Aminoglutethimide Side Effects

Not all side effects for aminoglutethimide may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to aminoglutethimide: oral tablet

Along with its needed effects, aminoglutethimide may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests. Some of the unwanted effects that may be caused by aminoglutethimide are listed below. 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 while taking aminoglutethimide:

Rare
  • Black, tarry stools
  • blood in urine or stools
  • cough or hoarseness, accompanied by fever or chills
  • fever or chills
  • lower back or side pain, accompanied by fever or chills
  • painful or difficult urination, accompanied by fever or chills
  • pinpoint red spots on skin
  • shortness of breath
  • unusual bleeding or bruising
  • yellow eyes or skin

Check with your doctor as soon as possible if any of the following side effects occur while taking aminoglutethimide:

More common
  • Drowsiness
  • measles-like skin rash or itching on face and/or palms of hands
Less common
  • Clumsiness
  • dizziness or lightheadedness (especially when getting up from a lying or sitting position)
  • fast heartbeat
  • mental depression
  • shakiness
  • slurred speech
  • uncontrolled eye movements
  • unusual tiredness or weakness
Rare
  • Neck tenderness or swelling

This medicine may also cause the following side effects that your doctor will watch for:

More common
  • Low red blood cell count
  • low white blood cell count

Some side effects of aminoglutethimide 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
  • Loss of appetite
  • nausea
Less common or rare
  • Deepening of voice in females
  • headache
  • increased hair growth in females
  • irregular menstrual periods
  • muscle pain
  • vomiting

For Healthcare Professionals

Applies to aminoglutethimide: oral tablet

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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