Summary
Commonly reported side effects of everolimus include: infection, decreased hemoglobin, increased serum glucose, lymphocytopenia, and stomatitis. Other side effects include: pneumonitis, pneumonia, and increased hdl cholesterol. Continue reading for a comprehensive list of adverse effects.
Applies to everolimus: oral tablets, oral tablets for oral suspension.
Warning
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Malignancies and Serious Infections
- Only clinicians experienced in immunosuppressive therapy and management of transplant patients should prescribe everolimus (i.e., Zortress®).13
- Patients should be managed in facilities with adequate laboratory and supportive medical resources; the clinician responsible for maintenance therapy should have complete information for patient follow-up.13
- Immunosuppression may result in increased susceptibility to infection and possible development of malignancies (e.g., lymphoma, skin cancer). (See Malignancies and Serious Infections under Cautions.)13
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Kidney Graft Thrombosis
- Increased risk of kidney arterial and venous thrombosis, resulting in graft loss; occurs principally within the first 30 days posttransplantation.13
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Nephrotoxicity
- Risk of nephrotoxicity may be increased with concomitant use of standard dosages of cyclosporine and everolimus.13 19 20 Reduce dosage of cyclosporine when used in combination with everolimus; monitor cyclosporine and everolimus whole blood trough concentrations. (See Renal Allotransplantation under Dosage and Administration and also see Nephrotoxicity under Cautions).13
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Mortality in Cardiac Transplantation
- Increased mortality, often associated with serious infections, observed within the first 3 months after transplantation in patients receiving everolimus in an immunosuppressive regimen with or without induction therapy in a clinical trial of de novo cardiac transplant patients;13 39 use of everolimus in cardiac transplantation is not recommended.13
Side effects include:
In patients with advanced HER2-negative breast cancer: Stomatitis (e.g., mouth ulceration, aphthous stomatitis, glossodynia, gingival pain, glossitis, lip ulceration), infections, rash, fatigue or asthenia, diarrhea, decreased appetite, nausea, weight loss, cough, dysgeusia, headache, dyspnea, arthralgia, peripheral edema, pneumonitis (e.g., interstitial lung disease, lung infiltration, pulmonary fibrosis), epistaxis, vomiting, pyrexia, back pain, constipation, pruritus, insomnia, dry mouth, alopecia, hypercholesterolemia, hyperglycemia, increased AST, anemia, leukopenia, thrombocytopenia, lymphopenia, increased ALT, hypertriglyceridemia, decreased albumin, neutropenia, hypokalemia, increased Scr.
In patients with advanced PNET: Stomatitis, rash, diarrhea, fatigue/malaise, edema (peripheral or generalized), abdominal pain, fever, headache/migraine, decreased appetite, vomiting, weight loss, nasopharyngitis/rhinitis/upper respiratory tract infection, cough, nail disorders, epistaxis, pruritus, dyspnea, dysgeusia, pneumonitis, urinary tract infection, arthralgia, back pain, pain in extremity, insomnia, constipation, dry skin, hypertension, dizziness, dry mouth, oropharyngeal pain, diabetes mellitus, muscle spasms, anemia, increased alkaline phosphatase, hyperglycemia, hypercholesterolemia, decreased bicarbonate, increased AST, increased ALT, lymphopenia, thrombocytopenia, leukopenia, hypophosphatemia, hypertriglyceridemia, hypocalcemia, neutropenia, hypokalemia, increased Scr, hypoalbuminemia.
In patients with renal cell carcinoma: Stomatitis, infections, asthenia, fatigue, diarrhea, cough, rash, anemia, hypercholesterolemia, increased Scr, hypertriglyceridemia, hyperglycemia, lymphopenia.
In patients with renal angiomyolipoma with TSC: Stomatitis, hypercholesterolemia, acne, cough, vomiting, diarrhea, arthralgia, amenorrhea, peripheral edema, upper respiratory tract infection, anemia, hypertriglyceridemia.
In patients with SEGA with TSC: Stomatitis (e.g., mouth and lip ulceration), respiratory tract infection, elevated cholesterol, increased ALT and AST, elevated PTT, neutropenia, reduced hemoglobin, pyrexia, fatigue, vomiting, diarrhea, constipation, gastroenteritis, psychiatric disorders (e.g., anxiety, aggression, other behavioral disturbances), hyperglycemia, cellulitis, rash, acne, increased Scr, hypertriglyceridemia, pharyngitis.
In renal transplant patients: Infections, peripheral edema, constipation, hypertension, nausea, anemia, urinary tract infection, hyperlipidemia, diarrhea, pyrexia, headache, hyperkalemia, increased Scr, hypercholesterolemia, insomnia, incision site pain, upper respiratory tract infection, dyslipidemia, procedural pain, vomiting, abdominal pain, hypomagnesemia, hypophosphatemia, extremity pain, hematuria, hyperglycemia, hypokalemia, back pain, dysuria.
In hepatic transplant patients: Infections, diarrhea, headache, peripheral edema, hypertension, nausea, leukopenia, abdominal pain, pyrexia.
For Healthcare Professionals
Applies to everolimus: oral tablet, oral tablet dispersible.
General
The most common side effects included stomatitis, infection, rash, fatigue, diarrhea, edema, peripheral edema, anemia, nausea, hyperlipidemia, headache, abdominal pain, fever, asthenia, cough, constipation, hypertension, urinary tract infection, leukopenia, and decreased appetite.[Ref]
Metabolic
Very common (10% or more): Hypercholesterolemia (85%), cholesterol increased (77%), glucose increased (75%), alkaline phosphatase increased (74%), triglycerides increased (73%), bicarbonate decreased (56%), hypertriglyceridemia (52%), creatinine increased (50%), hypophosphatemia (49%), phosphate decreased (40%), calcium decreased (37%), appetite decreased (30%), potassium decreased (29%), weight decreased (28%), anorexia (25%), hyperlipidemia (21%), hyperkalemia (18%), sodium decreased (16%), dyslipidemia (15%), hyperglycemia (14%), hypomagnesemia (14%), hypokalemia (12%), diabetes mellitus (10%)
Common (1% to 10%): Dehydration, blood urea increased, acidosis, gout, hypercalcemia, hyperuricemia, hypocalcemia, hypoglycemia, hyponatremia, iron deficiency, vitamin B12 deficiency, potassium increased[Ref]
Hematologic
Very common (10% or more): Decreased hemoglobin (92%), elevated partial thromboplastin time (72%), anemia (up to 61%), WBC decreased (58%), lymphocytes decreased (54%), platelets decreased (54%), neutropenia (46%), leukopenia (37%), albumin decreased (33%), neutrophils decreased (31%), lymphopenia (20%), thrombocytopenia (19%)
Common (1% to 10%): Hemorrhage, leukocytosis, lymphadenopathy, pancytopenia
Uncommon (0.1% to 1%): Pure red cell aplasia[Ref]
Gastrointestinal
Very common (10% or more): Stomatitis (78%), diarrhea (50%), constipation (38%), abdominal pain (36%), nausea (32%), vomiting (29%), dry mouth (up to 11%), gastroenteritis (10%)
Common (1% to 10%): Abdominal distention, dyspepsia, dysphagia, epigastric discomfort, flatulence, gastritis, gastroesophageal reflux disease, gingival hypertrophy, hematemesis, hemorrhoids, ileus, mouth ulceration, oral candidiasis, oral pain, peritonitis[Ref]
Other
Very common (10% or more): Fatigue (45%), peripheral edema (45%), edema (39%), asthenia (33%), pyrexia (31%), mucosal inflammation (19%), incision site pain (16%), procedural pain (15%)
Common (1% to 10%): Mucosal inflammation, irritability, blood lactate dehydrogenase increased, non-cardiac chest pain, chills, incisional hernia, edema[Ref]
Dermatologic
Very common (10% or more): Rash (59%), cellulitis (29%), nail disorders (22%), acne (22%), pruritus (21%), dry skin (13%), alopecia (10%)
Common (1% to 10%): Dermatitis acneiform, erythema, folliculitis, hand-foot syndrome, hirsutism, hyperhidrosis, hypertrichosis, night sweats, onychoclasis, onychomycosis, oral herpes skin exfoliation, skin lesion, tinea pedis
Uncommon (0.1% to 1%): Angioedema, herpes zoster[Ref]
Respiratory
Very common (10% or more): Respiratory tract infection (31%), cough (30%), dyspnea (24%), epistaxis (22%), pneumonitis (19%), oropharyngeal pain (11%), streptococcal pharyngitis (10%)
Common (1% to 10%): Nasopharyngitis, pharyngitis, pneumonia, pulmonary embolism, bronchitis, sinusitis, pleural effusion, rhinorrhea, atelectasis, nasal congestion, pulmonary edema, sinus congestion, wheezing
Uncommon (0.1% to 1%): Hemoptysis, acute respiratory distress syndrome[Ref]
Genitourinary
Very common (10% or more): Amenorrhea (17%), urinary tract infection (16%), hematuria (12%), dysuria (11%), menorrhagia (10%), menstrual irregularities (10%)
Common (1% to 10%): Urethritis, bladder spasm, micturition urgency, pollakiuria, polyuria, pyuria, urinary retention, erectile dysfunction ovarian cyst, scrotal edema, blood luteinizing hormone increased, vaginal hemorrhage, blood follicle stimulating hormone increased, metrorrhagia, dysmenorrhea, delayed menstruation[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (20%), back pain (15%), extremity pain (14%), muscle spasms (10%)
Common (1% to 10%): Osteomyelitis, jaw pain, joint swelling, muscular weakness, myalgia, osteonecrosis, osteopenia, osteoporosis, spondylitis[Ref]
Hepatic
Very common (10% or more): AST increased (69%), ALT increased (51%), hepatitis C (11%), bilirubin increased (10%)
Common (1% to 10%): Transaminases increased[Ref]
Nervous system
Very common (10% or more): Headache (30%), dysgeusia (22%), dizziness (12%)
Common (1% to 10%): Tremor, paresthesia, hemiparesis, hypoesthesia, lethargy, neuralgia, somnolence, syncope
Uncommon (0.1% to 1%): Ageusia[Ref]
Psychiatric
Very common (10% or more): Behavioral disturbances (21%), insomnia (17%)
Common (1% to 10%): Depression, agitation, anxiety, hallucination[Ref]
Cardiovascular
Very common (10% or more): Hypertension (30%)
Common (1% to 10%): Angina pectoris, hot flush, atrial fibrillation, congestive cardiac failure, hypotension, palpitations, tachycardia, venous thromboembolism (including deep vein thrombosis)[Ref]
Immunologic
Very common (10% or more): Infections (50%)
Common (1% to 10%): BK virus infection, bacteremia, candidiasis, influenza, otitis media, sepsis[Ref]
Renal
Common (1% to 10%): Renal failure, proteinuria, pyelonephritis, hydronephrosis, interstitial nephritis, renal artery thrombosis[Ref]
Ocular
Common (1% to 10%): Cataract, conjunctivitis, blurred vision, eyelid edema[Ref]
Endocrine
Common (1% to 10%): Cushingoid, hyperparathyroidism, hypothyroidism[Ref]
Hypersensitivity
Common (1% to 10%): Hypersensitivity[Ref]
