Hypervitaminosis A produces a wide spectrum of signs and symptoms primarily of the mucocutaneous, musculoskeletal, hepatic, neuropsychiatric, and central nervous systems. Many of the clinical adverse reactions reported to date with Soriatane administration resemble those of the hypervitaminosis A syndrome.
Adverse Events/Postmarketing Reports
In addition to the events listed in the tables for the clinical trials, the following adverse events have been identified during postapproval use of Soriatane. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Aggressive feelings and/or suicidal thoughts have been reported. These events, including self-injurious behavior, have been reported in patients taking other systemically administered retinoids, as well as in patients taking Soriatane. Since other factors may have contributed to these events, it is not known if they are related to Soriatane (see PRECAUTIONS).
Vulvo-vaginitis due to Candida albicans
Skin and Appendages
Thinning of the skin, skin fragility and scaling may occur all over the body, particularly on the palms and soles; nail fragility is frequently observed.
During clinical trials with Soriatane, 513/525 (98%) of patients reported a total of 3545 adverse events. One-hundred sixteen patients (22%) left studies prematurely, primarily because of adverse experiences involving the mucous membranes and skin. Three patients died. Two of the deaths were not drug related (pancreatic adenocarcinoma and lung cancer); the other patient died of an acute myocardial infarction, considered remotely related to drug therapy. In clinical trials, Soriatane was associated with elevations in liver function test results or triglyceride levels and hepatitis. The tables below list by body system and frequency the adverse events reported during clinical trials of 525 patients with psoriasis.
Table 3: Adverse Events Frequently Reported During Clinical
Trials Percent of Patients Reporting
|BODY SYSTEM||> 75%||50% to 75%||25% to 50%||10% to 25%|
|Mucous Membranes||Cheilitis||Rhinitis||Dry mouth Epistaxis|
|Musculoskeletal||Arthralgia Spinal hyperostosis (progression of existing lesions)|
|Skin and Appendages||Alopecia Skin peeling||Dry skin Nail disorder Pruritus||Erythematous rash Hyperesthesia Paresthesia ParonychiaSkin atrophy Sticky skin|
Table 4: Adverse Events Less Frequently Reported During Clinical
Trials (Some of Which May Bear No Relationship to Therapy) Percent of Patients
|BODY||SYSTEM 1% to 10%||> 1%|
|Body as a Whole||Anorexia
Increased bleeding time
|CNS (also see Psychiatric)||Headache
|Pseudotumor cerebri (intracranial hypertension)|
|Eye Disorders||Abnormal/ blurred vision night
Corneal epithelial abnormality
|Decreased vision /night blindnessEye abnormality
|Itchy eyes and lids
Subepithelial corneal lesions
|Liver and Biliary||Hepatic function abnormal
|Mucous Membranes||Gingival bleeding
Peripheral joint hyperostosis (progression of existing lesions)
|Spinal hyperostosis (new lesions)
|Skin and Appendages||Abnormal skin odor
Abnormal hair texture
Sweat gland disorder
|Special Senses/ Other||Earache
Soriatane therapy induces changes in liver function tests in a significant number of patients. Elevations of AST (SGOT), ALT (SGPT) or LDH were experienced by approximately 1 in 3 patients treated with Soriatane. In most patients, elevations were slight to moderate and returned to normal either during continuation of therapy or after cessation of treatment. In patients receiving Soriatane during clinical trials, 66% and 33% experienced elevation in triglycerides and cholesterol, respectively. Decreased high density lipoproteins (HDL) occurred in 40% (see WARNINGS). Transient, usually reversible elevations of alkaline phosphatase have been observed.
Table 5 lists the laboratory abnormalities reported during clinical trials.
Table 5: Abnormal Laboratory Test Results Reported During
Clinical Trials Percent of Patients Reporting
|BODY SYSTEM||50% to75%||25% to 50%||10% to 25%||1% to 10%|
Increased and decreased:
Increased and decreased:
Increased or decreased:
Increased and decreased:
–Fasting blood sugar
–High occult blood
|Renal||WBC in urine||Acetonuria||–Creatinine
RBC in urine
Read the Soriatane (acitretin) Side Effects Center for a complete guide to possible side effects »
Clinical evidence has shown that etretinate can be formed with concurrent ingestion of acitretin and ethanol (see boxed CONTRAINDICATIONS AND WARNINGS and CLINICAL PHARMACOLOGY: Pharmacokinetics).
In a study of 7 healthy male volunteers, acitretin treatment potentiated the blood glucose lowering effect of glibenclamide (a sulfonylurea similar to chlorpropamide) in 3 of the 7 subjects. Repeating the study with 6 healthy male volunteers in the absence of glibenclamide did not detect an effect of acitretin on glucose tolerance. Careful supervision of diabetic patients under treatment with Soriatane is recommended (see CLINICAL PHARMACOLOGY: Pharmacokinetics and DOSAGE AND ADMINISTRATION).
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 “minipill” preparations. Microdosed “minipill” progestin preparations are not recommended for use with Soriatane (see CLINICAL PHARMACOLOGY: Pharmacokinetic Drug Interactions). It is not known whether other progestational contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy.
An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with acitretin is also contraindicated (see CONTRAINDICATIONS).
If acitretin is given concurrently with phenytoin, the protein binding of phenytoin may be reduced.
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.
There appears to be no pharmacokinetic interaction between acitretin and cimetidine, digoxin, or glyburide. Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.
If significant abnormal laboratory results are obtained, either dosage reduction with careful monitoring or treatment discontinuation is recommended, depending on clinical judgment.
Some patients receiving retinoids have experienced problems with blood sugar control. In addition, new cases of diabetes have been diagnosed during retinoid therapy, including diabetic ketoacidosis. In diabetics, blood-sugar levels should be monitored very carefully.
In clinical studies, the incidence of hypertriglyceridemia was 66%, hypercholesterolemia was 33% and that of decreased HDL was 40%. Pretreatment and follow-up measurements should be obtained under fasting conditions. It is recommended that these tests be performed weekly or every other week until the lipid response to Soriatane has stabilized (see WARNINGS).
Liver Function Tests
Elevations of AST (SGOT), ALT (SGPT) or LDH were experienced by approximately 1 in 3 patients treated with Soriatane. It is recommended that these tests be performed prior to initiation of Soriatane therapy, at 1- to 2-week intervals until stable and thereafter at intervals as clinically indicated (see CONTRAINDICATIONS and boxed WARNINGS).
Last reviewed on RxList: 12/9/2011
This monograph has been modified to include the generic and brand name in many instances.
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