known whether substances other than ethanol are associated with transesterification. […]
Used for
From the label: indications and usageAcitretin Capsules, USP are indicated for the treatment of severe psoriasis in adults.
Forms and strengths
- 10 mg
- 17.5 mg
- 22.5 mg
- 25 mg
Capsule.
On the market
- Earliest approval on file
- October 28, 1996 Soriatane, Stiefel Labs Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first April 4, 2013; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 8 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $2.59 per capsule Acitretin 10 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4,849 through July 30, 2026
What is acitretin used for?
From the label: indications and usageAcitretin Capsules, USP are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules, USP should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules, USP should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS – Acitretin Capsules, USP can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. […]
Conditions named in the indications of acitretin's FDA labels, with every medicine labeled for each:
From other acitretin labelsPsoriasis: INDICATIONS AND USAGE Acitretin Capsules, USP are indicated for the treatment of severe psoriasis in adults.
FDA pharmacologic class: Retinoid.
Source: FDA drug label (ACITRETIN), Sigmapharm Laboratories, LLC, effective August 5, 2026 (SPL set a6546625-acb8-460e-b34e-f795bfb3680a), via openFDA; the full label on DailyMed
What does the patient leaflet for acitretin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about acitretin capsules?Acitretin capsules can cause serious side effects, including: Severe birth defects. If you are a female who can get pregnant, you should use acitretin capsules only if you are not pregnant now, can avoid becoming pregnant for at least 3 years, and other medicines do not work for your severe psoriasis or you cannot use other psoriasis medicines. Information about effects on unborn babies and about how to avoid pregnancy is found in the next section: “What are the important warnings and instructions for females taking acitretin capsules?” Liver problems, including abnormal liver function tests and inflammation of your liver (hepatitis). Your prescriber should do blood tests to check how your liver is working before you start taking and during treatment with acitretin capsules. Stop taking acitretin capsules and call your prescriber right away if you have any of the following signs or symptoms of a serious liver problem: yellowing of your skin or the whites of your eyes nausea and vomiting loss of appetite dark urine
From the patient leaflet: What should I avoid while taking acitretin capsules?Avoid pregnancy. See “What is the most important information I should know about acitretin capsules?”, and “What are the important warnings and instructions for females taking acitretin capsules?” Avoid breastfeeding. See “What are the important warnings and instructions for females taking acitretin capsules?” Avoid alcohol. Females who are able to become pregnant must avoid drinks, foods, medicines, and over-the-counter products that contain alcohol. The risk of birth defects may continue for longer than 3 years if you swallow any form of alcohol during treatment with acitretin capsules and for 2 months after stopping acitretin capsules (see “What are the important warnings and instructions for females taking acitretin capsules?”). Avoid giving blood. Do not donate blood while you are taking acitretin capsules and for at least 3 years after stopping treatment with acitretin capsules. […]
From the patient leaflet: How should I store acitretin?Store acitretin capsules at 68° to 77°F (20°C to 25°C). See USP Controlled Room Temperature. Keep acitretin capsules away from sunlight, high temperature, and humidity. Keep acitretin capsules and all medicines out of the reach of children.
Source: FDA drug label (ACITRETIN), Sigmapharm Laboratories, LLC, effective August 5, 2026 (SPL set a6546625-acb8-460e-b34e-f795bfb3680a), via openFDA; the full label on DailyMed
Is there a generic for acitretin (Soriatane)?
The FDA approved the first generic acitretin on April 4, 2013. 7 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists acitretin from 8 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1996 earliest approval on file
- 2013 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for acitretin (Soriatane)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.59 per Acitretin 10 mg capsule, down 41% from $4.41 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Acitretin 10 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Acitretin 10 mg capsule | Generic | $2.59 per capsule | $77.84 | -41% |
| Acitretin 17.5 mg capsule | Generic | $4.52 per capsule | $135.55 | -12% |
| Acitretin 25 mg capsule | Generic | $3.54 per capsule | $106.27 | -7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the acitretin label say about other medicines?
The acitretin label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name acitretin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cimetidine | drug interactions | Drug Interactions ): In studies of in vivo pharmacokinetic drug interactions, no interaction was seen between acitretin and cimetidine, digoxin, phenprocoumon, or glyburide. |
| Digoxin | drug interactions | Drug Interactions ): In studies of in vivo pharmacokinetic drug interactions, no interaction was seen between acitretin and cimetidine, digoxin, phenprocoumon, or glyburide. |
| Glyburide | drug interactions | In a trial of 7 healthy male volunteers, acitretin treatment potentiated the blood glucose-lowering effect of glyburide (a sulfonylurea similar to chlorpropamide) in 3 of the 7 subjects. |
| Isotretinoin | warnings | Some of these events involved concomitant use of isotretinoin and tetracyclines. |
| Methotrexate | contraindications | An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. |
| Phenytoin | drug interactions | If acitretin is given concurrently with phenytoin, the protein binding of phenytoin may be reduced. |
| Tetracycline | warnings | However, the event seen in a single patient receiving acitretin was not associated with tetracycline use. |
| Vitamin a | drug interactions | Vitamin A and Oral Retinoids: Concomitant administration of vitamin A and/or other oral retinoids with acitretin must be avoided because of the risk of hypervitaminosis A. |
| Warfarin | drug interactions | Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction. |
Other labels that name acitretin
Source: FDA drug label (ACITRETIN), Sigmapharm Laboratories, LLC, effective August 5, 2026 (SPL set a6546625-acb8-460e-b34e-f795bfb3680a), via openFDA; the full label on DailyMed
What do FAERS reports show for acitretin?
The FDA Adverse Event Reporting System holds 4,849 reports that list acitretin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 277 are coded as a death and 1,404 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as acitretin?
4 other medicines are given the same way (oral) and in the same FDA class as acitretin or labeled mainly for the same use (psoriasis), the same class first. Psoriasis lists all 38 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Apremilast | Psoriasis | none listed | $90.57 per tablet 30 mg tablet | No current entry |
| Deucravacitinib | Psoriasis | none listed | n/a | No current entry |
| Icotrokinra | Psoriasis | none listed | n/a | No current entry |
| Methoxsalen | Psoriasis | 1 labeler | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to acitretin
- 4 medicines for the same use
- Other retinoids
- the pharmacologic class, with prices and generics
- Acitretin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other