Medication Guide — Acitretin

Patient-friendly FDA guidance and safety information.

Last updated · May 13, 2026Source: DailyMed ↗

Boxed Warning

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.

Acitretin has been shown to be embryotoxic and/or teratogenic in rabbits, mice, and rats at oral doses of 0.6, 3, and 15 mg per kg, respectively. These doses are approximately 0.2, 0.3, and 3 times the maximum recommended therapeutic dose, respectively, based on a mg-per-m2 comparison.

Major human fetal abnormalities associated with acitretin and/or etretinate administration have been reported including meningomyelocele; meningoencephalocele; multiple synostoses; facial dysmorphia; syndactyly; absence of terminal phalanges; malformations of hip, ankle, and forearm; low-set ears; high palate; decreased cranial volume; cardiovascular malformation; and alterations of the skull and cervical vertebrae.

Acitretin should be prescribed only by those who have special competence in the diagnosis and treatment of severe psoriasis, are experienced in the use of systemic retinoids, and understand the risk of teratogenicity.

Because of the teratogenicity of acitretin, a program called the H.A.E.R.T. program, Healthier Acitretin Education and Remission Treatment, has been developed to educate women of childbearing potential and their healthcare providers about the serious risks associated with acitretin and to help prevent pregnancies from occurring with the use of this drug and for 3 years after its discontinuation. The H.A.E.R.T. program requirements are described below and program materials are available at https://www.alembicusa.com/AcitretinHAERT or may be requested by calling 1-866-210-9797 (see also PRECAUTIONS section).

Important Information for Women of Childbearing Potential:
Acitretin should be considered only for women with severe psoriasis unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments.

Females of reproductive potential must not be given a prescription for acitretin until pregnancy is excluded. Acitretin are contraindicated in females of reproductive potential unless the patient meets ALL of the following conditions:

Must have had 2 negative urine or serum pregnancy tests with a sensitivity of at least 25 mIU per mL before receiving the initial prescription for acitretin. The first test (a screening test) is obtained by the prescriber when the decision is made to pursue therapy with acitretin. The second pregnancy test (a confirmation test) should be done during the first 5 days of the menstrual period immediately preceding the beginning of therapy with acitretin. For patients with amenorrhea, the second test should be done at least 11 days after the last act of unprotected sexual intercourse (without using 2 effective forms of contraception [birth control] simultaneously). If the second pregnancy test is negative, initiation of treatment with acitretin should begin within 7 days of the specimen collection. Acitretin should be limited to a monthly supply.

Must have a pregnancy test with a sensitivity of at least 25 mIU per mL repeated every month during treatment with acitretin. The patient must have a negative result from a urine or serum pregnancy test before receiving a prescription for acitretin. To encourage compliance with this recommendation, a monthly supply of the drug should be prescribed. For at least 3 years after discontinuing therapy with acitretin, a pregnancy test must be repeated every 3 months.

Must have selected and have committed to use 2 effective forms of contraception (birth control) simultaneously, at least 1 of which must be a primary form, unless absolute abstinence is the chosen method, or the patient has undergone a hysterectomy or is clearly postmenopausal.

Patients must use 2 effective forms of contraception (birth control) simultaneously for at least 1 month prior to initiation of therapy with acitretin, during therapy with acitretin, and for at least 3 years after discontinuing therapy with acitretin. Counseling about contraception and behaviors associated with an increased risk of pregnancy must be repeated on a monthly basis by the prescriber during therapy with acitretin and every 3 months for at least 3 years following discontinuation of acitretin.

Effective forms of contraception include both primary and secondary forms of contraception. Primary forms of contraception include: tubal ligation, partner’s vasectomy, intrauterine devices, birth control pills, and injectable/implantable/insertable/topical hormonal birth control products. Secondary forms of contraception include condoms (with or without spermicide), diaphragms and cervical caps (which must be used with a spermicide), and vaginal sponges (contains spermicide).

Any birth control method can fail. Therefore, it is critically important that women of childbearing potential use 2 effective forms of contraception (birth control) simultaneously. It has not been established if there is a pharmacokinetic interaction between acitretin and combined oral contraceptives. However, it has been established that acitretin interferes with the contraceptive effect of microdosed progestin preparations.1 Microdosed “minipill” progestin preparations are not recommended for use with acitretin. It is not known whether other progestin¬only contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy. Prescribers are advised to consult the package insert of any medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products. Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John’s wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John’s wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John’s wort (see PRECAUTIONS).

Must have signed a Patient Agreement/Informed Consent for Female Patients that contains warnings about the risk of potential birth defects if the fetus is exposed to acitretin, about contraceptive failure, about the fact that they must not ingest beverages or products containing ethanol while taking acitretin and for 2 months after treatment with acitretin has been discontinued, and about preventing pregnancy while taking acitretin and for at least 3 years after discontinuing acitretin.
If pregnancy does occur during therapy with acitretin or at any time for at least 3 years following discontinuation of acitretin, the prescriber and patient should discuss the possible effects on the pregnancy. The available information is as follows:

Acitretin, the active metabolite of etretinate, is teratogenic and is contraindicated during pregnancy. The risk of severe fetal malformations is well established when systemic retinoids are taken during pregnancy. Pregnancy must also be prevented after stopping acitretin therapy, while the drug is being eliminated to below a threshold blood concentration that would be associated with an increased incidence of birth defects. Because this threshold has not been established for acitretin in humans and because elimination rates vary among patients, the duration of posttherapy contraception to achieve adequate elimination cannot be calculated precisely. It is strongly recommended that contraception be continued for at least 3 years after stopping treatment with acitretin, based on the following considerations:

o   In the absence of transesterification to form etretinate, greater than 98% of the acitretin would be eliminated within 2 months, assuming a mean elimination half-life of 49 hours.
o   In cases where etretinate is formed, as has been demonstrated with concomitant administration of acitretin and ethanol,
     ♦ greater than 98% of the etretinate formed would be eliminated in 2 years, assuming a mean elimination half-life of 120 days.
    ♦ greater than 98% of the etretinate formed would be eliminated in 3 years, based on the longest demonstrated elimination half-life of 168 days. However, etretinate was found in plasma and subcutaneous fat in one patient reported to have had sporadic alcohol intake, 52 months after she stopped acitretin therapy.2

Severe birth defects have been reported where conception occurred during the time interval when the patient was being treated with acitretin and/or etretinate. In addition, severe birth defects have also been reported when conception occurred after the mother completed therapy. These cases have been reported both prospectively (before the outcome was known) and retrospectively (after the outcome was known). The events below are listed without distinction as to whether the reported birth defects are consistent with retinoid-induced embryopathy or not.

♦ There have been 318 prospectively reported cases involving pregnancies and the use of etretinate, acitretin, or both. In 238 of these cases, the conception occurred after the last dose of etretinate (103 cases), acitretin (126), or both (9). Fetal outcome remained unknown in approximately one-half of these cases, of which 62 were terminated and 14 were spontaneous abortions. Fetal outcome is known for the other 118 cases and 15 of the outcomes were abnormal (including cases of absent hand/wrist, clubfoot, GI malformation, hypocalcemia, hypotonia, limb malformation, neonatal apnea/anemia, neonatal ichthyosis, placental disorder/death, undescended testicle, and 5 cases of premature birth). In the 126 prospectively reported cases where conception occurred after the last dose of acitretin only, 43 cases involved conception at least 1 year but less than 2 years after the last dose. There were 3 reports of abnormal outcomes out of these 43 cases (involving limb malformation, GI tract malformations, and premature birth). There were only 4 cases where conception occurred at least 2 years after the last dose but there were no reports of birth defects in these cases.

♦ There is also a total of 35 retrospectively reported cases where conception occurred at least 1 year after the last dose of etretinate, acitretin, or both. From these cases there are 3 reports of birth defects when the conception occurred at least 1 year but less than 2 years after the last dose of acitretin (including heart malformations, Turner’s Syndrome, and unspecified congenital malformations) and 4 reports of birth defects when conception occurred 2 or more years after the last dose of acitretin (including foot malformation, cardiac malformations [2 cases], and unspecified neonatal and infancy disorder). There were 3 additional abnormal outcomes in cases where conception occurred 2 or more years after the last dose of etretinate (including chromosome disorder, forearm aplasia, and stillbirth).

♦ Females who have taken TEGISON (etretinate) must continue to follow the contraceptive recommendations for TEGISON. TEGISON is no longer marketed in the US; for information, call Alembic Pharmaceuticals Limited at 1-866-210-9797.
♦ Patients should not donate blood during and for at least 3 years following the completion of therapy with acitretin because women of childbearing potential must not receive blood from patients being treated with acitretin.

Important Information for Males Taking Acitretin:
Patients should not donate blood during and for at least 3 years following therapy with acitretin because women of childbearing potential must not receive blood from patients being treated with acitretin.

Samples of seminal fluid from 3 male patients treated with acitretin and 6 male patient treated with etretinate have been assayed for the presence of acitretin. The maximum concentration of acitretin observed in the seminal fluid of these men was 12.5 ng per mL. Assuming an ejaculate volume of 10 mL, the amount of drug transferred in semen would be 125 ng, which is 1/200,000 of a single 25-mg capsule. Thus, although it appears that residual acitretin in seminal fluid poses little, if any, risk to a fetus while a male patient is taking the drug or after it is discontinued, the no-effect limit for teratogenicity is unknown and there is no registry for birth defects associated with acitretin. The available data are as follows:

There have been 25 cases of reported conception when the male partner was taking acitretin. The pregnancy outcome is known in 13 of these 25 cases. Of these, 9 reports were retrospective and 4 were prospective (meaning the pregnancy was reported prior to knowledge of the outcome)3.

Timing of Paternal Acitretin Treatment Relative to Conception
Delivery of Healthy Neonate
Spontaneous Abortion
Induced Abortion
Total

At time of conception

Discontinued ~4 weeks prior

Discontinued ~6 to 8 months prior

a Four of 5 cases were prospective
b With malformation pattern not typical of retinoid embryopathy (bilateral cystic hygromas of neck. hypoplasia of lungs bilateral. VSD with overriding truncus arteriosus).

For All Patients : AN ACITRETIN MEDICATION GUIDE MUST BE GIVEN TO THE PATIENT EACH TIME ACITRETIN IS DISPENSED, AS REQUIRED BY LAW.

Poison Help

If you suspect an overdose or accidental ingestion, call Poison Control: 1-800-222-1222 (free, 24/7, U.S.). For life-threatening symptoms, call 911.

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 08/2024

acitretin logo

MEDICATION GUIDE
Acitretin (A si TRE tin)
Capsules, USP

Read this Medication Guide carefully before you start taking acitretin capsules and read it each time you get more acitretin capsules. There may be new information.

The first information in this Medication Guide is about birth defects and how to avoid pregnancy.

After this section there is important safety information about possible effects for any patient taking acitretin capsules. All patients

should read this entire Medication Guide carefully. This information does not take the place of talking with your prescriber about your medical condition or treatment.

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:

o yellowing of your skin or the whites of your eyes

o nausea and vomiting

o loss of appetite

o dark urine

What are the important warnings and instructions for females taking acitretin capsules?
• Before you receive your first prescription for acitretin capsules, you should have discussed and signed a Patient Agreement/Informed Consent for Female Patients form with your prescriber. This is to help make sure you understand the risk of birth defects and how to avoid getting pregnant. If you did not talk to your prescriber about this and sign the form, contact your prescriber.
Important: If you are a female who can become pregnant:
• You must not take acitretin capsules if you are pregnant or might become pregnant during treatment or at any time for at least 3 years after you stop treatment because acitretin capsules can cause severe birth defects.
• During treatment with acitretin capsules and for 2 months after you stop treatment with acitretin capsules, you must avoid drinks, foods, and all medicines that contain alcohol. This includes over-the-counter products that contain alcohol.

Avoiding alcohol is very important, because alcohol changes acitretin capsules into a drug that may take longer than 3 years to leave your body. The chance of birth defects may last longer than 3 years if you swallow any form of alcohol during treatment with acitretin capsules and for 2 months after you stop taking acitretin capsules.

• You and your prescriber must be sure you are not pregnant before you start therapy with acitretin capsules. You must have negative results from 2 pregnancy tests before you start treatment with acitretin capsules.

A negative result shows you are not pregnant. Because it takes a few days after pregnancy begins for a test to show that you are pregnant, the first negative test may not ensure you are not pregnant. Do not start acitretin capsules until you have negative results from 2 pregnancy tests.

o The

first pregnancy test

(urine or blood) will be done at the time you and your prescriber decide if acitretin capsules might be right for you.

o The

second pregnancy test

will usually be done during the first 5 days of your menstrual period. You must start taking acitretin capsules within 7 days of when the urine or blood for the second pregnancy test is collected.

• After you start taking acitretin capsules, you must have a pregnancy test repeated each month that you are taking acitretin capsules. This is to be sure that you are not pregnant during treatment because acitretin capsules can cause birth defects. In addition, your prescription of acitretin capsules will be limited to a monthly supply.

• For at least 3 years after stopping treatment with acitretin capsules, you must have a pregnancy test repeated every 3 months to make sure that you are not pregnant.

•

Discuss effective birth control (contraception) with your prescriber. You must use 2 effective forms of birth control (contraception) at the same time during all of the following:

o for at least 1 month before beginning treatment with acitretin capsules

o during treatment with acitretin capsules

o for at least 3 years after stopping treatment with acitretin capsules

•

If you are sexually active, you must use 2 effective forms of birth control (contraception) at the same time even if you think you cannot become pregnant, unless 1 of the following is true for you:

o You had your womb (uterus) removed during an operation (a hysterectomy).

o Your prescriber said you have gone completely through menopause (the “change of life”).

The following are considered effective forms of birth control:

Primary Forms:

o having your tubes tied (tubal ligation)

o partner’s vasectomy

o IUD (Intrauterine device)

o birth control pills that contain both estrogen and progestin (combination oral contraceptives); not progestin-only “minipills”

o hormonal birth control products that are injected, implanted, or inserted in your body

o birth control patch

Secondary Forms (use with a Primary Form):

o diaphragms with spermicide

o condoms (with or without spermicide)

o cervical caps with spermicide

o vaginal sponge (contains spermicide)

At least 1 of your 2 methods of birth control must be a primary form.
• If you have sex at any time without using 2 effective forms of birth control (contraception) at the same time, or if you get pregnant or miss your period, stop using acitretin capsules and call your prescriber right away.
• Consider “Emergency Contraception” (EC) if you have sex with a male without correctly using 2 effective forms of birth control (contraception) at the same time.

EC is also called “emergency birth control” which includes the “morning after” pill. Contact your prescriber

as soon as possible

if you have sex without using 2 effective forms of birth control (contraception) at the same time, because EC works best if it is used within 1 or 2 days after sex. EC is not a replacement for your usual 2 effective forms of birth control (contraception) because it is not as effective as regular birth control methods.

Contact your prescriber, women’s health centers, pharmacies, or hospital emergency rooms for information on how to get emergency contraception. A 24-hour, toll-free number (1-866-210-9797) is also available for patients to receive automated birth control and emergency contraception information.

•

Stop taking acitretin capsules right away and contact your prescriber if you get pregnant while taking acitretin capsules or at any time for at least 3 years after treatment has stopped. You need to discuss the possible effects on the unborn baby with your prescriber.
• If you do become pregnant while taking acitretin capsules or at any time for at least 3 years after stopping acitretin capsules, you should report your pregnancy to Alembic Pharmaceuticals Limited at 1-866-210-9797 or directly to the Food and Drug Administration (FDA) MedWatch program at 1-800-FDA-1088.

Your name will be kept in private (confidential). The information you share will help the FDA and the manufacturer evaluate the Pregnancy Prevention Program for acitretin capsules.

•

Do not take acitretin capsules if you are breastfeeding.

Acitretin can pass into your milk and may harm your baby. You will need to choose either to breast feed or take acitretin capsules, but not both.

What should males know before taking acitretin capsules?

Small amounts of acitretin are found in the semen of males taking acitretin capsules. Based upon available information, it appears that these small amounts of acitretin in semen pose little, if any, risk to an unborn child while a male patient is taking the drug or after it is discontinued. Discuss any concerns you have about this with your prescriber.

All patients should read the rest of this Medication Guide.
What are acitretin capsules?

Acitretin capsules are a medicine used to treat severe forms of psoriasis in adults. Psoriasis is a skin disease that causes cells in the outer layer of the skin to grow faster than normal and pile up on the skin’s surface. In the most common type of psoriasis, the skin becomes inflamed and produces red, thickened areas, often with silvery scales.

Because acitretin capsules can have serious side effects,

you should talk with your prescriber about whether possible benefits of acitretin capsules outweigh its possible risks.

Acitretin capsules may not work right away. You may have to wait 2 to 3 months before you get the full benefit of acitretin capsules. Psoriasis gets worse for some patients when they first start treatment with acitretin capsules.

Acitretin capsules have not been studied in children.

Who should not take acitretin capsules?

•

Do NOT take acitretin capsules if you can get pregnant.

Do not take acitretin capsules if you are pregnant or might get pregnant during treatment with acitretin capsules or at any time for

at least 3 years

after you stop treatment with acitretin capsules (see

“What are the important warnings and instructions for females taking acitretin capsules?”

•

Do NOT take acitretin capsules if you are breastfeeding.

Acitretin can pass into your milk and may harm your baby. You will need to choose either to breast feed or take acitretin capsules, but not both.

•

Do NOT take acitretin capsules if you have severe liver or kidney disease.

•

Do NOT take acitretin capsules if you have repeated high blood lipids

(fat in the blood).

•

Do NOT take acitretin capsules if you take these medicines:

o methotrexate

o tetracyclines

The use of these medicines with acitretin capsules may cause serious side effects.

•

Do NOT take acitretin capsules if you are allergic to acitretin,

the active ingredient in acitretin capsules, to any of the other ingredients in acitretin capsules (see the end of this Medication Guide for a list of all the ingredients in acitretin capsules), or to any medicines that are like acitretin capsules. Ask your prescriber or pharmacist if any medicines you are allergic to are like acitretin capsules.

Before taking acitretin capsules, tell your prescriber about all your medical conditions, including if you have or have had:

• diabetes or high blood sugar

• liver problems

• kidney problems

• high cholesterol or high triglycerides (fat in the blood)

• heart disease

• depression

• alcoholism

• an allergic reaction to a medication

Your prescriber needs this information to decide if acitretin capsules are right for you and to know what dose is best for you.

Tell your prescriber about all the medicines you take,

including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines can cause serious side effects if taken while you also take acitretin capsules. Some medicines may affect how acitretin capsules works, or acitretin capsules may affect how other medicines work.

Be especially sure to tell your prescriber if you are taking the following medicines:

• methotrexate

• tetracyclines

• glyburide

• phenytoin

• vitamin A supplements

• progestin-only oral contraceptives (“minipills”)

• TEGISON or TIGASON (etretinate). Tell your prescriber if you have ever taken this medicine in the past.

• St. John’s wort herbal supplement

Tell your prescriber if you are getting phototherapy treatment.

Your doses of phototherapy may need to be changed to prevent a burn.

How should I take acitretin capsules?

• Take acitretin capsules with food.

• Be sure to take your medicine as prescribed by your prescriber. The dose of acitretin capsules varies from patient to patient. The number of capsules you must take is chosen specially for you by your prescriber. This dose may change during treatment.

• If you miss a dose, do not double the next dose. Skip the missed dose and resume your normal schedule.

• If you take too much acitretin capsules (overdose), call your local poison control center or emergency room.

You should have blood tests for liver function, cholesterol, and triglycerides before starting treatment and during treatment to check your body’s response to acitretin capsules. Your prescriber may also do other tests.

Once you stop taking acitretin capsules, your psoriasis may return. Do not treat this new psoriasis with leftover acitretin capsules. It is important to see your prescriber again for treatment recommendations because your situation may have changed.

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. Acitretin capsules in your blood can harm an unborn baby if your blood is given to a pregnant woman. Acitretin capsules do not affect your ability to receive a blood transfusion.

•

Avoid progestin-only birth control pills (“minipills”).

This type of birth control pill may not work while you take acitretin capsules. Ask your prescriber if you are not sure what type of pills you are using.

•

Avoid night driving if you develop any sudden vision problems.

Stop taking acitretin capsules and call your prescriber if this occurs (see “What are the possible side effects of acitretin capsules?”).

•

Avoid non-medical ultraviolet (UV) light.

Acitretin capsules can make your skin more sensitive to UV light. Do not use sunlamps, and avoid sunlight as much as possible. If you are taking light treatment (phototherapy), your prescriber may need to change your light dosages to avoid burns.

•

Avoid dietary supplements containing vitamin A.

Acitretin capsules is related to vitamin A. Therefore, do not take supplements containing vitamin A, because they may add to the unwanted effects of acitretin capsules. Check with your prescriber or pharmacist if you have any questions about vitamin supplements.

•

Do not share acitretin capsules with anyone else, even if they have the same symptoms.

Your medicine may harm them or their unborn child.

What are the possible side effects of acitretin capsules?
Acitretin capsules can cause serious side effects, including:
• 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?”
Stop taking acitretin capsules and call your prescriber right away if you get the following signs or symptoms of possible serious side effects:

•

Bad headaches, nausea, vomiting, blurred vision.

These symptoms can be signs of increased brain pressure that can lead to blindness or even death.

•

Vision problems. Decreased vision in the dark (night blindness).

Since this can start suddenly, you should be very careful when driving at night. This problem usually goes away when treatment with acitretin capsules stops. Stop taking acitretin capsules and call your prescriber if you develop any vision problems or eye pain.

•

Depression.

There have been some reports of patients developing mental problems including a depressed mood, aggressive feelings, or thoughts of ending their own life (suicide). These events, including suicidal behavior, have been reported in patients taking other drugs similar to acitretin capsules as well as patients taking acitretin capsules. Since other things may have contributed to these problems, it is not known if they are related to acitretin capsules.

•

Aches or pains in your bones, joints, muscles, or back, trouble moving, or loss of feeling in your hands or feet.

These can be signs of abnormal changes to your bones or muscles.

•

Frequent urination, great thirst or hunger.

Acitretin capsules can affect blood sugar control, even if you do not already have diabetes. These are some of the signs of high blood sugar.

•

Shortness of breath, dizziness, nausea, chest pain, weakness, trouble speaking, or swelling of a leg. These may be signs of a heart attack, blood clots, or stroke.

Acitretin capsules can cause serious changes in blood fats (lipids). It is possible for these changes to cause blood vessel blockages that lead to heart attacks, strokes, or blood clots.

•

Blood vessel problems.

Acitretin capsules can cause fluid to leak out of your blood vessels into your body tissues.

Call your prescriber right away if you have any of the following symptoms:

sudden swelling in one part of your body or all over your body, weight gain, fever, lightheadedness or feeling faint, or muscle aches. If this happens, your prescriber will tell you to stop taking acitretin capsules.

•

Serious allergic reactions.

See “Who should not take acitretin capsules?” Serious allergic reactions can happen during treatment with acitretin capsules.

Call your prescriber right away if you get any of the following symptoms of an allergic reaction:

hives, itching, swelling of your face, mouth, or tongue, or problems breathing.

If this happens, stop taking acitretin capsules and do not take it again.

•

Serious skin problems

. Acitretin capsules can cause skin problems that can begin in a small area and then spread over large areas of your body.

Call your prescriber right away if your skin becomes red and swollen (inflamed), you have peeling of your skin, or your skin becomes itchy and painful.

You should stop acitretin capsules if this happens.

Common side effects

If you develop any of these side effects or any unusual reaction, check with your prescriber to find out if you need to change the amount of acitretin capsules you take. These side effects usually get better if the dose of acitretin capsules is reduced or acitretin capsules are stopped.

•

Chapped lips, peeling fingertips, palms, and soles, itching, scaly skin all over, weak nails, sticky or fragile (weak) skin, runny or dry nose, or nosebleeds.

Your prescriber or pharmacist can recommend a lotion or cream to help treat drying or chapping.

•

Dry mouth

•

Joint pain

•

Tight muscles

•

Hair loss.

Most patients have some hair loss, but this condition varies among patients. No one can tell if you will lose hair, how much hair you may lose or if and when it may grow back. You may also lose your eyelashes.

•

Dry eyes.

Acitretin capsules may dry your eyes. Wearing

contact lenses

may be uncomfortable during and after treatment with acitretin capsules because of the dry feeling in your eyes. If this happens, remove your contact lenses and call your prescriber. Also read the section about vision problems under “Serious side effects”.

•

Rise in blood fats (lipids).

Acitretin capsules can cause your blood fats (lipids) to rise.

Most

of the time this is not serious. But sometimes the increase can become a serious problem (see information under “Serious side effects”). You should have blood tests as directed by your prescriber.

Psoriasis gets worse for some patients when they first start treatment with acitretin capsules. Some patients have more redness or itching. If this happens, tell your prescriber. These symptoms usually get better as treatment continues, but your prescriber may need to change the amount of your medicine.

These are not all the possible side effects of acitretin capsules. For more information, ask your prescriber or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store acitretin capsules?

• Store acitretin capsules at 25

C (77

F); excursions permitted to 15

to 30

C (59

to 86

F).

• Keep

acitretin capsules away from sunlight, high temperature, and humidity.

• Acitretin capsules come in a child-resistant package.

Keep acitretin capsules and all medicines out of the reach of children.
General information about the safe and effective use of acitretin capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use acitretin capsules for a condition for which it was not prescribed. Do not give acitretin capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about acitretin capsules that is written for health professionals.

What are the ingredients in acitretin capsules?
Active ingredient:

acitretin

Inactive ingredients:

microcrystalline cellulose, maltodextrin, sodium ascorbate, sodium lauryl sulfate, colloidal silicon dioxide and magnesium stearate.

Gelatin capsule shells contain gelatin, iron oxide yellow, iron oxide red, titanium dioxide and sodium lauryl sulfate. Additionally, 10 mg and 25 mg gelatin capsule shells contains iron oxide black.

The gelatin capsule shells are printed with edible black ink containing shellac, iron oxide black and potassium hydroxide.

The brands listed are the registered trademarks of their respective owners, and are not trademarks of Alembic Pharmaceuticals Limited.

Dispense with Medication Guide available at

https://www.alembicusa.com/medicationguide.aspx

or call 1-866-210-9797.

Manufactured by:

Alembic Pharmaceuticals Limited

(Formulation Division),

Panelav 389350, Gujarat, India

Manufactured for:

Alembic Pharmaceuticals, Inc.

Bedminster, NJ 07921, USA

For more information call Alembic Pharmaceuticals Limited at 1-866-210-9797.

Sources

RxCUI: 199689

NDC: 62332-741

Last fetched: May 13, 2026

Source: DailyMed ↗

⚠️ Disclaimer

This information is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.