MITOTANE for Hypercorticoidism: Side Effects & Safety Data
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There are 5 adverse event reports in the FDA FAERS database where MITOTANE was used for Hypercorticoidism.
Most Reported Side Effects for MITOTANE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Nausea | 210 | 20.8% | 6 | 37 |
| Fatigue | 205 | 20.3% | 10 | 42 |
| Off label use | 154 | 15.2% | 11 | 25 |
| Diarrhoea | 123 | 12.2% | 3 | 22 |
| Vomiting | 97 | 9.6% | 6 | 29 |
| Drug ineffective | 86 | 8.5% | 10 | 25 |
| Decreased appetite | 77 | 7.6% | 5 | 25 |
| Adrenal insufficiency | 76 | 7.5% | 2 | 18 |
| Dizziness | 76 | 7.5% | 2 | 12 |
| Asthenia | 70 | 6.9% | 3 | 24 |
| Malignant neoplasm progression | 61 | 6.0% | 15 | 14 |
| Neutropenia | 48 | 4.8% | 4 | 7 |
| Febrile neutropenia | 42 | 4.2% | 2 | 4 |
| Headache | 42 | 4.2% | 1 | 11 |
| Anaemia | 41 | 4.1% | 2 | 12 |
Other Indications for MITOTANE
Adrenocortical carcinoma (461)
Adrenal gland cancer (250)
Product used for unknown indication (88)
Metastases to lung (25)
Metastases to liver (23)
Cushing's syndrome (22)
Metastatic neoplasm (22)
Adjuvant therapy (18)
Chemotherapy (10)
Neoplasm malignant (10)