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Zortress Side Effects

Generic name: everolimus

Medically reviewed by Drugs.com. Last updated on Mar 28, 2022.

Note: This document contains side effect information about everolimus. Some of the dosage forms listed on this page may not apply to the brand name Zortress.

For the Consumer

Applies to everolimus: oral tablets, oral tablets for oral suspension

Warning

    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

    Kidney Graft Thrombosis
  • Increased risk of kidney arterial and venous thrombosis, resulting in graft loss; occurs principally within the first 30 days posttransplantation.13

    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

    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]

Frequently asked questions

References

1. "Product Information. Afinitor (everolimus)." Novartis Pharmaceuticals (2009):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.