Table 3.
Reported adverse effects of mTOR inhibitors.
| General disorder classification | Specific adverse event | Reported percent incidence | Duration on Meds (days) | Agent | Clinical management options | Outcome |
|---|---|---|---|---|---|---|
| Cutaneous | Delayed wound healing | Multiple mTOR inhibitors | Manageable | |||
| Skin rash | Ridaforolimus | Manageable | ||||
| Spongiotic dermatitis with eosinophils | 14 | Temsirolimus | Clobetasol | Resolution | ||
| Hematological | Thrombocytopenia | 8–22.7 | Everolimus and sirolimus | Interleukin 11 | Manageable | |
| Anemia (microcytic) | 9–20 | Temsirolimus and everolimus and sirolimus | Erythropoietin | Manageable | ||
| Leukopenia | 18.2 | Everolimus and sirolimus | Colony stimulating factor | Manageable | ||
| Hepatic | Transaminase Elevations | 10 | Everolimus | Periodic liver function tests | ||
| Alkaline phosphatase elevations | 8 | Everolimus | Periodic liver function tests | |||
| Immunological | Severe infections | 2.3 | ||||
| Metabolic | Hypercholesterolemia | 50 | Sirolimus and everolimus | Statin therapy | Manageable | |
| Hypertriglyceridemia | 31.8 | Sirolimus and everolimus | Fibrates | Manageable | ||
| Hyperglycemia | 11 | temsirolimus | Glucose lowering agents | Manageable | ||
| Fatigue | 11 | Temsirolimus | ||||
| Hypophosphatemia | 5 | Temsirolimus | ||||
| Hyperlipidemia | 5 | Everolimus | Lipid lovering drugs | |||
| Oral | Ulcerations | 66 | 5 | Deforolimus | Discontinuation | Reversible |
| Mucositis | 6 | Discontinuation | Reversible | |||
| Aphthous stomatitis | 6 | Discontinuation | Reversible | |||
| Pulmonary | Noninfectious pneumonitis | 4.8–18 | 60–1500 | Sirolimus and everolimus | Withdrawal, antibiotics and steroids | Reversible |
| Dyspnea | 9 | |||||
| Grade 1 (asymptomatic) | 3.3 | Everolimus | Reduction | Reversible | ||
| Grade 2 (Ok daily living) | 6.6 | Everolimus | Withdrawal | Reversible | ||
| Grade 3 ( oxygen indicated) | 3.6 | Everolimus | Withdrawal, antibiotics and steroids | Reversible | ||
| Grade 4 (life threatening) | 0 | Everolimus | None | |||
| Renal | Proteinuria | 1.6–4.1 | 540–1500 | Sirolimus and everolimus | Withdrawal | Reversible |
| Proteinuria (grade 3 to 4) | 25 | 273 | Bevacizumab + everolimus | Discontinuation | Reversible | |
| Reproductive | Infertility (oligospermia) | 66.6 | 150–360 | Sirolimus | Discontinuation | Full recovery |
| amenorrhea | 14.2 | 150–360 | Sirolimus | Discontinuation | Reversible |