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Cytadren Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Cytadren in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects from aminoglutethimide, contact your doctor immediately:
- an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or
- fainting or dizziness, especially when standing up.
Other, less serious side effects may be more likely to occur. Continue taking aminoglutethimide and talk to your doctor if you experience:
- dizziness, drowsiness, poor coordination, or weakness;
- nausea, vomiting, or loss of appetite;
- headache; or
- rash and itching.
Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with aminoglutethimide.
Read the entire detailed patient monograph for Cytadren (Aminoglutethimide) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Cytadren FDA Prescribing Information: Side Effects
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 (aminoglutethimide) 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 (aminoglutethimide) . 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 (aminoglutethimide) .
Endocrine: Adrenal insufficiency occurred in about 1 in 30 patients with Cushing's syndrome who were treated with Cytadren (aminoglutethimide) 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.
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 (aminoglutethimide) 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.
Read the entire FDA prescribing information for Cytadren (Aminoglutethimide) »
Additional Cytadren Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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