Cytadren Side Effects

Please note - some side effects for Cytadren may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Cytadren - for the Consumer

Cytadren

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cytadren:

Dizziness; drowsiness; headache; loss of appetite; muscle pain or weakness; nausea; rash; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast heartbeat; fever, chills, or sore throat; severe or prolonged dizziness; unusual tiredness; yellowing of the skin or eyes.

Cytadren Side Effects - for the Professional

Cytadren

Untoward effects have been reported in about 2 out of 3 patients with Cushing’s syndrome who were treated for 4 or more weeks with Cytadren as the only adrenocortical suppressant.

   The most frequent and reversible side effects were drowsiness (approximately 1 in 3 patients), morbilliform skin rash (1 in 6 patients), nausea and anorexia (each approximately 1 in 8 patients), and dizziness (about 1 in 20 patients). The dizziness was possibly caused by lowered vascular resistance or orthostasis. These reactions often disappear spontaneously with continued therapy.

Other Effects Observed

Hematologic: Single instances of neutropenia, leukopenia (patient received concomitant o,p'-DDD), pancytopenia (patient received concomitant 5-fluorouracil), and agranulocytosis occurred in 4 of 27 patients with Cushing’s syndrome caused by adrenal carcinoma who were treated for at least 4 weeks. In 1 patient with adrenal hyperplasia, hemoglobin levels and hematocrit decreased during the course of treatment with Cytadren. From the earlier experience with the drug used as an anticonvulsant in 1,214 patients, transient leukopenia was the only hematologic effect and was reported once; Coombs’-negative hemolytic anemia also occurred once. In approximately 300 patients with nonadrenal malignancy, 1 in 25 showed some degree of anemia, and 1 in 150 developed pancytopenia during treatment with Cytadren.

   Endocrine: Adrenal insufficiency occurred in about 1 in 30 patients with Cushing’s syndrome who were treated with Cytadren for 4 or more weeks. This insufficiency tended to involve glucocorticoids as well as mineralocorticoids. Hypothyroidism is occasionally associated with thyroid enlargement and may be detected or confirmed by measuring plasma levels of the thyroid hormone. Masculinization and hirsutism have occasionally occurred in females, as has precocious sexual development in males.

   Central Nervous System: Headache was reported in about 1 in 20 patients.

   Cardiovascular: Hypotension, occasionally orthostatic, occurred in 1 in 30 patients receiving Cytadren. Tachycardia occurred in 1 in 40 patients.

   Gastrointestinal and Liver: Vomiting occurred in 1 in 30 patients. Isolated instances of abnormal findings on liver function tests were reported. Suspected hepatotoxicity occurred in less than 1 in 1000 patients.

   Skin: In addition to rash (1 in 6 patients, and often reversible with continued therapy), pruritus was reported in 1 in 20 patients. These may be allergic or hypersensitive reactions. Urticaria has occurred rarely.

   Miscellaneous: Fever was reported in several patients who were treated with Cytadren for less than 4 weeks; some of these patients also received other drugs. Myalgia occurred in 1 in 30 patients. Pulmonary hypersensitivity, including allergic alveolitis and interstitial alveolar infiltrates, has occurred rarely.

Side Effects by Body System

General

In general, side effects have been reported to have occurred in approximately two-thirds of patients, often limiting the use of the drug. Side effects typically manifest as sedation or lethargy and skin rash.

Nervous system

Somnolence and lethargy are dose-related and are more common early in therapy. Although these effects are usually transient, some patients may require a dosage reduction to alleviate severe lethargy.

Nervous system side effects have included lethargy (up to 40% incidence), ataxia (up to 10%), malaise, confusion, dizziness, and headache.

Dermatologic

Although these rashes are generally mild and transient, they have also occurred in conjunction with more serious side effects, such as cholestatic jaundice and blood dyscrasias. In addition, patients on radiotherapy in close temporal association with aminoglutethimide administration have developed erythema, confluent and plaque-like rashes, and marked desquamation in the areas of radiation exposure.

Dermatologic side effects have included rash of the morbilliform or maculopapular types in up to 30% of patients, pruritus, petechiae, ecchymoses, urticaria, oral ulcerations, and capillaritis (purpura simplex).

Gastrointestinal

Gastrointestinal side effects have included nausea (14%) and vomiting (3%).

Hematologic

Hematologic side effects have included thrombocytopenia, leukopenia, eosinophilia, pancytopenia, and agranulocytosis.

In a multicenter analysis involving 1,233 patients treated with aminoglutethimide, 0.9% of patients developed hematologic toxicity. Thrombocytopenia and/or leukopenia were noted. One patient with marrow aplasia developed septicemia and died.

Additional cases of fatal thrombocytopenia and fatal agranulocytosis have been reported, although most patients recover with discontinuation of aminoglutethimide and supportive care.

Hepatic

Elevations in SGOT, SGPT, GGT, alkaline phosphatase, lactate dehydrogenase, and total bilirubin have been reported with the use of aminoglutethimide. Two cases of cholestatic jaundice without evidence of hepatosplenomegaly or hepatic tenderness have also been reported and may be a manifestation of drug hypersensitivity.

Hepatic side effects have included elevations in liver function tests and very rarely, cholestatic jaundice.

Respiratory

Respiratory side effects have included an isolated case of diffuse alveolar damage and hemorrhage. A case of pulmonary eosinophilia has also been reported.

Cardiovascular

Cardiovascular side effects have included hypotension, orthostatic hypotension, and tachycardia.

Because aminoglutethimide may suppress aldosterone production, orthostatic hypotension or persistent hypotension may develop in some patients. Patients should be instructed to report symptoms of hypotension such as weakness or dizziness. The addition of fludrocortisone to the drug regimen may alleviate this side effect in some patients.

Endocrine

Endocrine side effects have included hypothyroidism and adrenal insufficiency.

The concurrent administration of glucocorticoids is often necessary to help prevent reflex ACTH secretion in response to low cortisol levels. In addition, some patients may require supplementation with fludrocortisone, a mineralocorticoid.

Iatrogenic adrenal insufficiency does not occur in all patients. However, adrenal function should be monitored regularly. In one case report, a patient developed adrenal failure approximately two years after starting an aminoglutethimide/cortisone acetate regimen.

Hypersensitivity

Hypersensitivity side effects have included skin rashes, pruritus, and rarely, Stevens-Johnson syndrome.

Immunologic

Immunologic side effects have included positive antinuclear antibody and drug-induced systemic lupus erythematosus.

Musculoskeletal

Musculoskeletal side effects have included leg cramps and myalgia.

Metabolic

Aminoglutethimide interferes with the conversion of cholesterol to delta-5-pregnenolone. Consequently, serum cholesterol levels may become elevated. In one study, 68% of patients treated with aminoglutethimide 500 mg per day experienced elevations in total cholesterol and 100% of patients treated with 1000 mg per day experienced this effect. In another study, patients who were normolipidemic at baseline developed elevated GGT in addition to elevated lipoproteins.

Metabolic side effects have included elevations in total cholesterol, low density lipoprotein cholesterol, apoprotein B, and apoprotein C-III. Aminoglutethimide has been reported to decrease thyroid hormone secretion. Hyponatremia may also occur.

Other

Other side effects have included malaise, fever, chills, and facial fullness. A case of worsening Meniere's disease has been reported.

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