- Contraindications and Warnings:
- 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, 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 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/kg, respectively. These doses are approximately 0.2, 0.3 and 3 times the maximum recommended therapeutic dose, respectively, based on a mg/m(2) 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 acitretin's teratogenicity , a program called the Do Your P.A.R.T program Pregnancy Prevention Actively Required During and After 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.
- 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 is 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/mL before receiving the initial acitretin prescription. The first test (a screening test) is obtained by the prescriber when the decision is made to pursue acitretin therapy. The second pregnancy test (a confirmation test) should be done during the first 5 days of the menstrual period immediately preceding the beginning of acitretin therapy. 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).
- Must have a pregnancy test repeated every month during acitretin treatment. The patient must have a negative result from a urine or serum pregnancy test before receiving a acitretin prescription. To encourage compliance with this recommendation, a limited supply of the drug should be prescribed. For at least 3 years after discontinuing acitretin therapy, 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 acitretin therapy, during acitretin therapy, and for at least 3 years after discontinuing acitretin therapy. An acitretin Patient Referral Form is available so that patients can receive an initial free contraceptive counseling session and pregnancy testing. Counseling about contraception and behaviors associated with an increased risk of pregnancy must be repeated on a monthly basis by the prescriber during acitretin therapy and every 3 months for at least 3 years following discontinuation of acitretin therapy.
- 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 latex condoms (with or without spermicide), diaphragms and cervical caps (which must be used with a 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. Microdosed "minipill" progestin preparations are not recommended for use with acitretin. It is not known whether other progestational 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.
- 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 acitretin treatment has been discontinued, and about preventing pregnancy while taking acitretin and for at least 3 years after discontinuing acitretin therapy.
- If pregnancy does occur during acitretin therapy or at any time for at least 3 years following discontinuation of acitretin therapy, 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:
- 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.
- 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.
- 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 one 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 etretinate must continue to follow the contraceptive recommendations for etretinate . Etretinate is no longer marketed in the US; for information, call Stiefel at 1-888-500-DERM (3376).
- Patients should not donate blood during and for at least 3 years following the completion of acitretin therapy 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 acitretin therapy 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 patients 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/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). When the paternal acitretin treatment was ongoing at the time of conception (n=11), neonatal outcomes were as follows: 5 healthy neonates delivered (4 of 5 cases were prospective), 5 spontaneous abortions, and 1 induced abortion. When paternal acitretin treatment was discontinued approximately 4 weeks prior conception (n=1), the neonatal outcome was induced abortion with malformation pattern not typical of retinoid embryopathy (bilateral cystic hygromas of neck, hypoplasia of lungs bilateral, pulmonary atresia, VSD with overriding truncus arteriosus). When the paternal acitretin treatment was discontinued 6 to 8 months prior to conception, the neonatal outcome was 1 spontaneous abortion.
- For All Patients: A acitretin medication guide must be given to the patient each time acitretin is dispensed, as required by law.
- Of the 525 patients treated in the US clinical trials, 2 had clinical jaundice with elevated serum bilirubin and transaminases considered related to acitretin treatment. Liver function test results in these patients returned to normal after acitretin was discontinued. Two of the 1289 patients treated in European clinical trials developed biopsy-confirmed toxic hepatitis. A second biopsy in one of these patients revealed nodule formation suggestive of cirrhosis. One patient in a Canadian clinical trial of 63 patients developed a three-fold increase of transaminases. A liver biopsy of this patient showed mild lobular disarray, multifocal hepatocyte loss and mild triaditis of the portal tracts compatible with acute reversible hepatic injury. The patient's transaminase levels returned to normal 2 months after acitretin was discontinued.
- The potential of acitretin therapy to induce hepatotoxicity was prospectively evaluated using liver biopsies in an open-label study of 128 patients. Pretreatment and posttreatment biopsies were available for 87 patients. A comparison of liver biopsy findings before and after therapy revealed 49 (58%) patients showed no change, 21 (25%) improved and 14 (17%) patients had a worsening of their liver biopsy status. For 6 patients, the classification changed from class 0 (no pathology) to class I (normal fatty infiltration; nuclear variability and portal inflammation; both mild); for 7 patients, the change was from class I to class II (fatty infiltration, nuclear variability, portal inflammation and focal necrosis; all moderate to severe); and for 1 patient, the change was from class II to class IIIb (fibrosis, moderate to severe). No correlation could be found between liver function test result abnormalities and the change in liver biopsy status, and no cumulative dose relationship was found.
- Elevations of AST (SGOT), ALT (SGPT), GGT (GGTP) or LDH have occurred in approximately 1 in 3 patients treated with acitretin. Of the 525 patients treated in the clinical trials in the US, treatment was discontinued in 20 (3.8%) due to elevated liver function test results. If hepatotoxicity is suspected during treatment with acitretin, the drug should be discontinued and the etiology further investigated.
- Ten of 652 patients treated in US clinical trials of etretinate, of which acitretin is the active metabolite, had clinical or histologic hepatitis considered to be possibly or probably related to etretinate treatment. There have been reports of hepatitis-related deaths worldwide; a few of these patients had received etretinate for a month or less before presenting with hepatic symptoms or signs .
Acitretin is teratogenic and major human fetal abnormalities have been reported with the administration of acitretin. Acitretin is also associated with hepatotoxicity. 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. Ethanol must not be ingested by female patients either during treatment or for 2 months after cessation of therapy. Prior to treatment, females must have two negative urine or serum pregnancy tests, then repeat pregnancy tests once every month during treatment and once every 3 months for at least 3 years after treatment discontinuation. . Two effective forms of contraception must be used simultaneously for at least 1 month prior to initiation of therapy, during therapy, and for at least 3 years following cessation of therapy. Use of St. John's Wort should be avoided during contraception treatment. The do your P.A.R.T. booklet must be provided to educate women of childbearing potential of the program requirements to prevent pregnancy. Informed consent is required for female patients warning about the risks of therapy. Patients should not donate blood during and for at least 3 years following acitretin therapy. All patients must receive the medication guide each time acitretin is dispensed .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antipsoriatic
Chemical Class: Retinoid
Uses For acitretin
Acitretin is used to treat severe skin disorders, such as psoriasis. It works by allowing normal growth and development of the skin. Acitretin will continue to work after you stop taking it, but after a time, the skin condition returns and you may need to take it again.
Acitretin must not be used to treat women who are able to bear children unless other forms of treatment have been tried first and have failed. Acitretin must not be taken during pregnancy because it causes birth defects in humans. If you are able to bear children, it is very important that you read, understand, and follow the pregnancy warnings for acitretin.
acitretin is available only with your doctor's prescription.
Before Using acitretin
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For acitretin, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to acitretin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of acitretin in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of acitretin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving acitretin.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Using acitretin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using acitretin with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use acitretin, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of acitretin. Make sure you tell your doctor if you have any other medical problems, especially:
- Depression, history of or
- Eye or vision problems or
- Heart disease or
- Hypercholesterolemia (high cholesterol in the blood) or
- Hyperostosis (bone growth that is not normal) or
- Hypertriglyceridemia (high triglycerides or fats in the blood) or
- Hypervitaminosis A (too much vitamin A in the body), or history of or
- Pancreatitis (inflammation of the pancreas) or
- Pseudotumor cerebri (brain problem) or
- Psychosis, history of—Use with caution. May make these conditions worse.
- Diabetes mellitus, or a family history of or
- Obesity—Use with caution. May increase risk for side effects.
- Hyperlipidemia, severe (high fats in the blood) or
- Kidney disease, severe or
- Liver disease, severe—Should not be used in patients with these conditions.
Proper Use of acitretin
It is very important that you take acitretin only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
Acitretin comes with a patient information form and medication guide. It is very important that you read and understand this information. Be sure to follow these instructions carefully and ask your doctor if you have any questions. You will be asked to sign a consent form before you starting taking acitretin to show that you understand the instructions.
You will be given information about the Do Your P.A.R.T. program, which is also called the Pregnancy Prevention Actively Required During and After Treatment program. This is important information about how to prevent pregnancy while you are using acitretin. Ask your doctor about this program if you have any questions.
It is best to take acitretin with a main meal.
For women—acitretin may cause birth defects. To make sure that you are not pregnant before beginning treatment, your doctor will ask you to:
- Use two effective forms of birth control (contraception) together for at least 1 month before beginning treatment.
- Report when your menstrual periods are normal.
- Take a pregnancy test within 1 week before beginning treatment to make sure you are not pregnant.
- Begin your acitretin treatment on Day 2 or Day 3 of your next menstrual period.
- Sign a paper to show that you understand the importance of not becoming pregnant for at least 2 to 3 years after you stop taking acitretin.
Women who are able to bear children must use two effective forms of birth control together for at least 2 to 3 years after they stop taking acitretin to help prevent an unplanned pregnancy. If you do not think this is reasonable or feel like you can not do this, talk to your doctor before you start taking acitretin.
You must not share acitretin with anyone else because of the risk for birth defects and other serious side effects.
The dose of acitretin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of acitretin. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For severe psoriasis:
- Adults—25 to 50 milligrams (mg) once a day as a single dose. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
If you miss a dose of acitretin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using acitretin
It is important that your doctor check your progress at regular visits to make sure that acitretin is working properly. Blood tests may be needed to check for unwanted effects.
Using acitretin while you are pregnant can cause very serious birth defects. You must use two forms of birth control together for 1 month before starting acitretin, for the entire time that you are being treated with acitretin, and for 3 years after you take your last dose of acitretin. You will need to have two negative pregnancy tests to be sure that you are not pregnant before you start using acitretin. You will also need to have pregnancy tests every month during treatment, and every 3 months for 3 years after you stop taking the medicine. If you think you have become pregnant while using acitretin, stop taking it and call your doctor right away.
Do not use methotrexate (Rheumatrex®, Trexall®) or a tetracycline medicine to treat an infection (such as doxycycline, minocycline, tetracycline, Minocin®, or Vibramycin®) while you are using acitretin. Using these medicines together may cause unwanted side effects.
Do not take other medicines without checking first with your doctor. This includes vitamins, herbal products, prescription or nonprescription (over-the-counter [OTC]) medicines. Some of these medicines or nutritional supplements (e.g., St. John's wort) may make your birth control pills not work.
Do not take vitamin A or any supplement containing vitamin A while you are using acitretin, unless otherwise directed by your doctor. To do so may increase the chance of side effects.
Your skin condition may improve or get worse during the first few weeks of treatment and you also may notice some skin irritation from the medicine. With continued use, the expected skin irritation will lessen after a few weeks. Check with your doctor if the skin irritation becomes worse or if your skin condition does not improve within 8 to 12 weeks.
Women who are able to bear children must avoid all forms of alcohol while they are taking acitretin and for 2 months after they stop. Do not eat foods, drink beverages, or take medicines that contain alcohol. Drinking alcohol will make the medicine remain in the body for an extended period of time and will increase the chance for side effects. If a woman consumes alcohol during acitretin treatment, she should consider delaying a pregnancy for longer than 2 to 3 years. Talk to your doctor if you have any questions about this.
Do not donate blood during treatment with acitretin, for 3 years following treatment, or as otherwise directed by your doctor. Women who are able to bear children must not receive blood containing the medicine.
Liver problems may occur while you are using acitretin. Stop using acitretin and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.
Acitretin may cause bone or muscle problems, including joint pain, muscle pain or stiffness, or difficulty moving. You may get hurt more easily during rough sports. You may heal more slowly.
Acitretin may cause blurred vision or a decrease in night vision (night blindness). The night blindness may occur suddenly. Do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. Stop taking the medicine and check with your doctor right away if you have vision changes.
Acitretin may cause dry eyes. Wearing contact lenses may become uncomfortable while using acitretin. To help relieve dry eyes, check with your doctor about using a lubricating solution, such as artificial tears. If severe eye irritation or inflammation occurs, check with your doctor.
Acitretin may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of developing dental disease, including tooth decay, gum disease, and fungus infections.
Avoid exposing your skin to wind, cold weather, and sunlight, even on cloudy days. Your skin will be more prone to sunburn, dryness, or irritation, especially during the first 2 or 3 weeks. You should not stop taking acitretin, unless the skin irritation becomes too severe. Do not use a sunlamp or tanning bed. Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m.
Unless your doctor tells you otherwise, you should avoid skin products that can irritate the skin. Some examples are:
- Any topical acne product or skin product containing a peeling agent (such as benzoyl peroxide, resorcinol, salicylic acid, or sulfur).
- Hair products that are irritating, such as permanents or hair removal products.
- Skin products that cause sensitivity to the sun, such as those containing spices or limes.
- Skin products containing a large amount of alcohol, such as astringents, shaving creams, or after-shave lotions.
- Skin products that are too drying or abrasive, such as some cosmetics, soaps, or skin cleansers.
For diabetic patients:
- acitretin may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.
Pancreatitis may occur while you are using acitretin. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
Acitretin may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, check with you doctor right away.
acitretin Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
- Back pain
- bad, unusual, or unpleasant (after) taste
- bone or joint pain
- change in taste
- continuing ringing or buzzing or other unexplained noise in the ears
- difficulty with moving or walking
- excessive muscle tone
- feeling of warmth
- headache (severe and continuing)
- hearing loss
- increased sensitivity to pain
- increased sensitivity to touch
- muscle stiffness
- muscle tension or tightness
- nausea or vomiting (severe and continuing)
- redness of the face, neck, arms, and occasionally, upper chest
- redness of the skin
- stiff, painful muscles
- thinning of the skin with easy bruising
- tingling in the hands and feet
- tongue irritation
- trouble sleeping
- unable to sleep
- Acid or sour stomach
- blurred vision
- breast pain
- eye pain
- eye problems, such as loss of eyebrows or eyelashes, redness or swelling of the eyelid, redness of the eyes, sensitivity of the eyes to light, or watery eyes
- general feeling of discomfort or illness
- increased hair growth on the forehead, back, arms, and legs
- itching of the vagina or genital area
- loosening of the fingernails
- pain during sexual intercourse
- redness or soreness around the fingernails
- sore mouth or tongue
- thick, white vaginal discharge with no odor or with a mild odor
- white patches in the mouth or on the tongue
Incidence not known
- Abdominal or stomach pain
- bleeding gums
- bleeding time increased
- chest pain
- coughing, hoarseness, trouble in speaking, or flu-like symptoms
- coughing up blood
- darkened urine
- difficulty in breathing or swallowing
- double vision or other problems in seeing, including decreased night vision after sunset and before sunrise
- increased menstrual flow or vaginal bleeding
- itchy or painful ears
- light-colored stools
- pale or cold hands or feet
- prolonged bleeding from cuts
- red or dark brown urine
- shortness of breath
- skin problems, such as abnormal sensation of burning or stinging, cracking, redness, skin irritation or rash (including a rash that looks like psoriasis), infection, ulcers, unusual odor, or small red spots in the skin
- sore on the edge of the eyelid (stye)
- thick, white, curd-like vaginal discharge
- unpleasant breath odor
- unusual tiredness or weakness
- vaginal itching or irritation
- vomiting of blood
- yellowing of the skin or eyes
- burning, numbness, tingling, or painful sensations
- chest pain or discomfort
- difficulty with breathing
- difficulty with speaking
- doing things to injure oneself
- inability to move the arms, legs, or facial muscles
- inability to speak
- pain in the chest, groin, or legs, especially calves
- pain or discomfort in the arms, jaw, back, or neck
- shortness of breath
- slow speech
- slurred speech
- sudden loss of coordination
- sudden, severe weakness or numbness in the arms or legs
- sudden, unexplained shortness of breath
- thoughts of killing oneself
- unsteadiness or awkwardness
- vision changes
- weakness in the arms, hands, legs, or feet
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
- Dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- sensation of spinning
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Chapped, red, or swollen lips
- difficulty in wearing contact lenses
- dry or runny nose
- dryness of the eyes
- increased ability to sunburn
- increased amount of ear wax (unusual)
- irritation in the mouth or swollen gums
- itchy skin
- loss of hair (usually reversible)
- scaling and peeling of the eyelids, fingertips, palms, and soles of feet
- sticky skin
- unusual thirst
Incidence not known
- increased sweating
- Cracking fingernails or fingernails break easily
- muscular pain, tenderness, wasting, or weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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